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Executive Summary

NONBINDING FDA GUIDELINES POSE DECREASE IN INDUSTRY-FDA INTERACTION, PMA says, because guidelines and advisory opinions not binding on the agency "would be of little value if the FDA subsequently changes its mind" so firms would request them less often. Under a proposed revision of administrative practices published in the Oct. 15 Federal Register, advisory opinions and guidelines would no longer "be construed to bind FDA legally to a particular course of action." The Pharmaceutical Manufacturers Association submitted its comments to the agency Dec. 14. The proposal explains that the revision is warranted because of a small number of court cases in which it was alleged that advisory opinions and guidelines procedures appeared to bind the agency to certain actions in conflict with the "general principle that the government may not be estopped" from enforcing other applicable statutes. In addition to eliminating the binding nature of advisory opinions/guidelines, the proposed revision "would make clear that FDA can initiate regulatory action when consistent with the applicable statutes and regulations." The proposal emphasizes that although the agency would no longer be bound by advisory opinions and guidelines, advisory opinions would still "represent the agency's best advice on the matter at issue at the time they are rendered," and guidelines would continue to provide "useful information about procedures or practices that the agency believes are generally desirable." The proposed revision would not affect final orders, such as those issued through formal rulemaking. PMA particularly objected to the proposal's retroactive liberation of FDA from guidelines and advisory opinions promulgated in the past. PMA said this power would "permit the agency to bring legal action against a party which has relied in good faith, and to its detriment, on the formal advice issued by the agency." Such action "might engender public perceptions that the FDA was arbitrary and capricious," PMA said. If the proposal is adopted, the trade association asked that "its effect be prospective only." PMA noted that FDA advisory opinions and guidelines "may be amended or revoked at any time, provided proper notice is given." Therefore, the trade group said, "the only action which FDA is estopped from taking is enforcement action against a party conforming its conduct in reliance on an advisory opinion or guideline." If decisions were not binding on the agency, PMA speculated that FDA "would be less likely to devote its limited resources to giving a thorough consideration to the issues covered by advisory opinions or guidelines." The proposal is "unreasonable" and "unfair" because it would "require businesses to operate under a system which would constantly be fraught with uncertainty and unreliability," the group said. Comments jointly submitted Dec. 14 by the Nonprescription Drug Manufacturers Association, the Cosmetic, Toiletry, and Fragrance Association, Health Industry Manufacturers Association and the Grocery Manufacturers of America also argue against the proposal on grounds similar to those voiced by PMA. The groups said they oppose the revision because "formal advisory opinions and guidelines that bind the agency provide needed clarification and certainty to persons attempting to comply with statutory and regulatory requirements and also benefit the agency by assuring consistency in the actions taken by its employees." "Although existing case law may not clearly define the status of intermediate pronouncements such as advisory opinions and guidelines, FDA should not discard these useful documents by taking the position that such pronouncements are as meaningless as oral advice received from a single agency employee in the field," the groups said. The manufacturers' associations also argued that "in all likelihood, FDA will face greater demands on its time and resources" if the proposed rule is made final. "FDA may save a small amount of time by dispensing with the need to announce changes to previously issued advisory opinions and guidelines, but this insignificant saving will be more than offset by the agency's need to litigate more cases where regulated parties believe that they have been treated in an arbitrary fashion whenever the agency deviates from its formal advice." Other groups that have submitted comments in opposition to the proposed rule have raised concerns similar to the health care and grocery trade groups. They include the American Association of Blood Banks and the Washington, D.C. law firm of Arnold & Porter.

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