FDA
TALK PAPER

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.)
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