Mr. Chairman, members of the Committee, I appreciate the opportunity to
appear before you and present the 1998 Food and Drug Administration budget
proposal.
As a background for our 1998 budget request, I would like to begin with a
description of the FDA's Congressional mandates and the expectations of the
American public, and how we are accomplishing our mission.
FDA's Core Missions
The American people have come to expect and rely on the FDA for many
services that contribute to their sense of security and enable them to lead
productive lives--protection of the safety and wholesomeness of our food supply,
maintenance of the high standards of effectiveness arid safety of our drugs and
medical devices, and assurance of the safety of our blood supply and vaccines,
etc. We are committed to upholding those standards and meeting those
expectations.
The promotion and protection of the public health is our principal mission.
FDA's responsibilities annually cover more than $1 trillion worth of products,
many of which are vital for human health. Our diverse activities include--but
are not limited to licensing blood banks, monitoring clinical investigations, as
well as reviewing and approving prescription drugs, generic drugs, animal drugs,
vaccines, biologicals, medical devices, devices that emit X-rays, and food
additives.
Our mission, as the nation's oldest consumer protection agency, is to
provide the basic public health protection for the foods we eat and the drugs we
take. The assurance that FDA is present, everyday, doing its job is so
fundamental to what we know and expect as public health protection, that we
almost take it for granted. Americans have the luxury of not needing to worry
about thousands of products including breakfast cereal, pain relievers, contact
lenses, vaccines, and cough medicine.
When we inspect manufacturing establishments to make sure they use the
materials and processes necessary to produce safe and effective products, and
when we monitor imported products to make certain they meet the same high
standards as domestic products, we help sustain the American public's confidence
and peace of mind.
We have been protecting consumers against an ever-growing number of
potential public health risks for more than nine decades. As significant
advances are steadily made in science and technology, FDA is continually
presented with complex new questions, for which we are committed to seeking and
finding new answers. At the same time, we are also committed to improving the
FDA's many operations so that all of its work isarch (CDER) illustrates why reauthorization of PDUFA is a top priority for
FDA.
All drugs approved by FDA are important, but perhaps none are as meaningful
in bringing new hope to patients as new molecular entities (NMEs). These are
products that include active ingredients never before marketed in this country.
The number of NMEs approved each year is regarded as one indication of real and
meaningful medical progress. Last year, that progress was exceptional: FDA
approved 53 NMEs submitted by the pharmaceutical industry, nearly twice as many
as the year before.
Let me put last year's figures into perspective by referring back to the
passage of the Kefauver-Harris amendments. The average annual total of NMEs in
the decade of the 1960's was 13.7. In the 1970s, the corresponding figure went
up to 17.3. In the 1980s, the average was 21.7 NMEs, and in the first half of
this decade, the average was 25.6 NMEs. In 1996, the 53 NME approvals were a
doubling.
Last year's approvals also were much faster than in the past. In the late
1980s, the median times for NME approval approached 30 months. The median time
to approval for the 53 drugs approved in calendar year 1996 was 14.3 months,
less than half the time it took as recently as the late 1980s. Chart 1
New cancer drugs approved last year were notable for their effectiveness
against a broad spectrum of cancers: Hycamtin is used for the treatment of
patients with metastatic carcinoma of the ovary; Camptosar for those with
carch (CDER) illustrates why reauthorization of PDUFA is a top priority for
FDA.
All drugs approved by FDA are important, but perhaps none are as meaningful
in bringing new hope to patients as new molecular entities (NMEs). These are
products that include active ingredients never before marketed in this country.
The number of NMEs approved each year is regarded as one indication of real and
meaningful medical progress. Last year, that progress was exceptional: FDA
approved 53 NMEs submitted by the pharmaceutical industry, nearly twice as many
as the year before.
Let me put last year's figures into perspective by referring back to the
passage of the Kefauver-Harris amendments. The average annual total of NMEs in
the decade of the 1960's was 13.7. In the 1970s, the corresponding figure went
up to 17.3. In the 1980s, the average was 21.7 NMEs, and in the first half of
this decade, the average was 25.6 NMEs. In 1996, the 53 NME approvals were a
doubling.
