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Food and Drug Administration: Insufficient Planning for Field Laboratory Consolidation Decisions

HRD-88-21 Published: Dec 04, 1987. Publicly Released: Jan 05, 1988.
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Highlights

In response to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) plans to close or consolidate its field laboratories, particularly the: (1) criteria it used to determine which of its laboratories to close or merge; (2) cost-effectiveness of the closings; and (3) impact of the closings on FDA ability to carry out its functions.

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 defer decisions regarding laboratory closure/consolidation until FDA has developed a long-range plan based on its future program needs. This plan should identify the extent to which vacant work stations may be in excess of current and future laboratory needs. If a significant amount of unused and unneeded laboratory capacity is identified, the Secretary should direct the Commissioner to explore the full range of alternatives available to deal with the problem.
Closed – Not Implemented
FDA dropped its plan to close laboratories. If laboratory closings are considered in the future, the recommendation would be valid.
Department of Health and Human Services In considering the closure/consolidation option, the Secretary of Health and Human Services should direct the Commissioner, FDA, to identify the laboratories for closure/consolidation by evaluating all appropriate factors, including forecasts of future analytical needs, to ensure that the resulting laboratory network can support the FDA consumer protection mandate in a timely, cost-effective manner.
Closed – Not Implemented
FDA dropped its plan to close laboratories. If laboratory closings are considered in the future, the recommendation would be valid.
Department of Health and Human Services In considering the closure/consolidation, the Secretary of Health and Human Services should direct the Commissioner, FDA, to develop accurate and comprehensive costs/savings analyses detailing the economic consequences of closures decisions.
Closed – Not Implemented
FDA dropped its plan to close laboratories. If laboratory closings are considered in the future, the recommendation would be valid.

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Business Regulation and Consumer Protection
Agency missionsCost analysisFacility managementFederal facilitiesFood and drug lawInspectionLaboratoriesRegulatory agenciesTest facilitiesFood