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

Mark B. McClellan

Every 5 or 10 years, Congress enacts major legislation addressing pressing issues at the Food and Drug Administration (FDA). This year, the biggest reforms since at least 1997 are expected. A decade ago, reform was motivated by the perception that the agency wasn’t getting new medicines to patients as efficiently as possible. Today, a leading concern is that it isn’t protecting the public from drugs’ risks as effectively as it might. 

 A key incident in raising such concern was the 2004 withdrawal by Merck of rofecoxib (Vioxx) because of an apparent increased risk of serious cardiovascular events. The withdrawal came amid questions about the FDA’s handling of a possible association between selective serotonin-reuptake inhibitors and suicidal ideation in adolescents. Further concerns were raised about the agency’s handling of staff disagreements about these and other drugs. In this context, the FDA sought a review from the Institute of Medicine (IOM).

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