Last year's approvals also were much faster than in the past. In the late
1980s, the median times for NME approval approached 30 months. The median time
to approval for the 53 drugs approved in calendar year 1996 was 14.3 months,
less than half the time it took as recently as the late 1980s. Chart 1
New cancer drugs approved last year were notable for their effectiveness
against a broad spectrum of cancers: Hycamtin is used for the treatment of
patients with metastatic carcinoma of the ovary; Camptosar for those with
colorectal cancer; Taxotere for women with advanced breast cancer; Gemzar for
patients with cancer of the pancreas; and Nilutamide for men with cancer of the
prostate.
The NME category also included Accolate, the first of a new class of drugs
for asthma sufferers; Aricept, the second treatment for patients with
Alzheimer's disease; and Copaxone, a treatment for those with
relapsing-remitting multiple sclerosis.
Nine of the NMEs approved last year, including two drugs for cancer and
three for HIV, were approved in six months or less. Crixivan a protease
inhibitor for the treatment of HIV, was approved in just 1.4 months. Twelve of
the NMEs, including three protease inhibitors, were developed from the first
commercial Investigational New Drug submission to marketing approval--in less
than six years.
Moreover, the total number of new drugs and biological products-- including
NMEs-approved in the last calendar year was 139, which is 63 percent more than
the total the year before. Charts 2-3 New Drug Applications (NDAs) accounted
for 131 of these products, and their median time to approval was 15.4 months, 7
percent faster than the 16.5 months the year before.
Biologics and Blood Safety
Our Center for Biologics Evaluation and Research (CBER) last year made
decisions that represent important contributions to the safety of the blood
supply, including two new test kits for the detection of HIV infection. One of
these kits is designed for screening of donated blood for HIV-1 antigen, a
substance that in most cases is detected before the virus antibodies. By
reducing the so-called"window" period, when donors may be HIV-infected but their
tests are still negative for HIV antibodies, the antigen screening could prevent
an estimated 5-10 transfusions of HIV- infected blood a year.
The other HIV test kit approved last year was the first system that includes
collection of blood samples at home. It was developed to facilitate blood
testing by the more than 60 percent of Americans who are at risk of HIV, but do
not visit a medical facility to have their health status checked. In addition,
FDA also approved the Amplicore HIV-1 monitor test, the first test approved for
the quantification of the HIV-1 virus in human blood.
In all, CBER last year completed 17 major biological approvals, as compared
with 12 such approvals the year before. Last year's major biological approvals
included Raspigam, the first medication to protect infants against respiratory
syncytial virus, a potentially fatal disease; Avonex, the second interferon
product for multiple sclerosis; and Veduma, a new diagnostic imaging agent that
can determine the extent of small cell cancer in different parts of the body at
one time. The median approval time for the 17 biological products was 14.9
months, 15 percent faster than in 1995.
The public health has also been well served by the approval of the acellular
pertussis vaccine, which is safer than the traditional whole-cell pertussis
vaccines. Another notable approval, issued earlier this year, was for a new
recombinant Factor IX for treating people with Factor IX deficiency hemophilia.
This product does not contain any pooled plasma derived proteins, and therefore
presents no risk of transmitting viral infection.
Comparison with Foreign Regulatory Bodies
There are many other ways to measure our performance in drug review. One of
them--which is frequently used by the media and some critics of our Agency--is
comparing our performance with that of our counterparts abroad.
We have checked this performance gauge before, and last year we took another
look, this time by comparing all new drugs that were approved last year by both
the FDA and the new centralized drug approval process of the European Union.
There were 15 of such drugs, and their median time for FDA review and marketing
approval was 5.8 months. The median time for review by the Committee for
Proprietary Medicinal Products and final EU authorization for a company to sell
those 15 common drugs in Europe was 12.2 months. In four instances, the EU
authorization came first in one case, just three days ahead of FDA. In 11
instances, the drugs were first approved in the U.S.
These results are another illustration of FDA's commitment to improve the
quality of life of citizens. Nonetheless, our goal is not to compete with any
foreign regulatory authority, but rather with time itself. Our goal is to
continue to challenge ourselves to constantly improve our own
performance--patients, those that care for them, everyone expects no less.
