T97-8 Donald C. McLearn February 6, 1997 (301) 827-6242 1998 BUDGET PROPOSAL FOR FDA The Clinton Administration's budget proposal for FDA for fiscal year (FY) 1998 calls for total resources of $1,064 million - - $69 million above the total level authorized in FY 1997 -- $820 million in budget authority, including $58 million for two important public health initiatives and $244 million in user fees. These are the highlights of the President's 1998 funding request for FDA: New Public Health Initiatives: $58 million. In August 1996, President Clinton announced a new FDA regulation which -- together with efforts to be undertaken by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Disease Control and Prevention (CDC) -- is designed to decrease the use of tobacco by young people by 50 percent over the next seven years. Currently, 1 million minors become regular smokers each year, and as a result one-third of them will eventually die prematurely. FDA's budget includes $34 million to implement its regulation of nicotine-containing tobacco products. The agency is also joining CDC, the U.S. Department of Agriculture and the Environmental Protection Agency in launching an important food safety initiative to prevent thousands of cases of food contamination each year by such pathogens as E. coli and salmonella. FDA is requesting $24 million for a variety of activities: greater food safety surveillance, including the development of an early warning system; enhanced seafood inspections; greater coordination among public health agencies; public education; risk assessment; and bioscience research. Implementation of these activities should prevent hundreds of thousands of illnesses and hundreds of deaths. Prescription Drug User Fees: $91 million, a 4 percent increase. The agency has not only met or exceeded all goals of the Prescription Drug User Fee Act (PDUFA), but last year it approved 139 new drugs and biological products, a record increase of 63 percent over 1995. Fifty-three of these medications -- 89 percent more than the 28 such drugs in 1995 -- were new molecular entities (NMEs), products containing an active substance that had never before been approved for marketing in any form in the United States. The 1997 approval times for both drugs and biological products were significantly shorter than in 1996. Mammography Quality Standards Fees: 14 million, 4 percent more than in 1997. In its first two years, the inspection program conducted under the Mammography Quality Standards Act (MQSA) showed that more than 80 percent of the nation's mammography facilities had either no violations or minor ones and that only two percent had violations serious enough to warrant a warning letter from FDA. Other User Fees: $132 million. Consistent with the Vice Presidentþs National Performance Review, the Administration is proposing new user fees that would enable it to continue FDA's performance in other activity areas. These new user fees would cover portions of FDA's traditional pre-market and post-market work in each program area -- foods, human drugs, biologics, animal drugs, and devices. In addition, the agency will continue collecting fees for certification of exports, insulin and color additives. (Table faxed upon request.) ####