Summary

In reviewing Food and Drug Administration (FDA) regulations, GAO discovered several differences in how the agency ensures the safety and effectiveness of over-the-counter versus prescription drugs. GAO found that (1) unlike prescription drugs, many over-the-counter drugs have not been required to demonstrate their safety and effectiveness before being made available to the public; (2) during FDA inspections for compliance with current good manufacturing practices, FDA has statutory authority to inspect records and documents of prescription drug manufacturers but not those of over-the-counter drug manufacturers; and (3) FDA collects less postmarketing surveillance information and conducts fewer product performance analyses for over-the-counter drugs than for prescription drugs. Postmarketing analyses routinely conducted for prescription drugs include patterns of usage, the magnitude of any identified problem and the appropriate level of response, and trends in adverse reactions.

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.