Late last year, the FDA ordered home genetics testing company 23andMe to cease marketing its diagnostic service, which informed customers about their predispositions to a wide variety of health issues. In response, TechFreedom launched a Change.org petition to call for a reversal of the FDA’s actions. Over 10,000 people have now signed on, uniting in opposition to the FDA’s overreach and support of the home genomics revolution.
The following statement may be attributed to TechFreedom President Berin Szoka:
As our petition shows, thousands of Americans were appalled when the FDA ordered 23andMe to stop marketing its home genetics testing kits. The agency claims such tests will cause users to get too little, or too much, treatment. But the FDA hasn’t offered any real evidence that Americans are so foolish about their own health — not a single example of someone being hurt, even indirectly, from a test like 23andMe. Nor does the FDA acknowledge perhaps the greatest benefit of 23andMe: encouraging Americans to talk to their doctors about genomics, thus forcing old docs to learn new tricks.
The FDA crackdown has forced 23andMe to cease providing new customers with health-related reports, the primary value of the service. Worse, it has forced at least one upstart competitor to close its doors. This regulatory uncertainty will only slow the inevitable integration of genomics into everyday medicine.
Then-Senator Barack Obama acknowledged this coming revolution in 2007, declaring that “in no area of research is the promise greater than in personalised medicine.” Unfortunately, his FDA has undermined this revolution by denying Americans access to information about their own genomes.