FDA Regulations

Over the years, the Food and Drug Administration (FDA) has experienced major delays in developing and publishing regulations. For example, of 301 regulations published as proposed rules to obtain public comment as of April 1991, 217 had been pending for more than 5 years; two had been pending for 29 years. In GAO's view, FDA's ability to effectively address public health problems and enforce compliance with federal law is being jeopardized. Because FDA's management of regulation development and issuance has been generally ineffective, GAO supports the agency's establishment of a regulations council to oversee and direct management of the rulemaking process. GAO also believes that a single automated tracking system encompassing agencywide regulation activities is needed to improve management's oversight of the rulemaking process. GAO summarized this report in testimony before Congress; see: FDA Regulations: Sustained Management Attention Needed to Improve Timely Issuance, by Mark V. Nadel, Associate Director for National and Public Health Issues, before the Subcommittee on Health and the Environment, House Committee on Energy and Commerce. GAO/T-HRD-92-19, Apr. 1, 1992 (14 pages).

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.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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