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She has won several regional Emmy awards, a regional and a national Edward R. Murrow award. The Association for Health Journalists awarded Lesley best beat coverage. The Society of Professional Journalists has recognized her reporting several times. The Society of Environmental Journalists spotlighted her ongoing coverage of California's historic drought. \u003c/span>\u003cspan style=\"font-weight: 400;\">Before joining KQED in 2016, she covered food and sustainability for Capital Public Radio, the environment for Colorado Public Radio, and reported for both KUOW and KCTS9 in Seattle. \u003c/span>\u003cspan style=\"font-weight: 400;\">When not hunched over her laptop Lesley enjoys skiing with her toddler, surfing with her husband or scheming their next globetrotting adventure. Before motherhood she relished dancing tango till sunrise. When on deadline she fuels herself almost exclusively on chocolate chips.\u003c/span>\r\n\r\n\u003cspan style=\"font-weight: 400;\"> \u003c/span>","avatar":"https://secure.gravatar.com/avatar/3fb78e873af3312f34d0bc1d60a07c7f?s=600&d=blank&r=g","twitter":"lesleywmcclurg","facebook":null,"instagram":null,"linkedin":null,"sites":[{"site":"arts","roles":["author"]},{"site":"news","roles":["editor"]},{"site":"futureofyou","roles":["editor"]},{"site":"stateofhealth","roles":["author"]},{"site":"science","roles":["editor"]}],"headData":{"title":"Lesley McClurg | KQED","description":"KQED Health Correspondent","ogImgSrc":"https://secure.gravatar.com/avatar/3fb78e873af3312f34d0bc1d60a07c7f?s=600&d=blank&r=g","twImgSrc":"https://secure.gravatar.com/avatar/3fb78e873af3312f34d0bc1d60a07c7f?s=600&d=blank&r=g"},"isLoading":false,"link":"/author/lesleymcclurg"}},"breakingNewsReducer":{},"campaignFinanceReducer":{},"firebase":{"requesting":{},"requested":{},"timestamps":{},"data":{},"ordered":{},"auth":{"isLoaded":false,"isEmpty":true},"authError":null,"profile":{"isLoaded":false,"isEmpty":true},"listeners":{"byId":{},"allIds":[]},"isInitializing":false,"errors":[]},"navBarReducer":{"navBarId":"news","fullView":true,"showPlayer":false},"navMenuReducer":{"menus":[{"key":"menu1","items":[{"name":"News","link":"/","type":"title"},{"name":"Politics","link":"/politics"},{"name":"Science","link":"/science"},{"name":"Education","link":"/educationnews"},{"name":"Housing","link":"/housing"},{"name":"Immigration","link":"/immigration"},{"name":"Criminal Justice","link":"/criminaljustice"},{"name":"Silicon Valley","link":"/siliconvalley"},{"name":"Forum","link":"/forum"},{"name":"The California Report","link":"/californiareport"}]},{"key":"menu2","items":[{"name":"Arts & Culture","link":"/arts","type":"title"},{"name":"Critics’ Picks","link":"/thedolist"},{"name":"Cultural Commentary","link":"/artscommentary"},{"name":"Food & Drink","link":"/food"},{"name":"Bay Area Hip-Hop","link":"/bayareahiphop"},{"name":"Rebel Girls","link":"/rebelgirls"},{"name":"Arts Video","link":"/artsvideos"}]},{"key":"menu3","items":[{"name":"Podcasts","link":"/podcasts","type":"title"},{"name":"Bay Curious","link":"/podcasts/baycurious"},{"name":"Rightnowish","link":"/podcasts/rightnowish"},{"name":"The Bay","link":"/podcasts/thebay"},{"name":"On Our Watch","link":"/podcasts/onourwatch"},{"name":"Mindshift","link":"/podcasts/mindshift"},{"name":"Consider This","link":"/podcasts/considerthis"},{"name":"Political Breakdown","link":"/podcasts/politicalbreakdown"}]},{"key":"menu4","items":[{"name":"Live Radio","link":"/radio","type":"title"},{"name":"TV","link":"/tv","type":"title"},{"name":"Events","link":"/events","type":"title"},{"name":"For Educators","link":"/education","type":"title"},{"name":"Support KQED","link":"/support","type":"title"},{"name":"About","link":"/about","type":"title"},{"name":"Help Center","link":"https://kqed-helpcenter.kqed.org/s","type":"title"}]}]},"pagesReducer":{},"postsReducer":{"stream_live":{"type":"live","id":"stream_live","audioUrl":"https://streams.kqed.org/kqedradio","title":"Live Stream","excerpt":"Live Stream information currently unavailable.","link":"/radio","featImg":"","label":{"name":"KQED Live","link":"/"}},"stream_kqedNewscast":{"type":"posts","id":"stream_kqedNewscast","audioUrl":"https://www.kqed.org/.stream/anon/radio/RDnews/newscast.mp3?_=1","title":"KQED Newscast","featImg":"","label":{"name":"88.5 FM","link":"/"}},"news_11980822":{"type":"posts","id":"news_11980822","meta":{"index":"posts_1591205157","site":"news","id":"11980822","score":null,"sort":[1711489146000]},"guestAuthors":[],"slug":"supreme-court-expected-to-preserve-access-to-abortion-medication-mifepristone","title":"Supreme Court Expected to Preserve Access to Abortion Medication Mifepristone","publishDate":1711489146,"format":"standard","headTitle":"Supreme Court Expected to Preserve Access to Abortion Medication Mifepristone | KQED","labelTerm":{"site":"news"},"content":"\u003cp>The \u003ca href=\"https://apnews.com/hub/us-supreme-court\">Supreme Court\u003c/a> on Tuesday seemed likely to preserve access to a medication that was used in \u003ca href=\"https://apnews.com/article/abortion-pills-mifepristone-supreme-court-27d18f91242eb08c4d805880ddb5bb60\">nearly two-thirds of all abortions\u003c/a> in the U.S. last year, in the court’s first abortion case since conservative justices \u003ca href=\"https://apnews.com/article/abortion-supreme-court-decision-854f60302f21c2c35129e58cf8d8a7b0\">overturned Roe v. Wade\u003c/a> two years ago.\u003c/p>\n\u003cp>In nearly 90 minutes of arguments, a consensus appeared to emerge that the abortion opponents who challenged the FDA’s approval of the medication, mifepristone, and subsequent actions to ease access to it lack the legal right or standing to sue.\u003c/p>\n\u003cp>Such a decision would leave in place the current rules that allow patients to receive the drug through the mail, without any need for an in-person visit with a doctor, and to take the medication to induce an abortion through 10 weeks of pregnancy. Should the court take the no-standing route, it would avoid the more politically sensitive aspects of the case.\u003c/p>\n\u003cp>The high court’s return to the abortion thicket is taking place in a political and regulatory landscape that was reshaped by its abortion decision in 2022 that led many Republican-led states to ban or severely restrict abortion.\u003c/p>\n\u003cp>Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, said the court should dismiss the case and make clear that anti-abortion doctors and organizations don’t “come within 100 miles” of having standing.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Even three justices who were in the majority to overturn Roe posed skeptical questions about standing to the lawyer for the abortion opponents. Justices Amy Coney Barrett, Neil Gorsuch and Brett Kavanaugh are former President Donald Trump’s three Supreme Court appointees.\u003c/p>\n\u003cp>Barrett, for example, seemed to doubt that the doctors identified by lawyer Erin Hawley could show that they were actually harmed by the FDA’s actions, one of the requirements for showing standing.\u003c/p>\n\u003cp>“The difficulty, to me, is that the affidavits do read more like conscience objections,” Barrett said.\u003c/p>\n\u003cp>Kavanaugh had only one question during the entire session and it too seemed to be focused on the technical issue of standing. He asked Prelogar to confirm that “under federal law, no doctors can be forced against their consciences to perform or assist in an abortion.”\u003c/p>\n\u003cp>[aside postID=\"news_11980696,news_11973441,news_11958412\" label=\"Related Stories\"]Abortion opponents are asking the justices to ratify \u003ca href=\"https://apnews.com/article/abortion-pill-restrictions-appeals-court-402be732d162af449c40ed1315cfb851\">a ruling\u003c/a> from a conservative federal appeals court that would limit access to mifepristone, one of two \u003ca href=\"https://apnews.com/article/mifepristone-supreme-court-abortion-d451e14148ffbe6ce4811b1a37651480\">drugs used in medication abortions\u003c/a>.\u003c/p>\n\u003cp>That ruling had immediate political consequences, and the outcome in the current case, expected by early summer, could affect races for Congress and the White House.\u003c/p>\n\u003cp>Another abortion case is already on the docket. Next month, the justices will hear arguments over whether \u003ca href=\"https://apnews.com/article/supreme-court-abortion-medical-emergencies-idaho-8ca89d7de0c1fa9256dcd27d1847e144\">a federal law on emergency treatment \u003c/a>at hospitals must include abortions, even in states that have otherwise banned them.\u003c/p>\n\u003cp>The scene outside the Supreme Court was lively Tuesday morning, with demonstrators occupying the streets surrounding the court and groups on both sides of the issue marching and chanting. The police also blocked traffic surrounding the court.\u003c/p>\n\u003cp>The practical consequences of a ruling for abortion opponents would be dramatic, including possibly halting the delivery of mifepristone through the mail and at large pharmacy chains and ending increasingly popular telehealth visits at which the drug can be prescribed.\u003c/p>\n\u003cp>President Joe Biden’s administration and drug manufacturers warn that such an outcome could also undermine the FDA’s drug approval process more widely by inviting judges to second-guess the agency’s scientific judgments. The Democratic administration and New York-based Danco Laboratories, which makes mifepristone, say that the \u003ca href=\"https://apnews.com/article/mifepristone-abortion-pill-supreme-court-1d2221251197a391c9bca833918e4554\">drug is among the safest\u003c/a> the FDA has ever approved.\u003c/p>\n\u003cp>Justice Ketanji Brown Jackson, a Biden appointee who joined the court just after the last abortion case, signaled her agreement with some of those arguments when she asked Jessica Ellsworth, Danco’s lawyer, whether she has concerns “about judges parsing medical and scientific studies.”\u003c/p>\n\u003cp>The abortion opponents argue that the FDA’s decisions in 2016 and 2021 to relax restrictions on getting the drug were unreasonable and, as Hawley wrote in her clients’ main legal brief, “jeopardize women’s health across the nation.” She argued Tuesday that she was asking the court to affirm a ruling that “merely restored long-standing and crucial protections under which millions of women used abortion drugs.” Her husband, Sen. Josh Hawley, R-Missouri, and one of their children were in the courtroom to watch her first arguments.\u003c/p>\n\u003cp>The mifepristone case began five months after the Supreme Court overturned Roe v. Wade. Abortion opponents initially won a sweeping ruling nearly a year ago from \u003ca href=\"https://apnews.com/article/texas-judge-matthew-kacsmaryk-abortion-pill-fda-75964b777ef09593a1ad948c6cfc0237\">U.S. District Judge Matthew Kacsmaryk\u003c/a>, a Trump nominee in Texas, which would have revoked the drug’s approval entirely. The 5th U.S. Circuit Court of Appeals left intact the FDA’s initial approval of mifepristone. However, it would reverse the changes that regulators made in 2016 and 2021, which eased some of the conditions for administering the drug.\u003c/p>\n\u003cp>The Supreme Court put the appeals court’s modified ruling on hold, then agreed to hear the case, though Justices Samuel Alito, the author of the decision overturning Roe, and Clarence Thomas would have allowed some restrictions to take effect while the case proceeded.\u003c/p>\n\u003cp>In arguments highly focused on technical legal issues, Alito and Thomas asked some of the few questions Tuesday on the substance of the case, including about sending mifepristone through the mail.\u003c/p>\n\u003cp>They referred to the Comstock Act, a rarely used, 151-year-old criminal law that has been revived by anti-abortion advocates seeking to block the delivery of mifepristone through the U.S. mail. Addressing Ellsworth, Thomas said the law is “fairly broad, and it specifically covers drugs such as yours.”\u003c/p>\n\u003cp>Even if the court doesn’t address the Comstock Act in its ruling, some abortion rights advocates fear that a future administration that favors abortion restrictions could invoke the law to roll back access to mifepristone.\u003c/p>\n\u003cp>Mifepristone is one of two drugs, along with misoprostol, used in medication abortions. Their numbers have been rising for years. More than 6 million people have used mifepristone since 2000. \u003ca href=\"https://apnews.com/article/mifepristone-supreme-court-abortion-d451e14148ffbe6ce4811b1a37651480\">Mifepristone\u003c/a> is taken first to dilate the cervix and block the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>Health care providers have said that if mifepristone is no longer available or is too hard to obtain, they would switch to using only misoprostol, which is somewhat less effective in ending pregnancies.\u003c/p>\n\n","blocks":[],"excerpt":"The Supreme Court seems likely to preserve access to a medication that was used in nearly two-thirds of all abortions in the U.S. last year, in the court’s first abortion case since conservative justices overturned Roe v. Wade two years ago.","status":"publish","parent":0,"modified":1711566453,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":26,"wordCount":1118},"headData":{"title":"Supreme Court Expected to Preserve Access to Abortion Medication Mifepristone | KQED","description":"The Supreme Court seems likely to preserve access to a medication that was used in nearly two-thirds of all abortions in the U.S. last year, in the court’s first abortion case since conservative justices overturned Roe v. Wade two years ago.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"sticky":false,"nprByline":"Mark Sherman \u003cbr> Associated Press","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/news/11980822/supreme-court-expected-to-preserve-access-to-abortion-medication-mifepristone","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The \u003ca href=\"https://apnews.com/hub/us-supreme-court\">Supreme Court\u003c/a> on Tuesday seemed likely to preserve access to a medication that was used in \u003ca href=\"https://apnews.com/article/abortion-pills-mifepristone-supreme-court-27d18f91242eb08c4d805880ddb5bb60\">nearly two-thirds of all abortions\u003c/a> in the U.S. last year, in the court’s first abortion case since conservative justices \u003ca href=\"https://apnews.com/article/abortion-supreme-court-decision-854f60302f21c2c35129e58cf8d8a7b0\">overturned Roe v. Wade\u003c/a> two years ago.\u003c/p>\n\u003cp>In nearly 90 minutes of arguments, a consensus appeared to emerge that the abortion opponents who challenged the FDA’s approval of the medication, mifepristone, and subsequent actions to ease access to it lack the legal right or standing to sue.\u003c/p>\n\u003cp>Such a decision would leave in place the current rules that allow patients to receive the drug through the mail, without any need for an in-person visit with a doctor, and to take the medication to induce an abortion through 10 weeks of pregnancy. Should the court take the no-standing route, it would avoid the more politically sensitive aspects of the case.\u003c/p>\n\u003cp>The high court’s return to the abortion thicket is taking place in a political and regulatory landscape that was reshaped by its abortion decision in 2022 that led many Republican-led states to ban or severely restrict abortion.\u003c/p>\n\u003cp>Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, said the court should dismiss the case and make clear that anti-abortion doctors and organizations don’t “come within 100 miles” of having standing.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Even three justices who were in the majority to overturn Roe posed skeptical questions about standing to the lawyer for the abortion opponents. Justices Amy Coney Barrett, Neil Gorsuch and Brett Kavanaugh are former President Donald Trump’s three Supreme Court appointees.\u003c/p>\n\u003cp>Barrett, for example, seemed to doubt that the doctors identified by lawyer Erin Hawley could show that they were actually harmed by the FDA’s actions, one of the requirements for showing standing.\u003c/p>\n\u003cp>“The difficulty, to me, is that the affidavits do read more like conscience objections,” Barrett said.\u003c/p>\n\u003cp>Kavanaugh had only one question during the entire session and it too seemed to be focused on the technical issue of standing. He asked Prelogar to confirm that “under federal law, no doctors can be forced against their consciences to perform or assist in an abortion.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"postid":"news_11980696,news_11973441,news_11958412","label":"Related Stories "},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Abortion opponents are asking the justices to ratify \u003ca href=\"https://apnews.com/article/abortion-pill-restrictions-appeals-court-402be732d162af449c40ed1315cfb851\">a ruling\u003c/a> from a conservative federal appeals court that would limit access to mifepristone, one of two \u003ca href=\"https://apnews.com/article/mifepristone-supreme-court-abortion-d451e14148ffbe6ce4811b1a37651480\">drugs used in medication abortions\u003c/a>.\u003c/p>\n\u003cp>That ruling had immediate political consequences, and the outcome in the current case, expected by early summer, could affect races for Congress and the White House.\u003c/p>\n\u003cp>Another abortion case is already on the docket. Next month, the justices will hear arguments over whether \u003ca href=\"https://apnews.com/article/supreme-court-abortion-medical-emergencies-idaho-8ca89d7de0c1fa9256dcd27d1847e144\">a federal law on emergency treatment \u003c/a>at hospitals must include abortions, even in states that have otherwise banned them.\u003c/p>\n\u003cp>The scene outside the Supreme Court was lively Tuesday morning, with demonstrators occupying the streets surrounding the court and groups on both sides of the issue marching and chanting. The police also blocked traffic surrounding the court.\u003c/p>\n\u003cp>The practical consequences of a ruling for abortion opponents would be dramatic, including possibly halting the delivery of mifepristone through the mail and at large pharmacy chains and ending increasingly popular telehealth visits at which the drug can be prescribed.\u003c/p>\n\u003cp>President Joe Biden’s administration and drug manufacturers warn that such an outcome could also undermine the FDA’s drug approval process more widely by inviting judges to second-guess the agency’s scientific judgments. The Democratic administration and New York-based Danco Laboratories, which makes mifepristone, say that the \u003ca href=\"https://apnews.com/article/mifepristone-abortion-pill-supreme-court-1d2221251197a391c9bca833918e4554\">drug is among the safest\u003c/a> the FDA has ever approved.\u003c/p>\n\u003cp>Justice Ketanji Brown Jackson, a Biden appointee who joined the court just after the last abortion case, signaled her agreement with some of those arguments when she asked Jessica Ellsworth, Danco’s lawyer, whether she has concerns “about judges parsing medical and scientific studies.”\u003c/p>\n\u003cp>The abortion opponents argue that the FDA’s decisions in 2016 and 2021 to relax restrictions on getting the drug were unreasonable and, as Hawley wrote in her clients’ main legal brief, “jeopardize women’s health across the nation.” She argued Tuesday that she was asking the court to affirm a ruling that “merely restored long-standing and crucial protections under which millions of women used abortion drugs.” Her husband, Sen. Josh Hawley, R-Missouri, and one of their children were in the courtroom to watch her first arguments.\u003c/p>\n\u003cp>The mifepristone case began five months after the Supreme Court overturned Roe v. Wade. Abortion opponents initially won a sweeping ruling nearly a year ago from \u003ca href=\"https://apnews.com/article/texas-judge-matthew-kacsmaryk-abortion-pill-fda-75964b777ef09593a1ad948c6cfc0237\">U.S. District Judge Matthew Kacsmaryk\u003c/a>, a Trump nominee in Texas, which would have revoked the drug’s approval entirely. The 5th U.S. Circuit Court of Appeals left intact the FDA’s initial approval of mifepristone. However, it would reverse the changes that regulators made in 2016 and 2021, which eased some of the conditions for administering the drug.