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Highlights

Due to recent congressional concern about the significant decrease in the number of regulatory actions taken by the Food and Drug Administration (FDA), GAO reviewed FDA compliance activities to determine whether appropriate and timely regulatory actions are being taken against firms violating the law.

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Recommendations

Matter for Congressional Consideration

Matter Status
Congress should amend section 304(g) of the Food, Drug and Cosmetic Act by adding drug products to the language which gives FDA the authority to administratively detain medical devices.
Closed - Not Implemented

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services 1. The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop a mechanism to measure the extent to which voluntary corrective actions result in compliance.
Closed - Implemented
FDA developed a mechanism which uses data already in the field information system. This mechanism is reassessed periodically.
Department of Health and Human Services 2. The Secretary of Health and Human Services should require the Commissioner, FDA, to develop and distribute to all districts definitive policies on actions to be taken on violations involving medically insignificant drugs and technical violations of good manufacturing practice regulations.
Closed - Implemented
FDA believes that its current policy is adequate. Cases which demonstrate significant policy issues are distributed with appropriate policy analysis and interpretation.
Department of Health and Human Services 3. The Secretary of Health and Human Services should require the Commissioner, FDA, to provide additional guidance to the district offices on evidence required to support proposed regulatory actions.
Closed - Implemented
FDA issued regulatory procedures manual guidance regarding routine and nonroutine injunction and prosecution cases. This procedure will be periodically assessed and modified as necessary.
Department of Health and Human Services 4. The Secretary of Health and Human Services should require the Commissioner, FDA, to encourage greater coordination and communications among district investigators, district compliance officials, and headquarters officials to better ensure: (1) district and headquarters officials agree on actions to be taken; and (2) documentation to support recommended actions is appropriate.
Closed - Implemented
FDA initiated various activities to foster improved field headquarters communications. These include new procedures to speed up case processing and revised procedures for reviewing inspection warrant requests.
Department of Health and Human Services 5. The Secretary of Health and Human Services should direct the Commissioner, FDA, to revise the Inspection Operations Manual to require inspectors to: (1) determine the current status of all prior unresolved deficiencies; and (2) discuss the status of these deficiencies in subsequent inspection reports.
Closed - Implemented
A revision to the FDA Inspection Operations Manual, section 592, 31(a)(4), dated September 1984, adopted procedures which meet the intent of this recommendation.

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