Drug Safety Reform at the FDA — Pendulum Swing or Systematic Improvement?

Abstract

Major legislation on drug safety is almost certain to be enacted before fall, as Congress reauthorizes the Prescription Drug User Fee Act (PDUFA). Dr. Mark McClellan writes that this represents an opportunity to implement a more systematic approach to improving drug safety and effective use, if some challenges can be overcome. Jerry Avorn and Mark McClellan debate the reauthorization of the Prescription Drug User Fee Act, the effect of user fees on drug safety, and ways of improving post-marketing surveillance. Jerry Avorn is a professor of medicine at Harvard Medical School. Mark McClellan is a visiting senior fellow at the AEI-Brookings Joint Center for Regulatory Studies, Washington, DC, and a former commissioner of the FDA.