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Executive Summary

Pioneer manufacturers should be allowed to "capitalize freely" on exclusive label indications in promotional campaigns, D.C. attorney Frank Sasinowski (Hyman, Phelps & McNamara) said at a Food and Drug Law Institute conference March 28. Sasinowski, a former FDAer, maintained that "FDA should relax its strict interpretation of 'new use' exclusivity in product promotional material." This flexibility would permit a company to "recoup its research and development" expenditures, he added. "I think everyone will benefit, both pioneer and generic [firms], because even after the three years, if you have far more indications that are available for everyone to market the product, then everyone will benefit in that wider marketplace," Sasinowski said. "But I think in order to keep that stream of new uses flowing you have to get something of meaning [and] that means exclusivity." In support of his view, Sasinowski cited the NAPM v. Ayerst case. Ayerst had sent out a "Dear Pharmacist" letter warning that generic substitution of Inderal for post-MI might result in pharmacist liability. The court did not find the letter to be "deceptive as a matter of law" ("The Pink Sheet" May 11, p. 11). Sasinowski noted that after the court concluded that FDA had approved Inderal for that exclusive indication, it said: "Having encouraged Ayerst to compete aggressively on the merits, we should not punish its innovative success." Sasinowski also predicted that companies could "hook" their new use exclusivity on to new dosage forms to block out market competition. The development of these types of products, Sasinowski said, would waste money and resources, increase the number of applications pending at FDA, and cause "a hopeless morass" in the drug "armamentarium" for pharmacists and doctors. FDA Associate Chief Counsel for the Center for Drug Evaluation and Research (CDER) David Adams also pointed out that the new use exclusivity provisions will cause "a proliferation of products that will be based on companies coming up with unique dosage forms." He noted that "it's important and really a benefit [to have] exclusive rights for this new indication on your label." Adams said he agrees with the provisions, but "it's not clear to me how FDA is going to be able to or even want to change its basic policies in terms of allowing companies to go as far as [Sasinowski] may have suggested . . . in terms of this sort of labeling." Adams suggested that "there may be some room for fine tuning this sort of advertising if you want to bypass FDA again, but I can tell you, quite honestly, I really don't think that's the answer to the problem of new use exclusivity not having a great value." The FDA counsel said that the answer is "probably going to be more creativity in terms of thinking of ways to advertise your product without directly or indirectly talking about the fact that you improved on the generics or not making at least [a] direct or indirect suggestion that they're not therapeutically equivalent." "I think there are things that you can talk about with Ken Feather in the advertising division of FDA" that have not been identified by FDA as inappropriate, Adams reassured. He added: "I think there's still room for creativity and for working some things out" and for finding "interesting and creative ways to advertise your product."

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