Bioethics/Policy Discussion: 23andMe vs. FDA

On Wednesday, members of the Penn Science Policy Group met to discuss the current regulatory friction between the FDA and the genetic testing company 23andMe.

23andMe provides personalized DNA results that are interpreted to provide information about ancestry and health risks for various diseases. Because the results provided by 23andMe border on medical information, the FDA has been working closely with the company since 2009 to ensure that their marketing and analysis were accurate and in accordance with federal regulations. However, in May of 2013 23andMe ceased communications with the FDA and simultaneously ramped up marketing of their Personal Genome Service (PGS) for providing “health reports on 254 diseases and conditions.” In retaliation, the FDA sent a letter to 23andMe on Nov 22 warning them to stop marketing their PGS without approval or face harsh regulatory actions. This letter sparked a public debate about how much regulation should be imposed on this new technology, which was the focus of our discussion on Wednesday.

The question at the heart of the debate is: do individuals have the right to access their own genetic information (and interpretations of it) without medical (and hence FDA) oversight?

The laissez-faire argument is that individuals have the right to know their genetics, and governmental paternalism should not restrict that access over fears that certain individuals might react negatively to their DNA interpretations. For instance, a woman might find out she is slightly predisposed to breast cancer and get an unnecessary radical mastectomy (for which it might be challenging to find a doctor that would perform this procedure solely based on the 23andMe PGS, anyways). These scenarios shouldn’t prevent more responsible people from obtaining it. To their credit, 23andMe is very open about allowing people to access more information regarding their personalized interpretations. Curious users can find detailed explanations and links to scientific studies if they care to investigate.

Those in favor of regulation argue that the accuracy of the PGS needs to be verified. They caution that faulty tests could cause unnecessary worry and lead to increased healthcare expenditure to verify or refute the result. The FDA states that most of the intended uses for PGS are consistent with uses that regularly require approval by the FDA. The rationale in favor of regulation is that a company marketing its genetic test as health information should be required to demonstrate the information is correct and reliable. More debates arise from this point about what is correct and reliable and who should determine it. 23andMe insists that the FDA needs to set clear guidelines on this technology before it is feasible for them to comply.

That, in essence, was the purpose of the ongoing communication between the FDA and 23andMe. To many people, it appeared strange that 23andMe all of a sudden ceased talks with the FDA. Some have hypothesized that it was a marketing ploy, and one that seems to have worked thanks to extensive media coverage. While it is too soon to determine their motive for severing communication, currently 23andMe has resumed talks with the FDA and halted their health-related genetic reports (ancestry is still available). The CEO Anne Wojcicki commented that their “goal is to work cooperatively with the FDA... to make sure consumers have direct access to health information in the near future.”

It will be interesting to watch this process unfold. In the future personal genetic tests will become more popular as our knowledge of human genetic variation and disease grows, so the regulation of 23andMe will be crucial to set the standard for other companies offering this service. 

What do you think about the FDA regulating 23andMe? Comments are welcome.

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