DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
Fiscal Year 2001 Budget Request
Witnesses appearing before the
House Subcommittee on Agriculture, Rural Development,
Food and Drug Administration, and Related Agencies
Jane E. Henney, M.D.
Commissioner, Food and Drug Administration
accompanied by
Dr.
Bernard Schwetz, Acting Deputy Commissioner
Mr.
Robert J. Byrd, Deputy Commissioner for Management and Systems, Chief Financial
Officer, Food and Drug Administration
Mr.
Dennis P. Williams, Deputy Assistant Secretary, Budget, Department of Health
and Human Services
2/25/00
Mr. Chairman and members of Congress, it is my
privilege today as Commissioner of Food and Drugs to present FDA’s plans and
expectations as reflected in the Administration’s proposed budget for fiscal
year 2001. One year ago, I told you
that I was lured from the enchantments of New Mexico to renewed public service
by the dedication, energy and commitment of the talented people in FDA. I was equally attracted by the enormity of
the changing demands upon the Agency and the difference this agency can make in
improving the public health.
Patients, researchers, health professionals,
manufacturers, educators, grocers, public sector administrators or just
ordinary citizens want a public health regulatory agency such as the FDA to be fair, competent and, above all, credible. I have heard this message in different words
on many occasions in many settings this year.
I believe that the accomplishments of the past year will demonstrate
that FDA has done a remarkable job in maintaining the public’s confidence and
credibility even though we face numerous unpredictable issues on a day-to-day
basis.
It may be all too easy for Americans to assume
FDA’s competence and credibility because we have long enjoyed public confidence
in the past. However, from listening to
my European counterparts, public confidence, once lost, is not easily or
quickly restored. A series of highly
publicized crises in Europe over the past several years have caused my
counterparts to ask: What is FDA’s secret and how does FDA utilize science and
build consensus answers to so many inherently contentious issues? The answers are not found in FDA’s
organizational diagrams or job titles.
We find ourselves explaining modern versions of
two very old history lessons -- what Alexis de Toqueville reported long ago to
Europe about the uniquely open processes
for American lawmaking (and in its modern derivative--rulemaking), and Dr.
Harvey Wiley’s discussions with President Theodore Roosevelt at the beginning
of the last century about the importance of science-based regulatory decisions. From a world perspective, FDA’s
utilization of public issue meetings, access to agency information,
voting advisory committees, requirements for scientific evidence and reliance
on scientific facts in its decision-making process are more uniquely American
than we may realize. The interplay of these features into an independent
regulatory function that coexists with prescribed Congressional and Judicial
roles constitutes the most envied regulatory model in the world.
Today, I share with you my priorities for
preserving this capability and for preserving the agency’s credibility with the
American public. As we begin the 21st
Century, fiscal Year 2001 will be critically important for FDA because so much
of our environment is changing rapidly and our capability to understand, adapt
and respond will be stretched to new limits. To maintain our strength:
Stronger
science -- FDA’s commitment to assuring safe products rests
squarely on our ability to keep pace with the explosion in scientific advances
- and then to use that knowledge to assure safe products. We must apply our intellectual capital at
every point in the life cycle of the product.
When consumers buy food items, drugs or medical devices, they’re
purchasing not only the product itself, but FDA’s implicit assurance that the
product is safe. To give them such
assurance in a world with so many new products, FDA must quickly understand
these sophisticated new products and the science within them and judge their
suitability for the market place. Timing is everything! Wayne Gretzky, of ice hockey fame, was asked
to tell what made him a successful player.
He said: “I skate to where the
puck will be.” FDA is in a similar
position. We must be able to
anticipate and access the cutting-edge science that will be needed to regulate
the products of future technology. When
this is possible, we can apply this science at the point when the new technology arrives, and when it is
absolutely essential to steward these products, many of them lifesaving, to the
market.
FDA is the regulatory gateway through which an
estimated $50 billion in annual biomedical research and development investment
must pass and be judged. During the
President’s State of the Union address last month, he noted that innovations in
science and technology will be the key to miraculous improvements in the
quality of our lives and advances in the economy as we enter the 21st
Century. He discussed the remarkable
fruits of research – much of it taxpayer funded – that promise to improve both
our health and the way health care is delivered. You and your colleagues on other appropriations committees have
overseen a major expansion of Federal research in recent years, and those
investments will pay dividends many times over for us all.
If FDA is not in a state of scientific readiness
when applications are received, then we must either delay regulatory decisions
on important new applications until we have adequate knowledge or make very
conservative decisions in order to err on the side of caution. Neither of these choices is good for the
American people because they delay the availability of critically needed
treatment as well as result in
increased health and economic costs. A
recent industry survey by Pricewaterhouse Coopers concerning FDA’s
relationships with its regulated industries reinforces the need for FDA to be scientifically
prepared. The survey concludes that FDA
must invest in recruiting and training exceptionally qualified personnel at all
levels. So I would urge your careful consideration
of our resource needs as they relate to
FDA’s scientific strength.
