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Marchant: How the FDA could set personal genetics back decades


December 02, 2013

Last week, the U.S. Food and Drug Administration directed 23andMe, perhaps the world’s best-known personal genetic testing company, to “immediately discontinue” marketing its genetic tests directly to consumers until it receives FDA approval.

23andMe provides individuals unprecedented, affordable access to important, private genetic information, and the FDA’s action will prevent consumers from accessing that data for the foreseeable future, argues Gary Marchant, Regents’ Professor at the Sandra Day O’Connor College of Law and director of the Center for Law, Science and Innovation.

In a Future Tense article for Slate magazine, Marchant argues that the FDA’s effort to stop 23andMe’s services is a “shortsighted, heavy-handed, double-standard act of paternalism.” The regulatory pathways that the FDA is requiring 23andMe to pursue will take several years to complete and cost millions of dollars. Worse yet, by the time the FDA’s reviews are complete, most existing genetic tests will be outdated, since the field of genetics is refining its methods so rapidly.

According to Marchant, the FDA’s action creates a double standard because consumers have access to approximately 3,000 genetic tests if they are ordered by a doctor, and only a handful of these have received FDA approval. But ordering each individual test through a doctor is expensive and time-consuming, while 23andMe makes the testing process fast, easy and more private for people who don’t want their results recorded in medical records.  

To learn more about the promises and perils of personal genetic testing, the surprising psychological effects of adverse genetic test results on individuals and how Marchant is using 23andMe in his ASU class on genetics and law, read the full article at Future Tense.

Future Tense is a collaboration among ASU, the New America Foundation and Slate magazine that explores how emerging technologies affect policy and society.

Article source: Slate magazine

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