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.

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About Dov Fox

Dov Fox is Professor of Law and founding Faculty Director of the Center for Health Law Policy and Bioethics at the University of San Diego School of Law. He has published dozens of articles in leading journals of law and medical ethics, most recently “Reproductive Negligence” in 117 Columbia Law Review 149 (2017). His current book project, Birth Rights and Wrongs, is under contract with Oxford University Press. His work has been featured in CNN, ABC, NPR, BBC, Reuter’s, Bloomberg, the Boston Globe, and the Washington Post. Fox is a regular columnist for The Huffington Post and contributor to the Bill of Health blog. He also serves on the advisory boards of the American Constitution Society and Appellate Defenders, the non-profit law firm that administers all appointed counsel for indigent defendants in California's Fourth Appellate District. Prior to teaching, Fox served as a law clerk to the Honorable Stephen Reinhardt of the U.S. Court of Appeals for the Ninth Circuit. He has also worked at the law firm of Wachtell, Lipton, Rosen & Katz; the consulting firm of McKinsey & Company; and the Civil Appellate Staff at the U.S. Department of Justice. Fox was awarded a Rhodes Scholarship to attend Oxford University, where he earned his DPhil and then received a Soros Fellowship for New Americans to attend Yale Law School, where he served as projects editor for the Yale Law Journal and all three years was awarded the prize for best student paper in law and the sciences.

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