FDA COSMETIC SAFETY AND LABELING FY 1995 BUDGET OF $5 MIL.
This article was originally published in The Rose Sheet
Executive Summary
FDA COSMETIC SAFETY AND LABELING FY 1995 BUDGET OF $5 MIL. is included in the "justification of estimates" document the Department of Health and Human Services prepared for a March 16 budget hearing held by the House Appropriations/Agriculture Subcommittee. The fiscal 1995 cosmetics allocation is even with FDA's fiscal 1994 current estimate for the program. The allocation for cosmetic safety and labeling accounts for 2.2% of the total fiscal 1995 foods program budget of $221.6 mil. Funding for the foods program also is level with 1994 estimated spending.
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FDA COSMETIC SAFETY AND LABELING FY 1995 BUDGET OF $5 MIL. is included in the "justification of estimates" document the Department of Health and Human Services prepared for a March 16 budget hearing held by the House Appropriations/Agriculture Subcommittee. The fiscal 1995 cosmetics allocation is even with FDA's fiscal 1994 current estimate for the program. The allocation for cosmetic safety and labeling accounts for 2.2% of the total fiscal 1995 foods program budget of $221.6 mil. Funding for the foods program also is level with 1994 estimated spending. FDA said it is holding its allocations steady "to continue efforts to support streamlining the Federal Government." The agency pointed out that it will be "absorbing all inflationary increases in FY 1995." The fiscal 1995 budget calls for a reduction in the number of full time equivalent (FTE) positions for the cosmetic safety and labeling program to 56 from an estimated 59 in fiscal 1994. The total number of FTEs allocated for the foods program in fiscal 1995 is 2.6 mil., down from an estimated 2.7 mil. FTEs in fiscal 1994. FDA predicted that its fiscal 1995 cosmetic safety and labeling program output will decline compared to fiscal 1994. The agency expects to analyze 284 cosmetics samples and perform 189 cosmetics inspections in fiscal 1995 versus an estimated 300 samples analyzed and 200 inspections conducted in fiscal 1994. FDA projects that 67 food and color additive petitions will be completed in fiscal 1995 versus an estimated 70 in fiscal 1994. Submitted to Congress Feb. 7, the Clinton Administration's budget requests $988 mil. for FDA, with $343 mil. coming from user fees. While cosmetics are not identified as candidates for user fees, $228 mil. in "new" user fees are expected to be collected from FDA-regulated industries other than prescription drugs, medical devices and mammography. The proposed budget recommends fiscal 1995 fee collection of $79.4 mil. under the Prescription Drug User Fee Act, $24 mil. in medical devices user fees, $6.5 mil. under the Mammography Quality Standards Act and $5 mil. under a long-standing certification program for insulin and color additives and Freedom of Information Act services. The balance of the Administration's budget request for FDA consists of $645 mil. in appropriations. FDA estimates that it spent $934.2 mil. in fiscal 1994. FDA Commissioner Kessler told the House Appropriations/Agriculture Subcommittee that the agency currently is "analyzing" where to find new sources of user fee revenues. In response to a question on where the agency expects to generate the $228 mil. in new user fees, Kessler said that "we are in the process of analyzing a very complex issue." Noting the broad "jurisdiction" of the agency, Kessler pointed out that "there are foods, there are over-the-counter drugs, there are generic drugs, there are blood products,...animal drug products,...there are a lot of other regulated products that are certainly part of the analysis." HHS said in materials released at a Feb. 7 budget briefing that the new user fees would be collected "from industries other than prescription drugs, medical devices and mammography...that benefit from FDA activities" ("The Rose Sheet" Feb. 14, p. 7). Without specifically addressing the Administration's new user fees proposal, Subcommittee Chairman Richard Durbin (D-IL) emphasized his position that "user fees are to be used to enhance and not to meet the ordinary expenses of the agency." Rep. John Myers (R-IL) added, "I completely agree, and this committee completely agrees that we do not want to see user fees used to reduce the deficit." Concerned about the possible application of user fees to cosmetics, the Cosmetic, Toiletry and Fragrance Association joined a number of food industry associations in opposing user fees for industries other than prescription drugs in a Feb. 16 letter to Durbin. The groups argued that user fees amount to "a tax," the cost of which ultimately will be passed along to consumers, and that "the full commitment of the government is needed to insure public confidence in FDA." |