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Executive Summary

FDA's approval of OTC ibuprofen on the commitment from Whitehall and Bristol-Myers to include a hypersensitivity warning in consumer promotions goes beyond the agency's regulatory authority, McNeil asserted in a May 24 suit filed in D.C. Federal Court. Noting that "FDA has no authority to supervise, regulate or control the consumer advertising of OTC drugs," McNeil asserted that "FDA's approval of ibuprofen for OTC sale based on the consumer advertising 'conditions' agreed to by AHP and Upjohn is in excess of its statutory jurisdiction and authority, and is therefore unlawful." In support of its contention, McNeil cited the summary basis of approval (SBA) for OTC ibuprofen, in which FDA stated the conditions for approval. According to the SBA, NDA applicants "advised the agency" that their promotional material would include the name of the active ingredient, ibuprofen, in association with the brandname and would warn that aspirin-sensitive individuals should not take the product "at least during the introduction of ibuprofen into the OTC market." In a petition filed with the court on the same day, McNeil asked that it be given access to the background documents concerning the approval of OTC ibuprofen which it said would be the basis of its case that the agency acted improperly with regard to the consumer promotion agreement with the firms. The McNeil petition requests a court order requiring FDA to prouce by May 31 agency correspondence with American Home Products, Upjohn and Bristol-Myers; documents relating to meetings and discussions on ibuprofen consumer advertising; and agency correspondence with its Arthritis Advisory Cmte. since August 1983 and with the Federal Trade Commission. McNeil also wants the three companies' correspondence with FDA and with the ad agencies handling OTC ibuprofen by June 1 (for AHP and B-M) and June 4 (for Upjohn). "We have no desire to delay this litigation so as interfere with the launch of" Advil and Nuprin, McNeil stated. "On the other hand, we believe that the basis on which these drugs have been approved for OTC sale is a clear violation of the FDA's authority." McNeil contended in the complaint that FDA "entered into arrangements with AHP and Upjohn that effectively involve the agency in the supervision and control of ibuprofen consumer advertising, while at the same time creating the appearance that the agency is not asserting any jurisdiction over such advertising." "The sole standards for determining whether a drug may be sold for OTC use" pertain to a drug's labeling, the company argued. "They do not permit consideration of the effect of advertising on the safe and effective use of the drug." In March, McNeil submitted a petition to FDA maintaining that the labeling for OTC ibuprofen should be based on Rx package insert information as a condition of approval ("The Pink Sheet" March 26, T&G-1). The firm also stated that approval of ibuprofen should "not be conditioned upon the agency's control, on either a voluntary or mandatory basis, of consumer advertising for the drug." McNeil concluded in its suit that its sale of Tylenol "will be damaged" by FDA's approval of ibuprofen for OTC sale. In addition, the company said FDA's arrangements with AHP and Upjohn will have "far-reaching, and damaging, consequences for the OTC drug industry" since FDA could impose similar conditions on other marketers of OTC products.

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