FDA Regulations:

Sustained Management Attention Needed to Improve Timely Issuance

HRD-92-35: Published: Feb 21, 1992. Publicly Released: Apr 1, 1992.

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Pursuant to a congressional request, GAO reviewed Food and Drug Administration (FDA) efforts to improve its rulemaking process, focusing on: (1) the number of FDA regulations that are either under development and review or in pending status; (2) the general causes for delays in issuing regulations; and (3) FDA plans to issue regulations in a more timely manner.

GAO found that: (1) as of April 1991, FDA had 388 regulations that it had begun to develop, but had not completed or published in the Federal Register as final regulations; (2) of the 388 regulations, 87 regulations were under development and review at the five FDA centers, and 301 regulations were published as proposed rules to obtain public comment; (3) 271 of 301 proposed regulations had been pending for more than 5 years; (4) the processing time for high-priority regulations is long, because such regulations require approval from both the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB); (5) factors that delay the issuance of regulations include the emergence of significant problems during the development process, required FDA, HHS, and OMB reviews, lack of resources, and the need to coordinate with other agencies; (6) high-level management involvement helps to ensure that regulations are issued relatively quickly; (7) FDA lacks an effective, agencywide comprehensive automated tracking system for regulations management; (8) in August 1991, FDA announced an initiative to focus management attention on the rulemaking process, streamline the process, and develop information systems to effectively manage the process; and (9) FDA also established a Regulations Council to oversee, direct, and manage the agency rulemaking process.

Recommendation for Executive Action

  1. Status: Closed - Implemented

    Comments: The FDA contractor completed prototype testing and an initial adjustment or familiarization process by agency personnel on July 30, 1993. FDA changed the date on which it plans to begin operation of an agencywide automated tracking system for all Federal Register documents from September 30, 1993, to March 31, 1994. This change was necessitated by additional unforeseen work associated with establishing the agencywide system. FDA continued to have problems, however, and further adjustments to the system were necessary. In the interim, FDA trained its staff on how to use the system. The system became operational on August 31, 1994.

    Recommendation: To improve internal management oversight of the FDA regulation process, the Commissioner, FDA, should develop a single automated regulation tracking system that: (1) monitors the progress being made on all regulations under development within the five FDA centers; (2) generates recurring reports to top agency officials and center directors; and (3) serves as the primary basis for identifying delays in issuing regulations and initiating appropriate actions, when necessary, to overcome internal delays in the development of individual regulations.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration


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