While these improvements could not have been made without the resources
added by PDUFA, there has also been a concerted effort to streamline and
optimize our entire management system. A substantial reorganization of parts of
the Agency has been taking place in the last few years. As a result, all FDA
Centers last year achieved notable results.
Medical Devices
As a striking example, the Center for Devices and Radiological Health (CDRH)
improved its premarket approval reviews (PMAs) while maintaining the review
times for abbreviated application--510(k)s. This latter category of
applications-- which accounts for the vast majority of all submissions to CDRH--
covers devices that are substantially equivalent to devices already on the
market. In fiscal year 1996, CDRH approved 43 PMAs, a six year high, and 24
major new products, an all-time high. Chart 4
One of the notable products approved in 1996 was the Thoratec Ventricular
Assist Device System that serves as a bridge to cardiac transplantation. The
Center also approved many first- of-a-kind products such as the Ultramark 9 High
Definition Ultrasound System, an aid in differentiating benign from malignant
breast lesions; the Seprafilm Bioresorbable Membrane, used for reduction of
postsurgical adhesion; and the Reliance Urinary Control Insert, a device
intended for the management of stress urinary incontinence in adult women.
Chart 5
Eight of the 15 PMAs submitted to the agency in the first half of fiscal
year 1996, received a first action within the 180- day deadline. This was a
significantly better performance than in 1994 or 1995.
Even though we are approving more PMAs for increasingly complex devices, and
we have improved the time to first action, the PMA approval time is coming down
only slowly. It takes too long--more than two years--to complete the entire
process. CDRH and the agency are focusing now on innovative ways of bringing
down the PMA review times, just as we have done for NDAs. But, here again, much
depends on the level of resources available to do the work.
CDRH has also successfully managed the review times for 510(k) applications.
In fiscal year 1996, the median review time for these devices that received a
finding of substantial equivalence was 85 days. At their peak in 1993, the
reviews were almost 70 percent longer --144 days. Even accounting for
applications that had to be returned to the manufacturer for more information,
the average 510(k) review time in fiscal year 1996 was 110 days, down from the
peak of 184 days in fiscal year 1994. Overall, CDRH has done a remarkable job
in solving review problems that had plagued the Center for years. They have
significantly shortened review times without sacrificing the increased
scientific and medical rigor of the reviews. We are not satisfied with our
performance, but we are steadily moving in the right direction. Chart 6
We also take real satisfaction in the high standards for mammography
facilities achieved under the Mammography Quality Standards Act (MQSA) of 1992.
Since the law was passed CDRH, working with the American College of Radiology
and state authorities, has set standards, and inspected and certified more than
10,000 facilities. The first year's inspections after the program went into
effect showed that 80 percent of the facilities had only minor violations, if
any at all. A recent report by the General Accounting Office found that
second-year inspections revealed "considerable reduction in the proportion of
facilities" with violations.
The performance of our drug and device Centers deserves special attention
because of the public health importance of their work, and high interest in
their achievements. Other FDA Centers, however, also had results last year that
reflected gains in efficiency and positive effects on the public health.
Food and Veterinary Medicine
The Center for Food Safety and Applied Nutrition (CFSAN) has implemented
several initiatives to speed up the food additive petition review process and
reduce the inventory of pending petitions. The Center brought in scientists from
other program areas; allocated additional resources to modernize its electronic
information processing infrastructure, and to contract the technical services of
"third party" reviewers; instituted changes in its Office of Premarket Approval
to better respond to legislative mandate and industry demands; and used various
means--from one-on-one meetings to the World Wide Web--to provide guidance to
petitioners on how to improve the quality of their submissions to the Agency.
