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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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 for Executive Action

  1. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  8. Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

 

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