FDA SUPPLEMENTAL APPROPRIATIONS BILL TO TRIGGER USER FEES

FDA SUPPLEMENTAL APPROPRIATIONS BILL TO TRIGGER USER FEES will be formally requested by the Clinton Administration, FDA Commissioner David Kessler testified at a March 16 budget hearing before the House Appropriations/Agriculture Subcommittee. "There will be a supplemental request to enact that user fee bill as written," Kessler said. Limits for user fees to be collected in any given year are to be set in appropriations bills, according to the program's authorizing legislation. User fee collection for fiscal 1993, the first year of the program, must be triggered by a supplemental appropriations bill. Kessler said the administration would not attempt to change the program from the form in which it was enacted; FDA will collect user fees as specified in the legislation and use revenues to enhance the NDA review and approval process. Kessler's declaration that the Clinton Administration will proceed on schedule with appropriations for prescription drug user fees follows a successful effort during the week of March 8 by Reps. John Dingell (D-Mich.) and Henry Waxman (D-Calif.) and Sen. Edward Kennedy (D-Mass.) to convince the Office of Management and Budget not to alter the user fee law as enacted last October ("The Tan Sheet" March 15, p. 9). Noting that the legislation requires that user fee revenues "be additive" to FDA appropriations, Kessler said it now "is the administration's position that [the 1992] Act should be implemented as it was written and intended by Congress" so that user fees are "additive, on top of the base, to go toward [the hiring of] medical reviewers to help speed the availability of new drugs." An economic package released by the Clinton Administration on Feb. 17 called for collecting drug and device user fees totaling $ 167 mil. in fiscal 1994. The legislation enacted by Congress calls for collection of user fees for drugs only capped at a total of $ 54 mil. in fiscal 1994. Rep. Joe Skeen (R-N.M.) said he was "concerned about" Clinton Administration proposals to apply user fee revenues to deficit reduction rather than enhancing FDA resources. Kessler assured the subcommittee that "the administration is very committed to implementing the Prescription Drug User Fee Act of 1992." He added that the agency is "working hard" in preparation for the collection of user fees for brandname prescription drugs and Rx- to-OTC switch products. However, the administration is considering user fees for other FDA-related industries and using all or part of those revenues for deficit reduction, Kessler indicated. "Beyond that [1992] Act is the broader question of user fees, and there is no question that this administration is committed to reducing the deficit, and all appropriate ways to do that are on the table, including additional user fees beyond the prescription drug user fee act in different industries we regulate," Kessler said. "That is on the table; it is under discussion." He added that "the administration is very committed to analyzing and working with the Congress to go beyond the prescription drug user fee act and look at the broader picture."