Invited Commentary
January 2014

Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted?

Author Affiliations
  • 1Department of Government and Center for American Political Studies, Radcliffe Institute for Advanced Study, Harvard University, Cambridge, Massachusetts

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

JAMA Intern Med. 2014;174(1):95-97. doi:10.1001/jamainternmed.2013.9202

Like blood itself flowing through the human circulatory network, several billion prescriptions and hundreds of billions of drugs course every year through the vast web of factories, wholesale suppliers, hospitals, physicians’ offices, pharmacies, medicine cabinets, and pill boxes that together compose the health system in the United States.1 That network comprises a vast social machine; besides money, the main lubricant is trust premised on evidence. Physicians prescribe drugs in part because they know they have been tested and that their initial safety and efficacy has met the approval criteria of the US Food and Drug Administration (FDA).2 When a generic medication is prescribed, the physician trusts, consciously or unconsciously, that basic conditions of quality manufacturing and bioequivalence have been met. In most instances, the physician does not see the evidence but assumes that someone else, principally the FDA, has rigorously reviewed the underlying data.

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