The effort has paid off in reduced petition inventory and faster reviews. In
June, 1995, there were 295 petitions in the CFSAN inventory, including food and
color additive petitions, GRAS affirmation petitions, and citizen petitions. By
the end of last fiscal year, the Center had received an additional 82 petitions,
but the inventory was 60 petitions below the total in June 1995. During calendar
year 1996, CFSAN took final action on 88 petitions, 54 of which were
approvals--the highest number in any year in a decade. Chart 7 Moreover, the
median time from receipt to approval of food and color additive petitions
decreased from 37 months for petitions approved in fiscal year 1993 to 27 months
for petitions approved in the last fiscal year. Again, we have not yet achieved
the results we want, but we are continuing to advance toward them.
CFSAN has also authorized health claims providing information on the
relationship between food components and health. Last year, FDA issued a final
rule covering health claims that associate adequate dietary intake of folic acid
and the reduced risk of neural tube birth defects, which in this country affect
approximately 2500 children each year. In August, 1996, a claim was authorized
on the relationship between sugar alcohols and reduced risk of dental caries. In
January, 1997, the Agency authorized health claims stating that foods containing
soluble fiber from whole oats may under certain circumstances reduce the risk of
heart disease.
Our Center for Veterinary Medicine has been working closely with animal drug
manufacturers, producers, and veterinarians designing a new and more flexible
animal drug approval process that reduces the time and cost necessary for
meeting the requirements for a new animal drug approval. Chart 8 Full
implementation of the changes was made possible by the enactment of the Animal
Drug Availability Act of 1996. Among other improvements, the ADAA eliminates
the need for dose titration and optimization, and provides the Agency with the
latitude to redefine the statutory term "substantial evidence" of drug
effectiveness. The changes are evidence of the remarkable achievements that
become possible when government and the private sector work together.
Achievements of the Office of Regulatory Affairs
One of the most demanding tasks of our Office of Regulatory Affairs, whose
inspectors and investigators operate in offices throughout the United States and
Puerto Rico, is surveillance of the rapidly mounting number of imports of
FDA-regulated products. While the number of our port-of-entry personnel has
increased by only 285, the number of shipments with products within FDA purview
has increased from 500,000 in 1970 to nearly 3.7 million last year.
Last year, ORA began implementing a new automated system-- called
Operational and Administrative System for Import Support (OASIS)-- that greatly
speeds up FDA's handling and clearance of imported products by maintaining
electronic communications between the agency and the brokers. With OASIS, the
broker receives FDA's initial admissibility determination on every shipment
within eight minutes after the broker submits the necessary data to the agency.
For eight out of ten shipments, the initial FDA clearance is final. The
paper-less system, whose implementation will be completed by the end of
September, will cover every U.S. port of entry where FDA-regulated products
arrive by sea, land and air.
Another major responsibility of ORA's regional, district and field offices
and laboratories is to maintain a round-the-clock vigilance against hazards to
the public health. A typical example of this demanding duty is the recent action
by FDA's field office in Los Angeles against several products that were supposed
to be mildly intoxicating but instead were implicated in cases of nausea,
vomiting and respiratory arrest among mostly young people who had ingested them
at a New Year's Eve concert.
FDA field office launched investigation within hours after the incident, and
on January 1, we issued a public statement warning consumers against the
so-called "fX" products-"CHERRY fX BOMBS," "LEMON fX DROPS" and "ORANGE fX
RUSH" which apparently had been distributed for free to the concert goers.
Subsequently, FDA took possession of more than 9,000 vials with the fX potion
and notified the distributor that the products present an unreasonable risk of
illness or injury to those who consume them.
Mr. Chairman, I have mentioned the highlights of FDA's performance last year
as evidence that our agency is dedicated to its public health mission,
competently staffed, and steadily advancing in its scientific skills while
introducing flexible, less burdensome but no less valid regulatory procedures.
We have taken important strides forward, and we are well positioned to make
even more effective use of day-to-day operating resources as well as to
strategically plan for managing new responsibilities.
In addition to our important ongoing efforts, there are three major tasks
that we perceive to be fundamental for the fulfillment of our public health
mission in fiscal year 1998.
First of all, we must implement--in cooperation with federal, state and
local public health authorities--the Administration's food safety initiative.
Food Safety Initiative
Americans rightfully expect their food to be wholesome and safe, and with
rare exceptions, it is. We know, however, that problems do exist. According to
the Council for Agricultural Science and Technology, up to 33 million
foodborne illnesses occur each year, and as many as 9,000 people--mostly the
very young and the elderly--die as a result.
