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Department of Health and Human Services

Office of Inspector General -- AUDIT

"Follow-Up Review of the Food and Drug Administration's Generic Drug Approval Process," (A-15-91-00025)

September 16, 1992

Complete Text of Report is available in PDF format (444 kb). Copies can also be obtained by contacting the Office of Public Affairs at 202-619-1343.


This final audit report points out that the Food and Drug Administration (FDA) has not taken sufficient action to correct a material weakness in FDA's generic drug approval process. The FDA needs to: (1) modify the method by which generic drug applications are assigned to reviewers to remove any opportunity for showing partiality or favoritism; (2) revise its "first-in, first-reviewed" policy for generic drugs because the current policy may allow for the unequal treatment of drug firms' applications; (3) develop comprehensive guidelines to assure that generic drug applications are reviewed in a uniform and consistent manner; and (4) establish a quality control review system outside the Office of Generic Drugs to ensure the propriety of individual generic drug application reviews and the integrity of the review process.