Over the Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System

GAO discussed the Food and Drug Administration's (FDA) system for approving and monitoring nonprescription drugs. GAO noted that: (1) the majority of nonprescription drugs reach the market through a drug review monograph, which specifies the therapeutic categories of ingredients that are generally recognized as safe and effective and thus permissible in a given drug product, as well as dosage, labelling, and mode of administration; (2) FDA has been slow to develop monographs for nonprescription drugs, resulting in an undetermined number of products that have not been measured against generally accepted standards of safety and effectiveness; (3) FDA does not know the number of nonprescription products currently being marketed in the United States; and (4) since FDA does not have statutory authority to inspect nonprescription drug manufacturer's records, it is largely dependent on voluntary reports on monograph-controlled products from manufacturers, health providers, and consumers for post-marketing information.