Summary: 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).
