FDA's Approach to Reviewing Over-the-Counter Drugs Is Reasonable, but Progress Is Slow

GAO reported on the Food and Drug Administration's (FDA) evaluation of the safety and effectiveness of over-the-counter drugs, a review which began in 1972 and which is not expected to be completed until 1990.

The FDA strategy for reviewing over-the-counter drugs involves making a scientific analysis of available data and setting standards of safety and effectiveness for each ingredient used in classes of drugs, instead of reviewing each drug product separately. The review process consists of the review of the scientific data by expert advisory panels, FDA review of the panel findings, drafting and publishing of monographs, and the enforcement of the monographs. In 10 years, FDA has completed only 4 of 64 planned final regulations. Average processing time has risen despite a greatly increased staff. The review has resulted in unsafe or ineffective products being removed from the market. Also, products have been voluntarily reformulated and relabeled, and some drugs that previously were available only by prescription are now sold over the counter. However, most of the review's expected benefits have not been realized. The review turned out to be a much larger task than anticipated. Additional factors which contributed to delays included: poor prioritizing, failure to use status reports to track progress in the completion of monographs, delayed policy decisions, and the ineffective use of staff in branch offices. A GAO review of two pilot compliance programs indicated potential problems for future compliance efforts. These problems were caused by the lack of an accurate listing of over-the-counter drugs and the FDA failure to adequately monitor or evaluate enforcement efforts.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

Director: Franklin A. Curtis Team: General Accounting Office: Human Resources Division Phone: (202) 275-5451