FDA can deliver when properly resourced. Congress’ authorization and support of the
Prescription Drug User Fee Act and its Reauthorization in the FDA Modernization
Act is a prime example. Review of drugs
and biologics in the U.S. is now as fast or faster than anywhere in the world
and this has been accomplished without lowering our very high standard for
safety and effectiveness. We want to be
able to perform this well in all of our products that require premarket
evaluation.
Assuring
Safety by Managing Risk
A strong FDA science capability is equally
critical in understanding and managing risks associated with products that are
already in the market place. Each year,
hundreds of thousands of adverse experiences are reported in association with
foods, drugs and medical devices. When
we can apply cutting edge science to these problems, particularly in
cooperation with our health and regulatory partners, as well as those in the
regulated industry, we can quickly identify significant risks and minimize
them.
In managing risk, FDA has always adhered to the
principle that the most serious risks should be addressed first. This idea takes on added meaning, given the
complexities of our 21st Century environment. You will see evidence throughout our budget
that the most serious problems are at the top of our list. To illustrate:
While we have identified the aforementioned as
investments that would be focused on high risk in each of our product review
centers, we must also focus and invest in applications that have the greatest
potential for providing widespread health benefits. A critical provision provided by FDAMA is our ability to delegate
to third parties the responsibility for reviewing medical device applications
in lower risk categories. In this
year’s budget request, a Device user fee is proposed to further encourage
reviews to be performed by third parties which will result in greater
efficiencies for both FDA and the industry.
This allows our Agency’s scientific review resources to be dedicated to
the more complex new products that often carry significant risks but have the
potential for great health benefits.
Collaboration
and Leveraging Opportunities
Working with FDA’s assets alone is not
sufficient to address the complex risk management challenges that we face. Many of the initiatives in the FY 2001
budget require our Agency to work in concert with a broad spectrum of
stakeholders to strengthen the safety net for the U.S. consumer. A prime illustration of this approach is in
Food Safety.
Because we regulate in a global market place,
our collaborative efforts must extend beyond our domestic borders. In this regard, we collaborate with our
foreign regulatory counterparts in joint efforts that include setting standards
to reduce the risks of products to the consumer. Whether it’s within our domestic boundaries, or beyond, FDA
undertakes such collaborative initiatives because all parties can unify behind
goals that are in the best interest of public health and safety. With such collective efforts we will be
able to move our world to better health outcomes.
Open,
transparent and predictable regulatory processes – Another
key provision of the FDA Modernization Act of 1997 directed our Agency to
consult with our many stakeholders on an ongoing basis, to keep them apprised
of our strategies and new product decisions, and to generally make them an
informed participant in our regulatory processes. The relevant principle, here, is that a confident and
well-informed individual or industry also becomes a partner in shouldering the
management of risks.
A recent example of this principle in action is
the success FDA is enjoying in the “Take Time to Care” Initiative. This involves a partnership between FDA, the
National Association of Chain Drug Stores, senior citizen groups, professional
associations, business/labor women’s organizations and other health
organizations. This partnership
effectively delivered an important message about safe drug use by distributing
a brochure titled “My Medicines” through more than 20,000 pharmacy outlets to
millions of citizens. The intent was to positively affect their use of
medications. A national evaluation has revealed that 99% of both men and women
found the drug information they received to be useful and 86% indicated an
intention to speak with their physician or pharmacist about their medication.
We intend to keep these communication channels
alive and “humming.” This Spring we will listen at two additional stakeholder
forums – the first at Stanford University in March, and the second at Duke
University in April. At both of these
sessions, we will no doubt receive suggestions on how to improve our programs
and further strengthen our working relationships with our constituencies.
These 21st Century ways of doing
business -- strengthening science; addressing the highest risk priorities;
collaborating effectively with our partners and leveraging our resources; and
using open, transparent regulatory processes -- must be applied across the
entire spectrum of product development, review and postmarket monitoring. The total safety assurance system requires
FDA’s best performance at several critical points. It starts with effective communication with industry prior to
the submission of applications, thus improving the quality of submissions
received and helping to reduce product development times. Next, we must monitor the progress of new
therapies as they are developed, including the important responsibility of
overseeing clinical trials. Once a
product is approved for the market place, we must continue to assess and manage
risk through regular plant inspections and analysis of adverse event
reports. Feedback from our monitoring
and analysis activities also influences future pre-market review decisions and
appropriately informs us so that directed intervention can take place in the
postmarket arena should threats to the public health and safety arise. Interventions can take several forms, including
education, technical assistance and when necessary, enforcement actions and
product removals. When we are able to
play all of these roles effectively – bolstered by science and augmented by
partners who share our goals – American citizens can be confident that an
effective safety assurance system is in place.
