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Drug-review deadlines and safety problems.

Daniel Carpenter1, Evan James Zucker, Jerry Avorn

  • 1Department of Government, Faculty of Arts and Sciences, Harvard University, Cambridge, MA 02138, USA. dcarpenter@gov.harvard.edu

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|March 28, 2008
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Summary

Prescription Drug User Fee Act (PDUFA) deadlines may lead to rushed FDA drug approvals. Drugs approved just before PDUFA deadlines show increased postmarketing safety issues, including withdrawals and black-box warnings.

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Area of Science:

  • Pharmacovigilance
  • Drug regulatory affairs
  • Health policy

Background:

  • The Prescription Drug User Fee Act (PDUFA) mandates timely drug reviews by the Food and Drug Administration (FDA).
  • Concerns exist that PDUFA deadlines may compromise drug safety by encouraging expedited approvals.

Purpose of the Study:

  • To investigate the association between PDUFA deadlines and FDA drug approval timing.
  • To determine if PDUFA deadlines correlate with increased postmarketing safety problems for new molecular entities.

Main Methods:

  • Dynamic Cox proportional-hazards models analyzed review times for drugs approved 1950-2005.
  • Exact logistic regression assessed postmarketing safety issues (e.g., withdrawals, black-box warnings) for drugs approved post-January 1993.

Main Results:

  • PDUFA implementation concentrated FDA approval decisions near deadlines.
  • Drugs approved within two months pre-PDUFA deadline had significantly higher odds of safety-related withdrawals (OR 5.5), black-box warnings (OR 4.4), and voluntary discontinuations (OR 3.3).

Conclusions:

  • PDUFA deadlines have demonstrably altered FDA approval patterns.
  • Approvals immediately preceding PDUFA deadlines are linked to a greater likelihood of discovering safety problems post-market.