FDA takes steps to boost drug safety evaluations
Patient Safety Monitor Alert, November 9, 2004
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The Food and Drug Administration (FDA) on November 5 announced steps to strengthen the nation's drug safety program in the wake of the Vioxx withdrawal and the link between antidepressants and youth suicide.
Acting FDA Commissioner Lester Crawford authorized the Center for Drug Evaluation and Research to take the following steps:
- Sponsor an IOM study on the U.S. drug safety system
- Put a program in place to allow differing opinions of scientific reviewers
- Appoint a director of the Office of Drug Safety
- Conduct drug safety and risk management consultations, including whether a particular safety concern affects the benefit of a drug
- Publish risk management guidelines to help pharmaceutical companies manage risks involving drugs and biological products
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