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Executive Summary

OTC DRUGS APPROVED VIA ANDAs SHOULD REQUIRE IDENTICAL LABELING ONLY IN WARNINGS and directions for use, Chattem asserted in recent comments to FDA objecting to a citizen petition by the D.C. law firm Royer, Shacknai and Mehle. The petition, filed in January, requested that FDA not rate as therapeutically equivalent any two drugs not regarded as the "same" (e.g., drugs that do not have the same labeling) under the Waxman/Hatch law. Chattem stated that "the rigid application of the Royer, Shacknai interpretation would fly in the face of FDA's conclusion on OTC exclusivity policy and would operate anti-competitively, frustrating the intention of Congress to promote competition in the pharmaceutical industry." Chattem asserted that "it would serve no useful purpose to effectively preclude essentially marketing copy (e.g., 'pleasant tasting' or 'new' or 'in a convenient foil pouch') by determining that such language causes an ANDA OTC candidate drug to be determined to be different from the pioneer drug in 'one or more material respects.'" In a follow-up response to Chattem, attorney Jonah Shacknai stated in a May 9 submission to FDA that the Royer, Shacknai petition, if granted, would not require "identical" labeling on ANDA'd drugs. "It should be evident from even a casual reading of the Drug Price Competition and Patent Term Restoration Act that terms such as 'pleasant tasting,' 'new,' or 'in a convenient foil pouch' do not come under the Act's 'sameness' requirement," Shacknai said. "Such terms do not bear on the question whether a drug contains the same active ingredient as another, is intended for use under the same route of administration as another, is in the same dosage form or at the same strength as another, or is bioequivalent to another." Chattem also maintained that Royer, Shacknai & Mehle did not identify for whom the petition was filed, and also did not include an environmental impact statement in the petition. With regard to the former, Shacknai said FDA regulations only require that a petition be signed in order that the agency can verify and clarify assertions of facts by petitioners. He noted that the firm did not include an environmental impact statement because the petition requested only "compliance with the law."

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