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Executive Summary

GPIA INACTIVE INGREDIENT LABELING GUIDELINES EXCLUDE FROM TRADE SECRET exemption substances that can be identified by "modern analytical technology." The Generic Pharmceutical Industry Assn. (GPIA) guides, which the assn. submitted to FDA on July 29, state that an inactive ingredient need not be disclosed on Rx drug labeling "if its presence gives the mfr. an advantage over competitors who do not know or use it and if the identity of the ingredient cannot be determined by using modern analytica. technology." In a letter addressed to FDA Drugs & Biologics Center Director Meyer and attached to the guidelines, GPIA President Dee Fensterer cited the trade secret exemption as an illustration that the generic assn.'s guides are more stringent than those issued by the Pharmaceutical Mfrs. Assn. (PMA). "Although patterned after the labeling guidelines issued by the PMA, the voluntary guidelines adopted by our members are in some respects stronger or more explicit." Fensterer added that GPIA members "have already begun the process of revising their package inserts" so that "all Rx products packaged after Dec. 31, 1985 will be in full compliance" with the guidelines. In the filing, the assn. also asked FDA's aid in combatting what it called an "intensifying" antigeneric campaign by the brandname industry. Fensterer asked Meyer to consider launching "an active FDA program that informs the medical profession of the FDA standards for approving the inactive, as well as the active, ingredients of bioequivalent generic drugs." The campaign "questions the FDA's ability to assure the safety of inactive ingredients and the therapeutic equivalence of generic drugs," Fensterer said. GPIA sent same-day letters to Rep. Waxman (D-Calif.) and Sen. Hatch (R-Utah), coauthors of the post-1962 ANDA/patent extension law, to ask their help in stopping negative campaigning. "We believe the FDA must affirmatively address this challenge to its own regulatory standards, and we would welcome your assistance in this effort," the assn. said.

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