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Paternalism vs. Empowerment: The FDA & 23andMe Conflict

    

On November 22, the FDA blatantly demonstrated the full potential of its paternalistic capabilities.
In a frank letter, the FDA demanded that 23andMe stop marketing its PGS based on a claim that the Saliva Collection Kit used in PGS is a medical “device” as defined under section 201(h) of the Federal Food and Drug Cosmetic Act (FD&C Act). This section defines a device as an instrument, apparatus, etc. which is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease”. Because 23andMe markets PGS as providing “health reports on 254 diseases and conditions” and as a “first step in prevention”, the FDA claims PGS classifies as a medical device. The FDA is primarily concerned about “the public health consequences of inaccurate results from the PGS device.” In other words, the FDA is concerned that individuals might make bad choices based upon the genetic information they obtain via 23andMe.

Classifying PGS as a medical device on paternalistic grounds is troubling for two reasons.
First, the FDA fails to acknowledge a distinction between providing information and providing opportunities to act upon information. The difference is between the need for a “device” to be analytically valid and clinically valid (or both). 23andMe provides genetic information to individuals; any health and medical decisions people make based on that information are entirely separate from the services directly provided, and most (if not all) significant clinical decisions made on behalf of such information must be made utilizing additional technologies under physician consultation. Furthermore, 23andMe clearly advertised its product as being “for informational use only.” It in no way produces, markets, or distributes a device used by individuals in acting upon their medical decisions. A concern with the “clinical validity” of genetic information is not, in fact, a concern regarding PGS at all but a concern with our general understanding of genetics and health. Clinical validity should be addressed in discussions regarding the technologies individuals use to act on their genetic information, not in discussing information access.

Second, the FDA’s concern that individuals might misuse their genetic information by using it to make “poor” medical choices does not justify limiting every individual’s access to his or her own information. Information is information, and nothing more. Preventing people from accessing genetic tests such as PGS calls into question the FDA’s authority to limit the dissemination of information. In order to justify such a limitation, we would have to strip individuals of their autonomous capacities and challenge the scope of First Amendment rights to information.

The FDA should focus its regulatory efforts on empowering U.S. citizens by ensuring the analytical validity of technologies like 23andMe’s PGS. However, it must avoid restricting access to information simply because individuals might misuse it. Effective and efficient oversight of companies like 23andMe should both protect and promote an individual’s access to information.