By Kamal Menghrajani
Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug Avastin had been identified in the U.S. Most of those doctors were in California. Today the Wall Street Journal reports that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.
"We're deeply horrified by this counterfeit [product] being sold by one of my companies," said Thomas Haughton, a Canadian citizen who runs a network of drug distributors that sell to U.S. doctors. At the same time he said that his business operated legally. "We're doing everything we can to be sure that this never happens again.”
While experts say most U.S. drugs are safe, the probe may raise new concerns about the weakly regulated gray market in foreign drugs aimed at U.S. patients. The importation of foreign drugs by third parties, which takes advantage of the large price differential between the U.S. market and others abroad, is believed to represent a small but growing portion of the $300 billion U.S. prescription pharmaceutical business.
Haughton’s brother-in-law, Kris Thorkelson, is the second man under investigation. Both Haughton and Thorkelson sell low-cost medicines to doctors or directly to patients in the U.S. According to the Journal their Canada-based businesses are thought to be the end of a supply chain of counterfeit Avastin that may have started in China and made its way through Turkey, Egypt, Sweden, and Denmark before going through Canada to get to Tennessee. Tennessee-based Volunteer Distribution was then suspected of funneling those vials out to various clinics throughout the country, most of which were in Southern California. Again, from the Journal:
In the last several days, the U.S. Attorney in Los Angeles has subpoenaed California physicians for documents about their dealings with and products purchased from Messrs. Haughton and Thorkelson, three people who have worked for them and 12 companies that are affiliated with one or the other man, according to a copy of a subpoena reviewed by The Wall Street Journal.
At least some of the doctors who received a subpoena were warned last month by the FDA that they may have purchased fake Avastin from three companies named in the subpoena and linked to Mr. Haughton. The FDA, which is leading the investigation, declined to comment on the subpoenas or the ongoing investigation.
The fake Avastin contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche. The packaging didn't match U.S.-approved labels for the product, regulators said. As of Monday, the FDA hadn't received any reports of the fake Avastin being administered to patients.
The FDA is pursuing a criminal investigation against the Canadian drug sellers for shipping non-FDA approved drugs into the U.S.