Hospital stays associated with microbial foodborne illnesses are estimated
to cost more than $3 billion a year, and td
warning the public against consuming the juice they had already bought. As a
result of this rapid intervention, the outbreak was limited to 66 Americans and
Canadians. Tragically, one of them--a little girl in Colorado-- died of
complications of this foodborne disease.
We were able to help contain this outbreak thanks to the fast reaction and
cooperation from federal, state, and local public health officials as well as
from the juice manufacturer, who instituted an immediate recall of the unsold
products and warned the public against consuming the juice they had already
bought.
But we also were fortunate. First, Kings County in Washington has a disease
surveillance system similar to the FoodNet system supported by CDC, FDA, and
USDA. If the same outbreak had taken place in other areas of the country, we
might not have made the connection until many more people had become ill.
Second, Federal health officials took charge of the situation rapidly and
received prompt cooperation from all the relevant federal, state, local and
industry participants in the incident. But this was a fairly exceptional
experience. For the emergencies that take place under less favorable
circumstances, we need to have effective and consistent coordination in place
before the outbreak takes place.
Similarly, if we knew more precisely how this deadly form of E coli grows
and multiplies, how it infects the food and how it is transmitted to humans, we
could act more quickly and decisively whd
warning the public against consuming the juice they had already bought. As a
result of this rapid intervention, the outbreak was limited to 66 Americans and
Canadians. Tragically, one of them--a little girl in Colorado-- died of
complications of this foodborne disease.
We were able to help contain this outbreak thanks to the fast reaction and
cooperation from federal, state, and local public health officials as well as
from the juice manufacturer, who instituted an immediate recall of the unsold
products and warned the public against consuming the juice they had already
bought.
But we also were fortunate. First, Kings County in Washington has a disease
surveillance system similar to the FoodNet system supported by CDC, FDA, and
USDA. If the same outbreak had taken place in other areas of the country, we
might not have made the connection until many more people had become ill.
Second, Federal health officials took charge of the situation rapidly and
received prompt cooperation from all the relevant federal, state, local and
industry participants in the incident. But this was a fairly exceptional
experience. For the emergencies that take place under less favorable
circumstances, we need to have effective and consistent coordination in place
before the outbreak takes place.
Similarly, if we knew more precisely how this deadly form of E coli grows
and multiplies, how it infects the food and how it is transmitted to humans, we
could act more quickly and decisively when events of this sort take place. Our
research and risk assessment work will bring us closer to the knowledge we need
to devise educational programs to teach consumers and food processors how to
avoid and combat such contaminants. And we must have additional inspectors if we
are to ensure that food safety standards are being met.
In recent years, we have taken several significant steps to improve food
safety. We are now implementing the Hazard Analysis and Critical Control Point
(HACCP) system for seafood, and the U.S. Department of Agriculture is doing the
same for meat and poultry. FDA and USDA have supported the efforts of the
Centers for Disease Control and Prevention to create a system of FoodNet Sites
for identifying disease outbreaks. And Congress enacted new legislation last
year aimed at protecting the public-- particularly children--from pesticides.
But our system is still largely outmoded, and it is time to bring food safety
into the contemporary world of automation and modern science.
We are therefore asking your support for new resources to carry out FDA's
share in the Administration's food safety initiative which is described in
detail in the budget.
Prevention of Tobacco Use by Minors
A second major task is our public health and legal obligation to protect our
most vulnerable population--our youth-- against the devastating effects of
tobacco.
For the past three years, our agency conducted an extensive investigation
into public health aspects of the use of tobacco, which kills more than 400,000
Americans each year--more than acquired immune deficiency syndrome, alcohol, car
accidents, murders, suicides, illegal drugs, and fires combined.
We found evidence that nicotine is addictive; that it produces
pharmacological effects which are the primary reason why people use tobacco; and
that manufacturers know these facts.
