Nonprescription Drugs:

Over the Counter and Underemphasized

PEMD-92-9: Published: Jan 10, 1992. Publicly Released: Feb 27, 1992.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) procedures for approving and monitoring over-the-counter (OTC) drugs, focusing on: (1) procedural vulnerabilities that could result in the approval and marketing of unsafe and ineffective drugs; and (2) procedures for approving prescription drugs compared to OTC drug procedures.

GAO found that: (1) unlike prescription drugs, FDA does not require some OTC drugs to demonstrate their safety and effectiveness; (2) during FDA inspections for compliance with current good manufacturing practices, FDA has statutory authority to inspect prescription drug manufacturers' records and documents, but not OTC drug manufacturers' documents; (3) FDA collects less post-marketing surveillance information and conducts fewer product performance analyses for OTC drugs than for prescription drugs; and (4) post-marketing responses collected for prescription drugs include patterns of usage, the magnitude of any identified problems and the appropriate level of response, and trends in adverse reactions.