FDA’s budget proposal for FY 2001 moves us toward that desirable state
of affairs.
FDA
Accomplishments
When I appeared before you last year I outlined
five issues that I considered to be my highest priorities. These were implementation of FDAMA,
strengthening the Agency’s science base, implementing the Food Safety
initiative, assuring the safety of the U.S. blood supply, and reducing young
people’s use of tobacco products. I am
pleased to report to you today that thanks to your continued support we have
made significant progress in each of these priority areas:
FDAMA Implementation
Last year I committed to you that FDA’s energies
would be dedicated to carrying out both the spirit and letter of the Law. I am pleased to report another year of
exceptional accomplishments in this regard.
To meet the letter and spirit of FDAMA, a
scientifically strong and efficient FDA must join forces with other
organizations to address increasingly complex challenges in order to protect the
public health. While consultation and collaboration with our constituents is
not a new practice for FDA, the FDA Modernization Act made the collaborative
principle so central to the agency’s operations that its implementation
required a fresh look at some of our long-standing practices. The Agency’s record this past year
provides demonstrable evidence that FDA is meeting FDAMA’s expectations for
outstanding effort and bold new thinking.
FDA has continued working to implement the many
specific requirements of FDAMA.
Last
year I reported that the Agency had completed over 80 FDAMA-related actions. To
date, the Agency has completed over 110 FDAMA-related actions with more
expected; all within statutory deadlines. Some of the initiatives completed
within the past year include: the OTC
final monograph for sunscreens, a final
rule to exempt selected class I medical devices from pre-market notification, a
final rule that governs requirements associated with reporting adverse events
for medical devices, and guidance that grants market exclusivity to drug
sponsors who provide information relating to the use of the drug by children.
Another key provision of the FDA Modernization
Act was the reauthorization of the Prescription Drug User Fee Act of 1992. I am
proud to report once again that FDA has met or exceeded practically all
performance goals required. As I
mentioned earlier, FDA has demonstrated that if we are provided adequate
resources, we meet or exceed our goals.
Patients receiving safe and effective therapies they need in a timely fashion
is the primary public health benefit of this program. The median approval times
for NDA submissions in calendar 1999 was 13.8 months, but if the current rate
of first review approvals is sustained, 2001 and 2002 median approval times may
drop significantly. Median approval
times for priority applications submitted in calendar 1999 dropped to 6 months, which is more than twice as
fast as the corresponding times before PDFUA.
This shortening of development times also
results in incredible savings to the pharmaceutical industry. A report released this past summer by the
Tufts University Center for the Study of Drug Development shows that clinical
development times for new drugs in 1996-1998 dropped 18% from the period of
1992-1995; thus saving industry up to $2 billion for the $140 million annual
PDUFA investment. This savings is
realized not only because important new products go to market more rapidly, but
also because drug firms are able to operate in a more predictable regulatory
climate – one that makes their own product development planning more efficient.
It is also heartening to note that several new
products that received approval this past year represented significant advances
over those previously available.
For
patients with HIV and AIDS FDA’s work in 1999 added several new
products to the growing number of treatments. One of them is Amprenavir
(Agenerase), a new protease inhibitor that received an accelerated approval for
use in children as young as four.
Amprenavir attempts to prevent HIV from making new copies of itself by
interfering with HIV protease enzyme.
For
the elderly FDA approved new medications and indications
added to the treatment options for many of the 18 million Americans – mostly
senior citizens – affected with rheumatoid arthritis and osteoarthritis. The Agency also approved a combination of
aspirin and extended-release dipyridamole (Aggrenox) to reduce the risk of
stroke.
For
people with diabetes three new products approved last year
will bring benefits to many of the 16 million Americans affected by diabetes, a
disease that can cause damage to the eyes, kidneys, heart and peripheral
circulation.
For
people with hepatitis C FDA approved several new treatments for
the almost four million people in the U.S. who suffer from this disease. Hepatitis C, is the nation’s most common
blood-borne infection that poses a serious risk of cirrhosis, liver cancer and
liver failure.
For
people with rare diseases I am pleased, also, to report major
progress in our Orphan Products Program, a key program developed after the
passage of the Orphan Drug Act of 1983.
Orphan products are those that treat diseases or conditions affecting
fewer than 200,000 people. That program
reached a major milestone last year by approving the 200th
designated orphan product. In 1999, 78
drugs and biological products received designation as orphan products – a 16%
increase over 1998. We estimate that
past levels of sponsor orphan designation applications may soon be
doubled. Nineteen designated orphan
drugs were approved for marketing in 1999, including treatments for neoplastic
meningitis, ovarian cancer and hemophilia.
