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Executive Summary

P-A's Rx-to-OTC Task Group can now get down to the issue of exclusive NDA rights for ingredients switched from Rx to OTC. FDA's May 18 approval of 200 mg dosage of ibuprofen for OTC marketing by Whitehall and Bristol-Myers (B-M) clears away the roadblock of a pending major NDA application and permits the assn. to take up the underlying policy issue -- are switched ingredients suitable for NDA filings or are they generally recognized as safe and effective based on long marketing histories. The task group -- appointed by P-A after the ibuprofen issue boiled to a near-crisis last winter -- has held several meetings, but reportedly has found the pending ibuprofen NDA as a block to most substantial discussions of future Rx-to-OTC switch policy. P-A Senior VP-General Counsel Dan O'Keefe reported on the progress of the Task Group at a May 14 breakfast session during P-A's 1984 annual meeting. O'Keefe indicated that the task group had reached a near impasse; he said the group "has met several times and it may meet several more times." P-A Chairman Charles Pergola identified the switch issue as one of the key subjects facing the industry in his chairman's address to the annual meeting. Pergola said the argument over the procedure for moving ibuprofen to OTC "bared the raw edge of serious issues still unresolved about switch." O'Keefe noted that the assn.'s long-term goal is to assure that the OTC Review decisions do not produce monographs which become "mere cookbooks" for future product development. "As the OTC Review moves into the next stage," O'Keefe said, "industry must consistently strive to keep FDA focused on the need to avoid stagnation in the OTC field. A mechanism must be found to assure that switch decisions are considered by the agency and to assure that the monographs resulting from the OTC Review do not become mere "cookbooks." Exclusivity Issue Under Review At OMB Along With A Package Of FDA Proposals -- Altman Reports Pergola noted that the debate over the assn. position in the ibuprofen switch argument "tested, as few things have done, the meetle of this assn. against the pressures of our competitive marketing system." Pointing out that the "ibuprofen issue has not been resolved yet," Pergola maintained: "We are able to discuss strong differences of opinion while maintaining reason and by acting in the common benefit to the assn., the industry and ultimately the consuming public. Diplomacy and statemanship prevailed." Pergola cited the switch task group as an example of the assn.'s "clearer understanding of what this assn. can and cannot do in such matters." The metaproterenol switch and reversal, Pergola said, will also stand as an important lesson for the industry and FDA about future switch procedures. "The metaproterenol situation over the past year," the P-A chairman said, "has made the FDA aware, as never before, that there is the need for govt. planning, for process, for consistency and for consultation on switch decisions." Pergola pointed out that "false starts are bad for everyone concerned: for FDA, the mfr., the industry, health professionals, and the consumer." P-A's outside counsel, Robert Altman, Clifford & Warnke, reported that the FDA exclusive labeling terms proposal (exclusivity proposal) is under review with a package of FDA material at the Office of Management & Budget (OMB). "Exclusivity," Altman said, "is apparently but one of a package of proposals by FDA under simultaneous review by the OMB and that office has requested further time to consider the entire package." Altman predicted that "at least some relaxation of the rule -- if not its complete abandonment -- will occur." He said that P-A believes that the FDA version of a Federal Register notice on exclusivity already is at OMB.

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