\u003c/p>\n\u003cp>The Supreme Court put the appeals court’s modified ruling on hold, then agreed to hear the case, though Justices Samuel Alito, the author of the decision overturning Roe, and Clarence Thomas would have allowed some restrictions to take effect while the case proceeded.\u003c/p>\n\u003cp>In arguments highly focused on technical legal issues, Alito and Thomas asked some of the few questions Tuesday on the substance of the case, including about sending mifepristone through the mail.\u003c/p>\n\u003cp>They referred to the Comstock Act, a rarely used, 151-year-old criminal law that has been revived by anti-abortion advocates seeking to block the delivery of mifepristone through the U.S. mail. Addressing Ellsworth, Thomas said the law is “fairly broad, and it specifically covers drugs such as yours.”\u003c/p>\n\u003cp>Even if the court doesn’t address the Comstock Act in its ruling, some abortion rights advocates fear that a future administration that favors abortion restrictions could invoke the law to roll back access to mifepristone.\u003c/p>\n\u003cp>Mifepristone is one of two drugs, along with misoprostol, used in medication abortions. Their numbers have been rising for years. More than 6 million people have used mifepristone since 2000. \u003ca href=\"https://apnews.com/article/mifepristone-supreme-court-abortion-d451e14148ffbe6ce4811b1a37651480\">Mifepristone\u003c/a> is taken first to dilate the cervix and block the hormone progesterone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Health care providers have said that if mifepristone is no longer available or is too hard to obtain, they would switch to using only misoprostol, which is somewhat less effective in ending pregnancies.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11980822/supreme-court-expected-to-preserve-access-to-abortion-medication-mifepristone","authors":["byline_news_11980822"],"categories":["news_8"],"tags":["news_23790","news_20402","news_932"],"featImg":"news_11946812","label":"news"},"news_11961481":{"type":"posts","id":"news_11961481","meta":{"index":"posts_1591205157","site":"news","id":"11961481","score":null,"sort":[1694863850000]},"guestAuthors":[],"slug":"after-panel-finds-no-evidence-for-leading-drug-in-cold-meds-doctors-warn-other-remedies-also-lack-proven-effectiveness","title":"After Leading Decongestant Found Ineffective, Many Doctors Say 'Not Much' Works for Treating Common Cold","publishDate":1694863850,"format":"audio","headTitle":"After Leading Decongestant Found Ineffective, Many Doctors Say ‘Not Much’ Works for Treating Common Cold | KQED","labelTerm":{"site":"news"},"content":"\u003cp>When you stroll down the cold and flu aisle in a drugstore it’s easy to get lost in the dizzying array of products promising to clear sinus pressure, dry up sniffles and stop plaguing coughs. Some concoctions even offer it all in one magical pill. However, a government panel has found the evidence behind some of these claims is lackluster — and doctors say that could extend all the way down the aisle.\u003c/p>\n\u003cp>“There’s just not much that’s very effective for treating the common cold,” said Dr. Lauren Eggert, clinical assistant professor in the Pulmonary Allergy and Critical Care Division at Stanford University. “Most of the things out there — antihistamines, decongestants, cough medicines — none of them have a lot of evidence that they’re super effective at improving cough or common cold symptoms.”\u003c/p>\n\u003cp>[aside postID=science_1936021 hero='https://cdn.kqed.org/wp-content/uploads/sites/35/2018/12/iStock-912854994-1180x787.jpg']This week the Food and Drug administration determined the country’s leading decongestant is really no better than a sugar pill. \u003ca href=\"https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine\">In a unanimous vote Tuesday\u003c/a>, advisers to the agency said the key drug, phenylephrine, found in Sudafed P.E., Mucinex Sinus Max, Dayquil and other oral medications is simply not effective. The review was prompted by \u003ca href=\"https://www.usatoday.com/story/money/business/2014/02/21/fda-overhauling-over-the-counter-regulations/5704165/\">inquiries dating back nearly a decade\u003c/a>. And experts warn the ineffectiveness is not limited to just that one drug. More reviews of over-the-counter drugs are expected.\u003c/p>\n\u003cp>Eggert pointed to the database \u003ca href=\"https://www.wolterskluwer.com/en/solutions/uptodate\">UpToDate\u003c/a>. Physicians use the resource when they want to see the summary of evidence for a group of medications. The conclusions for cold and flu remedies are disconcerting:\u003c/p>\n\u003cul>\n\u003cli>Antihistamines, vitamins and herbal remedies are deemed \u003cem>ineffective\u003c/em>.\u003c/li>\n\u003cli>Cough syrups, decongestants, expectorants, and zinc may have \u003cem>minimal or uncertain benefits\u003c/em>.\u003c/li>\n\u003cli>Nasal sprays and analgesics like Tylenol and ibuprofen \u003cem>may be effective\u003c/em>.\u003c/li>\n\u003c/ul>\n\u003cp>So, why are there so many cold and flu products on store shelves making big promises with little evidence to back them up?\u003c/p>\n\u003cp>The FDA’s \u003ca href=\"https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs#:~:text=An%20OTC%20drug%20monograph%20establishes,GRASE)%20for%20its%20intended%20use.\">over-the-counter drug list\u003c/a> has not been updated since 1995. And many of the drugs sold today were grandfathered during the ’60s and ’70s when scientific studies were much less rigorous.[pullquote align=\"right\" size=\"medium\" citation=\"Dr. Shalini Lynch, health sciences clinical professor, UCSF School of Pharmacy\"]‘You want to feel better instantly. But the reality is most cough and cold, viral types of upper respiratory infections, they just take time to go away.’[/pullquote]“Back in those days, statistics were not very developed,” said \u003ca href=\"https://pharmacy.ufl.edu/profile/hendeles-leslie/\">Dr. Leslie Hendeles\u003c/a>, PharmD, professor emeritus at the University of Florida in Gainesville, who was one of the petitioners who prompted this week’s FDA review. “The whole concept of clinical trials and study design was in its infancy.”\u003c/p>\n\u003cp>And since then the system for updating the drug list has traditionally taken many years or even decades, requiring multiple rounds of review and public comments.\u003c/p>\n\u003cp>The passage of \u003ca href=\"https://www.fda.gov/news-events/fda-voices/exciting-new-chapter-otc-drug-history-otc-monograph-reform-cares-act#:~:text=The%20beginning%20of%20an%20exciting,regulated%20in%20the%20United%20States.\">the 2020 CARES Act\u003c/a> should improve what’s available by streamlining the laborious process that may have allowed unchecked medications on the market. This week’s vote on phenylephrine, which was based on the latest scientific evidence, is the first test case for the law. But the FDA has not yet issued a final decision on whether the product will be removed from store shelves.\u003c/p>\n\u003cp>“The message here is that there are a lot of products on the market that fall into the same category as phenylephrine,” said Hendeles. “They’re not for diseases where people die or have to go to an emergency room. So they have not gotten the attention — even from the FDA — until now.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Hendeles believes regulators are likely to ultimately find that many other over-the-counter drugs are futile, too. “I know for sure that the cough suppressants and the expectorants are next in line.”\u003c/p>\n\u003cp>He points to a compilation of data he presented in \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/29669663/\">a 2018 paper\u003c/a> published in the journal Allergy and Asthma Proceedings, where he concluded the marketing claims on products designed for respiratory symptoms are overblown. And the evidence for decongestants, expectorants and cough suppressants does not “justify their use.”\u003c/p>\n\u003cp>Industry groups like the Consumer Healthcare Products Association maintain that phenylephrine has provided the public with clear health benefits for years. They asked the FDA not to remove it from a list of safe and effective over-the-counter drugs, arguing it provides the public with accessible treatment.\u003c/p>\n\u003cp>“Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. healthcare system, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications,” said Marcia Howard, the association’s vice president of regulatory and scientific affairs, \u003ca href=\"https://www.chpa.org/news/2023/09/statement-sept-11-12-2023-meeting-fda-ndac-evaluate-efficacy-oral-pe\">in a statement\u003c/a>.\u003c/p>\n\u003ch2>So, what can help your runny nose?\u003c/h2>\n\u003cp>Hendeles recommends steroidal nasal sprays for people suffering from allergies. Look for fluticasone (Flonase) or triamcinolone (Nascort). One squirt in each nostril. Evidence suggests Oxymetazoline Hydrochloride (Afrin or Sinex) is the best nasal spray for people who are sick with a respiratory illness.\u003c/p>\n\u003ch2>What about the rest of the meds lining your medicine cabinet?\u003c/h2>\n\u003cp>“If you’ve used something and you felt like it was helpful, I don’t think there’s a problem with that,” said Eggbert. “There’s little harm for people who are looking for relief. And I do believe in the placebo effect.”\u003c/p>\n\u003cp>But don’t look for a magical concoction. Single-ingredient products will help lower the possibility for side effects, according to Dr. Shalini Lynch, PharmD, health sciences clinical professor at UCSF’s School of Pharmacy. She says it should be obvious in a day or two if the product is relieving a desired symptom.\u003c/p>\n\u003cp>Science also supports some natural remedies. Saline nasal rinses may help clear your sinuses and \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/22869830/\">honey can quell your cough\u003c/a>. Additionally, it may be worth standing in a steamy shower or filling your humidifier to open your nasal passages. However, Lynch’s best advice is simply to lay low and hydrate.\u003c/p>\n\u003cp>“The common cold is something that pretty much needs to run its course,” she said. “You want to feel better instantly. But the reality is most cough and cold, viral types of upper respiratory infections, they just take time to go away.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":"A government panel this week announced that a leading decongestant, phenylephrine, was no more effective than a sugar pill. Doctors say it is not the only cold remedy that lacks evidence of effectiveness.","status":"publish","parent":0,"modified":1695326445,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":20,"wordCount":1109},"headData":{"title":"After Leading Decongestant Found Ineffective, Many Doctors Say 'Not Much' Works for Treating Common Cold | KQED","description":"A government panel this week announced that a leading decongestant, phenylephrine, was no more effective than a sugar pill. Doctors say it is not the only cold remedy that lacks evidence of effectiveness.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"audioUrl":"https://traffic.omny.fm/d/clips/0af137ef-751e-4b19-a055-aaef00d2d578/ffca7e9f-6831-4[…]f-aaef00f5a073/b5bb1deb-7528-4969-936c-b08301176d65/audio.mp3","excludeFromSiteSearch":"Include","articleAge":"0","path":"/news/11961481/after-panel-finds-no-evidence-for-leading-drug-in-cold-meds-doctors-warn-other-remedies-also-lack-proven-effectiveness","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>When you stroll down the cold and flu aisle in a drugstore it’s easy to get lost in the dizzying array of products promising to clear sinus pressure, dry up sniffles and stop plaguing coughs. Some concoctions even offer it all in one magical pill. However, a government panel has found the evidence behind some of these claims is lackluster — and doctors say that could extend all the way down the aisle.\u003c/p>\n\u003cp>“There’s just not much that’s very effective for treating the common cold,” said Dr. Lauren Eggert, clinical assistant professor in the Pulmonary Allergy and Critical Care Division at Stanford University. “Most of the things out there — antihistamines, decongestants, cough medicines — none of them have a lot of evidence that they’re super effective at improving cough or common cold symptoms.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"postid":"science_1936021","hero":"https://cdn.kqed.org/wp-content/uploads/sites/35/2018/12/iStock-912854994-1180x787.jpg","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>This week the Food and Drug administration determined the country’s leading decongestant is really no better than a sugar pill. \u003ca href=\"https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine\">In a unanimous vote Tuesday\u003c/a>, advisers to the agency said the key drug, phenylephrine, found in Sudafed P.E., Mucinex Sinus Max, Dayquil and other oral medications is simply not effective. The review was prompted by \u003ca href=\"https://www.usatoday.com/story/money/business/2014/02/21/fda-overhauling-over-the-counter-regulations/5704165/\">inquiries dating back nearly a decade\u003c/a>. And experts warn the ineffectiveness is not limited to just that one drug. More reviews of over-the-counter drugs are expected.\u003c/p>\n\u003cp>Eggert pointed to the database \u003ca href=\"https://www.wolterskluwer.com/en/solutions/uptodate\">UpToDate\u003c/a>. Physicians use the resource when they want to see the summary of evidence for a group of medications. The conclusions for cold and flu remedies are disconcerting:\u003c/p>\n\u003cul>\n\u003cli>Antihistamines, vitamins and herbal remedies are deemed \u003cem>ineffective\u003c/em>.\u003c/li>\n\u003cli>Cough syrups, decongestants, expectorants, and zinc may have \u003cem>minimal or uncertain benefits\u003c/em>.\u003c/li>\n\u003cli>Nasal sprays and analgesics like Tylenol and ibuprofen \u003cem>may be effective\u003c/em>.\u003c/li>\n\u003c/ul>\n\u003cp>So, why are there so many cold and flu products on store shelves making big promises with little evidence to back them up?\u003c/p>\n\u003cp>The FDA’s \u003ca href=\"https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs#:~:text=An%20OTC%20drug%20monograph%20establishes,GRASE)%20for%20its%20intended%20use.\">over-the-counter drug list\u003c/a> has not been updated since 1995. And many of the drugs sold today were grandfathered during the ’60s and ’70s when scientific studies were much less rigorous.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘You want to feel better instantly. But the reality is most cough and cold, viral types of upper respiratory infections, they just take time to go away.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Dr. Shalini Lynch, health sciences clinical professor, UCSF School of Pharmacy","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“Back in those days, statistics were not very developed,” said \u003ca href=\"https://pharmacy.ufl.edu/profile/hendeles-leslie/\">Dr. Leslie Hendeles\u003c/a>, PharmD, professor emeritus at the University of Florida in Gainesville, who was one of the petitioners who prompted this week’s FDA review. “The whole concept of clinical trials and study design was in its infancy.”\u003c/p>\n\u003cp>And since then the system for updating the drug list has traditionally taken many years or even decades, requiring multiple rounds of review and public comments.\u003c/p>\n\u003cp>The passage of \u003ca href=\"https://www.fda.gov/news-events/fda-voices/exciting-new-chapter-otc-drug-history-otc-monograph-reform-cares-act#:~:text=The%20beginning%20of%20an%20exciting,regulated%20in%20the%20United%20States.\">the 2020 CARES Act\u003c/a> should improve what’s available by streamlining the laborious process that may have allowed unchecked medications on the market. This week’s vote on phenylephrine, which was based on the latest scientific evidence, is the first test case for the law. But the FDA has not yet issued a final decision on whether the product will be removed from store shelves.\u003c/p>\n\u003cp>“The message here is that there are a lot of products on the market that fall into the same category as phenylephrine,” said Hendeles. “They’re not for diseases where people die or have to go to an emergency room. So they have not gotten the attention — even from the FDA — until now.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Hendeles believes regulators are likely to ultimately find that many other over-the-counter drugs are futile, too. “I know for sure that the cough suppressants and the expectorants are next in line.”\u003c/p>\n\u003cp>He points to a compilation of data he presented in \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/29669663/\">a 2018 paper\u003c/a> published in the journal Allergy and Asthma Proceedings, where he concluded the marketing claims on products designed for respiratory symptoms are overblown. And the evidence for decongestants, expectorants and cough suppressants does not “justify their use.”\u003c/p>\n\u003cp>Industry groups like the Consumer Healthcare Products Association maintain that phenylephrine has provided the public with clear health benefits for years. They asked the FDA not to remove it from a list of safe and effective over-the-counter drugs, arguing it provides the public with accessible treatment.\u003c/p>\n\u003cp>“Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. healthcare system, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications,” said Marcia Howard, the association’s vice president of regulatory and scientific affairs, \u003ca href=\"https://www.chpa.org/news/2023/09/statement-sept-11-12-2023-meeting-fda-ndac-evaluate-efficacy-oral-pe\">in a statement\u003c/a>.\u003c/p>\n\u003ch2>So, what can help your runny nose?\u003c/h2>\n\u003cp>Hendeles recommends steroidal nasal sprays for people suffering from allergies. Look for fluticasone (Flonase) or triamcinolone (Nascort). One squirt in each nostril. Evidence suggests Oxymetazoline Hydrochloride (Afrin or Sinex) is the best nasal spray for people who are sick with a respiratory illness.\u003c/p>\n\u003ch2>What about the rest of the meds lining your medicine cabinet?\u003c/h2>\n\u003cp>“If you’ve used something and you felt like it was helpful, I don’t think there’s a problem with that,” said Eggbert. “There’s little harm for people who are looking for relief. And I do believe in the placebo effect.”\u003c/p>\n\u003cp>But don’t look for a magical concoction. Single-ingredient products will help lower the possibility for side effects, according to Dr. Shalini Lynch, PharmD, health sciences clinical professor at UCSF’s School of Pharmacy. She says it should be obvious in a day or two if the product is relieving a desired symptom.\u003c/p>\n\u003cp>Science also supports some natural remedies. Saline nasal rinses may help clear your sinuses and \u003ca href=\"https://pubmed.ncbi.nlm.nih.gov/22869830/\">honey can quell your cough\u003c/a>. Additionally, it may be worth standing in a steamy shower or filling your humidifier to open your nasal passages. However, Lynch’s best advice is simply to lay low and hydrate.\u003c/p>\n\u003cp>“The common cold is something that pretty much needs to run its course,” she said. “You want to feel better instantly. But the reality is most cough and cold, viral types of upper respiratory infections, they just take time to go away.