The most striking discovery, however, was the overwhelming evidence that the
enormous public health burden linked with tobacco products originates when the
users are young, a stage of life that's most carefree and susceptible to
risk-taking. Eighty- two percent of adults with any history of smoking had their
first cigarette before the age of 18, and more than half of them had already
become regular smokers by that age.
Each year, one million youngsters in this country become regular
smokers--and one-third of them will die prematurely of lung cancer, emphysema,
and similar diseases linked to their addiction. About three million of our
adolescents smoke, and another one million boys use smokeless tobacco. Tobacco
use and nicotine addiction can be properly called a "pediatric disease."
Based on these findings, FDA last year determined that it has jurisdiction
over cigarettes and other tobacco products, and issued regulations restricting
their sale and distribution to children and adolescents.
This year, we--together with our sister public health agencies and state and
local authorities--are embarking on an enforcement program designed to reduce
young people's use of tobacco products by 50 percent in seven years. It is an
enormous undertaking: despite the fact that it is against the law in all 50
states to sell cigarettes and smokeless tobacco to minors, our young people
purchase an estimated 1.26 billion dollars' worth of tobacco products each year,
Recent surveys have shown that adolescent smoking, after several years of
decline, is again on the rise.
As a public health agency we feel a deep obligation to see this program
carded out. Earlier, I mentioned our implementation of the Mammography Quality
Standards Act, the most important advance in the public health protection for
the nation's women. Protecting their children--our youth--from nicotine and
tobacco is an equally urgent and deserving task whose future benefits will far
outweigh the current funding needs.
PDUFA and MQSA Reauthorization
Our third important task is to achieve reauthorization of two user fee
programs PDUFA and MQSA, both of which expire on October 1 of this year. Both of
these programs set demanding performance goals and provided the additional
resources necessary to accomplish the agreed-upon objectives. As I have
discussed earlier, the principle of linking higher productivity, through
performance measures and goals, and the collection of user fees to finance
specific program activities has been a success, and there are important
opportunities for these existing programs. The Administration has proposed
expanding the use of that principle to other FDA activities which I will address
in more detail shortly.
Three Long-Range Challenges
Beyond these immediate tasks, FDA faces longer-term challenges for which we
must find solutions if this country's public health is to continue to be as well
served as Americans expect and merit.
One of the most demanding problems--as well as the greatest opportunity--is
the prodigious outpouring of new scientific knowledge that directly impacts on
our responsibilities as a public health agency. Scientific information is
growing far more rapidly than could be foreseen even a decade ago, and the sheer
volume of new insights is nearly unimaginable.
While our agency scientists, such as those at the National Center for
Toxicological Research, are hard at work to keep abreast of these developments,
we face a constantly expanding task. At any particular moment, we have to be
thoroughly competent in understanding such disparate issues as the biology of
genetically altered tomatoes, the safety and effectiveness of eye surgery with a
laser beam, and the effectiveness and side effects of new unique classes of
highly toxic drugs. Our mission involves therapeutics, restoratives,
diagnostics, nutritionals, and many other scientific disciplines whose
complexity is constantly growing. We must devise additional ways of making the
best use of the cutting edge of new knowledge. In order to properly oversee the
translation of basic science observations to applied practical application, we
must have this facility.
Another challenge we will have to meet is improving accessibility to
meaningful health information. Accurate product information is absolutely vital
to patients and health care professionals. In many ways, information is our new
currency. Having a new drug or a new food or a new medical device, without
having the information how to use it properly or safely, is to no one's
advantage. We must struggle not just to get new products on the market, but to
make sure that there is information about their benefits and risks, so that the
health care provider and individual can make informed decision about proper use.
We have learned from our experience with the new food label and with
prescription drug information leaflets that well-presented and accessible
information may be the most powerful tool we have to improve the public health.
With the cooperation of the industry, we are about to institute major
improvements in the labeling of non-prescription drugs, but more remains to be
done.
Finally, I must include one more important long-range challenge that FDA has
to address in order to continue maintaining this country's traditional
standards. With the globalization of manufacturing, trade, and consumption,
members of the international community--including ourselves--recognize the value
of harmonized regulatory standards and, possibly, shared compliance
surveillance. It is our only realistic option for ensuring the standards of
foreign-made regulated products, whose imports to this country have increased
seven-fold in the last 25 years.
