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Executive Summary

FDA APPROPRIATIONS: NEW DRUG REVIEW PROCESS WOULD BE LENGTHENED as a result of the Senate Budget Resolution's $403 mil. FY 1987 appropriation for the agency, Com. Young warned at a hearing before the Senate Agriculture Appropriations Subcmte., April 28. An appropriation of $403 mil. would result in "a substantial slowdown in the approval process," Young testified. "Instead of our hoped-for decrease in approval time from 24 to 12 months on NDAs . . . we would approach 40 months." Subcmte. Chairman Cochran (R-Miss.) pointed out that the 1987 "budget resolution being considered by the Senate today provides authority for this agency of only $403 mil." and asked what effect such an appropriation would have on FDA's "ability to discharge its legal responsibilities." Young responded that if the resolution were enacted it would have "grave consequences." In addition to the impact on NDA review, "our device approval [process], which is already in substantial difficulty, would be slower," Young said. The Senate Budget Resolution's FY 1987 appropriation for FDA is $43 mil. less than the Administration's budget proposal would earmark for FDA. The Administration requested $449 mil. in funding for FDA in fiscal 1987 -- $423 in appropriations (of which $156 mil. would be earmarked for drugs and biologics) and $26 mil. in user charge revenues ("The Pink Sheet" Feb. 10, p. 7). Young said $11.4 mil. of the projected $26 mil. in user fee revenues would go toward FDA's operational budget for existing needs, while only $14 mil. would be used for improvements in new drug evaluation. Young was asked by Cochran whether the Administration would push for enabling legislation for authority to collect user fees for new drug review or whether FDA would simply settle for an appropriation of $423 mil. if the proposal for the third consecutive year receives no congressional support. Young replied: "Not only is the $26 mil. dependent on the user fees, but also $11.4 mil. of our existing operational budget" is within that amount.

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