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11961481/after-panel-finds-no-evidence-for-leading-drug-in-cold-meds-doctors-warn-other-remedies-also-lack-proven-effectiveness","authors":["11229"],"categories":["news_8","news_356"],"tags":["news_33205","news_20402","news_22326","news_683","news_32295"],"featImg":"news_11961486","label":"news"},"news_11946802":{"type":"posts","id":"news_11946802","meta":{"index":"posts_1591205157","site":"news","id":"11946802","score":null,"sort":[1681592861000]},"guestAuthors":[],"slug":"with-supreme-court-decision-pending-california-braces-for-what-comes-next-in-abortion-pill-legal-saga","title":"With Supreme Court Decision Pending, California Braces for What Comes Next in Abortion Pill Legal Saga","publishDate":1681592861,"format":"standard","headTitle":"With Supreme Court Decision Pending, California Braces for What Comes Next in Abortion Pill Legal Saga | KQED","labelTerm":{"site":"news"},"content":"\u003cp>The Supreme Court issued an order Friday that temporarily stays any changes to federal rules for use of an abortion drug, while it takes time to more fully consider the issues raised in a court challenge.\u003c/p>\n\u003cp>The order, signed by Justice Samuel Alito, put a five-day pause on the fast-moving case so the justices can decide whether lower court rulings restricting the Food and Drug Administration’s approval of the drug, mifepristone, should be allowed to take effect in the short term.\u003c/p>\n\u003cp>The justices are being asked at this point only to determine what parts of an April 7 ruling by U.S. District Judge Matthew Kacsmaryk in Texas, as modified by \u003ca href=\"https://apnews.com/article/texas-abortion-pill-appeal-fe13d36218f1fb43590aff29b5ba4e9c\">an appellate ruling Wednesday\u003c/a>, can be enforced while the case continues. The order expires late Wednesday, suggesting the court will decide that issue by then.\u003c/p>\n\u003cp>The legal saga that has unfolded over mifepristone — one of two drugs commonly used for medication abortions in the U.S. — has caused concern in California, where access to abortion is\u003ca href=\"https://www.kqed.org/news/11931183/californians-vote-to-protect-abortion-in-constitution\"> a constitutional right\u003c/a> under state law. Gov. Gavin Newsom announced last week the \u003ca href=\"https://www.kqed.org/news/11946207/california-strikes-deal-to-stockpile-abortion-pill-in-wake-of-texas-judge-ruling\">state would begin stockpiling abortion medications\u003c/a> in the event that restrictions come into effect. \u003ca href=\"https://www.gov.ca.gov/2023/04/07/governor-newsom-statement-on-texas-judge-restricting-access-to-medication-abortion/\">The governor reiterated that abortion is still legal and accessible\u003c/a> in California as “a fundamental freedom.”\u003c/p>\n\u003cp>In a statement to KQED on Friday, the California Department of Public Health said it was assessing the implications of recent rulings and evaluating various options on how to ensure access to reproductive services and medications, saying it was working with “multiple departments across the California Health and Human Services Agency to ensure that individuals in California are not adversely impacted by the recent court rulings regarding the use of Mifepristone.”\u003c/p>\n\u003cfigure id=\"attachment_11946807\" class=\"wp-caption alignright\" style=\"max-width: 1024px\">\u003cimg decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-11946807\" src=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495.jpg\" alt='An African American woman with short hair speaks into a microphone surrounded by people holding signs that say \"Abortion Is Health Care\"' width=\"1024\" height=\"683\" srcset=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495-800x534.jpg 800w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495-1020x680.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495-160x107.jpg 160w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003cfigcaption class=\"wp-caption-text\">Rep. Barbara Lee (D-Calif.) speaks at a news conference to reintroduce the Abortion Is Health Care Everywhere Act outside the US Capitol on March 23, 2023, in Washington, DC. The bill authorizes the use of certain foreign assistance funds to provide comprehensive reproductive health care services in developing countries, including abortion services, training and equipment. \u003ccite>(Tasos Katopodis/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>U.S. Rep. Barbara Lee (D-Calif.), who is co-chair of the Pro-Choice Caucus, said that while Alito’s decision Friday meant that mifepristone is still accessible, she warned that this access is still “under threat” pending the high court’s decision, and urged continued vigilance.\u003c/p>\n\u003cp>“I think we need to realize that this is another step toward Republicans trying to put into law a national ban on abortion,” said Lee in an interview with KQED. “My constituents are saying they’re worried, because some of these broad, really backwards types of decisions could turn the clock back on scientifically approved drugs nationwide.”\u003c/p>\n\u003cp>The East Bay Congressmember added that she and her colleagues were prepared to act if legislation was needed to strengthen the FDA’s authority and prevent court decisions from undermining that authority, warning of the implications such decisions may have down the line.\u003c/p>\n\u003cp>“[The] FDA approves the safety and efficacy of drugs for all types of medical conditions, including Alzheimer’s,” Lee said. “So what does this say about a process that could hinder other kinds of scientific research for other types of medical conditions? That is very dangerous and people are concerned about that, in terms of the precedent setting with these decisions.”\u003c/p>\n\u003cp>The Supreme Court finds itself immersed in a new fight involving abortion less than a year after\u003ca href=\"https://apnews.com/article/abortion-supreme-court-decision-854f60302f21c2c35129e58cf8d8a7b0\"> conservative justices reversed Roe v. Wade\u003c/a> and allowed more than a dozen states to effectively ban abortion outright.\u003c/p>\n\u003cp>President Joe Biden’s administration and New York-based Danco Laboratories, maker of the pill, asked the justices to intervene.\u003c/p>\n\u003cp>White House Press Secretary Karine Jean-Pierre said in a statement Friday evening that the administration continues “to stand by FDA’s evidence-based approval of mifepristone, and we will continue to support the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.”[pullquote align=\"right\" size=\"medium\" citation=\"Rep. Barbara Lee (D-Calif.)\"]‘I think we need to realize that this is another step toward Republicans trying to put into law a national ban on abortion.’[/pullquote]She added, “The stakes of this fight could not be higher in the face of ongoing attacks on women’s health, and we will continue to fight to restore the protections of Roe v. Wade.”\u003c/p>\n\u003cp>A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the court’s action Friday was “standard operating procedure” and urged the justices to allow the appeals court-ordered changes to take effect by the middle of next week.\u003c/p>\n\u003cp>The type of order issued by the court Friday, an administrative stay, ordinarily is not an indication of what the justices will do going forward. It was signed by Alito because he handles emergency filings from Texas. Alito also is the author of last year’s opinion overturning Roe v. Wade.\u003c/p>\n\u003cp>The Justice Department and Danco both warned of “regulatory chaos” and harm to women if the high court doesn’t block the lower-court rulings that had the effect of tightening FDA rules under which the drug, mifepristone, can be prescribed and dispensed.\u003c/p>\n\u003cfigure id=\"attachment_11946813\" class=\"wp-caption alignnone\" style=\"max-width: 1024px\">\u003cimg decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-11946813\" src=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353.jpg\" alt='Protesters march holding signs that read \"Abortion Is Health Care\" with the U.S. Capitol in the backdrop.' width=\"1024\" height=\"684\" srcset=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353-800x534.jpg 800w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353-1020x681.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353-160x107.jpg 160w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003cfigcaption class=\"wp-caption-text\">Demonstrators rally in support of abortion rights at the US Supreme Court in Washington, DC, April 15, 2023. \u003ccite>(Andrew Caballero-Reynolds/AFP via Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The new limits would have taken effect Saturday if the court hadn’t acted.\u003c/p>\n\u003cp>“This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling.\u003c/p>\n\u003cp>The Biden administration and Danco now want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.\u003c/p>\n\u003cp>The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved.[aside label=\"Related Stories\" postID=\"news_11946073,news_11946193,news_11938516\"]A ruling from the 5th U.S. Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor. It also would withdraw the Food and Drug Administration’s approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe through 10 weeks.\u003c/p>\n\u003cp>Still, the appeals court did not entirely withdraw FDA approval of mifepristone \u003ca href=\"https://apnews.com/article/abortion-telehealth-mifepristone-9ba8f3ce130fae246e1d87ce428b74a0\">while the fight over it continues\u003c/a>. The 5th Circuit narrowed an April 7 ruling by \u003ca href=\"https://apnews.com/article/texas-judge-matthew-kacsmaryk-abortion-pill-fda-75964b777ef09593a1ad948c6cfc0237\">U.S. District Judge Matthew Kacsmaryk\u003c/a>, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.\u003c/p>\n\u003cp>“To the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years,” Prelogar wrote.\u003c/p>\n\u003cp>Erin Hawley, lawyer for the challengers, said in a statement that the FDA has put politics ahead of health concerns in its actions on medication abortion.\u003c/p>\n\u003cp>“The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place,” said Hawley, senior counsel with Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.\u003c/p>\n\u003cp>Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market.\u003c/p>\n\u003cp>It’s unclear how the FDA can comply with court orders in both cases, a situation that Prelogar described Friday as untenable.\u003c/p>\n\u003cp>Health and Human Services Secretary Xavier Becerra, in a statement Friday night, said the April 7 ruling out of Texas poses “an existential threat to the FDA’s authority to review and approve a wide range of drugs. If it stands, no medicine approved by the FDA would be safe from these attacks.”[pullquote align=\"right\" size=\"medium\" citation=\"Elizabeth Prelogar, US solicitor general\"]‘[T]his is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years.’[/pullquote]Use of medication abortion jumped significantly after the FDA’s 2016 rule expansion, according to data gathered by the Guttmacher Institute, a research group that supports abortion rights. In 2017, medication abortion accounted for 39% percent of abortions, but by 2020 it had increased to become the most common method, accounting for 53% of all abortions.\u003c/p>\n\u003cp>Experts have said the use of medication abortion has increased since the court overturned Roe.\u003c/p>\n\u003cp>When the drug was initially approved, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences of the drug.\u003c/p>\n\u003cp>If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.\u003c/p>\n\u003cp>At the core of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.\u003c/p>\n\u003cp>Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely overturning the drug’s approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the U.S. The ruling late Wednesday overturned multiple decisions made by FDA regulators after years of scientific review.\u003c/p>\n\u003cp>Common side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhea. In rare cases, patients can experience excess bleeding that requires surgery to stop.\u003c/p>\n\u003cp>Still, in loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.”\u003c/p>\n\u003cp>More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one-tenth of 1% of women who took the drug.\u003c/p>\n\u003cp>\u003cem>This story includes reporting by Mark Sherman and Jessica Gresko of The Associated Press and by KQED’s Attila Pelit and Azul Dahlstrom-Eckman.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":"The Supreme Court temporarily keeps in place federal rules for the use of the abortion drug mifepristone while it takes time to more fully consider the issues raised in a court challenge, with a decision expected Wednesday, April 19, as California waits and prepares for what happens next.","status":"publish","parent":0,"modified":1681753479,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":38,"wordCount":1934},"headData":{"title":"With Supreme Court Decision Pending, California Braces for What Comes Next in Abortion Pill Legal Saga | KQED","description":"The Supreme Court temporarily keeps in place federal rules for the use of the abortion drug mifepristone while it takes time to more fully consider the issues raised in a court challenge, with a decision expected Wednesday, April 19, as California waits and prepares for what happens next.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"nprByline":"The Associated Press and KQED News Staff","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/news/11946802/with-supreme-court-decision-pending-california-braces-for-what-comes-next-in-abortion-pill-legal-saga","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Supreme Court issued an order Friday that temporarily stays any changes to federal rules for use of an abortion drug, while it takes time to more fully consider the issues raised in a court challenge.\u003c/p>\n\u003cp>The order, signed by Justice Samuel Alito, put a five-day pause on the fast-moving case so the justices can decide whether lower court rulings restricting the Food and Drug Administration’s approval of the drug, mifepristone, should be allowed to take effect in the short term.\u003c/p>\n\u003cp>The justices are being asked at this point only to determine what parts of an April 7 ruling by U.S. District Judge Matthew Kacsmaryk in Texas, as modified by \u003ca href=\"https://apnews.com/article/texas-abortion-pill-appeal-fe13d36218f1fb43590aff29b5ba4e9c\">an appellate ruling Wednesday\u003c/a>, can be enforced while the case continues. The order expires late Wednesday, suggesting the court will decide that issue by then.\u003c/p>\n\u003cp>The legal saga that has unfolded over mifepristone — one of two drugs commonly used for medication abortions in the U.S. — has caused concern in California, where access to abortion is\u003ca href=\"https://www.kqed.org/news/11931183/californians-vote-to-protect-abortion-in-constitution\"> a constitutional right\u003c/a> under state law. Gov. Gavin Newsom announced last week the \u003ca href=\"https://www.kqed.org/news/11946207/california-strikes-deal-to-stockpile-abortion-pill-in-wake-of-texas-judge-ruling\">state would begin stockpiling abortion medications\u003c/a> in the event that restrictions come into effect. \u003ca href=\"https://www.gov.ca.gov/2023/04/07/governor-newsom-statement-on-texas-judge-restricting-access-to-medication-abortion/\">The governor reiterated that abortion is still legal and accessible\u003c/a> in California as “a fundamental freedom.”\u003c/p>\n\u003cp>In a statement to KQED on Friday, the California Department of Public Health said it was assessing the implications of recent rulings and evaluating various options on how to ensure access to reproductive services and medications, saying it was working with “multiple departments across the California Health and Human Services Agency to ensure that individuals in California are not adversely impacted by the recent court rulings regarding the use of Mifepristone.”\u003c/p>\n\u003cfigure id=\"attachment_11946807\" class=\"wp-caption alignright\" style=\"max-width: 1024px\">\u003cimg decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-11946807\" src=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495.jpg\" alt='An African American woman with short hair speaks into a microphone surrounded by people holding signs that say \"Abortion Is Health Care\"' width=\"1024\" height=\"683\" srcset=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495-800x534.jpg 800w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495-1020x680.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1475601495-160x107.jpg 160w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003cfigcaption class=\"wp-caption-text\">Rep. Barbara Lee (D-Calif.) speaks at a news conference to reintroduce the Abortion Is Health Care Everywhere Act outside the US Capitol on March 23, 2023, in Washington, DC. The bill authorizes the use of certain foreign assistance funds to provide comprehensive reproductive health care services in developing countries, including abortion services, training and equipment. \u003ccite>(Tasos Katopodis/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>U.S. Rep. Barbara Lee (D-Calif.), who is co-chair of the Pro-Choice Caucus, said that while Alito’s decision Friday meant that mifepristone is still accessible, she warned that this access is still “under threat” pending the high court’s decision, and urged continued vigilance.\u003c/p>\n\u003cp>“I think we need to realize that this is another step toward Republicans trying to put into law a national ban on abortion,” said Lee in an interview with KQED. “My constituents are saying they’re worried, because some of these broad, really backwards types of decisions could turn the clock back on scientifically approved drugs nationwide.”\u003c/p>\n\u003cp>The East Bay Congressmember added that she and her colleagues were prepared to act if legislation was needed to strengthen the FDA’s authority and prevent court decisions from undermining that authority, warning of the implications such decisions may have down the line.\u003c/p>\n\u003cp>“[The] FDA approves the safety and efficacy of drugs for all types of medical conditions, including Alzheimer’s,” Lee said. “So what does this say about a process that could hinder other kinds of scientific research for other types of medical conditions? That is very dangerous and people are concerned about that, in terms of the precedent setting with these decisions.”\u003c/p>\n\u003cp>The Supreme Court finds itself immersed in a new fight involving abortion less than a year after\u003ca href=\"https://apnews.com/article/abortion-supreme-court-decision-854f60302f21c2c35129e58cf8d8a7b0\"> conservative justices reversed Roe v. Wade\u003c/a> and allowed more than a dozen states to effectively ban abortion outright.\u003c/p>\n\u003cp>President Joe Biden’s administration and New York-based Danco Laboratories, maker of the pill, asked the justices to intervene.\u003c/p>\n\u003cp>White House Press Secretary Karine Jean-Pierre said in a statement Friday evening that the administration continues “to stand by FDA’s evidence-based approval of mifepristone, and we will continue to support the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.”\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘I think we need to realize that this is another step toward Republicans trying to put into law a national ban on abortion.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Rep. Barbara Lee (D-Calif.)","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>She added, “The stakes of this fight could not be higher in the face of ongoing attacks on women’s health, and we will continue to fight to restore the protections of Roe v. Wade.”\u003c/p>\n\u003cp>A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the court’s action Friday was “standard operating procedure” and urged the justices to allow the appeals court-ordered changes to take effect by the middle of next week.\u003c/p>\n\u003cp>The type of order issued by the court Friday, an administrative stay, ordinarily is not an indication of what the justices will do going forward. It was signed by Alito because he handles emergency filings from Texas. Alito also is the author of last year’s opinion overturning Roe v. Wade.\u003c/p>\n\u003cp>The Justice Department and Danco both warned of “regulatory chaos” and harm to women if the high court doesn’t block the lower-court rulings that had the effect of tightening FDA rules under which the drug, mifepristone, can be prescribed and dispensed.