The FDA and 23andMe: violating the First Amendment or protecting the rights of consumers?

Abstract

One of the largest direct-to-consumer (DTC)2 genetic testing facilities, 23andMe, was ordered by the U.S. Food and Drug Administration (FDA) to cease marketing its Personal Genome Service (PGS) test on Nov. 22, 2013 (1). This occurred after 23andMe failed to respond to questions from the FDA about the analytical and clinical validity of this test (see Table 1 for definitions). In response to the FDA's order, 23andMe no longer provides health-related genetic risk assessments but still provides the genetic data (i.e., genotypes) and ancestry-related genetic reports. Although some support the FDA's actions because of the test's potential for harm to consumers, other personalized medicine advocates are crying foul, saying that the FDA is being overly paternalistic and impeding medical advances. Green and Farahany, in a recent commentary in Nature , argued that the FDA's actions are “unwarranted without evidence of harm” (2). They further stated that these types of FDA regulations are disallowing advertising (“commercial speech”) as well as preventing individuals from their right to receive information, both of which are protected under the First Amendment. The FDA might counter that this medical device is subject to all of the same regulations as all other medical devices. View this table: Table 1. Definitions of terms.a Part of the complaint by some has been that the FDA should not presume that consumers are unable to understand their own genomic information and therefore deny consumers access to these data. However, in its personalized medicine document, the FDA states that its “mission is to protect and promote the health of all Americans through assuring the safety, efficacy, and security of drugs, biologics …, and medical devices. … In the case of medical products, FDA determines that products are safe and effective before marketing through a careful evaluation of benefits and risks that considers the available scientific data in the context …