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Executive Summary

FDA EXOCRINE PANCREATIC INSUFFICIENCY DRUGS WORKSHOP will be held on April 23 to discuss testing procedures that will be required for NDAs for all OTC digestive aids for cystic fibrosis and chronic pancreatitis patients. The workshop will begin at 8:30 a.m. in conference rooms D & E at FDA's Parklawn Building in Rockville, Md. The idea of holding a workshop was suggested by FDA at a Nov. 26 meeting with the Cystic Fibrosis Foundation at which the parties discussed FDA's July 15, 1991 proposal that all exocrine pancreatic insufficiency products be considered new drugs requiring an approved NDA for continued marketing ("The Pink Sheet" Dec. 2, 1991, T&G-2). FDA also proposed that the products be available only by prescription. The agency is concerned that a pancreatic drug's formulation and manufacturing process may affect its safety and efficacy and believes that the issue can be best addressed under the NDA review process. Topics that will be considered at the workshop include design of studies "to show that the drugs provide and deliver the enzyme content that is declared on the container labeling and that the stated activity is released in the intestine to show that the drug will have bioactivity," a March 11 Federal Register notice announcing the meeting states. Workshop participants will discuss the appropriate study populations for these studies. FDA posed the following questions for consideration at the meeting: "Do cystic fibrosis patients have to be used in the studies, or can the needed information be obtained using normal volunteers?" and "Is it possible to use patients with other pancreatic insufficiency problems?" Other issues for the workshop are study endpoints, enzyme measurement, manufacturing controls, reference standards, dissolution rates, and enzyme content and labeling. Marketed OTC pancreatic enzyme drugs include: Hoechst- Roussel's OTC Festal II (the company also markets an Rx Festal), A. H. Robins' Donnazyme, Entozyme, Entolase and Viokase, McNeil's Pancrease, Organon's Cotazym and Zymase, Solvay's Creon and Vitaline's Pancreatin. FDA is reopening the administrative record for the OTC rulemaking for these products until July 23 to allow submission of comments resulting from the workshop.

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