Petition In Support of Lifting the FDA Ban on 23andMe Gene Testing Reaches 10,000

Back in November, the Food and Drug
Administration
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.

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.