Accession Number : ADA290229

Title :   Nonprescription Drugs; Over the Counter and Underemphasized.

Corporate Author : GENERAL ACCOUNTING OFFICE WASHINGTON DC PROGRAM EVALUATION AND METHODOLOGY DI V

PDF Url : ADA290229

Report Date : 08 APR 1992

Pagination or Media Count : 10

Abstract : OTC drugs are a common part of our daily lives. Products such as cold remedies, analgesics, and sleep-aids are used for the relief of symptoms and improve the quality of life for many. Similar to other developed nations, Americans take only a small percent of their health complaints to doctors -- about 10 percent. More often, minor health problems are treated by self-medication. Estimated OTC drug sales in the United States for 1990 were $11.2 billion, or nearly 2 percent of all national health care expenditures. FDA has estimated that there are between 125,000 and 300,000 different OTC products currently being marketed. In our comparison of FDA regulation of OTC and prescription drugs, we found several differences in how FDA ensures the safety and effectiveness of each. Specifically, we found that (1) unlike prescription drugs, many OTC drug products 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 (CGMP), FDA has statutor authority to inspect records and documents of prescription drug manufacturers, but not those of OTC drug manufacturers; and (3) FDA collects less postmarketing surveillance information and conducts less product performance analysis for OTC drugs than for prescription drugs. JMD

Descriptors :   *ANALGESICS, UNITED STATES, MANUFACTURING, HEALTH, PERFORMANCE TESTS, QUALITY, DRUGS, PHYSICIANS, SURVEILLANCE, LIVING STANDARDS.

Subject Categories : Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE