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Executive Summary

BUFFERIN "BETTER TOLERATED" CLAIM GETS QUALIFIED GO-AHEAD FDA at an OTC feedback meeting between representatives of the agency and Bristol-Myers Squibb June 19. Discussing when Bristol-Myers Squibb could begin using a claim for Bufferin of decreased stomach upset, FDA Director of OTC Drug Evaluation William Gilbertson suggested: "You could probably make them now without any action." He noted that "similar claims have been in the rulemaking already. They're basically Category III claims." The meeting was requested by Bristol-Myers Squibb after a March 7 feedback letter from FDA that favorably reviewed a series of studies Bristol submitted in 1987-1988 in support of a Category I stomach protection claim for Bufferin in the OTC monograph for internal analgesics ("The Pink Sheet" March 26, p. 16) The agency said the studies -- conducted with Tri-Buffered Bufferin, Extra-Strength Tri-Buffered Bufferin, and Arthritis Strength Tri-Buffered Bufferin -- "provided adequate evidence" of the formulations' efficacy "in decreasing the incidence of aspirin-related stomach upset in subjects with a history of intolerance to aspirin" during short term use. One issue that drew FDA concern was whether Bristol-Myers Squibb would agree to do endoscopic and long-term studies to find out if Bufferin is objectively safer (causes fewer ulcers in the stomach lining) than plain aspirin, in addition to causing fewer subjective symptoms, such as stomach upset. Another major concern was whether monograph standards can be developed to measure other buffered aspirins' ability to support a decreased stomach upset claim. On this issue, in order "to ensure that other products would show the same benefit...we'll need data on the batches used in the clinical trials, composition and release specifications that you used in terms of accepting batches ...[and] manufacturing control information," Stephen Fredd, MD, Director of Gastrointestinal and Coagulation Drugs, informed Bristol-Myers Squibb at the meeting. The company already has supplied pharmacokinetic data on extent and rate of dissolution and route of elimination to the agency, Arnold Marcus, Bristol's director of regulatory affairs, R&D, noted at the meeting. The company is also preparing data "for each concentration of aspirin, on the total acid neutralizing capacity of each product as determined by the method made official in the antacid monograph." With regard to the additional studies sought by FDA, Bristol-Myers VP and Director of R&D George Blewitt said that while the company would "consider" the studies, the firm had no current plans to undertake them. However, Bristol-Myers was urged to do additional studies by Office of Drug Evaluation I Director Robert Temple, MD. Admitting that the further studies are not "have-to-dos," Temple observed: "I'm not telling you your business. Anything with a claim that it's better tolerated is plainly going to do well. But if you could also show fewer ulcers each day in the course of 10 days, you could replace other aspirins." Temple also asked: "Could you explain why not an NDA? We don't fundamentally care, but why would you rather [add the better tolerance claim] through the monograph?" Blewitt responded: "Frankly, there are those of us [at the company] who feel that there's enough exclusivity here in terms of what has been done, since we're the only ones who did the studies."

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