E-DRUG: The safety of newly approved drugs
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JAMA. 1999;281:1728-1734 Abstract - May 12, 1999
The Safety of Newly Approved Medicines
Do Recent Market Removals Mean There Is a Problem?
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.
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