Summary

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.