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Executive Summary

FDA USER FEE PROVISION INCLUDED IN SENATE APPROPRIATIONS CMTE. REPORT on an Agricultural Appropriations bill, which the cmte. passed at a Sept. 24 markup. The FDA funding measure "will permit the crediting directly to this ]FDA[ account of up to $5 mil. collected from new user charges to be implemented in 1986," the report states. The fees, to be charged to NDA and ANDA sponsors for new drug review, provide agency funding "in addition to the $394,044,000 appropriated by this cmte. for necessary expenses for FDA in fiscal year 1986," the cmte. noted. By approving the FDA-proposed user fee concept, the Senate cmte. has opposed the House Appropriations Cmte., whose July 18 report included language to prohibit FDA collection of user fees for NDA review ("The Pink Sheet" July 29, In Brief). The Senate panel "has stricken House bill language prohibiting the collection of user fees," the report notes. The House passed its Agricultural Appropriations bill on July 24. As proposed by FDA, up to $5 mil. of user fees collected would be retained by the agency for use in new drug review; funds beyond $5 mil. would be submitted to the general Treasury. "This ]$5 mil.[ amount is to be retained by FDA and used for improvements in the new drug approval process. This will allow the agency to process and approve NDAs more expeditiously so that better pharmaceutical products are available to combat disease affecting the American population," the Senate panel explained. The Senate cmte.'s $394 mil. appropriation is $1.7 mil. more than the House allowance of $392.4 mil., and $6.9 mil. more than FDA's FY 1985 funding level of $387.2 mil. The additional revenue from user charges would raise the agency's total funding to $399 mil. Like the House measure, the Senate Appropriations bill earmarks "not less than $3.5 mil." for orphan products and stipulates that "not less than $1.8 mil. of the total amount shall be used for funding orphan product grants." Unlike the House bill, the Senate cmte.'s report makes no stipulation regarding AIDS products. The House specified that $2 mil. be channeled to speeding availability of AIDS diagnostic kits. If the Senate bill passes the full Senate, differences with the House version -- such as the user fee provision -- will have to be reconciled in a House/Senate conference. The deadline for Congress to enact an agricultural appropriations bill has been deferred from Oct. 1, the start of the fiscal year, to Nov. 14. Because the legislature has passed no funding measures for FY 1986, it has enacted a continuing resolution, H.J. Res. 388, as a stop-gap measure to continue funding for all federal programs at their present fiscal 1985 levels until Nov. 14. The House passed the measure (272-152) Sept. 18, and the Senate Appropriations Cmte. approved it without change on Sept. 24. FDA funding has depended upon continuing resolutions the last two years; the most recent agricultural appropriations bill to be enacted was for fiscal 1983.

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