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Executive Summary

CONTRACT RESEARCH LAB REGS TO DEFINE RELATIONSHIPS between the testing labs and generic drug companies should be implemented as part of the reforms growing out of the generic drug investigations, the American Pharmaceutical Association suggested in recent comments to FDA. The agency "should promulgate regulations which will specifically address the nature of the relationship between generic drug manufacturers and the independent contract research laboratories that perform definitive bioequivalency studies," APhA said. The pharmacy group's comments respond to an FDA notice published in the Feb. 21 Federal Register that asked for suggestions on how to improve the generic drug approval process. APhA also recommended that "tighter control procedures for drug product sample control and retention should be implemented" for contract testing labs. The association weighed in strongly against vested stakes in the outcome of contract research, suggesting that "the ability of such laboratories to have an equity interest in a product should be prohibited." APhA's focus on contract research labs reflects pharmacy concern that some companies have or could submit fraudulent drug samples to contract research labs for bioequivalence tests. That concern derives from revelations that Bolar and Vitarine may have switched innovator products for generic versions of its own drugs that were sent to the contract research lab, PharmaKinetics, for bioequivalence testing. FDA has developed regulations that will require the retention of samples of drugs used to conduct bioavailability and bioequivalence studies. According to a regulatory agenda for FDA published in the April 23 Federal Register, the agency disclosed a tentative deadline for the regs in interim rule form by the end of May. However, FDA is unlikely to meet that deadline since the regs were sent to the Department of Health and Human Services for review, and HHS sent them back to FDA. Once HHS clears them, the regs still have to go to the Office of Management and Budget for approval. The retention of testing samples was proposed by FDA as part of its plans for revamping the generic drug approval process. In an April 6 letter to FDA Acting Commissioner Benson, House Energy & Commerce Committee Chairman Dingell (D-Mich.) put on record some of his recommendations for the generic drug review procedures ("The Pink Sheet" April 16, p. 6). Dingell spotlighted contract labs with the suggestion that FDA tighten requirements and inspections.

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