FDA's OTC OFFICE WOULD BE FUNDED IN FY 1994 AT SAME LEVEL AS FY 1993

FDA's OTC OFFICE WOULD BE FUNDED IN FY 1994 AT SAME LEVEL AS FY 1993 under the administration's proposed budget, according to HHS' fiscal 1994 budget "justification of estimates" document, released May 18. Under the proposal, FDA's OTC office would continue to receive an annual budget of $ 6.55 mil., which represents only a slight increase from the OTC office's FY 1992 appropriation of $ 6.39 mil. Although FDA has requested that full-time equivalents for the OTC office remain at the same level as FY 1993 (71 FTEs), the Clinton Administration budget estimates that actual FTEs in the OTC program will drop to 61 in fiscal 1994. The HHS document says that "FDA's Human Drugs Program supports the President's initiative to reduce the deficit by cutting federal employment and administrative costs." The 10 FTEs expected to come out of OTC operations are part of a total reduction in force at CDER of 43 FTEs, according to the budget document. Total funding requested for FDA's human drugs program in FY 1994 is $ 233.4 mil., which represents a 4% increase compared to a revised FY 1993 figure of $ 224.5 mil. However, the revised FY 1993 budget figure assumes that funds would be collected under prescription drug user fees. The FY 1994 budget request for FDA's human drugs program also assumes user fee revenues -- put at $ 28 mil. Removing the amount provided by user fees, which the legislation stipulates must be additive, leaves a base budget of $ 205.4 mil. for drugs in 1994, just below the original 1993 appropriation of $ 205.5 mil. Under the 1992 user fee law, FDA is authorized to collect $ 36 mil. in FY 1993, $ 54 mil. in 1994, and larger amounts in each of the three following years to be used as supplemental funds to enhance FDA's drug and biologic review programs including the evaluation of Rx-to-OTC switch applications. The human drugs program also expects to reduce administrative costs by $ 81,000 in 1994, according to the budget document. The agency is absorbing inflationary increases for 1994. The only substantial increases in the proposed 1994 FDA budget, aside from those which will come from user fees, are for vaccines, medical devices (a $ 30 mil. investment package to fund the Safe Medical Devices Act and Mammography Quality Act) and rental payments, which had been frozen for several years. FDA also requested $ 208.9 mil. to support fiscal 1994 operations of the Center for Food Safety and Applied Nutrition, which includes the Office of Special Nutritionals. The request is roughly equivalent to CFSAN's $ 209 mil. appropriation for FY 1993. The $ 208.9 mil. figure includes $ 6.6 mil. for risk assessment research and policy development for foods and cosmetics, $ 2.4 mil. for postmarket surveillance and epidemiology for foods and cosmetics, $ 19.6 mil. for food and cosmetic technical assistance, and $ 19.7 mil. for food and color additive petition review and policy development. The agency estimated that it receives 60-70 new food additive petitions a year for premarket safety evaluation. FDA also has proposed cutting 49 FTEs from CFSAN in 1994 and decreasing administrative costs by $ 83,000. Most of the proposed FTE reductions at CFSAN are to come from the foodborne biological hazards and diet/toxicity interaction programs. The overall FY 1994 budget request for FDA is $ 937.5 mil. (counting $ 12.9 mil. in "reimbursables"). The budget request includes: a $ 64.6 mil. "investment package" comprised of $ 34.6 mil. for vaccine safety under the administration's vaccine initiative; $ 20 mil. to help implement the Safe Medical Devices Act; $ 10 mil. to fund FDA standards-writing for mammography screening; $ 54 mil. from pharmaceutical and biologics user fees; and savings of $ 296,000 from a reduction in administrative expenses. In addition, the budget authorization includes $ 200 mil. from user fees for OTCs, devices and foods, which would have to be legislated.