April 24, 2017

Opening the Door for Medical Innovation

Robert Graboyes

Senior Research Fellow

The Food and Drug Administration announced on April 6 that it will allow the California-based genomics and biotechnology company 23andMe to sell direct-to-consumer tests for 10 genetic risks, including Parkinson's, late-onset Alzheimer's, Celiac and Gaucher type 1 diseases. Having this information may help customers prolong their lives, improve well-being and alleviate health-related costs.

This is cause for celebration, but also some consternation: Before the FDA became involved, 23andMe's $99 service analyzed not just 10 genetic conditions, but around 250.

The new policy partially reverses the FDA's 2013 warning letter to 23andMe, which ordered the company to cease marketing its kits. In the intervening years, 23andMe continued selling its kits in Europe. Americans could purchase them, but only for genealogical research. The now-approved, scaled-back version underscores the FDA's capacity to obstruct health care innovation.

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