This report investigates the risks associated with FDA drug approvals during the period of 1976 to 1985. The U.S. Government Accountability Office (GAO), an independent agency serving Congress, conducted this review to examine the effectiveness and potential pitfalls of the Food and Drug Administration's post-approval surveillance of pharmaceutical products. The report aims to identify any systemic issues or overlooked risks that may have emerged during this specific decade, providing an analysis of federal spending and government operations.

This report is a factual document produced by the U.S. Government Accountability Office (GAO), an independent agency tasked with auditing federal spending and operations for Congress. As such, its reception is primarily measured by its utility to policymakers and its accuracy in reporting on government activities. The document serves as a record of the GAO's findings and analysis concerning FDA drug approval risks during a specific historical period, intended for governmental and potentially academic review.