NEJM Publishes Several Perspectives On FDA User Fee Reauthorization, Prescription Drug Safety
- Wednesday, April 18, 2007, 21:54
- Pharma Industry, Public Health
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Drug Safety Reform at the FDA — Pendulum Swing or Systematic Improvement?” New England Journal of Medicine: In the perspective, former FDA Commissioner Mark McClellan discusses an Institute of Medicine report that focused on FDA drug approval and postmarket safety and how recommendations could affect user fee reauthorization (McClellan, NEJM, 4/13).
Paying for Drug Approvals — Who’s Using Whom?” NEJM: In the perspective, Jerry Avorn, a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, discusses reauthorization of the Prescription Drug User Fee Act. He writes that the fees paid to FDA pull resources from regulatory services, which leads to decreased drug safety. He concludes that the user fees should be renewed for a limited period to give policymakers time to debate revisions (Avorn, NEJM, 4/13).
PDUFA Reauthorization — Drug Safety’s Golden Moment of Opportunity?” NEJM: In the perspective, Sean Hennessy and Brian Strom, special government employees of FDA, write that FDA’s postmarket monitoring of drug safety is underfunded and FDA recommendations for user fee reauthorization are inadequate for improving safety (Hennessy/Strom, NEJM, 4/13).
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