sent a letter to the genotype-screening company, 23andMe, basically ordering it to stop offering its $99 direct-to-consumer Personal Genome Service to the public. In December, the company knuckled under the regulators' demands.Back in November, the Food and Drug Administration
The TechFreedom think tank launched a Change.org petition with the goal of urging FDA regulators to back off. The petition stated:
The FDA seems to think that Americans can’t be trusted with more information about their potential health risks because some people might make rash decisions with it. But hampering the sales of personal genomics devices isn’t the answer.
We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.
We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of hamstringing new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.
The TechFreedom petition has now garnered 10,000 signatures. In a media statement, TechFreedom president Berin Szoka said:
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.
See Reason's topic tag for 23andMe more background on this sorry example of regulatory overreach.