\u003c/p>\n\u003cfigure id=\"attachment_11946813\" class=\"wp-caption alignnone\" style=\"max-width: 1024px\">\u003cimg decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-11946813\" src=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353.jpg\" alt='Protesters march holding signs that read \"Abortion Is Health Care\" with the U.S. Capitol in the backdrop.' width=\"1024\" height=\"684\" srcset=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353.jpg 1024w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353-800x534.jpg 800w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353-1020x681.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/GettyImages-1251856353-160x107.jpg 160w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003cfigcaption class=\"wp-caption-text\">Demonstrators rally in support of abortion rights at the US Supreme Court in Washington, DC, April 15, 2023. \u003ccite>(Andrew Caballero-Reynolds/AFP via Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The new limits would have taken effect Saturday if the court hadn’t acted.\u003c/p>\n\u003cp>“This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling.\u003c/p>\n\u003cp>The Biden administration and Danco now want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.\u003c/p>\n\u003cp>The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"label":"Related Stories ","postid":"news_11946073,news_11946193,news_11938516"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>A ruling from the 5th U.S. Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor. It also would withdraw the Food and Drug Administration’s approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe through 10 weeks.\u003c/p>\n\u003cp>Still, the appeals court did not entirely withdraw FDA approval of mifepristone \u003ca href=\"https://apnews.com/article/abortion-telehealth-mifepristone-9ba8f3ce130fae246e1d87ce428b74a0\">while the fight over it continues\u003c/a>. The 5th Circuit narrowed an April 7 ruling by \u003ca href=\"https://apnews.com/article/texas-judge-matthew-kacsmaryk-abortion-pill-fda-75964b777ef09593a1ad948c6cfc0237\">U.S. District Judge Matthew Kacsmaryk\u003c/a>, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.\u003c/p>\n\u003cp>“To the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years,” Prelogar wrote.\u003c/p>\n\u003cp>Erin Hawley, lawyer for the challengers, said in a statement that the FDA has put politics ahead of health concerns in its actions on medication abortion.\u003c/p>\n\u003cp>“The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place,” said Hawley, senior counsel with Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.\u003c/p>\n\u003cp>Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market.\u003c/p>\n\u003cp>It’s unclear how the FDA can comply with court orders in both cases, a situation that Prelogar described Friday as untenable.\u003c/p>\n\u003cp>Health and Human Services Secretary Xavier Becerra, in a statement Friday night, said the April 7 ruling out of Texas poses “an existential threat to the FDA’s authority to review and approve a wide range of drugs. If it stands, no medicine approved by the FDA would be safe from these attacks.”\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘[T]his is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Elizabeth Prelogar, US solicitor general","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Use of medication abortion jumped significantly after the FDA’s 2016 rule expansion, according to data gathered by the Guttmacher Institute, a research group that supports abortion rights. In 2017, medication abortion accounted for 39% percent of abortions, but by 2020 it had increased to become the most common method, accounting for 53% of all abortions.\u003c/p>\n\u003cp>Experts have said the use of medication abortion has increased since the court overturned Roe.\u003c/p>\n\u003cp>When the drug was initially approved, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences of the drug.\u003c/p>\n\u003cp>If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.\u003c/p>\n\u003cp>At the core of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.\u003c/p>\n\u003cp>Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely overturning the drug’s approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the U.S. The ruling late Wednesday overturned multiple decisions made by FDA regulators after years of scientific review.\u003c/p>\n\u003cp>Common side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhea. In rare cases, patients can experience excess bleeding that requires surgery to stop.\u003c/p>\n\u003cp>Still, in loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.”\u003c/p>\n\u003cp>More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one-tenth of 1% of women who took the drug.\u003c/p>\n\u003cp>\u003cem>This story includes reporting by Mark Sherman and Jessica Gresko of The Associated Press and by KQED’s Attila Pelit and Azul Dahlstrom-Eckman.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11946802/with-supreme-court-decision-pending-california-braces-for-what-comes-next-in-abortion-pill-legal-saga","authors":["byline_news_11946802"],"categories":["news_31795","news_457","news_6188","news_8","news_13","news_356"],"tags":["news_866","news_30251","news_23790","news_22880","news_22185","news_6456","news_20402","news_27626","news_25015","news_30394","news_32618","news_30743","news_31046","news_31059","news_932"],"featImg":"news_11946812","label":"news"},"news_11946073":{"type":"posts","id":"news_11946073","meta":{"index":"posts_1591205157","site":"news","id":"11946073","score":null,"sort":[1680987637000]},"guestAuthors":[],"slug":"texas-judge-halts-fda-approval-of-abortion-pill-mifepristone-newsom-slams-ruling","title":"Access to Abortion Pill in Limbo After Competing Rulings as Biden, Newsom Slam Texas Judge","publishDate":1680987637,"format":"standard","headTitle":"Access to Abortion Pill in Limbo After Competing Rulings as Biden, Newsom Slam Texas Judge | KQED","labelTerm":{"site":"news"},"content":"\u003cp>\u003cem>Updated 2 p.m. Saturday\u003c/em>\u003c/p>\n\u003cp>Access to the most commonly used method of abortion in the U.S. plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone, which has been widely available for more than 20 years.\u003c/p>\n\u003cp>For now, the drug that the Food and Drug Administration approved in 2000 remains at least immediately available in the wake of the separate rulings that were issued just minutes apart by federal judges in Texas and Washington.\u003c/p>\n\u003cp>U.S. District Judge Matthew Kacsmaryk, a Trump appointee and formerly an attorney for a religious liberty legal group with a long history of pushing conservative causes, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision was quickly followed by U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordering the opposite and directing U.S. authorities to not make any changes that would restrict access to the drug.\u003c/p>\n\u003cp>“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.\u003c/p>\n\u003cp>The extraordinary timing of the competing orders revealed the high stakes that surround the drug a year after the U.S. Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country. President Joe Biden said his administration would fight the Texas ruling.[pullquote align=\"right\" size=\"medium\" citation=\"Gov. Gavin Newsom\"]‘Today’s ruling, by an extremist judge pursuing a radical political agenda, ignores facts, science, and the law.’[/pullquote]“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden said. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”\u003c/p>\n\u003cp>Gov. Gavin Newsom’s office \u003ca href=\"https://www.gov.ca.gov/2023/04/07/governor-newsom-statement-on-texas-judge-restricting-access-to-medication-abortion/\">issued a statement Friday\u003c/a> condemning the decision by the “far-right federal judge.”\u003c/p>\n\u003cp>“Today’s ruling, by an extremist judge pursuing a radical political agenda, ignores facts, science, and the law — putting the health of millions of women and girls at risk,” said Newsom. “Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away.”\u003c/p>\n\u003cp>In \u003ca href=\"https://oag.ca.gov/news/press-releases/attorney-general-bonta-denounces-texas-court-decision-suspending-approval\">a press release Friday\u003c/a>, Attorney General Rob Bonta called the ruling in Texas “unconscionable” and “another chapter in a very dark period of American history,” saying, “I will continue doing everything in my power to ensure that our state remains a safe haven for all those seeking, supporting, and providing reproductive care,” and reminding Californians of their \u003ca href=\"https://oag.ca.gov/reprorights\">reproductive rights\u003c/a>.\u003c/p>\n\u003cp>U.S. Rep. Barbara Lee (CA-12), co-chair of the Pro-Choice Caucus, issued a \u003ca href=\"https://lee.house.gov/news/press-releases/congresswoman-barbara-lee-condemns-ruling-by-trump-appointed-judge-undermining-fda-approval-of-abortion-medication-\">press statement\u003c/a> in which she called the Texas judge’s decision part of a coordinated and decades-long attack on abortion rights in the country.[aside label=\"Related Stories\" postID=\"news_11945838,news_11938516,news_11943903\"]“If the Supreme Court upholds this extreme and dangerous ruling, it will be the greatest loss for abortion rights since the fall of Roe\u003cem> … \u003c/em>We can’t let that happen,” said Lee. “As Co-Chair of the Pro-Choice Caucus, I am working closely with our partners to respond to this egregious ruling and preserve access to mifepristone nationwide. People — not politicians — should have the freedom to make their own health care decisions, and we won’t stop fighting until they do.”\u003c/p>\n\u003cp>Senator Dianne Feinstein (D-Calif.) \u003ca href=\"https://www.feinstein.senate.gov/public/index.cfm/press-releases?id=76D1DECB-6B1E-4566-B674-8CF33B157D6A\">issued a statement Saturday\u003c/a> saying the ruling in Texas wasn’t about the “safety of the drug or protecting patients” but about “overriding the FDA’s processes and expertise to attack women’s reproductive rights.”\u003c/p>\n\u003cp>Abortion providers also slammed the Texas ruling, including Whole Woman’s Health, which operates six clinics in five states and said it would continue to dispense mifepristone in person and by mail over the next week as they review the rulings.\u003c/p>\n\u003cp>President and CEO Jodi Hicks of Planned Parenthood Affiliates of California said the ruling was in stark contrast to public opinion.\u003c/p>\n\u003cp>“Attacks on reproductive health care, including medication abortion, are all about power and control, and this is no different,” said Hicks in an interview with KQED. “This ruling will create additional barriers to care, and people will be hurt by this. But let’s be clear, despite this ruling and the efforts of extremists, abortion remains legal and accessible in California. Planned Parenthood in California will continue to support Californians and out-of-state patients seeking care they need here.”\u003c/p>\n\u003cp>In a statement Friday, American Medical Association President Dr. Jack Resneck Jr., said “the court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm.”\u003c/p>\n\u003cp>“By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians,” said Resneck. “Mifepristone has been studied extensively for over two decades and has been proven to be safe time and time again … We will continue to support access to evidence-based health care, including abortion medication, and oppose intrusions that undermine our patients’ health.”\u003c/p>\n\u003cp>The abortion drug has been widely used in the U.S. since 2000, and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.\u003c/p>\n\u003cp>Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.\u003c/p>\n\u003cp>The lawsuit in the Texas case was \u003ca href=\"https://apnews.com/article/abortion-us-food-and-drug-administration-donald-trump-texas-medication-bdd99c39613c71f62d10dfc2f2d1bf07\">filed by the Alliance Defending Freedom\u003c/a>, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.\u003c/p>\n\u003cp>Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.[pullquote align=\"right\" size=\"medium\" citation=\"Greer Donley, professor specializing in reproductive health care, University of Pittsburgh Law School\"]‘This has never happened before in history — it’s a huge deal … You have a federal judge who has zero scientific background second-guessing every scientific decision that the FDA made.’[/pullquote]Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s filing. Kacsmaryk essentially agreed with the plaintiffs on all of their major points, including that the FDA didn’t adequately review mifepristone’s safety.\u003c/p>\n\u003cp>“The Court does not second-guess FDA’s decision-making lightly.” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”\u003c/p>\n\u003cp>Mifepristone has been used by millions of women over the past 23 years, and complications from the drug occur at a lower rate than that seen with wisdom teeth removal, colonoscopies and other routine medical procedures, medical groups have recently noted.\u003c/p>\n\u003cp>Elsewhere, Kacsmaryk sided with plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part, by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.” The judge brushed aside FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a “natural process essential to perpetuating human life.”\u003c/p>\n\u003cp>His order also agreed with plaintiffs in invoking a controversial 19th-century law that anti-abortion groups are now trying to revive to block sending abortion medications through the mail. Originally passed in 1873 and named for an “anti-vice crusader,” the Comstock Act was used to prohibit the mailing of contraceptives, “lewd” writings and “instruments” that could be used in an abortion. The law was seldom invoked in the 50 years after Roe established a federal right to abortion.[pullquote align=\"right\" size=\"medium\" citation=\"President Joe Biden\"]‘If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.’[/pullquote]Kacsmaryk, though, agreed with plaintiffs that the law — as literally interpreted — prohibits mailing mifepristone.\u003c/p>\n\u003cp>His order, if upheld, would also dismantle a number of recent FDA actions intended to ease access to the drug.\u003c/p>\n\u003cp>In late 2021, the FDA — under the Biden administration — dropped a requirement that patients pick up the drug in person, opening the door to delivery by mail-order pharmacies. In January the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.\u003c/p>\n\u003cp>Anti-abortion groups, which are newly encouraged about their ability to further restrict abortion and prevail in court since last’s year’s reversal of Roe v. Wade, embraced the Texas ruling.\u003c/p>\n\u003cp>“The court’s decision today is a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicized approval of these dangerous drugs,” said March for Life President Jeanne Mancini.\u003c/p>\n\u003cp>Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.\u003c/p>\n\u003cp>“This has never happened before in history — it’s a huge deal,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School. “You have a federal judge who has zero scientific background second-guessing every scientific decision that the FDA made.”\u003c/p>\n\u003cp>Still, because of the contradictory nature of the rulings, Donley and other experts said there would be little immediate impact.\u003c/p>\n\u003cp>“In the short term, nothing’s going to change,” Donley said. “This is the time to be preparing for the fact that in a week, potentially, mifepristone becomes an unapproved drug in this country.”\u003c/p>\n\u003cp>\u003cem>This story includes reporting by Paul J. Weber, Matthew Perrone and Lindsay Whitehurst of The Associated Press and by Azul Dahlstrom-Eckman and Attila Pelit of KQED.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":"A federal judge in Texas has thrown into jeopardy the most common method of abortion in the US, ordering regulators to temporarily halt their approval of the drug mifepristone for abortion, while another federal judge ordered the opposite, directing US authorities not to make any changes that would restrict access to the drug.","status":"publish","parent":0,"modified":1681160437,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":36,"wordCount":1914},"headData":{"title":"Access to Abortion Pill in Limbo After Competing Rulings as Biden, Newsom Slam Texas Judge | KQED","description":"A federal judge in Texas has thrown into jeopardy the most common method of abortion in the US, ordering regulators to temporarily halt their approval of the drug mifepristone for abortion, while another federal judge ordered the opposite, directing US authorities not to make any changes that would restrict access to the drug.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"nprByline":"The Associated Press and KQED News Staff","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/news/11946073/texas-judge-halts-fda-approval-of-abortion-pill-mifepristone-newsom-slams-ruling","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cem>Updated 2 p.m. Saturday\u003c/em>\u003c/p>\n\u003cp>Access to the most commonly used method of abortion in the U.S. plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone, which has been widely available for more than 20 years.\u003c/p>\n\u003cp>For now, the drug that the Food and Drug Administration approved in 2000 remains at least immediately available in the wake of the separate rulings that were issued just minutes apart by federal judges in Texas and Washington.\u003c/p>\n\u003cp>U.S. District Judge Matthew Kacsmaryk, a Trump appointee and formerly an attorney for a religious liberty legal group with a long history of pushing conservative causes, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision was quickly followed by U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordering the opposite and directing U.S. authorities to not make any changes that would restrict access to the drug.\u003c/p>\n\u003cp>“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.\u003c/p>\n\u003cp>The extraordinary timing of the competing orders revealed the high stakes that surround the drug a year after the U.S. Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country. President Joe Biden said his administration would fight the Texas ruling.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘Today’s ruling, by an extremist judge pursuing a radical political agenda, ignores facts, science, and the law.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Gov. Gavin Newsom","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden said. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”\u003c/p>\n\u003cp>Gov. Gavin Newsom’s office \u003ca href=\"https://www.gov.ca.gov/2023/04/07/governor-newsom-statement-on-texas-judge-restricting-access-to-medication-abortion/\">issued a statement Friday\u003c/a> condemning the decision by the “far-right federal judge.”\u003c/p>\n\u003cp>“Today’s ruling, by an extremist judge pursuing a radical political agenda, ignores facts, science, and the law — putting the health of millions of women and girls at risk,” said Newsom. “Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away.”\u003c/p>\n\u003cp>In \u003ca href=\"https://oag.ca.gov/news/press-releases/attorney-general-bonta-denounces-texas-court-decision-suspending-approval\">a press release Friday\u003c/a>, Attorney General Rob Bonta called the ruling in Texas “unconscionable” and “another chapter in a very dark period of American history,” saying, “I will continue doing everything in my power to ensure that our state remains a safe haven for all those seeking, supporting, and providing reproductive care,” and reminding Californians of their \u003ca href=\"https://oag.ca.gov/reprorights\">reproductive rights\u003c/a>.