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Executive Summary

ALCON WANS IS NEW DRUG BECAUSE OF POST-1962 CHANGE IN CONDITIONS OF USE, FDA contended in a filing with the Supreme Court in opposition to Alcon's certiorari petition. Responding to Alcon's contention that additional warnings and precautions should not take a product out of grandfather status, FDA said in the brief: "Petitioners' argument misreads the court of appeals' opinion . . . The court rejected petitioners' claims to the grandfather exemption [because] the current label suggests use for conditions that were not listed in 1962." FDA's brief is in opposition to Alcon's appeal of a First Circuit Court ruling in September overturning a March 17 jury decision that WANS is not a new drug because it qualified for the grandfather clause exemption and was generally recognized by experts as safe and effective. In overturning the decision, the appeals court held that WANS did not qualify for the grandfather clause because "the conditions of use recited in their labeling and changed since 1962 and, second, there was no evidence whatever that, in 1962, the products were generally recognized as safe by qualified experts," FDA's brief states. Alcon's petition contends that the court of appeals misapplied precedent in requiring that some scientific testing for safety must have been performed prior to 1962 to fulfill the grandfather clause. Alcon's argument, that the Hynson, Westcott & Dunning case is not controlling because it involved only the evidentiary requirements for demonstrating effectiveness, and not safety, contains "no merit," FDA contended in its brief. "The court of appeals recognized that distinction, but correctly concluded that it provided 'no justification for ignoring the court's reasoning,'" FDA stated. FDA also responded to Alcon's contention that the court ignored expert testimony regarding the bioequivalence of WANS and Emerserts. "The court found," FDA asserts, "that the testimony was insufficient, as a matter of law, to prove that WANS and Emerserts -- a product that had been pulled from the market -- were bioequivalent." FDA added that even if bioequivalence had been shown, "all petitioners would have established is that WANS was functionally identical to an unapproved new drug, a product that cannot be legally sold."

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