Patients Push Back on FDA Threats to 23andMe Genetic Testing Products

By Kevin E. Noonan --

In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe to continue to market the company's Personal Genomic Services (PGS) product.  The petition is a response to the FDA sending a Warning Letter to 23andMe, threatening the company with "seizure, injunction, and civil money penalties" unless the company ceases offering its services until it obtained FDA approval under 21 U.S.C. § 321(h) as a "medical device" (see "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing").

The text of the petition reads as follows:

We, the healthcare consumers of America, demand that we maintain access to genomics testing services like 23andMe's, which serve as a 100% privately purchased complement to government-regulated healthcare.

The FDA grossly overstates the risks associated with 23andMe's assessments.  Statements such as those suggesting that dangers like false positives may "lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions" are outrageous and patently false.

Risks associated with services like 23andMe's are understood by private consumers, while the benefits of these services (such as early diagnoses for chronic diseases) are significant.  The price of over-regulation is lengthy delays in potentially life-saving medical innovations.

The petition has a goal of 100,000 signatures by December 25, 2013 (according to the website) and since it went live yesterday has garnered 1,904 signatures.  The website notes that the purpose of the site is to provide a new way for citizens to petition the government by exercsing their First Amendment rights.  The site asserts that "[i]f a petition gets enough support, White House staff will review it, ensure it's sent to the appropriate policy experts, and issue an official response."  It will be interesting to see what part of the policy apparatus of the Obama Administration responds to the petition (presuming there are enough signatures, where "enough" is undefined):  that part of the Administration having a populist cast that might support the company, or the part responsible for the government's antagonism to diagnostic testing.

Comments

[Sharon Royal]

Thanks for the information about the petition. When I read the FDA letter yesterday, I was appalled at yet another example of big "guberment" interference. Signing a petition at least allows us to vent a little.

[Richard Start]

It is the inovation of private groups such as this that contribute to the improvement in medicine! We have moved beyond basement labs and too many bosses can stiffel dedicated and creative work that brings results.
Parts of our Government are acting as if they can write Law (Congress has that responsibility) or make decisions for grown adults.
How can we consider our selves free if we are not allowed to make simple life decisions on our own? We can be wrong as easy as them but it is our Right and Freedom to choose!
WE need to get a few Agencies back in line with what their jobs are and take some powers away.