FDA USER FEE PROVISION FOR OTCs, DIETARY SUPPLEMENTS AND DEVICES DROPPED

FDA USER FEE PROVISION FOR OTCs, DIETARY SUPPLEMENTS AND DEVICES DROPPED from the FDA fiscal 1994 appropriations bill that emerged from conference committee on Aug. 3 and was passed by the House on Aug. 6. At press time, the Senate had not yet voted on the bill. Based on a Clinton Administration budget proposal to extend user fees to OTCs, foods and devices, the Senate Appropriations/agriculture subcommittee had proposed to raise $ 175 mil. by extending user fee collection beyond prescription drugs to cover other industries regulated by FDA ("The Tan Sheet" July 26, p. 16). The provision in the Senate appropriations bill covering expanded user fee collection ran into trouble during floor debate on July 26 when several committee members and key Senate health legislators expressed reservations about the feasibility and fairness of the provision ("The Tan Sheet" Aug. 2, p. 14). The Nonprescription Drug Manufacturers Association has not supported user fees for OTC drugs beyond Rx-to-OTC switch applications, which are covered in last year's user fee bill for prescription drugs, and is opposed to user fees that are not dedicated to enhancing FDA review activities. The conference agreement provides FDA with $ 867.3 mil. for salaries and general expenses (including the $ 54 mil. in Rx user fees), $ 8.4 mil. for buildings and facilities and $ 48.6 mil. for rental payments. Both the House and Senate had approved $ 54 mil. in prescription drug fees, which is consistent with funding levels contained in the law passed last year that authorized collection of prescription drug user fees. The House-Senate compromise retains House provisions to shift some of the Clinton Administration's proposed allocations in order to provide budget increases for FDA's orphan drugs and generic drugs programs. The House had proposed to allot $ 15.2 mil. for orphan drugs, up by $ 3 mil. from the administration request, and $ 46.6 mil. for generic drugs, up by $ 4 mil. The House derived the monies by reducing funding the administration had earmarked for new immunization-related activities at the Center for Biologics Evaluation and Research; the reduction was justified based on the overall scaling-back of the administration's child immunization initiative. The House proposed to provide CBER with $ 130 mil., including $ 10 mil. for immunization activities and the full administration request for CBER's current programs. The Senate Appropriations Committee concurred with the House's increase for orphan drugs and noted concern about generic drugs although it did not specifically address the House's funding level for generics. Since the generic funding provision was not listed by conferees as an item in disagreement, however, the House's figure stands. Similarly, the Senate's directive that $ 2 mil. of FDA's appropriations be used to establish an Office of Women's Health in the Office of the Commissioner remains in force.