\u003c/p>\n\u003cp>U.S. Rep. Barbara Lee (CA-12), co-chair of the Pro-Choice Caucus, issued a \u003ca href=\"https://lee.house.gov/news/press-releases/congresswoman-barbara-lee-condemns-ruling-by-trump-appointed-judge-undermining-fda-approval-of-abortion-medication-\">press statement\u003c/a> in which she called the Texas judge’s decision part of a coordinated and decades-long attack on abortion rights in the country.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"label":"Related Stories ","postid":"news_11945838,news_11938516,news_11943903"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“If the Supreme Court upholds this extreme and dangerous ruling, it will be the greatest loss for abortion rights since the fall of Roe\u003cem> … \u003c/em>We can’t let that happen,” said Lee. “As Co-Chair of the Pro-Choice Caucus, I am working closely with our partners to respond to this egregious ruling and preserve access to mifepristone nationwide. People — not politicians — should have the freedom to make their own health care decisions, and we won’t stop fighting until they do.”\u003c/p>\n\u003cp>Senator Dianne Feinstein (D-Calif.) \u003ca href=\"https://www.feinstein.senate.gov/public/index.cfm/press-releases?id=76D1DECB-6B1E-4566-B674-8CF33B157D6A\">issued a statement Saturday\u003c/a> saying the ruling in Texas wasn’t about the “safety of the drug or protecting patients” but about “overriding the FDA’s processes and expertise to attack women’s reproductive rights.”\u003c/p>\n\u003cp>Abortion providers also slammed the Texas ruling, including Whole Woman’s Health, which operates six clinics in five states and said it would continue to dispense mifepristone in person and by mail over the next week as they review the rulings.\u003c/p>\n\u003cp>President and CEO Jodi Hicks of Planned Parenthood Affiliates of California said the ruling was in stark contrast to public opinion.\u003c/p>\n\u003cp>“Attacks on reproductive health care, including medication abortion, are all about power and control, and this is no different,” said Hicks in an interview with KQED. “This ruling will create additional barriers to care, and people will be hurt by this. But let’s be clear, despite this ruling and the efforts of extremists, abortion remains legal and accessible in California. Planned Parenthood in California will continue to support Californians and out-of-state patients seeking care they need here.”\u003c/p>\n\u003cp>In a statement Friday, American Medical Association President Dr. Jack Resneck Jr., said “the court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm.”\u003c/p>\n\u003cp>“By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians,” said Resneck. “Mifepristone has been studied extensively for over two decades and has been proven to be safe time and time again … We will continue to support access to evidence-based health care, including abortion medication, and oppose intrusions that undermine our patients’ health.”\u003c/p>\n\u003cp>The abortion drug has been widely used in the U.S. since 2000, and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.\u003c/p>\n\u003cp>Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.\u003c/p>\n\u003cp>The lawsuit in the Texas case was \u003ca href=\"https://apnews.com/article/abortion-us-food-and-drug-administration-donald-trump-texas-medication-bdd99c39613c71f62d10dfc2f2d1bf07\">filed by the Alliance Defending Freedom\u003c/a>, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.\u003c/p>\n\u003cp>Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘This has never happened before in history — it’s a huge deal … You have a federal judge who has zero scientific background second-guessing every scientific decision that the FDA made.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Greer Donley, professor specializing in reproductive health care, University of Pittsburgh Law School","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s filing. Kacsmaryk essentially agreed with the plaintiffs on all of their major points, including that the FDA didn’t adequately review mifepristone’s safety.\u003c/p>\n\u003cp>“The Court does not second-guess FDA’s decision-making lightly.” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”\u003c/p>\n\u003cp>Mifepristone has been used by millions of women over the past 23 years, and complications from the drug occur at a lower rate than that seen with wisdom teeth removal, colonoscopies and other routine medical procedures, medical groups have recently noted.\u003c/p>\n\u003cp>Elsewhere, Kacsmaryk sided with plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part, by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.” The judge brushed aside FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a “natural process essential to perpetuating human life.”\u003c/p>\n\u003cp>His order also agreed with plaintiffs in invoking a controversial 19th-century law that anti-abortion groups are now trying to revive to block sending abortion medications through the mail. Originally passed in 1873 and named for an “anti-vice crusader,” the Comstock Act was used to prohibit the mailing of contraceptives, “lewd” writings and “instruments” that could be used in an abortion. The law was seldom invoked in the 50 years after Roe established a federal right to abortion.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"President Joe Biden","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Kacsmaryk, though, agreed with plaintiffs that the law — as literally interpreted — prohibits mailing mifepristone.\u003c/p>\n\u003cp>His order, if upheld, would also dismantle a number of recent FDA actions intended to ease access to the drug.\u003c/p>\n\u003cp>In late 2021, the FDA — under the Biden administration — dropped a requirement that patients pick up the drug in person, opening the door to delivery by mail-order pharmacies. In January the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.\u003c/p>\n\u003cp>Anti-abortion groups, which are newly encouraged about their ability to further restrict abortion and prevail in court since last’s year’s reversal of Roe v. Wade, embraced the Texas ruling.\u003c/p>\n\u003cp>“The court’s decision today is a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicized approval of these dangerous drugs,” said March for Life President Jeanne Mancini.\u003c/p>\n\u003cp>Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.\u003c/p>\n\u003cp>“This has never happened before in history — it’s a huge deal,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School. “You have a federal judge who has zero scientific background second-guessing every scientific decision that the FDA made.”\u003c/p>\n\u003cp>Still, because of the contradictory nature of the rulings, Donley and other experts said there would be little immediate impact.\u003c/p>\n\u003cp>“In the short term, nothing’s going to change,” Donley said. “This is the time to be preparing for the fact that in a week, potentially, mifepristone becomes an unapproved drug in this country.”\u003c/p>\n\u003cp>\u003cem>This story includes reporting by Paul J. Weber, Matthew Perrone and Lindsay Whitehurst of The Associated Press and by Azul Dahlstrom-Eckman and Attila Pelit of KQED.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11946073/texas-judge-halts-fda-approval-of-abortion-pill-mifepristone-newsom-slams-ruling","authors":["byline_news_11946073"],"categories":["news_457","news_6188","news_8"],"tags":["news_30251","news_22880","news_20402","news_25015","news_30394","news_32618"],"featImg":"news_11946079","label":"news"},"news_11945610":{"type":"posts","id":"news_11945610","meta":{"index":"posts_1591205157","site":"news","id":"11945610","score":null,"sort":[1680639724000]},"guestAuthors":[],"slug":"fda-approves-second-bivalent-covid-booster-shots-for-some-people","title":"FDA Will Approve Second Bivalent COVID Booster Shots For Some People","publishDate":1680639724,"format":"standard","headTitle":"FDA Will Approve Second Bivalent COVID Booster Shots For Some People | KQED","labelTerm":{},"content":"\u003cp>The Food and Drug Administration has decided to allow some people to get \u003ca href=\"https://www.kqed.org/news/11941531/when-can-i-get-a-second-bivalent-covid-booster-heres-what-we-know-right-now\">a second booster\u003c/a> with one of the COVID-19 vaccines that have been updated to target the omicron variant, NPR has learned.\u003c/p>\n\u003cp>The second shots will be limited to those age 65 and older who got their first shot of the \u003ca href=\"https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccine-boosters\">bivalent vaccine\u003c/a> made by Moderna or Pfizer-BioNTech at least four months ago, and to those with weakened immune systems who got one of those shots at least two months ago, according to a federal official who was not authorized to speak publicly.\u003c/p>\n\u003cp>The decision to authorize a second booster is expected to be officially announced within the next two weeks.\u003c/p>\n\u003cp>While demand for another shot may not be high, the opportunity for extra protection will be welcomed by some people who got their first shot with one of the bivalent boosters last year.\u003c/p>\n\u003cfigure id=\"attachment_11945640\" class=\"wp-caption aligncenter\" style=\"max-width: 1920px\">\u003cimg decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-11945640\" src=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut.jpg\" alt=\"A woman with long blond hair, wearing a white face mask, fills a syringe from a small, clear vile that contains a Pfizer booster.\" width=\"1920\" height=\"1311\" srcset=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-800x546.jpg 800w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-1020x696.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-160x109.jpg 160w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-1536x1049.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\">\u003cfigcaption class=\"wp-caption-text\">Safeway pharmacist Ashley McGee fills a syringe with the Pfizer COVID-19 booster vaccination at a vaccination booster shot clinic on October 01, 2021 in San Rafael, California. Now, the FDA has decided to allow some people to get a second booster with one of the COVID-19 vaccines that have been updated to target the omicron variant. \u003ccite>(Justin Sullivan/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The FDA has only authorized one booster dose of the newest formulations of the COVID vaccines. The agency was instead focusing on planning for an \u003ca href=\"https://www.npr.org/sections/health-shots/2023/01/23/1150032238/fda-considers-major-shift-in-covid-vaccine-strategy\">annual COVID booster campaign \u003c/a>starting in the fall of 2023 — with vaccines that will have been updated to target whichever variant is expected to be circulating next winter.\u003c/p>\n\u003cp>[pullquote size=\"medium\" align=\"right\" citation=\"Dr. Peter Hotez, co-director, Texas Children's Hospital Center for Vaccine Development\"]‘Those doses are going to be expiring and will be thrown out. So it makes sense to have those shots in arms instead of being tossed in the waste basket.’[/pullquote]\u003c/p>\n\u003cp>But the FDA has now reconsidered the situation. This change will bring the U.S. more in line with the approach taken by \u003ca href=\"https://commonslibrary.parliament.uk/research-briefings/cbp-9332/\">Britain\u003c/a> and \u003ca href=\"https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/vaccines-immunization/national-advisory-committee-immunization-summary-guidance-additional-covid-19-booster-dose-spring-2023-individuals-high-risk-severe-illness-due-covid-19-march-3-2023/summary.pdf\">Canada (PDF)\u003c/a>, which is what some vaccine specialists have been urging — especially with the ample of supply of vaccines available.\u003c/p>\n\u003cp>“Those doses are going to be expiring and will be thrown out. So it makes sense to have those shots in arms instead of being tossed in the waste basket,” says Dr. \u003ca href=\"https://www.bcm.edu/people-search/peter-hotez-23229\">Peter Hotez\u003c/a>, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine.\u003c/p>\n\u003cp>The main concern is that the protection people got from their last shot has been fading, not just against getting infected but also possibly against getting seriously ill. So Hotez says people as young as 50 should be able to get a second bivalent booster if they want one.\u003c/p>\n\u003cp>“It’s better than nothing,” Hotez wrote in an email to NPR about the FDA’s decision. “I think 65 could be lowered to 50 or 55 unless they have specific data that only supports that age cutoff.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>He added: “Historically, when you look at the monovalent vaccines, the protection starts to wane after four or five months. We don’t know if that’s the case with bivalent boosters. But you don’t want to find out the hard way.”\u003c/p>\n\u003cp>But others scientists aren’t so sure. They say there just isn’t any good evidence showing protection against serious illness has faded significantly or that getting another shot would help that much.[aside postID=news_11945498 hero='https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS64178_GettyImages-1322494493-qut-1020x681.jpg']“I have no data to show me that a second bivalent is safe and effective. I have every reason to think it might be. But I don’t actually have data,” says Dr. \u003ca href=\"https://www.mayo.edu/research/faculty/poland-gregory-a-m-d/bio-00078220\">Gregory Poland\u003c/a>, director of the Mayo Clinic’s Vaccine Research Group.\u003c/p>\n\u003cp>In addition, there’s a theoretical possibility that it could kind of backfire — because the bivalent boosters target a strain that’s already been replaced by a new one called XBB.1.5.\u003c/p>\n\u003cp>“The concern is that if we continue to give boosters against a virus that’s not circulating when we do see the next variant you may not develop a vigorous immune response to that new viral variant,” Poland says.\u003c/p>\n\u003cp>Since it was authorized in late August, less than \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-total\">17% of those eligible for the bivalent shot have opted for one\u003c/a>, and so the demand for another right now would probably be even lower. But some people would rush to get one if they could, including Katen Moore, 63, a nurse practitioner from North Plainfield, N.J.[pullquote size=\"medium\" align=\"right\" citation=\"Katen Moore, nurse practitioner\"]‘I just don’t want to get COVID again. I don’t really know what the long-term risks are. And I don’t really want to find out.’[/pullquote]“I just don’t want to get COVID again,” says Moore. “I don’t really know what the long-term risks are. And I don’t really want to find out. I don’t want the risk of long COVID. I don’t want the breathing problems. I don’t want the fatigue. I don’t want those things.”\u003c/p>\n\u003cp>Moore is frustrated that she’s just missing the age cutoff. “The lack of clear information for those of us at the edges is difficult to understand,” she wrote in an email to NPR.\u003c/p>\n\u003cp>Copyright 2023 NPR. To see more, visit \u003ca href=\"https://www.npr.org\">NPR.org\u003c/a>.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=FDA+will+let+some+adults+get+a+second+boost+of+the+bivalent+COVID-19+shot&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/p>\n\u003cp>\u003c/p>\n","blocks":[],"excerpt":"The Food and Drug Administration decided to allow a certain group of people to receive a second booster with one of the COVID-19 vaccines that have been updated to target the omicron variant.","status":"publish","parent":0,"modified":1680712079,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":966},"headData":{"title":"FDA Will Approve Second Bivalent COVID Booster Shots For Some People | KQED","description":"The Food and Drug Administration decided to allow a certain group of people to receive a second booster with one of the COVID-19 vaccines that have been updated to target the omicron variant.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"source":"NPR","sourceUrl":"https://www.npr.org/","nprImageCredit":"Scott Olson","nprByline":" \u003ca href=\"https://www.npr.org/people/146944972/rob-stein\">Rob Stein\u003c/a>","nprImageAgency":"Getty Images","nprStoryId":"1166629853","nprApiLink":"http://api.npr.org/query?id=1166629853&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/health-shots/2023/03/29/1166629853/the-fda-may-soon-authorize-a-spring-round-of-covid-19-boosters-for-some-people?ft=nprml&f=1166629853","nprRetrievedStory":"1","nprPubDate":"Tue, 04 Apr 2023 12:03:00 -0400","nprStoryDate":"Wed, 29 Mar 2023 12:16:00 -0400","nprLastModifiedDate":"Tue, 04 Apr 2023 12:03:04 -0400","nprAudio":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2023/03/20230329_me_spring_boosters.mp3?orgId=1&topicId=1128&d=238&story=1166629853&ft=nprml&f=1166629853","nprAudioM3u":"http://api.npr.org/m3u/11166788630-96fc6c.m3u?orgId=1&topicId=1128&d=238&story=1166629853&ft=nprml&f=1166629853","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/news/11945610/fda-approves-second-bivalent-covid-booster-shots-for-some-people","audioUrl":"https://ondemand.npr.org/anon.npr-mp3/npr/me/2023/03/20230329_me_spring_boosters.mp3?orgId=1&topicId=1128&d=238&story=1166629853&ft=nprml&f=1166629853","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration has decided to allow some people to get \u003ca href=\"https://www.kqed.org/news/11941531/when-can-i-get-a-second-bivalent-covid-booster-heres-what-we-know-right-now\">a second booster\u003c/a> with one of the COVID-19 vaccines that have been updated to target the omicron variant, NPR has learned.\u003c/p>\n\u003cp>The second shots will be limited to those age 65 and older who got their first shot of the \u003ca href=\"https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-bivalent-vaccine-boosters\">bivalent vaccine\u003c/a> made by Moderna or Pfizer-BioNTech at least four months ago, and to those with weakened immune systems who got one of those shots at least two months ago, according to a federal official who was not authorized to speak publicly.\u003c/p>\n\u003cp>The decision to authorize a second booster is expected to be officially announced within the next two weeks.\u003c/p>\n\u003cp>While demand for another shot may not be high, the opportunity for extra protection will be welcomed by some people who got their first shot with one of the bivalent boosters last year.\u003c/p>\n\u003cfigure id=\"attachment_11945640\" class=\"wp-caption aligncenter\" style=\"max-width: 1920px\">\u003cimg decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-11945640\" src=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut.jpg\" alt=\"A woman with long blond hair, wearing a white face mask, fills a syringe from a small, clear vile that contains a Pfizer booster.\" width=\"1920\" height=\"1311\" srcset=\"https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-800x546.jpg 800w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-1020x696.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-160x109.jpg 160w, https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS52115_GettyImages-1344323369-qut-1536x1049.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\">\u003cfigcaption class=\"wp-caption-text\">Safeway pharmacist Ashley McGee fills a syringe with the Pfizer COVID-19 booster vaccination at a vaccination booster shot clinic on October 01, 2021 in San Rafael, California. Now, the FDA has decided to allow some people to get a second booster with one of the COVID-19 vaccines that have been updated to target the omicron variant. \u003ccite>(Justin Sullivan/Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>The FDA has only authorized one booster dose of the newest formulations of the COVID vaccines. The agency was instead focusing on planning for an \u003ca href=\"https://www.npr.org/sections/health-shots/2023/01/23/1150032238/fda-considers-major-shift-in-covid-vaccine-strategy\">annual COVID booster campaign \u003c/a>starting in the fall of 2023 — with vaccines that will have been updated to target whichever variant is expected to be circulating next winter.