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Comment & Response
April 2016

Balancing Accelerated Approval for Drugs With Accelerated Withdrawal

Author Affiliations
  • 1Alcohol Treatment Unit, University Hospital of Amiens, Amiens, France
  • 2Waikato Clinical School, University of Auckland, Auckland, New Zealand

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Intern Med. 2016;176(4):566-567. doi:10.1001/jamainternmed.2016.0351

To the Editor Observing that the US Food and Drug Administration (FDA) has, since 2008, been approving more and more cancer drugs on the basis of surrogate outcomes, Drs Kim and Prasad documented the tenuous or unknown links of surrogates with overall survival in a recent article in JAMA Internal Medicine and called for enforcement of follow-up studies that are legislatively required after all such approvals.1 This concern accords with a previous analysis2 that found that postmarketing studies were performed in only two-thirds of cases and with a median delay of 4 years.