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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 1. 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.
Closed - Implemented
The agency has augmented its drug specific monitoring by conducting, periodically, macro level assessments, looking for trends in post-approval problems.
Food and Drug Administration 2. 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.
Closed - Implemented
FDA has implemented an approach for capturing and analyzing the important post-approval risk information.

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