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Executive Summary

FDA WILL DENY SCHERING's PETITION AGAINST ANDAs FOR NON-SYSTEMICALLY absorbed drug products, FDA Associate Chief Counsel for Drugs David Adams told a Food and Drug Law Institute conference June 19 in Brussels, Belgium. "The agency is going to deny that petition and that issue will probably be resolved in court," Adams predicted. Schering maintained in the petition, filed late last year ("The Pink Sheet" Dec. 11, T&G-12), that "the statutory requirement of bioequivalence cannot be satisfied" for nonabsorbable products and, therefore, ANDAs based on bioequivalence should not be accepted. Adams indicated that the Waxman/Hatch Act "does not on its face mean that [blood level studies are] the only way. The statute does not necessarily have to be read as [blood level studies] being exclusive to showing bioequivalence." He asserted that bioequivalence could be shown through other means such as in vitro studies, dissolution studies and skin blanching tests. At the meeting, attorney Paul Hyman (D.C. law firm of Hyman, Phelps & McNamara) suggested that "nothing in the statute or legislative history...makes it clear what the answer should be." Adams responded: "It is extremely unlikely that Congress intended by writing the statute this way to stop FDA's approval of topical products."

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