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘Those doses are going to be expiring and will be thrown out. So it makes sense to have those shots in arms instead of being tossed in the waste basket.’","name":"pullquote","attributes":{"named":{"size":"medium","align":"right","citation":"Dr. Peter Hotez, co-director, Texas Children's Hospital Center for Vaccine Development","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But the FDA has now reconsidered the situation. This change will bring the U.S. more in line with the approach taken by \u003ca href=\"https://commonslibrary.parliament.uk/research-briefings/cbp-9332/\">Britain\u003c/a> and \u003ca href=\"https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/vaccines-immunization/national-advisory-committee-immunization-summary-guidance-additional-covid-19-booster-dose-spring-2023-individuals-high-risk-severe-illness-due-covid-19-march-3-2023/summary.pdf\">Canada (PDF)\u003c/a>, which is what some vaccine specialists have been urging — especially with the ample of supply of vaccines available.\u003c/p>\n\u003cp>“Those doses are going to be expiring and will be thrown out. So it makes sense to have those shots in arms instead of being tossed in the waste basket,” says Dr. \u003ca href=\"https://www.bcm.edu/people-search/peter-hotez-23229\">Peter Hotez\u003c/a>, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine.\u003c/p>\n\u003cp>The main concern is that the protection people got from their last shot has been fading, not just against getting infected but also possibly against getting seriously ill. So Hotez says people as young as 50 should be able to get a second bivalent booster if they want one.\u003c/p>\n\u003cp>“It’s better than nothing,” Hotez wrote in an email to NPR about the FDA’s decision. “I think 65 could be lowered to 50 or 55 unless they have specific data that only supports that age cutoff.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>He added: “Historically, when you look at the monovalent vaccines, the protection starts to wane after four or five months. We don’t know if that’s the case with bivalent boosters. But you don’t want to find out the hard way.”\u003c/p>\n\u003cp>But others scientists aren’t so sure. They say there just isn’t any good evidence showing protection against serious illness has faded significantly or that getting another shot would help that much.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"postid":"news_11945498","hero":"https://ww2.kqed.org/app/uploads/sites/10/2023/04/RS64178_GettyImages-1322494493-qut-1020x681.jpg","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“I have no data to show me that a second bivalent is safe and effective. I have every reason to think it might be. But I don’t actually have data,” says Dr. \u003ca href=\"https://www.mayo.edu/research/faculty/poland-gregory-a-m-d/bio-00078220\">Gregory Poland\u003c/a>, director of the Mayo Clinic’s Vaccine Research Group.\u003c/p>\n\u003cp>In addition, there’s a theoretical possibility that it could kind of backfire — because the bivalent boosters target a strain that’s already been replaced by a new one called XBB.1.5.\u003c/p>\n\u003cp>“The concern is that if we continue to give boosters against a virus that’s not circulating when we do see the next variant you may not develop a vigorous immune response to that new viral variant,” Poland says.\u003c/p>\n\u003cp>Since it was authorized in late August, less than \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-total\">17% of those eligible for the bivalent shot have opted for one\u003c/a>, and so the demand for another right now would probably be even lower. But some people would rush to get one if they could, including Katen Moore, 63, a nurse practitioner from North Plainfield, N.J.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘I just don’t want to get COVID again. I don’t really know what the long-term risks are. And I don’t really want to find out.’","name":"pullquote","attributes":{"named":{"size":"medium","align":"right","citation":"Katen Moore, nurse practitioner","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“I just don’t want to get COVID again,” says Moore. “I don’t really know what the long-term risks are. And I don’t really want to find out. I don’t want the risk of long COVID. I don’t want the breathing problems. I don’t want the fatigue. I don’t want those things.”\u003c/p>\n\u003cp>Moore is frustrated that she’s just missing the age cutoff. “The lack of clear information for those of us at the edges is difficult to understand,” she wrote in an email to NPR.\u003c/p>\n\u003cp>Copyright 2023 NPR. To see more, visit \u003ca href=\"https://www.npr.org\">NPR.org\u003c/a>.\u003cimg decoding=\"async\" src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=FDA+will+let+some+adults+get+a+second+boost+of+the+bivalent+COVID-19+shot&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/p>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11945610/fda-approves-second-bivalent-covid-booster-shots-for-some-people","authors":["byline_news_11945610"],"categories":["news_457","news_8"],"tags":["news_31854","news_26042","news_29058","news_29546","news_28801","news_27504","news_20402"],"featImg":"news_11945611","label":"source_news_11945610"},"news_11938916":{"type":"posts","id":"news_11938916","meta":{"index":"posts_1591205157","site":"news","id":"11938916","score":null,"sort":[1674512045000]},"guestAuthors":[],"slug":"fda-considers-major-shift-in-covid-vaccine-strategy","title":"FDA Considers Major Shift in COVID Vaccine Strategy","publishDate":1674512045,"format":"standard","headTitle":"NPR | KQED News","labelTerm":{"term":253,"site":"news"},"content":"\u003cp>The Food and Drug Administration is considering a major shift in the nation's COVID-19 vaccine strategy.\u003c/p>\n\u003cp>The goal is to simplify vaccination against COVID and perhaps adopt an approach similar to what is used for the flu vaccine, with annual updates to match whatever strain of the virus is circulating. This is according to a federal official who spoke under the condition of anonymity because they were not authorized to speak publicly.\u003c/p>\n\u003cp>NPR reported the proposed shift early Monday morning, and later Monday the FDA outlined it publicly in \u003ca href=\"https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement#event-materials\">a set of documents released\u003c/a> in advance of a meeting Thursday of the agency's \u003ca href=\"https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement\">Vaccine and Related Biological Products Advisory Committee\u003c/a> (VRBPAC). The committee will vote on the agency's proposal.\u003c/p>\n\u003cp>Currently, people who want to be fully vaccinated against COVID have to first get their primary vaccinations — two shots of the original vaccine spaced weeks apart. That's followed at least two months later by a booster, currently the bivalent shot that's tailored to protect against omicron.[aside label=\"Related Stories\" tag=\"coronavirus\"]Under the new approach, most people would be advised to simply get whatever the latest version of the vaccine is annually each fall like the flu vaccine. They wouldn't have to worry about how many shots they've already gotten and which one they got when. Those who still need to receive two doses initially, such as young children and older people, would use the same formulation for all three shots. Vaccine makers would update the annual shot through a process that would begin each spring to try a match the vaccine as closely as possible to whatever variant will likely be dominant in the coming winter. That's how the flu vaccine is formulated each year.\u003c/p>\n\u003cp>\"FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to engage VRBPAC in about early June of each year regarding strain selection for the fall season,\" the FDA wrote in its briefing document, adding that updated vaccines would be readied for use by September each year.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The agency notes that if a more dangerous COVID variant were to emerge, it might reconsider the vaccine strain at other times of the year on an \"as-needed and emergent basis.\"\u003c/p>\n\u003cp>Some immunologists and vaccine researchers say simplifying the process along the lines of the flu vaccine is appropriate at this point in the pandemic. However, many questions remain about emerging booster strategy.\u003c/p>\n\u003cp>\"As far as the tools that we have right now, I think it just makes the most sense to plan to update each year as close as we can to the currently circulating variant,\" says Deepta Bhattacharya, an immunologist at the University of Arizona. \"So I think all the things the FDA is considering make a lot of sense.\"\u003c/p>\n\u003ch2>Questions about efficacy of updated shots\u003c/h2>\n\u003cp>There's an intense debate about the wisdom of updating the COVID vaccines regularly to try to match new variants. Some researchers question whether that really makes the vaccines more effective. They also argue that the low demand for the latest booster shows the public has little appetite for continued boosting with the vaccines, even if they've been updated with new strains.\u003c/p>\n\u003cp>\"The public is voting with their arms if you will and said, 'No. I'm not going to get this. This doesn't make sense to us,'\" says Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic.\u003c/p>\n\u003cp>While endorsing continued boosters for those at high risk, such as the elderly, some question whether the current bivalent vaccines updated to target omicron have enhanced protection compared to the original vaccines. Most people are still well-protected against severe disease by the immunity they already have, they say.\u003c/p>\n\u003cp>\"We have no solid data about the performance of the bivalent boosters,\" says John Moore, an immunologist at Weill Cornell Medical College. \"The hard evidence is lacking, and the evidence that is out there is at the very least inconclusive and to me trends towards saying the bivalent boosters were little if no better.\"\u003c/p>\n\u003cp>Moore and others argue that the virus is changing so fast that it's pointless to constantly try to match the vaccines to the latest variants.\u003c/p>\n\u003cp>\"We shouldn't really be chasing these variants, which are evanescent and are often gone by the time you've created the vaccine,\" says Dr. Paul Offit of the University of Pennsylvania, one of the FDA's advisers.\u003c/p>\n\u003cp>Offit and others also question whether everyone will necessarily need to be boosted regularly, or just those at high risk, like the elderly.\u003c/p>\n\u003ch2>Arguments for alternate vaccine strategies\u003c/h2>\n\u003cp>Critics of the FDA's proposed new strategy argue that it would be better to invest in developing better vaccines that might be more appealing to people, and in campaigns to get more people vaccinated. Better vaccines could include those that could keep people from catching the virus in the first place not just from getting seriously ill — such as a nasal spray vaccine. Or perhaps vaccines that provide longer protection or are administered in pill form, to make them more acceptable to the needle-averse.\u003c/p>\n\u003cp>\"Particularly now when Congress is not allocating new funds for COVID response, we have to be especially judicious in how we spend our money and what would be most cost-effective,\" says Dr. Celine Gounder, a senior fellow at the Kaiser Family Foundation. \"It's unclear whether updating the booster formulations and repeatedly boosting people is the most effective approach to controlling COVID at this stage.\"\u003c/p>\n\u003cp>Another concern some researchers have is that the FDA continues to rely on antibody levels to test vaccine efficacy.\u003c/p>\n\u003cp>\"I think we need to raise the bar and require more evidence of clinical efficacy,\" says Dr. Eric Rubin, a professor of immunology and infectious diseases at Harvard who is also a member of the advisory committee. For instance, Rubin says the FDA should require proof the updated vaccines are actually reducing the risk of getting infected, getting sick, hospitalized and dying.\u003c/p>\n\u003cp>Others say updating the vaccines make sense to make sure people are as well-protected as possible while researchers continue to try to develop new vaccines.\u003c/p>\n\u003cp>\"Even if you don't have a booster that matches 100% what's circulating, you will have a booster that matches 75% to 80% to 90% of what's circulating,\" says David Martinez, an immunologist at the University of North Carolina, Chapel Hill. \"And that will be good enough. It would probably benefit most people.\"\u003c/p>\n\u003ch2>The FDA looks ahead to endemic COVID\u003c/h2>\n\u003cp>Some researchers think it's too soon to rely on annual boosters. COVID hasn't quite settled into a seasonal pattern like the flu, they note, and the SARS-CoV2 virus is changing more quickly than the flu virus. So people may need to be boosted more frequently, especially since protection against severe disease may only last about four to six months, they say.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"We're going to be reaching that pretty soon with the early adopters of the bivalent boosters, like myself,\" says Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital and dean of the National School of Tropical Medicine at Baylor College of Medicine. \"I don't know if an annual strategy is going to cut it.\"\u003c/p>\n\n","blocks":[],"excerpt":"The FDA is also considering making the shots interchangeable. That way people wouldn't have to worry about which brand they were getting. Again, the change is aimed at making COVID shots more like the flu shots.","status":"publish","parent":0,"modified":1674701108,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":25,"wordCount":1225},"headData":{"title":"FDA Considers Major Shift in COVID Vaccine Strategy | KQED","description":"The FDA is also considering making the shots interchangeable. That way people wouldn't have to worry about which brand they were getting. Again, the change is aimed at making COVID shots more like the flu shots.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"nprByline":"Rob Stein","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/news/11938916/fda-considers-major-shift-in-covid-vaccine-strategy","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration is considering a major shift in the nation's COVID-19 vaccine strategy.\u003c/p>\n\u003cp>The goal is to simplify vaccination against COVID and perhaps adopt an approach similar to what is used for the flu vaccine, with annual updates to match whatever strain of the virus is circulating. This is according to a federal official who spoke under the condition of anonymity because they were not authorized to speak publicly.\u003c/p>\n\u003cp>NPR reported the proposed shift early Monday morning, and later Monday the FDA outlined it publicly in \u003ca href=\"https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement#event-materials\">a set of documents released\u003c/a> in advance of a meeting Thursday of the agency's \u003ca href=\"https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement\">Vaccine and Related Biological Products Advisory Committee\u003c/a> (VRBPAC). The committee will vote on the agency's proposal.\u003c/p>\n\u003cp>Currently, people who want to be fully vaccinated against COVID have to first get their primary vaccinations — two shots of the original vaccine spaced weeks apart. That's followed at least two months later by a booster, currently the bivalent shot that's tailored to protect against omicron.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"label":"Related Stories ","tag":"coronavirus"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Under the new approach, most people would be advised to simply get whatever the latest version of the vaccine is annually each fall like the flu vaccine. They wouldn't have to worry about how many shots they've already gotten and which one they got when. Those who still need to receive two doses initially, such as young children and older people, would use the same formulation for all three shots. Vaccine makers would update the annual shot through a process that would begin each spring to try a match the vaccine as closely as possible to whatever variant will likely be dominant in the coming winter. That's how the flu vaccine is formulated each year.\u003c/p>\n\u003cp>\"FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to engage VRBPAC in about early June of each year regarding strain selection for the fall season,\" the FDA wrote in its briefing document, adding that updated vaccines would be readied for use by September each year.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The agency notes that if a more dangerous COVID variant were to emerge, it might reconsider the vaccine strain at other times of the year on an \"as-needed and emergent basis.\"\u003c/p>\n\u003cp>Some immunologists and vaccine researchers say simplifying the process along the lines of the flu vaccine is appropriate at this point in the pandemic. However, many questions remain about emerging booster strategy.\u003c/p>\n\u003cp>\"As far as the tools that we have right now, I think it just makes the most sense to plan to update each year as close as we can to the currently circulating variant,\" says Deepta Bhattacharya, an immunologist at the University of Arizona. \"So I think all the things the FDA is considering make a lot of sense.\"\u003c/p>\n\u003ch2>Questions about efficacy of updated shots\u003c/h2>\n\u003cp>There's an intense debate about the wisdom of updating the COVID vaccines regularly to try to match new variants. Some researchers question whether that really makes the vaccines more effective. They also argue that the low demand for the latest booster shows the public has little appetite for continued boosting with the vaccines, even if they've been updated with new strains.\u003c/p>\n\u003cp>\"The public is voting with their arms if you will and said, 'No. I'm not going to get this. This doesn't make sense to us,'\" says Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic.\u003c/p>\n\u003cp>While endorsing continued boosters for those at high risk, such as the elderly, some question whether the current bivalent vaccines updated to target omicron have enhanced protection compared to the original vaccines. Most people are still well-protected against severe disease by the immunity they already have, they say.\u003c/p>\n\u003cp>\"We have no solid data about the performance of the bivalent boosters,\" says John Moore, an immunologist at Weill Cornell Medical College. \"The hard evidence is lacking, and the evidence that is out there is at the very least inconclusive and to me trends towards saying the bivalent boosters were little if no better.\"\u003c/p>\n\u003cp>Moore and others argue that the virus is changing so fast that it's pointless to constantly try to match the vaccines to the latest variants.\u003c/p>\n\u003cp>\"We shouldn't really be chasing these variants, which are evanescent and are often gone by the time you've created the vaccine,\" says Dr. Paul Offit of the University of Pennsylvania, one of the FDA's advisers.\u003c/p>\n\u003cp>Offit and others also question whether everyone will necessarily need to be boosted regularly, or just those at high risk, like the elderly.\u003c/p>\n\u003ch2>Arguments for alternate vaccine strategies\u003c/h2>\n\u003cp>Critics of the FDA's proposed new strategy argue that it would be better to invest in developing better vaccines that might be more appealing to people, and in campaigns to get more people vaccinated. Better vaccines could include those that could keep people from catching the virus in the first place not just from getting seriously ill — such as a nasal spray vaccine. Or perhaps vaccines that provide longer protection or are administered in pill form, to make them more acceptable to the needle-averse.