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FDA INTERNAL REVIEW AND SIGN-OFF PROCEDURES FOR REGULATIONS

Executive Summary

FDA INTERNAL REVIEW AND SIGN-OFF PROCEDURES FOR REGULATIONS are the subject of an information request by Edwards Committee member Richard Merrill in a Sept. 21 memo to the committee's Executive Director Eric Katz. Merrill, a former FDA chief counsel and a professor at the University of Virginia School of Law, is a member of the committee's Foods, Cosmetics and Veterinary Medicine subcommittee. Merrill said the committee would like to see "the numbers of proposals and regulations leaving the centers, dates of departure, dates of Commissioner-approval, along with some description of the approval route outside the centers." The Edwards committee member said he also wanted to see "the official list of offices/officials with clearance authority" and "an account of all of the offices which are given an informal opportunity to see and comment on a proposal/regulation." In explaining his request, Merrill said he suspected that "one of the hidden causes of delay" at FDA "is the inclination of agency managers to allow everyone who asserts an interest an opportunity to see and comment on draft documents." He continued: "My impression is that there is often a reluctance to cut anyone out of the loop because of the costs of internal dissent, particularly if the dissent might later surface publicly in the trade press or at a congressional hearing." The former FDAer noted that this type of information cannot be derived from "data alone; one must talk with participants and examine examples." The committee member also requested more detailed accounts of FDA's regulation-making process. Regarding the committee's request to FDA for information, Merrill said that he is concerned that "it will elicit rather formal boiler-plate kinds of answers and data, rather than sensitive narrative descriptions of the regulation-issuing process." Merrill continued: "I don't believe FDA will be able to contribute much to our knowledge of the OMB [Office of Management and Budget] process -- beyond the data that [Acting Commissioner] Benson has already supplied -- unless we get them to describe some of the more egregious instances of delay." He added that "aggregate data disguise the outliers, which are often high-visibility, high-controversy proposals/regulations." Delays in promulgating regulations is a criticism that has often been leveled at FDA, and it is an issue that has been brought up during meetings of the Edwards Committee. The panel's recently issued interim report proposes several approaches for improving the process, including "delegating the commissioner authority to issue regulations directly, an arrangement that existed prior to 1981, and streamlining or eliminating multiple levels of review for budget, legislative and regulatory proposals" ("The Pink Sheet" Oct. 1, p. 10). The committee also wants data on "all forms" of FDA enforcement activity, including seizures, injunctions and regulatory letters, Merrill said. The panel would like the information "both by center and by category of action (e.g., economic violations, GMP violations, safety hazards, etc.)." He emphasized that the data should go back 20 years, and not 10 years. "The 10-year data will not reveal whether there were significant changes in the level of enforcement activity following Reagan's election, something that has been charged by Sidney Wolfe [Director of Public Citizen's Health Research Group] and others."

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