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

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Washington - White House #1In 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.

23andMeThe 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.

 

Topics:  23andMe, FDA, Genetic Testing, Medical Devices

Published In: Elections & Politics Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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