Author Affiliations: Office of the Commissioner (Dr Friedman), Center for Drug Research and Evaluation (Drs Woodcock and Lumpkin), Office of Policy, (Dr Shuren), Office of Performance Evaluation, (Mr Hass), and Office of Public Affairs (Mr thompson), Office of the Commissioner, The US Food and Drug Administration, Rockville, Md.
The removal of 5 pharmaceuticals from the market in a
12-month period because of unexpected adverse events raised concerns
about the adequacy of the drug review process at the US Food and Drug
Administration (FDA). Specifically, concerns were raised about
improvements in drug review efficiency that significantly reduced FDA
review times. We have reviewed the circumstances of the 5 removals to
determine whether there was any relationship to the increased
efficiencies in the drug review process. When the removed drugs were
analyzed by date of approval, no increase in the number of drugs taken
off the market was seen, demonstrating that reduced review processing
time was not the reason for the cluster of removals. We conclude that
the agency's drug review procedures and postmarketing surveillance
system after a drug has been marketed are currently adequate but must
continually adjust to future challenges.
Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem? JAMA. 1999;281(18):1728–1734. doi:10.1001/jama.281.18.1728
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