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FDA user fees

This article was originally published in The Rose Sheet

Executive Summary

CTFA and GMA are among 30 groups protesting additional FDA user fees in a Feb. 16 letter to Rep. Richard Durbin (D-IL), chair of the House Appropriations/FDA subcommittee. The groups oppose user fees because "the full commitment of the federal government is needed to ensure public confidence" in FDA and because user fees amount to "a tax" that will ultimately be "borne by the consumer," the letter says. The user fee provisions of the Prescription Drug User Fee Act of 1992, which stipulated that fees be used to accelerate the prescription drug approval process, are not applicable to the personal care products or food industries, the groups add. The administration's fiscal 1995 budget request includes new FDA user fees of $228 mil. to be collected "from industries other than prescription drugs, medical devices and mammography" ("The Rose Sheet" Feb. 14, p. 7)

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