FDA's Warning Letter to 23andMe Sparks Debate

Gerald Clarke

Genetics has gone mainstream; long the preserve of scientific minds, the only interaction the general public had with genetics was in sci-fi blockbusters and police procedurals. The astounding pace with which the price of genetic technology has dropped has put us in more regular contact with these world-changing technologies. However one of the vanguards of this oncoming wave has run into a spot of bother with the regulators.

23andMe a company named for the 23 pairs of chromosomes in the human genome, offered a genetic testing kit for the general public to find out more about themselves through the secrets hidden in their genes. When you purchase their $99 dollar kit, you are sent a spit kit which you spit into and then send off for testing. 23andMe don’t sequence genomes, they test for the presence of certain Single Nucleotide Polymorphisms (SNPs) which may indicate that you are a carrier of one or more of 53 disease SNPs, 122 disease risk SNPs, 25 drug response SNPs or 60 traits from hair curliness to AIDS resistance.

It is these claims that have caused 23andMe to run into trouble. On the 22ndNovember, the FDA issued a warning letter to Ann Wojcicki, the CEO of 23andMe Inc. to discontinue marketing of their Personal Genome Service as the FDA are of the opinion that 23andMe are marketing their service as a health diagnostic tool without having the process approved. According to the information in the FDA’s letter, it seems that the reason behind their warning was due to non-cooperation by 23andMe.

To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the Act, 21 U.S.C. § 360(k). 

Many people have remarked that the  tone of the letter (read on the FDA’s website) sounds exasperated, with the descriptions of the support that they have provided being particularly interesting.

As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.

23andMe submitted their 510(k)s on 2ndJuly, 2012 for PGS, however since then, they have added additional diagnostic tests to the raft of tests that it provides, all without addressing the FDA’s concerns about the original submission. The FDA stated that because of the failure to address these concerns or provide additional information they considered 23andMe’s 510(k)s withdrawn.

In the letter, the FDA stated their concerns over patients taking unnecessarily drastic measures in response to the information contained in these diagnostic tests, especially since these tests have not yet been classified. Pharma IQ has covered genetic testing before; however the FDA expressing their concerns over false positive genetic tests and a lack of genetic counseling may have been misguided in this context. The warning letter seems to have been prompted by a simple lack of compliance by 23andMe, a failure to submit the correct information to the regulator despite support from the regulator. By bringing concerns about genetic testing into the warning letter, the FDA has inadvertently changed the debate around the topic into one on informed consent, privacy and genetic counseling. There has also been somewhat of a backlash from some who believe that they have a right to know their genetic information and that the FDA shouldn’t be making decisions about who is qualified enough to know their genetic information.

23andMe have 15 days to reply to this letter with the steps they intend to take to remedy the situation. Their response will certainly make the news again and give more oxygen to the debates around the topic of genetic testing. It may be a setback for this one company, but by bringing this topic into the open, this warning may do a great deal to allow for more nuanced discussion over the issues in genetics which all of us may face over the coming years.