\u003c/p>\n\u003cp>\"Particularly now when Congress is not allocating new funds for COVID response, we have to be especially judicious in how we spend our money and what would be most cost-effective,\" says Dr. Celine Gounder, a senior fellow at the Kaiser Family Foundation. \"It's unclear whether updating the booster formulations and repeatedly boosting people is the most effective approach to controlling COVID at this stage.\"\u003c/p>\n\u003cp>Another concern some researchers have is that the FDA continues to rely on antibody levels to test vaccine efficacy.\u003c/p>\n\u003cp>\"I think we need to raise the bar and require more evidence of clinical efficacy,\" says Dr. Eric Rubin, a professor of immunology and infectious diseases at Harvard who is also a member of the advisory committee. For instance, Rubin says the FDA should require proof the updated vaccines are actually reducing the risk of getting infected, getting sick, hospitalized and dying.\u003c/p>\n\u003cp>Others say updating the vaccines make sense to make sure people are as well-protected as possible while researchers continue to try to develop new vaccines.\u003c/p>\n\u003cp>\"Even if you don't have a booster that matches 100% what's circulating, you will have a booster that matches 75% to 80% to 90% of what's circulating,\" says David Martinez, an immunologist at the University of North Carolina, Chapel Hill. \"And that will be good enough. It would probably benefit most people.\"\u003c/p>\n\u003ch2>The FDA looks ahead to endemic COVID\u003c/h2>\n\u003cp>Some researchers think it's too soon to rely on annual boosters. COVID hasn't quite settled into a seasonal pattern like the flu, they note, and the SARS-CoV2 virus is changing more quickly than the flu virus. So people may need to be boosted more frequently, especially since protection against severe disease may only last about four to six months, they say.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"We're going to be reaching that pretty soon with the early adopters of the bivalent boosters, like myself,\" says Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital and dean of the National School of Tropical Medicine at Baylor College of Medicine. \"I don't know if an annual strategy is going to cut it.\"\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11938916/fda-considers-major-shift-in-covid-vaccine-strategy","authors":["byline_news_11938916"],"categories":["news_457","news_8","news_356"],"tags":["news_27350","news_29058","news_30140","news_20402"],"affiliates":["news_253"],"featImg":"news_11938918","label":"news_253"},"news_11923913":{"type":"posts","id":"news_11923913","meta":{"index":"posts_1591205157","site":"news","id":"11923913","score":null,"sort":[1661725807000]},"guestAuthors":[],"slug":"coronavirus-faq-does-a-faint-line-on-a-self-test-mean-im-barely-contagious","title":"Coronavirus FAQ: Does a Faint Line on a Self-Test Mean I'm Barely Contagious?","publishDate":1661725807,"format":"standard","headTitle":"KQED News","labelTerm":{},"content":"\u003cp>\u003cem>We regularly answer frequently asked questions about life during the coronavirus crisis. If you have a question you'd like us to consider for a future post, email us at \u003c/em>\u003ca href=\"mailto:goatsandsoda@npr.org\">\u003cem>goatsandsoda@npr.org\u003c/em>\u003c/a>\u003cem> with the subject line: \"Weekly Coronavirus Questions.\" See an archive of our FAQs \u003c/em>\u003ca href=\"https://www.npr.org/tags/926361810/coronavirus-faqs\">\u003cem>here\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cp>Ah, the start of a new school year. Maybe you're one of millions of Americans who have started mingling with peers in the dorms and suddenly find yourself sniffling and wondering if you have COVID-19.\u003c/p>\n\u003cp>Or you're just getting back from your summer vacation and the back of your throat has a worrisome itch.\u003c/p>\n\u003cp>You consider taking an at-home rapid test, but you have lots of questions. With new \u003ca href=\"https://www.npr.org/sections/goatsandsoda/2022/08/12/1117072918/coronavirus-faq-im-confused-by-the-new-testing-advice-do-it-once-twice-thrice\">FDA \u003c/a>recommendations on \u003ca href=\"https://www.npr.org/sections/goatsandsoda/2022/08/12/1117072918/coronavirus-faq-im-confused-by-the-new-testing-advice-do-it-once-twice-thrice\">testing, \u003c/a>how many times should you test for a definitive result? And, how infectious are you if the positive line is faint? And what if the test turns positive — but only after an hour?\u003c/p>\n\u003cp>We posed your questions to the experts: \u003ca href=\"https://profiles.stanford.edu/abraar-karan\">Dr. Abraar Karan\u003c/a>, infectious disease researcher at Stanford; \u003ca href=\"https://www.unige.ch/medecine/demed/en/groupes-de-recherche/isabella-eckerle/\">Meriem Bekliz\u003c/a>, virologist at the University of Geneva; and \u003ca href=\"https://www.uofmhealth.org/profile/922/preeti-n-malani-md\">Dr. Preeti Malani\u003c/a>, professor of medicine at the University of Michigan. Here's the scoop:\u003c/p>\n\u003cp>\u003cstrong>So I caught COVID-19 and after 10 days I'm still testing positive. But the line on my rapid test is \u003c/strong>\u003cstrong>\u003cem>really \u003c/em>\u003c/strong>\u003cstrong>faint now compared to a week ago. What's the deal? Exactly how contagious am I? \u003c/strong>\u003c/p>\n\u003cp>\"The faintness or darkness of the line probably has some correlation to degree of infectiousness especially early on [during the infection],\" says Karan.\u003c/p>\n\u003cp>So if the line is faint, that could mean your risk of accidentally passing the virus on to others is low.\u003c/p>\n\u003cp>\"Some people may not be infectious because the tests could be picking up viral debris from a waning infection,\" says Bekliz.\u003c/p>\n\u003cp>But don't rip off your mask just yet: There could be other reasons for a faint line.\u003c/p>\n\u003cp>There is \"some room for error\" with those rapid tests, Karan says. You're sticking a cotton swab up your nose and hoping to snare some virus. A faint line could mean you've collected less virus this time around. Maybe you swabbed for less time or in only one nostril when your test instructions say to swab both.\u003c/p>\n\u003cp>\"In general, a darker line is a result of more virus [on the swab],\" says Malani. \"But antigen tests are not especially sensitive, so even with a negative test, you can be contagious.\"\u003c/p>\n\u003cp>So the bottom line, say our experts: If you're testing positive – even with a faint line — you should behave as if you are contagious.\u003c/p>\n\u003cp>If there's any hint of a positive line, Bekliz recommends you continue to wear a mask, work from home if possible and generally limit contact with other people.\u003c/p>\n\u003cp>\u003cstrong>Last week I tested positive for COVID-19 and went through the recommended 5 days of isolation and additional 5 days of masking. How many times do I need to test negative before it's OK to assume I'm virus-free?\u003c/strong>\u003c/p>\n\u003cp>Figuring out when it's OK to ease up on your safety measures after catching COVID-19 can be tricky.\u003c/p>\n\u003cp>If you suspect that you may have COVID but haven't tested positive yet, the \u003ca href=\"https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication#:~:text=The%20U.S.%20Food%20and%20Drug,SARS%2DCoV%2D2%20virus%20to\">FDA now recommends serial testing\u003c/a>, which means you should repeat your home test after 48 hours to make sure you aren't accidentally getting a false negative test.\u003c/p>\n\u003cp>And what should you do if you already tested positive and want to know when you're finally negative?\u003c/p>\n\u003cp>\"The recommendations for serial testing are for people that have been exposed and are trying to diagnose themselves,\" says Karan. \"They're saying to repeat the test after a day or two, but not if your first test is already positive and you're testing to become negative.\"\u003c/p>\n\u003cp>Once you have tested positive and your body starts clearing the virus, a negative rapid test should be a pretty good indication you're no longer infectious, so long as you follow the test protocols correctly and wait an appropriate amount of time before testing.\u003c/p>\n\u003cp>\"If it's been like five days [since the onset of symptoms], and the test is negative, then I would feel good about that,\" says Karan. \"If the test is negative one or two days after symptoms start, then I would maybe think you didn't get a good sample and should test again.\"\u003c/p>\n\u003cp>While that's reassuring, there wasn't agreement among our experts about exactly what to do. While Karan says one negative test after an appropriate amount of time is good enough, Malani says you should take two just to be sure.\u003c/p>\n\u003cp>\"Usually you want a couple negative tests,\" says Malani. \"If you have two negative antigen tests, that's really helpful.\"\u003c/p>\n\u003cp>So that first negative test is likely a good sign, but taking an additional test 24 hours later is a great way to confirm the result and rule out errors in testing.\u003c/p>\n\u003cp>\u003cstrong>I was feeling a bit off and took a COVID-19 test. After 15 minutes it looked like the test was negative. But when I came back to check the test an hour later a positive line had appeared! Then I retested three times and they all came back negative. Does this mean I could have COVID-19?\u003c/strong>\u003c/p>\n\u003cp>This is a pretty unusual circumstance, our experts say, but one that could potentially indicate bad news.\u003c/p>\n\u003cp>\"The tests aren't really meant to be read an hour later,\" says Malani. \"But it would be a little bit concerning for someone who has symptoms and has their test turn positive later.\"\u003c/p>\n\u003cp>Each test kit has its own recommended timeframe for reading the test. \u003ca href=\"https://www.fda.gov/media/144574/download\">BinaxNOW\u003c/a> and \u003ca href=\"https://www.fda.gov/media/153924/download#:~:text=Firmly%20and%20slowly%20brush%20against,procedure%20for%20the%20other%20nostril.\">iHealth\u003c/a> kits say you should read the test after 15 minutes, but not after 30 minutes. \u003ca href=\"https://www.fda.gov/media/151215/download\">INDICAID test kits\u003c/a> say you should read the test after 20 minutes, but not after 25 minutes. Reading the test after the recommended time frame could lead to a false positive.\u003c/p>\n\u003cp>However, Karan agrees that \"it would be less likely to be a false positive if someone's having symptoms and we're at a time when there's a high amount of virus being spread.\"\u003c/p>\n\u003cp>Following the FDA recommendation to test at least twice and waiting 48 hours between tests can help determine your true COVID-19 status as well.\u003c/p>\n\u003cp>\"My advice would be to probably stay put and not expose anyone, and then perhaps repeat the test,\" Malani says. \"Now, if you're feeling great the next day and your test is negative, maybe it was nothing.\"\u003c/p>\n\u003cp>Or simply \"assume you're positive if you have symptoms,\" Karan says. \"Try to get a PCR test and retest again [at home] in the next few days. If the PCR test is negative, you're probably OK.\"\u003c/p>\n\u003cp>No matter the circumstances, if you're worried that you could have COVID-19, our experts think your best bet is to repeat your at-home test over a couple of days. So if you want to ace COVID Testing 101 this school year, just remember that two negative tests are better than one.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2022 NPR. To see more, visit https://www.npr.org.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Coronavirus+FAQ%3A+Does+a+faint+line+on+a+self-test+mean+I%27m+barely+contagious%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":"These days the world of at-home testing for COVID-19 is confusing. How often do I need to test to see if I'm really positive — or negative? Does a faint line mean I'm less contagious? ","status":"publish","parent":0,"modified":1661726036,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":35,"wordCount":1206},"headData":{"title":"Coronavirus FAQ: Does a Faint Line on a Self-Test Mean I'm Barely Contagious? | KQED","description":"These days the world of at-home testing for COVID-19 is confusing. How often do I need to test to see if I'm really positive — or negative? Does a faint line mean I'm less contagious? ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"11923913 https://ww2.kqed.org/news/?p=11923913","disqusUrl":"https://ww2.kqed.org/news/2022/08/28/coronavirus-faq-does-a-faint-line-on-a-self-test-mean-im-barely-contagious/","disqusTitle":"Coronavirus FAQ: Does a Faint Line on a Self-Test Mean I'm Barely Contagious?","source":"NPR","sourceUrl":"https://www.npr.org","nprImageCredit":"Justin Paget","nprByline":"Max Barnhart","nprImageAgency":"Getty Images","nprStoryId":"1119589358","nprApiLink":"http://api.npr.org/query?id=1119589358&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/sections/goatsandsoda/2022/08/26/1119589358/coronavirus-faq-does-a-faint-line-on-a-self-test-mean-im-barely-contagious?ft=nprml&f=1119589358","nprRetrievedStory":"1","nprPubDate":"Fri, 26 Aug 2022 12:26:00 -0400","nprStoryDate":"Fri, 26 Aug 2022 12:26:10 -0400","nprLastModifiedDate":"Fri, 26 Aug 2022 12:26:10 -0400","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","path":"/news/11923913/coronavirus-faq-does-a-faint-line-on-a-self-test-mean-im-barely-contagious","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cem>We regularly answer frequently asked questions about life during the coronavirus crisis. If you have a question you'd like us to consider for a future post, email us at \u003c/em>\u003ca href=\"mailto:goatsandsoda@npr.org\">\u003cem>goatsandsoda@npr.org\u003c/em>\u003c/a>\u003cem> with the subject line: \"Weekly Coronavirus Questions.\" See an archive of our FAQs \u003c/em>\u003ca href=\"https://www.npr.org/tags/926361810/coronavirus-faqs\">\u003cem>here\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cp>Ah, the start of a new school year. Maybe you're one of millions of Americans who have started mingling with peers in the dorms and suddenly find yourself sniffling and wondering if you have COVID-19.\u003c/p>\n\u003cp>Or you're just getting back from your summer vacation and the back of your throat has a worrisome itch.\u003c/p>\n\u003cp>You consider taking an at-home rapid test, but you have lots of questions. With new \u003ca href=\"https://www.npr.org/sections/goatsandsoda/2022/08/12/1117072918/coronavirus-faq-im-confused-by-the-new-testing-advice-do-it-once-twice-thrice\">FDA \u003c/a>recommendations on \u003ca href=\"https://www.npr.org/sections/goatsandsoda/2022/08/12/1117072918/coronavirus-faq-im-confused-by-the-new-testing-advice-do-it-once-twice-thrice\">testing, \u003c/a>how many times should you test for a definitive result? And, how infectious are you if the positive line is faint? And what if the test turns positive — but only after an hour?\u003c/p>\n\u003cp>We posed your questions to the experts: \u003ca href=\"https://profiles.stanford.edu/abraar-karan\">Dr. Abraar Karan\u003c/a>, infectious disease researcher at Stanford; \u003ca href=\"https://www.unige.ch/medecine/demed/en/groupes-de-recherche/isabella-eckerle/\">Meriem Bekliz\u003c/a>, virologist at the University of Geneva; and \u003ca href=\"https://www.uofmhealth.org/profile/922/preeti-n-malani-md\">Dr. Preeti Malani\u003c/a>, professor of medicine at the University of Michigan. Here's the scoop:\u003c/p>\n\u003cp>\u003cstrong>So I caught COVID-19 and after 10 days I'm still testing positive. But the line on my rapid test is \u003c/strong>\u003cstrong>\u003cem>really \u003c/em>\u003c/strong>\u003cstrong>faint now compared to a week ago. What's the deal? Exactly how contagious am I? \u003c/strong>\u003c/p>\n\u003cp>\"The faintness or darkness of the line probably has some correlation to degree of infectiousness especially early on [during the infection],\" says Karan.\u003c/p>\n\u003cp>So if the line is faint, that could mean your risk of accidentally passing the virus on to others is low.\u003c/p>\n\u003cp>\"Some people may not be infectious because the tests could be picking up viral debris from a waning infection,\" says Bekliz.\u003c/p>\n\u003cp>But don't rip off your mask just yet: There could be other reasons for a faint line.\u003c/p>\n\u003cp>There is \"some room for error\" with those rapid tests, Karan says. You're sticking a cotton swab up your nose and hoping to snare some virus. A faint line could mean you've collected less virus this time around. Maybe you swabbed for less time or in only one nostril when your test instructions say to swab both.\u003c/p>\n\u003cp>\"In general, a darker line is a result of more virus [on the swab],\" says Malani. \"But antigen tests are not especially sensitive, so even with a negative test, you can be contagious.\"\u003c/p>\n\u003cp>So the bottom line, say our experts: If you're testing positive – even with a faint line — you should behave as if you are contagious.\u003c/p>\n\u003cp>If there's any hint of a positive line, Bekliz recommends you continue to wear a mask, work from home if possible and generally limit contact with other people.\u003c/p>\n\u003cp>\u003cstrong>Last week I tested positive for COVID-19 and went through the recommended 5 days of isolation and additional 5 days of masking. How many times do I need to test negative before it's OK to assume I'm virus-free?\u003c/strong>\u003c/p>\n\u003cp>Figuring out when it's OK to ease up on your safety measures after catching COVID-19 can be tricky.\u003c/p>\n\u003cp>If you suspect that you may have COVID but haven't tested positive yet, the \u003ca href=\"https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication#:~:text=The%20U.S.%20Food%20and%20Drug,SARS%2DCoV%2D2%20virus%20to\">FDA now recommends serial testing\u003c/a>, which means you should repeat your home test after 48 hours to make sure you aren't accidentally getting a false negative test.\u003c/p>\n\u003cp>And what should you do if you already tested positive and want to know when you're finally negative?\u003c/p>\n\u003cp>\"The recommendations for serial testing are for people that have been exposed and are trying to diagnose themselves,\" says Karan. \"They're saying to repeat the test after a day or two, but not if your first test is already positive and you're testing to become negative.\"\u003c/p>\n\u003cp>Once you have tested positive and your body starts clearing the virus, a negative rapid test should be a pretty good indication you're no longer infectious, so long as you follow the test protocols correctly and wait an appropriate amount of time before testing.\u003c/p>\n\u003cp>\"If it's been like five days [since the onset of symptoms], and the test is negative, then I would feel good about that,\" says Karan. \"If the test is negative one or two days after symptoms start, then I would maybe think you didn't get a good sample and should test again.\"\u003c/p>\n\u003cp>While that's reassuring, there wasn't agreement among our experts about exactly what to do. While Karan says one negative test after an appropriate amount of time is good enough, Malani says you should take two just to be sure.\u003c/p>\n\u003cp>\"Usually you want a couple negative tests,\" says Malani. \"If you have two negative antigen tests, that's really helpful.\"\u003c/p>\n\u003cp>So that first negative test is likely a good sign, but taking an additional test 24 hours later is a great way to confirm the result and rule out errors in testing.\u003c/p>\n\u003cp>\u003cstrong>I was feeling a bit off and took a COVID-19 test. After 15 minutes it looked like the test was negative. But when I came back to check the test an hour later a positive line had appeared! Then I retested three times and they all came back negative. Does this mean I could have COVID-19?\u003c/strong>\u003c/p>\n\u003cp>This is a pretty unusual circumstance, our experts say, but one that could potentially indicate bad news.\u003c/p>\n\u003cp>\"The tests aren't really meant to be read an hour later,\" says Malani. \"But it would be a little bit concerning for someone who has symptoms and has their test turn positive later.