FDA STAFFING FLOOR SET AT 9,824 FTEs IN FY 1994 APPROPRIATIONS BILL

FDA STAFFING FLOOR SET AT 9,824 FTEs IN FY 1994 APPROPRIATIONS BILL that cleared the House Appropriations Committee on June 23. The bill states that "none of the funds provided in this act may be used to reduce programs by establishing an end-of-year employment ceiling on full-time equivalent staff years below the level set herein" for FDA. The provision sets FDA's floor at 9,824 FTEs, substantially above both the level specified in the administration's proposed budget (8,539 FTEs) and the number authorized for FY 1993 (8,694). The provision appears to be aimed at the Office of Management & Budget's hiring freeze, which has complicated FDA's attempt to begin hiring additional staff to carry out activities that will be supported by drug user fees. According to the accompanying report on the bill, the provision is intended "to assure that personnel are compatible with funding levels provided by the Congress." The user fee/FDA hiring issue will soon be taken up by a House/Senate conference on the FY 1993 supplemental appropriations bill. The Senate Appropriations Committee is pressuring OMB to approve FDA's request for a waiver to begin hiring additional personnel to meet the requirements of the user fee legislation by withholding authority to begin collecting user fees ("The Tan Sheet" June 14, p. 15). The bill was approved by the full Senate on June 22. The House-approved supplemental money bill would allow user fee collections to begin. The Senate has not yet taken action on a 1994 agriculture/FDA funding bill. The committee-passed measure appropriates a total of $ 924.3 mil. to FDA, with $ 867.3 mil. for salaries and expenses, $ 8.4 mil. for buildings and facilities, and $ 48.6 mil. for rental payments. The appropriated monies would give the agency the full funding level requested by the administration. The budget proposal as submitted by the President to Congress on April 8 allocated $ 929 mil. for FDA, which includes $ 5 mil. from a self-funding certification program for insulin and color additives. The full committee concurred with the subcommittee's agreement that FDA could collect $ 54 mil. from drug and biologics user fees during FY 1994. Under the House measure, FDA's generic drug review program and orphan drug program will receive more funding than in the Clinton Administration's budget request. FDA's generic drug review program would receive $ 46.6 mil. for FY 1994, an increase of $ 4 mil., while orphan drugs would receive $ 15.2 mil., versus the administration's request of $ 12 mil. The funding level for FDA's Office of OTC Drugs is not broken out in the committee report; however, given that drug review funding levels increased by the exact amount of the generic and orphan funding increases, presumably OTCs will be funded at the same $ 6.55 mil. in the HHS budget justification document ("The Tan Sheet" May 24, p. 6). While FDA funding received little discussion during the full House committee session, Agriculture Subcommittee Chairman Richard Durbin (D-Ill.) took the opportunity to praise FDA for its recent handling of alleged tampering with Pepsico products, suggesting it reflected an overall high public regard for the agency. "I'm especially proud of what we've done to increase spending for the Food and Drug Administration," Durbin said. "Two weeks ago, when Pepsico, one of the major corporations in America, faced financial disaster, there was only one place they could turn to clear their name. It was Washington, D.C. and the FDA. [FDA Commissioner David] Kessler made a public announcement which then became accepted by America because of the stature of this agency. We are going to make certain that the funding and the stature of this agency continues." Separately, plans for consolidation of FDA's current facilities into a new two-site campus appear to be on track. The full House passed a Treasury/Postal Service appropriations bill on June 22 that provides $ 73.9 mil. to the General Services Administration for the FDA campus project, as requested in the President's budget proposal. The Senate has not yet scheduled a subcommittee markup on the GSA appropriations, but subcommittee member Sen. Barbara Mikulski (D-Md.), the key backer of the campus project, is said to be in favor of adopting the House approach. Congress provided GSA with $ 200 mil. for the project in FY 1992.