Dov Fox on the FDA’s ruling on 23andMe

Dov Fox has a new piece up at the Huffington Post on the 23andMe controversy: “Genetic Testing Needs a Nudge.” From the article:

Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease — no doctors needed.

Splashed across TV sets nationwide this past summer was 23andMe’s invitation to discover “hundreds of things about your health,” including that you “might have an increased risk of heart disease, arthritis, [or] gallstones.”

Since the company’s inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a “first step in prevention” to “mitigate[e] serious diseases.”

But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had “suspended” all sales of its “health-related genetic tests to comply” with the FDA directive, consumers brought aclass action lawsuit against the company, alleging that it “falsely and misleadingly advertises” the genetic test “as providing ‘health reports on 240+ conditions'” in the absence of “analytical or clinical validation.”

The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.

You can read the full piece here.

Dov Fox

Dov Fox

Dov Fox is Professor of Law and the Director of the Center for Health Law Policy and Bioethics at the University of San Diego School of Law, where he has been named Herzog Endowed Scholar for exceptional scholarship and teaching. He also won BIOCOM's Life Science Catalyst Award for "significant contributions to human health through research, discovery, and entrepreneurship." His work has been featured in CNN, ABC, NPR, NBC, Reuter’s, Bloomberg, Slate, Daily Beast, Today Show, Boston Globe, and Washington Post. His latest book project, "Birth Rights and Wrongs," is forthcoming with Oxford University Press.

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