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Executive Summary

FDA/INDUSTRY WORKSHOP ON PANCREATIC ENZYME NDA requirements may be convened in March. The idea for a workshop on pancreatic enzyme products, digestive aids used by cystic fibrosis and chronic pancreatitis patients, was suggested by OTC Products Division Deputy Director Gerald Rachanow at a Nov. 26 "feedback" meeting with the Cystic Fibrosis Foundation. The enzyme products are currently marketed OTC. "It would be beneficial to have some type of public meeting where all affected companies came and met with FDA and uniform [NDA standards] were developed in a workshop," Rachanow suggested. The agency was "looking target-wise toward early March" for the meeting, he added. FDA hopes to publish notice of the workshop in January, Rachanow said. "I wonder if the industry through your group [CFF] would be willing to come up with something to submit as a starting point" to help define NDA standards for the category, Rachanow asked. "If some background work is done over the next couple of months we could be a lot farther along . . . and have a fruitful discussion" at a workshop. CFF Exec VP-Medical Affairs Robert Beall, PhD, agreed to "touch base" with manufacturers of pancreatic enzyme replacement products and to respond to the agency within "two to three weeks." Marketers of pancreatic enzyme products include: Hoechst-Roussel (OTC Festall II), A.H. Robins (Donnazyme, Entozyme, Entolase and Viokase), McNeil (Pancrease), Organon (Cotazym and Zymase), Solvay (Creon) and Vitaline (Pancreatin). CFF requested a feedback meeting to respond to FDA's July 15 proposal to require all OTC exocrine pancreatic insufficiency drug products to have approved NDAs and to be available in future only by prescription. The proposed rule reversed FDA's 1985 Tentative Final Monograph for the category, which would have defined conditions to allow the products to remain OTC ("The Pink Sheet" July 15, T&G-16). FDA will "probably" go ahead and finalize the rule removing the products from the OTC market before the workshop, Rachanow said. Joining Rachanow and CFF at the feedback meeting were: OTC Products Office Acting Director Paula Bostein; members of FDA's Gastrointestinal and Coagulation Drug Products Division, including Director Stephen Fredd, MD; Office of Generic Drugs Executive Assistant to the Director Donald Hare; and representatives from Johnson & Johnson. Botstein reported that most comments on the proposed rule agree with CFF's position that the products should be prescription only. However, "the uniformity went away totally as I looked through the responses, because it's a tricky business to figure out how to bring these products under the NDA umbrella," Botstein said. FDA must determine "what to require that's consistent with having good products that do what they are supposed to do and yet not making too burdensome a requirement." FDA's Fredd said: "We're not doubting that these products have been used satisfactorily. We're trying to ensure that the active ingredients they say they contain will be released." The agency "really wants . . . no impediment to the availability of these products to patients," Fredd added. "Our purpose has been to get them studied, to get them available, to get them properly labeled." Suggested parameters that could be discussed at the workshop include manufacturing controls, dissolution and possible forms of controlled trials, Fredd added. CFF's Beall noted that 14,384 of 15,581 cystic fibrosis patients tracked by the foundation take pancreatic supplements. A mail-order pharmacy sponsored by CFF dispensed 2.6 mil. of McNeil's Pancrease tabs and 1.8 mil. of Solvay's Creon tabs in the year ended Oct. 31, Beall said. Because of the two products' high use rate and the existence of a body of "some 15" articles supporting their safety and efficacy, Beall proposed that Pancrease and Creon be chosen as "reference products" for the purpose of approving others. Botstein, however, noted that the agency may not be able to ensure that the products as manufactured today are the same as those used in previous trials.

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