FDA Drug Review:

Postapproval Risks 1976-1985

PEMD-90-15: Published: Apr 26, 1990. Publicly Released: May 30, 1990.

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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 for Executive Action

  1. Status: Closed - Implemented

    Comments: The agency has augmented its drug specific monitoring by conducting, periodically, macro level assessments, looking for trends in post-approval problems.

    Recommendation: The Commissioner, FDA, should establish formal systematic procedures to ensure that serious risks identified after a new drug has been approved are evaluated and used to enhance premarketing review of clinical trials and postmarketing surveillance of adverse reactions. GAO believes that the implementation of such procedures would, over the long run, contribute to better and more timely labelling, in both the review process and postmarketing surveillance.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: FDA has implemented an approach for capturing and analyzing the important post-approval risk information.

    Recommendation: For developing a system for capturing and analyzing postapproval risk information, GAO suggests that FDA should make an effort to introduce more quantitative risk analysis methods. To support such methods, the following kinds of information would be needed about a given drug: (1) the number of people exposed to the drug; (2) the proportion likely to be affected by the risk either for the general population or for specific subpopulations; (3) indicators reflecting the relative significance of fatalities and morbidity (including hospitalization, prolonged hospitalization, and permanent or temporary disability); and (4) the time period over which the population is exposed to the risk.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration


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