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January 22/29, 2014

Opening the FDA Black Box

Author Affiliations
  • 1Stanford University, Stanford, California
  • 2University of California, San Francisco, and Editor, JAMA Internal Medicine

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;311(4):361-363. doi:10.1001/jama.2013.283946

The US Food and Drug Administration (FDA) is sometimes described as the most powerful regulatory agency in the world, its decisions affecting billions of both lives and dollars. The agency has this distinction not just because of its legislative mandate or governmental role but in part because of its reputation.1 This reputation has been shaped by how it makes its decisions, by its “conceptual power” in the language and methodologic standards it uses for drug and device approval, and by its ability to gain legitimacy among multiple audiences via a combination of scientific rigor and flexibility.1

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