FDA’s USER FEE COLLECTION AUTHORITY FOR 1993 BEING WITHHELD BY SENATE APPROPRIATIONS COMMITTEE PENDING PROGRESS ON INCREASING AGENCY STAFFING LEVEL

The Senate Appropriations Committee is stepping up pressure on the Clinton Administration to increase FDA staffing levels in accordance with last year's Prescription Drug User Fee Act by denying, for now, authority to begin collecting user fees. Authorization to collect user fees was not included in a fiscal 1993 supplemental appropriations bill approved by the committee June 8. The version passed by the House on May 26 would allow FDA to collect the full $36 mil. authorized in the user fee act for 1993. The Senate committee is "concerned by testimony that no additional full-time equivalents [staff positions] have been approved to accompany this requested increase and the committee believes that the purposes for which these user fees are authorized cannot be fulfilled by the FDA without such a staff increase," the committee explained in a report accompanying the FY 1993 supplemental funding bill. If such "an increase is approved by the Office of Management & Budget, the committee will be more disposed to concur with the House." The report notes that the user fee law "allows FDA to collect user fees dedicated to enhancing the process for review of human drug and biologic applications . . . FDA may collect and spend these user fees only to the extent they are specified in appropriations acts each year." HHS recently has submitted to OMB a request to waive the Administration's federal personnel freeze so that FDA can proceed with user fee-related hirings. FDA also is looking for ways to accelerate its ongoing recruitment process to reach its goals for expanding its drug review staff (see following story). HHS also requested hiring waivers for other FDA initiatives. Objections that the Clinton Administration has not met with requirements of the user fee law to augment both appropriations and staff in the product review area were raised by the Pharmaceutical Manufacturers Association in a recent letter to the Senate Appropriations/Agriculture Committee ("The Pink Sheet" June 7, T&G-1). Permission for user fees was excluded from the "chairman's mark," the legislative proposal developed by both subcommittee Chairman Bumpers (D-Ark.) and full committee Chairman Byrd (D- W.Va.) and staff that is used to begin the markup. The issue could be revisited either on the Senate floor (floor debate has not yet been scheduled) or in conference with the House on the supplemental funding bill. The next step for user fees would depend on both the congressional schedule and timing of HHS actions. Both the House and Senate propose to provide 1993 supplemental funding of $30 mil. to the vaccine injury trust fund for pre-1988 claims. Funding of $80 mil. has already been provided this year under the regular 1993 appropriations law. A House Appropriations/Agriculture Subcommittee markup of FY 1994 appropriations for FDA and other agencies under subcommittee jurisdiction was postponed from June 9 to Jun 14.