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Executive Summary

SENATE's FDA FY 1993 BUDGET IS SAME AS HOUSE SPENDING BILL: $778.1 MIL. represents an $18.2 mil. (2.5%) increase over the agency's fiscal 1992 budget. The amount is $13 mil. below the Administration's fiscal 1993 budget estimate, which includes $200 mil. from user fees. The Senate agriculture/FDA appropriations bill was marked up by the agriculture appropriations subcommittee on July 21 and cleared the full Senate Appropriations Committee by voice vote on July 23. The House passed its agriculture/FDA appropriations bill on June 30. Like the House bill, the Senate bill would grant FDA $744.1 mil. for salaries and expenses in FY 1993 while holding appropriations for buildings and facilities ($8.35 mil.) and rental payments ($25.6 mil.) at fiscal 1992 levels. However, unlike the House committee report, the Senate report pays at least lip service to the proposal for consolidated FDA facilities. The Senate committee noted its support for "the construction of modern consolidated facilities for FDA as authorized in the Food and Drug Revitalization Act of 1990" but said that "budget constraints have not made it possible to include funding for this project in this bill." Instead, the committee encouraged "the Administration to move forward on consolidated facilities for FDA and to submit a budget request accordingly." The Senate budget for FDA provides less funding than the agency wanted but is not as bad as some dire FDA forecasts. Speaking at an FDA Council forum on July 20, Deputy Commissioner for External Affairs Carol Scheman expressed concern that the Senate's FDA spending bill would not "be close to" the Administration's budget estimate or the House budget. Scheman also declared that FDA is "in very big trouble" due to funding shortfalls and pointed out that the agency recently implemented a hiring freeze through FY 1992. Commissioner Kessler, meanwhile, has been scrambling to develop a consensus on user fee legislation among industry groups and key congressional figures ("The Pink Sheet" July 20, T&G-8). The executive committee of the Pharmaceutical Manufacturers Association's board discussed user fees July 23 and subsequently issued a statement that it "authorized continuing detailed discussions" between an industry task force and FDA. Reiterating PMA's long-standing position that any user fees should add to baseline appropriations and be dedicated to improving the product approval process, the executive committee said the discussions are aimed at identifying FDA's personnel and "management infrastructure" needs "to cope with expected approval workloads"; develop FDA performance goals based on both existing and increased resources; suggest ways for "independently assessing" progress toward those goals; and evaluate fee structures needed to generate additional resources. The Administration's user fee strategy has apparently hurt FDA's funding for the upcoming fiscal year; both congressional appropriations committees ignored the Administration's overall budget estimate (with $200 mil. from user fees) and are taking credit for providing $187.1 mil. above and beyond the Administration's appropriations estimate for FDA. In addition, the Senate committee report, like the House report, takes the Bush Administration to task for repeatedly including user revenues in its budget estimate for FDA despite the lack of congressional authorization for such fees. The report notes that the Senate Appropriations Committee "concurs with the House in expecting [HHS] to present credible appropriations requests in the future and not to rely on fictitious, unauthorized user fees for FDA as a means to offset other departmental needs. The committee directs that future budget proposals be based on current law." In rejecting the Administration's FDA budget proposal to fund $200 mil. in agency fiscal 1993 salaries and expenses via user fee revenues, the committee pointed out "that no authorization has been provided by Congress for user fees, and that the Administration's proposal assumes unrealistic collections that would be inadequate to operate the agency." The report also questions FDA's stepped-up enforcement activities. "The committee shares the concern of the House about reports of certain inefficient and excessive enforcement actions by the FDA, coupled with a continuing backlog of pending [NDAs and ANDAs]," the report states. "In considering future requests for enforcement funding, the committee intends to review FDA's efforts to eliminate the backlog and to achieve compliance with this statutory requirement for generic and brandname drugs." The report adds that "FDA is expected to apply its regulatory standards uniformly and consistently." Typical of appropriations bill reports, the Senate report contains several items of special interest to committee members. Included in the report language is a stipulation that "not less than $12 mil." be provided for FDA's orphan drug program, including "no less" than $9.145 mil. for extramural grants and contracts. The report also asks FDA "to consider allowing limited utilization of photopheresis for the treatment of scleroderma while reconsidering the therapy under the accelerated approval initiative." The committee report also specifically recognizes "the need to increase the number of trained biomedical scientific personnel in clinical pharmacology" and notes the committee's support for "the concept of a pilot training program for clinical pharmacologists." The Senate Appropriations Committee also voted on July 23 to add six noncontroversial amendments to the bill and 12 additions to report language. Only one of the changes affected FDA -- an amendment to the report language urging the agency to continue to assist women concerned with breast implants.

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