A month or so ago a small company in San Diego struck a deal with Walgreens. Together they were going to sell genetic tests directly to consumers from drug store shelves. Sort of like how some paternity tests are now sold.
The resulting furor has caused Walgreens to back off. It has also awakened the slumbering beast—the FDA.
Last week the FDA sent a letter out to five different direct to consumer genetic testing companies about the genetic tests they offer. The FDA is arguing that these genetic tests are medical devices and therefore it has the authority to regulate them.
These tests actually consist of thousands of individual tests. If the FDA wants to regulate each one separately, there is no way that these companies will be able to make a profit. They’ll have to raise prices beyond what most people are willing to pay or simply fold up shop.
This is probably why companies like 23andMe and deCODEme shied away from medical sorts of tests before and instead focused on recreational genomics. They offered tests to learn about the DNA behind your earwax, lactose intolerance and lots of other little, fun traits. But people would learn very little about their disease-causing DNA.
The companies must have found that they had trouble finding enough people willing to plunk down 400 or 500 dollars for a fun genetic test. A new TV, iPhone, Wii are all more fun and cheaper.
So to scare up some customers, the companies began to offer more medical information in these tests. Undoubtedly they thought that people would be willing to pony up 400 dollars to learn about their risks for diabetes, heart disease, lots of rare genetic diseases and much more. A bargain by any standard!
Leaving aside the fact that most of these individual tests aren’t as useful as you might think, including medical tests introduces another problem. Including medical tests puts these companies square in the sights of the FDA which is not known for its liberal attitude towards medical devices.
To get enough customers to stay profitable, these companies need to offer medical tests. But if the FDA regulates these tests then the profits will go away. Or the companies will have to charge a lot more money which will drive customers away. A Catch-22 if I’ve ever heard one!
These companies may need to provide detailed evidence for each individual genetic test. Many of them probably won’t stand up to the FDA’s scrutiny and will have to be removed. Let’s hope for their sake that the remaining ones are still interesting enough to consumers. If the companies can survive the cost of complying with the FDA that is…