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Executive Summary

FDA "FACTUALLY UNAWARE" OF "DRIFT" IN BRANDNAME MANUFACTURING PROCESESS, FDA Center for Drug Evaluation & Research Director Carl Peck, MD, told Generic Pharmaceutical Industry Association President Dee Fensterer in a Dec. 13 letter. Peck said while the agency is "unaware of any therapeutic problems that can be attributed" to cumulative formulation or manufacturing process changes made after market approval, FDA has no established procedure for analyzing the possibility of such "drift" in brandname products. He invited comment on any "specific problem situation" of which GPIA has knowledge. Peck referred to an April 17, 1989 Federal Register notice in which the agency announced its intention to establish a system under which FDA would track reformulated products, whether licensed under an NDA or an ANDA, for bioequivalence problems. The notice asked companies proposing to reformulate a product to submit voluntarily a history of that product's formulations. Peck noted that "the system was not actually set up due to the press of the other demands." He added that "applicants have not materially responded to our expression of interest in receiving voluntary submissions of data." Given "this lack of voluntary response and our own misgivings about how we would evaluate such data," Peck continued, "we do not expect to finalize a requirement for submission of such information." The letter is FDA's first detailed response to correspondence between the agency and GPIA begun May 31, when Fensterer wrote to Commissioner Kessler describing what she regarded as "significant differences" in the way FDA oversees the manufacturing processes of NDA and ANDA applicants ("The Pink Sheet" July 1, p. 9). Fensterer charged that NDA holders change manufacturing processes without notifying FDA and, in an Aug. 12 follow-up letter, urged FDA to adopt a brandname inspection program similar to that adopted by the agency for generic manufacturers early in its generic drug investigation ("The Pink Sheet" Aug. 19, T&G-9). Peck's response to GPIA concedes that "policies constructed with good intention can appear to collectively discriminate" between generic and brandname manufacturers, but adds that such "apparent differences" are due to the ongoing "rehabilitation" of the generic drug industry. The letter notes that Fensterer's call for the use of "for cause" and "not for cause" inspections of NDA holders is addressed in part by FDA's pre-approval inspection program and its biannual CGMP inspections. Peck said, however, that he does not agree with Fensterer's recommendation of "more and new inspections."

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