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

HRD-82-41 Published: Apr 26, 1982. Publicly Released: Apr 26, 1982.
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Highlights

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.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish priorities for completing individual monographs based on objective criteria, such as consumer sales or market impact, and establish detailed milestones for completing the development of monographs and the publication of final regulations based on actual experience, staff skills and experience, the work required, and the priority of the monographed document.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop a mechanism for high-level agency officials to promptly identify and resolve policy issues.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to review, and revise where appropriate, procedures for reviewing draft monograph documents to ensure that branch personnel are given the necessary supervision and authority to develop the products for which they are responsible.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to determine, based on the anticipated cost and timeliness of possible alternative approaches, whether the over-the-counter drug listing files are needed. If the listing is not needed, FDA should propose legislation to amend the Drug Listing Act to eliminate the reporting requirement. If it is needed, FDA should assess the relative efficiency of updating the entire system in the next few years or updating the system by drug category as monographs are published.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish measurable objectives for the over-the-counter drug enforcement effort and the expected timetables for performing the work.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to maintain for each category of drug product a complete master list of firms manufacturing the drug and a list of products as they are identified for each monograph.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to track the progress made in reviewing and following up on products subject to the monographs and highlight, through written reports or regular meetings with district representatives, problems encountered in enforcing monographs.
Closed – Implemented
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish goals for expediting the over-the-counter drug review and develop a system for measuring progress in completing all monograph documents which measures progress against projected milestones and provides feedback to HHS and FDA.
Closed – Not Implemented
HHS has taken actions to monitor progress in completing monographs differently than proposed. A system has been developed to monitor the length of time a document has been in an office. If closely monitored and enforced, this system could work. While GAO has doubts about implementation and practicality, it would require too much work to prove it.

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Topics

DrugsFood and drug lawLaw enforcementMonitoringPharmaceutical industryPharmacological researchProgram evaluationProgram managementSafety regulationSafety standards