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Executive Summary

FDA BIOEQUIVALENCE STUDY WAIVER LIMITATIONS is a policy option for FDA to eliminate the practice of "franchising" among generic drug manufacturers, the agency's Office of Drugs Director Peter Rheinstein, MD, declared at a Nov. 10 analysts meeting sponsored by L. F. Rothschild in New York. "There may be some changes in the FDA's waiver policy to make it consistent with our opposition" to the franchising concept, Rheinstein said, adding that FDA will be discussing the subject with industry groups "as soon as possible." FDA plans "to continue granting waivers of bioequivalence studies for single changes -- that is a change of plant site or a change of ownership not affecting direct management of the plant," Rheinstein explained. However, he said, "the agency currently believes that a bioequivalence study really establishes the ability of a particular ownership and management to produce a particular product in a particular plant. Thus it is opposed to this concept of franchising." ANDA franchising has occurred through" several schemes by which a single bioequivalence study has served as a basis for products from multiple manufacturers," the FDA official explained. Rheinstein observed: "One such scheme involves a bulk supplier [which] would sell a wet granulation to finished dosage form manufacturers. The bulk supplier itself would manufacture a single dosage finished product and perform the bioequivalence study, using that one single batch of finished product." Purchasers of the wet granulation "would use equipment specified by the bulk manufacturer; the purchasers would be given a right of reference to the bulk manufacturer's bioequivalence study and use that right of reference to get their own ANDAs. The finished dosage form would be manufactured in a different plant, under different ownership and different management," he said. "In another scheme, the holder of an approved ANDA would sell a part interest in that ANDA to an unrelated company," Rheinstein continued. "The ANDA holder would inspect the buyer's plant and determine whether the buyer's equipment and process were similar to its own. The buyer would use the ANDA holder's formulation to manufacture a product to be sold in the marketplace in addition to the product of the original ANDA holder. The result is two different products, made in two different plants with different ownership and management, sharing one ANDA."

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