FDA Regulations: Sustained Management Attention Needed to Improve Timely Issuance

GAO commented on the Food and Drug Administration's (FDA) rulemaking process, focusing on: (1) the amount of time it takes FDA to issue regulations; (2) factors that cause delays; and (3) FDA efforts to reduce delays and improve its rulemaking process. GAO noted that: (1) within the past 30 years, FDA has accumulated 388 regulations that it began to develop but never completed or published as proposed rules for public comment and never reserved as final rules; (2) of the 388 regulations, 51 percent were in an active work status as of April 1991 and the remaining 49 percent were either in an inactive status or the status was unknown; (3) the average length of time that the 301 regulations reviewed were in pending status awaiting publication in the Federal Register was 9 years; (4) 14 regulations that FDA considered to be significant took an average of 5 years to develop and issue; (5) 45 regulations required by federal statue had been in process for an average of 4 years; (6) factors that contribute to delays in the issuance of FDA regulations include lack of resources, required FDA, Department of Health and Human Services, and Office of Management and Budget reviews, and the need to coordinate with other agencies; (7) FDA lacks a comprehensive automated tracking system to monitor its rulemaking activities; and (8) FDA established a Regulations Council to oversee and direct the management of the rulemaking process.