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Executive Summary

SCHERING SEEKING FDA SUSPENSION OF COPLEY's ALBUTEROL SOLUTION ANDA approval in a motion for preliminary injunction filed against the agency in D.C. district court on Dec. 16. Schering-Plough's motion questions the scope of the agency's statutory authority to approve generic versions of albuterol sulfate solutions, which are nonsystemically absorbed, without satisfying the statutory definition of bioequivalence. A hearing is scheduled for Jan. 9. "Rate and extent of absorption has long been regarded as the touchstone of equivalence between drugs with respect to safety and effectiveness," the motion notes. "To waive the required showing of bioequivalence or to substitute a new definition of 'bioequivalence' for the statutory defintion departs from a clear Congressional mandate, and relies instead on unproven and unauthorized approaches for ensuring that generic copies are the same as products that have been shown to be safe and effective through extensive clinical testing," Schering argued. Copley Pharmaceutical's D.C. law firm, Akin, Gump, Hauer & Feld, noted that FDA's regulations allow companies to request a waiver of in vivo bioequivalence requirements when the products being tested are nonsystemically absorbed drugs. Copley received such a waiver for its ANDA for albuterol sulfate 0.5% solution for inhalation, which was approved on Nov. 27 as the first generic version of Schering-Plough's Proventil solution ("The Pink Sheet" Dec. 9, T&G-14). At the request of FDA, Copley has agreed to not sell its albuterol solution until Jan. 13. FDA made the request because it had promised Schering-Plough 10-days prior notice of any albuterol approval as part of ongoing litigation by the company over generic albuterals. FDA failed to give Schering advance notice of the Copley approval and so asked Copley to defer marketing. Schering initially petitioned FDA on Dec. 4, 1989, not to approve any ANDAs for nonsystemically absorbed drugs ("The Pink Sheet" Dec. 11, 1989, T&G-12). On June 29, 1990, FDA denied the petition by declaring that the agency has the authority to approve ANDAs based on local absorption data ("The Pink Sheet" July 16, 1990, T&G-2). In August 1990, Schering filed for declaratory and injunctive relief by challenging FDA's position that Schering's drugs are properly subject to generic competition. On Dec. 13, Copley filed a request in the D.C. Court for a declaratory judgment that FDA's "interpretation of the legal requirements for approval of generic copies of the drug albuterol sulfate solution for inhalation, 0.5%, is consistent with FDA's statutory authority; and that relying on that interpretation, FDA properly approved Copley's [ANDA]." Copley filed a motion on Dec. 18 to intervene in Schering's preliminary injunction request. Schering-Plough's Dec. 16 motion also requests that the preliminary injunction prohibit FDA "from approving ANDAs for copies of Schering's listed drugs that are nonsystemically effective drug products unless and until the ANDAs satisfy the requirement . . . for a showing of bioequivalence as defined in [the regulations]." Schering's memorandum to the court states that the company "stands to suffer substantial and irremediable economic and noneconomic injury as a consequence of FDA's action in approving a generic imitation of its products that does not satisfy the statutory health and safety criteria established by Congress." The firm estimates "that in the first year of sales of a generic, Schering's sales of Proventil Solution for Inhalation will decline by 35%, resulting in a loss of sales revenue for that product in excess of $ 13 mil."

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