\"\u003c/p>\n\u003cp>Each test kit has its own recommended timeframe for reading the test. \u003ca href=\"https://www.fda.gov/media/144574/download\">BinaxNOW\u003c/a> and \u003ca href=\"https://www.fda.gov/media/153924/download#:~:text=Firmly%20and%20slowly%20brush%20against,procedure%20for%20the%20other%20nostril.\">iHealth\u003c/a> kits say you should read the test after 15 minutes, but not after 30 minutes. \u003ca href=\"https://www.fda.gov/media/151215/download\">INDICAID test kits\u003c/a> say you should read the test after 20 minutes, but not after 25 minutes. Reading the test after the recommended time frame could lead to a false positive.\u003c/p>\n\u003cp>However, Karan agrees that \"it would be less likely to be a false positive if someone's having symptoms and we're at a time when there's a high amount of virus being spread.\"\u003c/p>\n\u003cp>Following the FDA recommendation to test at least twice and waiting 48 hours between tests can help determine your true COVID-19 status as well.\u003c/p>\n\u003cp>\"My advice would be to probably stay put and not expose anyone, and then perhaps repeat the test,\" Malani says. \"Now, if you're feeling great the next day and your test is negative, maybe it was nothing.\"\u003c/p>\n\u003cp>Or simply \"assume you're positive if you have symptoms,\" Karan says. \"Try to get a PCR test and retest again [at home] in the next few days. If the PCR test is negative, you're probably OK.\"\u003c/p>\n\u003cp>No matter the circumstances, if you're worried that you could have COVID-19, our experts think your best bet is to repeat your at-home test over a couple of days. So if you want to ace COVID Testing 101 this school year, just remember that two negative tests are better than one.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2022 NPR. To see more, visit https://www.npr.org.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Coronavirus+FAQ%3A+Does+a+faint+line+on+a+self-test+mean+I%27m+barely+contagious%3F&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11923913/coronavirus-faq-does-a-faint-line-on-a-self-test-mean-im-barely-contagious","authors":["byline_news_11923913"],"categories":["news_8"],"tags":["news_29122","news_20402","news_31523","news_31522"],"featImg":"news_11923914","label":"source_news_11923913"},"news_11917692":{"type":"posts","id":"news_11917692","meta":{"index":"posts_1591205157","site":"news","id":"11917692","score":null,"sort":[1656010727000]},"guestAuthors":[],"slug":"the-fda-orders-juul-to-pull-all-of-its-vaping-products-from-the-u-s-market","title":"The FDA Orders Juul to Pull All of its Vaping Products From the U.S. Market","publishDate":1656010727,"format":"standard","headTitle":"NPR | KQED News","labelTerm":{},"content":"\u003cp>The Food and Drug Administration has issued a marketing denial order to Juul, \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products\">telling the company to remove its e-cigarettes from the U.S. marketplace\u003c/a> — a decision that promises to shake up the vaping market.\u003c/p>\n\u003cp>The decision applies to \"all of their products currently marketed in the United States,\" the FDA said.\u003c/p>\n\u003cp>Citing the FDA's review of Juul, which accounts for a large portion of the U.S. e-cigarette market, \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products\">FDA Commissioner Robert M. Califf stated\u003c/a>, \"We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.\"\u003c/p>\n\u003cp>In response, a Juul representative said the company will fight the decision.\u003c/p>\n\u003cp>\"We respectfully disagree with the FDA's findings and decision,\" Joe Murillo, Juul Labs' chief regulatory officer, said in a statement sent to NPR.\u003c/p>\n\u003cp>\"We intend to seek a stay and are exploring all of our options under the FDA's regulations and the law,\" Murillo said, \"including appealing the decision and engaging with our regulator.\"\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003ch2>The FDA ruling sparks strong reactions from both sides\u003c/h2>\n\u003cp>The decision comes nearly two years after Juul \u003ca href=\"https://www.juullabs.com/juul-labs-submits-premarket-tobacco-product-application/\">submitted its application to the FDA\u003c/a>, hoping to continue selling its products.\u003c/p>\n\u003cp>News of the FDA's decision initially emerged in preliminary reports on Wednesday. It was welcomed by the advocacy group PAVe, or Parents Against Vaping e-cigarettes.\u003c/p>\n\u003cp>\"JUUL will finally be held accountable for creating the youth vaping epidemic, and igniting a new industry of highly-addictive flavored products that are harming millions of American kids,\" the group's founders, Meredith Berkman and Dorian Fuhrman, told NPR via email.\u003c/p>\n\u003cp>\"This is an enormous step in the right direction,\" they added.\u003c/p>\n\u003cp>But word of the decision incensed Amanda Wheeler, the president of the American Vapor Manufacturers Association.\u003c/p>\n\u003cp>Wheeler accused the FDA of waging a \"campaign of regulatory arson against the nicotine vaping products that millions of Americans rely on as an alternative to cigarettes.\" It was a sign, she said, of the FDA's \"staggering indifference to ordinary Americans and their right to switch\" to vaping.\u003c/p>\n\u003ch2>Vaping is seen as a potential aid for adults, and a risk for kids\u003c/h2>\n\u003cp>The FDA's denial could signal a dramatic shift in how regulators view e-cigarettes. Their supporters credit Juul and other vape companies with offering addicted smokers a less harmful alternative to cigarettes.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-issues-decisions-additional-e-cigarette-products\">The FDA itself acknowledges that potential\u003c/a>. In recent months, \u003ca href=\"https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders\">it has authorized other companies' vape devices and products\u003c/a> — but only after the agency became convinced the companies are doing enough to steer clear of youths.\u003c/p>\n\u003cp>In March, for instance, the FDA stated that in one case it reviewed, \"the likely benefit for adult smokers who significantly reduce their cigarette use ... outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.\"\u003c/p>\n\u003cp>But critics say the process of vaping highly addictive nicotine brings its own health risks — and they've accused Juul of targeting minors through its marketing practices and youth-friendly flavors. In recent years, the pushback prompted Juul to eliminate flavors such as mango and crème. \u003ca href=\"https://www.juul.com/discontinued-flavors\">It now sells just two variations\u003c/a>: tobacco and menthol.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-announces-plans-proposed-rule-reduce-addictiveness-cigarettes-and-other-combusted-tobacco\">According to the FDA\u003c/a>, nearly 10.7 million young people from 12-17 years old have used e-cigarettes or are open to trying them.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2022 NPR. To see more, visit \u003ca href=\"https://www.npr.org\">NPR.org\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=The+FDA+orders+Juul+to+pull+all+of+its+vaping+products+from+the+U.S.+market&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>\u003c/p>\n","blocks":[],"excerpt":"The company 'will finally be held accountable for creating the youth vaping epidemic,' the advocacy group Parents Against Vaping e-cigarettes told NPR. Juul said it plans to fight the decision.","status":"publish","parent":0,"modified":1656011316,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":571},"headData":{"title":"The FDA Orders Juul to Pull All of its Vaping Products From the U.S. Market | KQED","description":"The company 'will finally be held accountable for creating the youth vaping epidemic,' the advocacy group Parents Against Vaping e-cigarettes told NPR. Juul said it plans to fight the decision.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"11917692 https://ww2.kqed.org/news/?p=11917692","disqusUrl":"https://ww2.kqed.org/news/2022/06/23/the-fda-orders-juul-to-pull-all-of-its-vaping-products-from-the-u-s-market/","disqusTitle":"The FDA Orders Juul to Pull All of its Vaping Products From the U.S. Market","source":"NPR","sourceUrl":"https://www.npr.org/","nprImageCredit":"Justin Sullivan","nprByline":"Bill Chappell","nprImageAgency":"Getty Images","nprStoryId":"1106846310","nprApiLink":"http://api.npr.org/query?id=1106846310&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"https://www.npr.org/2022/06/23/1106846310/juul-fda-vaping-e-cigarettes?ft=nprml&f=1106846310","nprRetrievedStory":"1","nprPubDate":"Thu, 23 Jun 2022 13:21:00 -0400","nprStoryDate":"Thu, 23 Jun 2022 10:52:42 -0400","nprLastModifiedDate":"Thu, 23 Jun 2022 13:21:36 -0400","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","path":"/news/11917692/the-fda-orders-juul-to-pull-all-of-its-vaping-products-from-the-u-s-market","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration has issued a marketing denial order to Juul, \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products\">telling the company to remove its e-cigarettes from the U.S. marketplace\u003c/a> — a decision that promises to shake up the vaping market.\u003c/p>\n\u003cp>The decision applies to \"all of their products currently marketed in the United States,\" the FDA said.\u003c/p>\n\u003cp>Citing the FDA's review of Juul, which accounts for a large portion of the U.S. e-cigarette market, \u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products\">FDA Commissioner Robert M. Califf stated\u003c/a>, \"We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.\"\u003c/p>\n\u003cp>In response, a Juul representative said the company will fight the decision.\u003c/p>\n\u003cp>\"We respectfully disagree with the FDA's findings and decision,\" Joe Murillo, Juul Labs' chief regulatory officer, said in a statement sent to NPR.\u003c/p>\n\u003cp>\"We intend to seek a stay and are exploring all of our options under the FDA's regulations and the law,\" Murillo said, \"including appealing the decision and engaging with our regulator.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003ch2>The FDA ruling sparks strong reactions from both sides\u003c/h2>\n\u003cp>The decision comes nearly two years after Juul \u003ca href=\"https://www.juullabs.com/juul-labs-submits-premarket-tobacco-product-application/\">submitted its application to the FDA\u003c/a>, hoping to continue selling its products.\u003c/p>\n\u003cp>News of the FDA's decision initially emerged in preliminary reports on Wednesday. It was welcomed by the advocacy group PAVe, or Parents Against Vaping e-cigarettes.\u003c/p>\n\u003cp>\"JUUL will finally be held accountable for creating the youth vaping epidemic, and igniting a new industry of highly-addictive flavored products that are harming millions of American kids,\" the group's founders, Meredith Berkman and Dorian Fuhrman, told NPR via email.\u003c/p>\n\u003cp>\"This is an enormous step in the right direction,\" they added.\u003c/p>\n\u003cp>But word of the decision incensed Amanda Wheeler, the president of the American Vapor Manufacturers Association.\u003c/p>\n\u003cp>Wheeler accused the FDA of waging a \"campaign of regulatory arson against the nicotine vaping products that millions of Americans rely on as an alternative to cigarettes.\" It was a sign, she said, of the FDA's \"staggering indifference to ordinary Americans and their right to switch\" to vaping.\u003c/p>\n\u003ch2>Vaping is seen as a potential aid for adults, and a risk for kids\u003c/h2>\n\u003cp>The FDA's denial could signal a dramatic shift in how regulators view e-cigarettes. Their supporters credit Juul and other vape companies with offering addicted smokers a less harmful alternative to cigarettes.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-issues-decisions-additional-e-cigarette-products\">The FDA itself acknowledges that potential\u003c/a>. In recent months, \u003ca href=\"https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders\">it has authorized other companies' vape devices and products\u003c/a> — but only after the agency became convinced the companies are doing enough to steer clear of youths.\u003c/p>\n\u003cp>In March, for instance, the FDA stated that in one case it reviewed, \"the likely benefit for adult smokers who significantly reduce their cigarette use ... outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.\"\u003c/p>\n\u003cp>But critics say the process of vaping highly addictive nicotine brings its own health risks — and they've accused Juul of targeting minors through its marketing practices and youth-friendly flavors. In recent years, the pushback prompted Juul to eliminate flavors such as mango and crème. \u003ca href=\"https://www.juul.com/discontinued-flavors\">It now sells just two variations\u003c/a>: tobacco and menthol.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/news-events/press-announcements/fda-announces-plans-proposed-rule-reduce-addictiveness-cigarettes-and-other-combusted-tobacco\">According to the FDA\u003c/a>, nearly 10.7 million young people from 12-17 years old have used e-cigarettes or are open to trying them.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2022 NPR. To see more, visit \u003ca href=\"https://www.npr.org\">NPR.org\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=The+FDA+orders+Juul+to+pull+all+of+its+vaping+products+from+the+U.S.+market&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11917692/the-fda-orders-juul-to-pull-all-of-its-vaping-products-from-the-u-s-market","authors":["byline_news_11917692"],"categories":["news_457","news_8"],"tags":["news_20402","news_5252","news_22857"],"affiliates":["news_253"],"featImg":"news_11917693","label":"source_news_11917692"},"news_11915564":{"type":"posts","id":"news_11915564","meta":{"index":"posts_1591205157","site":"news","id":"11915564","score":null,"sort":[1654040594000]},"guestAuthors":[],"slug":"hepatitis-outbreak-in-us-canada-may-be-linked-to-strawberry-distributor-in-fresno-among-others","title":"Hepatitis Outbreak in US, Canada May Be Linked to Strawberry Distributor in Fresno, Among Others","publishDate":1654040594,"format":"standard","headTitle":"KQED News","labelTerm":{},"content":"\u003cp>Regulators are investigating a hepatitis A outbreak across the U.S. and Canada that may be linked to fresh organic strawberries, with more than a dozen cases reported in California so far.\u003c/p>\n\u003cp>In a joint weekend statement, the U.S. Food and Drug Administration and the Public Health Agency of Canada said \u003ca href=\"https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-hepatitis-virus-strawberries-may-2022#:~:text=The%20FDA%2C%20along%20with%20CDC,as%20FreshKampo%20and%20HEB%2C%20purchased\">people fell ill after consuming FreshKampo and H-E-B brand strawberries\u003c/a>.\u003c/p>\n\u003cp>There have been 17 illnesses and 12 hospitalizations reported in the U.S., the FDA said, with 15 of those cases occurring in California.\u003c/p>\n\u003cp>The agencies said the strawberries were purchased between March 5 and April 25. They were sold at various U.S. retailers, including Aldi, Kroger, Safeway, Walmart and Trader Joe’s.\u003c/p>\n\u003cp>Mexico-based FreshKampo, which grew the strawberries, said in a statement Sunday that it is working with regulators to determine how the problem occurred. FreshKampo said the label on the containers of potentially affected strawberries would have said “Product of Mexico” or “Distributed by Meridian Foods.”\u003c/p>\n\u003cp>Meridian Fine Foods, a FreshKampo subsidiary, is based in Fresno.\u003c/p>\n\u003cp>The potentially affected strawberries are past their shelf life, but health officials say consumers who purchased them and froze them to eat later should throw them away.\u003c/p>\n\u003cp>Hepatitis A is a virus that can cause liver disease and, in rare cases, liver failure and death. Illness usually occurs within 15 to 50 days after eating or drinking contaminated food or water. Symptoms include fatigue, nausea, vomiting, abdominal pain and jaundice.\u003c/p>\n\u003cp>Consumers who ate the potentially affected berries in the last two weeks and have not been vaccinated against hepatitis A should immediately consult with a physician, the FDA said.\u003c/p>\n","blocks":[],"excerpt":"California has seen the most US hepatitis A cases so far in an outbreak potentially linked to organic strawberries sold in the US and Canada, regulators said.","status":"publish","parent":0,"modified":1654043054,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":9,"wordCount":273},"headData":{"title":"Hepatitis Outbreak in US, Canada May Be Linked to Strawberry Distributor in Fresno, Among Others | KQED","description":"California has seen the most US hepatitis A cases so far in an outbreak potentially linked to organic strawberries sold in the US and Canada, regulators said.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"11915564 https://ww2.kqed.org/news/?p=11915564","disqusUrl":"https://ww2.kqed.org/news/2022/05/31/hepatitis-outbreak-in-us-canada-may-be-linked-to-strawberry-distributor-in-fresno-among-others/","disqusTitle":"Hepatitis Outbreak in US, Canada May Be Linked to Strawberry Distributor in Fresno, Among Others","source":"Food","sourceUrl":"/food/","nprByline":"Dee-Ann Durbin \u003cbr /> The Associated Press","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","path":"/news/11915564/hepatitis-outbreak-in-us-canada-may-be-linked-to-strawberry-distributor-in-fresno-among-others","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Regulators are investigating a hepatitis A outbreak across the U.S. and Canada that may be linked to fresh organic strawberries, with more than a dozen cases reported in California so far.\u003c/p>\n\u003cp>In a joint weekend statement, the U.S. Food and Drug Administration and the Public Health Agency of Canada said \u003ca href=\"https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-hepatitis-virus-strawberries-may-2022#:~:text=The%20FDA%2C%20along%20with%20CDC,as%20FreshKampo%20and%20HEB%2C%20purchased\">people fell ill after consuming FreshKampo and H-E-B brand strawberries\u003c/a>.\u003c/p>\n\u003cp>There have been 17 illnesses and 12 hospitalizations reported in the U.S., the FDA said, with 15 of those cases occurring in California.\u003c/p>\n\u003cp>The agencies said the strawberries were purchased between March 5 and April 25. They were sold at various U.S. retailers, including Aldi, Kroger, Safeway, Walmart and Trader Joe’s.\u003c/p>\n\u003cp>Mexico-based FreshKampo, which grew the strawberries, said in a statement Sunday that it is working with regulators to determine how the problem occurred. FreshKampo said the label on the containers of potentially affected strawberries would have said “Product of Mexico” or “Distributed by Meridian Foods.”\u003c/p>\n\u003cp>Meridian Fine Foods, a FreshKampo subsidiary, is based in Fresno.\u003c/p>\n\u003cp>The potentially affected strawberries are past their shelf life, but health officials say consumers who purchased them and froze them to eat later should throw them away.\u003c/p>\n\u003cp>Hepatitis A is a virus that can cause liver disease and, in rare cases, liver failure and death. Illness usually occurs within 15 to 50 days after eating or drinking contaminated food or water. Symptoms include fatigue, nausea, vomiting, abdominal pain and jaundice.\u003c/p>\n\u003cp>Consumers who ate the potentially affected berries in the last two weeks and have not been vaccinated against hepatitis A should immediately consult with a physician, the FDA said.\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/news/11915564/hepatitis-outbreak-in-us-canada-may-be-linked-to-strawberry-distributor-in-fresno-among-others","authors":["byline_news_11915564"],"categories":["news_24114","news_457","news_8"],"tags":["news_20402","news_37","news_4469"],"featImg":"news_11915615","label":"source_news_11915564"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. 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