Food and Drug Administration:

Insufficient Planning for Field Laboratory Consolidation Decisions

HRD-88-21: Published: Dec 4, 1987. Publicly Released: Jan 5, 1988.

Contact:

Janet L. Shikles
(202) 512-7119
contact@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

GAO found that FDA: (1) plans to close five of its field laboratories in order to reduce excess capacity; (2) did not consider any cost-effective alternatives to closure or the impact of closure on its future needs; (3) overstated some of the costs and savings it would realize from the proposed closure, and understated or omitted others; and (4) did not take into consideration possible increases in future shipping costs, sample transportation times, and laboratory processing times in making its decision.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

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

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

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

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

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

    Aug 13, 2014

    Aug 11, 2014

    Jul 30, 2014

    Jul 29, 2014

    Jul 23, 2014

    Jul 16, 2014

    Jul 15, 2014

    Jul 10, 2014

    Looking for more? Browse all our products here