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Prescription for a Stronger FDA

Section of Clinical Pharmacology at University Hospital, SUNY-Upstate Medical University, Syracuse, NY, guharoyr{at}upstate.edu

Gregory Cwikla, PharmD

University Hospital, SUNY-Upstate Medical University, Syracuse, NY

Andrew Burgdorf, PharmD

University Hospital, SUNY-Upstate Medical University, Syracuse, NY

Madan Joshi, MD

University Hospital, SUNY-Upstate Medical University, Syracuse, NY

Recently, an Institute of Medicine panel concluded that years of negligence, mismanagement, inadequate resources, infighting among staff members, and lack of a systemic drug approval and postmarketing surveillance process have diluted the effectiveness of the Food and Drug Administration (FDA) in protecting public health. The panel was commissioned by the FDA to assess the U.S. drug safety system, and they recommended 25 sweeping changes, most of which would require congressional authorization. The recommendations focus on the life cycle of a drug product, rather than just the approval process, and they would go a long way in protecting public health in the future.

Key Words: Drug approval process • drug effects • drug regulation • drug safety • Food and Drug Administration • IOM • postmarketing product surveillance.

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