FDA Drug Review

Postapproval Risks 1976-1985 Gao ID: PEMD-90-15 April 26, 1990

Pursuant to a congressional request, GAO assessed postapproval risks for drugs approved by the Food and Drug Administration (FDA) between 1976 and 1985, focusing on: (1) serious risks that arose after FDA marketing approval; and (2) whether the drugs and the review process contributed to those risks.

GAO found that: (1) between 1976 and 1985, FDA approved 198 drugs, and 51.5 percent of those drugs had serious postapproval risks; (2) FDA deemed all but six of the drugs to have benefits that outweighed their risks; (3) due to serious adverse reactions to certain drugs, FDA substantially changed the labelling for some of the drugs; and (4) the number of serious postapproval risks was small compared to the number of adverse reactions that had been identified at the time of approval.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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