For FDA, this is an expanding mission that calls for the development of
international contacts, knowhow and negotiating skills within a scientific
framework. Moreover, we find that--as one of the world's oldest consumer
protection agencies we are expected to do our full share. To advance our
country's national interests, we are doing our best to meet these expectations.
A good example of our contribution is the International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH), the most important international effort in the regulatory field
that seeks to harmonize submission data for drugs in the U.S., Europe and Japan.
Less than five years' old, ICH is completing the adoption of more than 40
consensus guidelines, many of which are based on our standards. We also are
providing leadership for similar international efforts to harmonize the
standards for veterinary drugs, and for medical devices.
All of these challenges are even more formidable because we realize that the
growth of our work load will continue to exceed our resources. The prescription
drug and medical device industries maintain a growth rate of more than 8 percent
a year, as measured by the value of manufactured shipments. Research and
development in the same industries increases by more than 12 percent each year,
and imports of all FDA regulated products are increasing at a rate greater than 7
percent a year. We are determined to meet this challenge by increasing our
cooperation with others, whether in government, academia or industry; by not
only working hard but also by employing novel solutions when old practices no
longer meet the need.
Budget Outline
Turning to FDA's FY 1998 budget, the Administration's request is a total of
$1,064,388,000, including $820,116,000 in budget authority and $244,272,000 in
user fees. A total program level of this amount will enable us to carry out the
core activities of premarket review and postmarket surveillance as well as move
forward with new initiatives to promote and protect the health of the American
people.
Food Safety Initiatives - $24 Million
For FDA's portion of the collaborative effort with CDC, EPA, and USDA, we
are requesting $24,000,000 to begin implementation of activities aimed at
reducing the incidence of foodborne illnesses and resultant economic losses by
enhancing the safety of the nation's food supply. This funding would provide the
elements pivotal to food safety such as seafood inspection efforts, consumer and
industry education (particularly at the retail level), surveillance, including
in particular the establishment of a new national early warning system for
outbreaks of foodborne disease, risk assessment and research. The activities
would lay a foundation of cooperation and communication to rapidly deal with
emerging public health hazards.
Youth Tobacco Prevention Initiative $34 million
On August 23, 1996, President Clinton approved FDA's final rule that limits
the availability and appeal of tobacco products to adolescents. For our part of
this effort, FDA's budget request includes $34,000,000 for the costs associated
with implementing this regulation. The funding will be used for outreach to
retailers, manufacturers, state and local officials and communities, and
enforcement and program evaluation.
Buildings and Facilities--$14.6 Million
The budget request includes $14,550,000 for the second phase of construction
of the Arkansas Regional Laboratory facility for FDA's field operation in
Jefferson, Arkansas. Construction of this laboratory is a cornerstone of FDA's
Field Lab Consolidation Plan, and will provide state-of-the-art analytical
services that are currently carried out at four laboratory facilities.
User Fees - $244.3 Million
A total of $244,272,000 is proposed in the budget for user fees. The
proposal includes $91,204,000 in connection with the reauthorization of the
Prescription Drug User Fee Act of 1992 and $13,966,000 in connection with the
reauthorization of the Mammography Quality Standards Act of 1992, both of which
sunset on October 1, 1997. The request also includes $7,459,000 in already
authorized user fees for export certification and the certification of insulin
and color additives.
In addition, the proposed budget includes new user fees of $131,643,000.
These new fees would partially cover premarket and postmarket activities costs
in most of FDA's major program areas-- foods, human drugs, biologics, animal
drugs, and medical devices. These industries derive great benefits from
consumers' confidence in FDA's review processes and product surveillance.
The Administration believes that FDA provides a vital public health service
by protecting consumers from unsafe and impure regulated products, and that
industry which greatly benefits from FDA's assurance of the quality of such
products--should help pay for a portion of the agency's costs. FDA will work
with Congress and the agency's many constituencies, including the regulated
industries, to implement the proposed fees in conjunction with agreed-upon
performance measures and goals that are linked with the provided resource
levels.