02 Mar As FDA loosens its grip, a win for innovation
On Feb. 19, the U.S. Food and Drug Administration took a huge step towards patient-centric medicine when it approved the marketing of genetics testing company 23andMe’s carrier test for Bloom Syndrome. This was a startling — and good — development because it affirmed the rights of consumers to drive their own health-care decisions and procedures. But it also means that it has become urgent to develop policies to regulate the rights of companies to resell data derived from the contents of our DNA and from our medical records.
Not only did the FDA allow 23andMe to resume business; it also took the step of exempting these types of carrier DNA tests (such as for Tay–Sachs disease) from its pre-market review requirements. This will have the effect of accelerating innovation, because the technology industry is “eating” medicine. Companies such as Apple, Google, IBM, and Microsoft are developing health platforms, artificial intelligence-based analysis tools, and wearable medical sensors. Medicine has become an information technology and is advancing on an exponential curve.
Here’s the back story to the FDA decision. You probably remember that the FDA forced 23andMe to remove its DNA testing product from the market in 2013 due to “lack of scientific evidence.” The FDA took pains to explain that it wanted to help 23andMe but that the company had failed to follow the regulatory process and to provide sufficient evidence to back up its claims of accurate detection of certain genetic markers common in breast cancer, warfarin sensitivity, and many other states of health. The shutdown riled Silicon Valley and techno-libertarians who felt that the FDA was unfairly regulating their right to information.
Many physicians, for their part, protested that consumers could easily misinterpret results. The FDA argued that 23andMe had never shown clear evidence that its tests were not throwing false positives at unacceptable rates. False signals could be dangerous if misconstrued or taken as gospel. For example, genetic testing for certain gene variants closely associated with particularly noxious forms of breast cancer might encourage a woman to put herself in significant peril by undergoing radical surgery or other risky treatment for no possible benefit.
This is a plausible argument. On the other hand, the regulatory process to date has stifled innovation in the area of consumer-driven genetic testing. Traditionally, anyone seeking genetic testing had to go through a physician or a formalized service with counseling and other information sessions as a key component. 23andMe, founded by Anne Wojicki, was built on the idea that consumers are smart enough to handle their own health-care information and guide their own care.
Now, apparently, the FDA is starting to agree with Wojicki not just in words but also in deeds.