Strengthening
FDA’s Science Base
As I have mentioned previously, strong science is
critical for FDA to safeguard the credibility of its regulatory decisions made
at every stage during the life span of the product. Science must underpin every
one of our activities including our consultation with product sponsors,
review of commercial applications, the establishment of product and process
standards, and the identification and
correction of hazards in the market.
FDA science must also provide the foundation for all of the Agency’s
negotiations on product standards in the international arena. In each of these facets of FDA
responsibility, the Agency must keep pace with the incredible pace and
complexity of new science developments.
The biomedical science community is developing novel approaches to
detect, treat, and prevent disease. If
FDA does not keep pace, our judgements and decisions may become risk averse and
at times slow, possibly wrong – or both.
Neither of these is an acceptable outcome. The Agency must build its own capabilities and have the ability
to leverage talents and expertise of scientists and scientific organizations
outside of the organization.
Let me provide a few examples of the importance
of science to our regulatory role:
These selected examples illustrate the direct
and immediate value of applying FDA’s science expertise at critical junctures
in the regulatory process.
To remain a strong science-based agency, we must
continue to assess emerging technologies well in advance of their arrival on
FDA’s doorstep. We must prepare for and
remain prepared to meet not only the public health challenges of today, but
also the future challenges of a rapidly changing science and technology
environment.
Food
Safety Initiative
FDA, in collaboration with the Centers for
Disease Control and Prevention (CDC), the U.S. Department of Agriculture
(USDA), and State and local governments, continued progress towards developing
an integrated national food safety system. Your support has also provided for
mechanisms in the shortening of several significant outbreaks of food borne illness,
translating into fewer deaths and illnesses. In 1999, FDA placed particular
emphasis on enhancing the safety of imported food products. At the border, FDA initiated a 1,000-sample
survey of high volume fresh produce imports. Overseas, FDA doubled the number
of foreign food establishment inspections, conducted five assessments of
foreign food safety systems, and provided extensive education and technical
assistance on use of the Good Agricultural Practices/Good Manufacturing
Practices guidance for produce.
Other accomplishments in the food safety arena
include the following:
Assuring
Safety of the U.S. Blood Supply
Last year I shared with you that more than 3.5
million Americans receive blood from volunteer donors. The most serious risk that these citizens
face is the possibility of transmitting undetected diseases. Blood shortages, however, can also present a
life-threatening situation. In February
1999, the National Blood Data Resource Center (NBDRC), a corporation affiliated
with the American Association of Blood Banks, published a projection that the
Nation’s demand for blood could exceed the available supply in the foreseeable
future. FDA has the responsibility for
balancing the need for greater blood supplies with the increased risk
associated with more diverse sources of blood and wider access.
Last year I indicated that FDA had developed a
Blood Action Plan to address these issues.
I can report to you now that with your support the Agency has continued
successful implementation of that Plan.
The Plan is being jointly carried out by FDA, the Centers for Disease
Control, the National Institutes of Health, and the Health Care Financing
Administration. The Plan addresses
highly focused areas of concern such as emergency operations, response to
emerging diseases, updating and reinvention of regulations, monitoring the
blood supply, and ensuring compliance with blood regulations. Last fiscal year,
the Agency satisfied several key elements of the Plan:
Assuring the safety of the blood supply is
paramount; but FDA also recognizes that assuring the availability of
safe blood is also a major public health challenge. To that end, FDA participated in a workshop this month sponsored
by the National Heart Lung and Blood Institute, entitled: “National Strategy to Increase Blood
Donation.” Several initiatives were
reviewed at this workshop, including: considering the use of previously
deferred blood donations – e.g., therapeutic hemochromatosis donations, using
computers to simplify blood donor interviews, and generally increasing donor
incentives for participation.
Challenges to the safety of the U.S. blood
supply remain ongoing. One of the
Agency’s most effective responses is to join forces with its fellow health and
regulatory partners to stem these threats.
The Blood Action Plan demonstrates such a united effort. I will keep you apprised of further
developments fulfilling this critical Agency priority.
Reducing
Young People’s Use of Tobacco
I reported to you last year that over 400,000
Americans die from tobacco-related illnesses each year. Virtually all of these people began the use
of tobacco as children. Thanks to funds you and your colleagues appropriated in
FY 1998 and FY 1999, FDA, in cooperation with its federal and state partners,
and with the retail community, has been able to launch an effective enforcement
and outreach effort. We have early
indications that these combined efforts are starting to have an effect. The University of Michigan’s Institute for
Social Research reported that although accessibility to cigarettes by 8th
graders was still very high (72%) that figure has been falling since 1996.
Let me cite a few highlights of the program
efforts in 1999 that are contributing to this hopeful turn-around in youth
smoking:
In addition to the priority areas I have
outlined above, we have also undertaken work in a variety of high profile and
controversial areas -- bioengineered foods and dietary supplements, to name a
few. We are making strides in these
areas, but each is a work in progress.
A final issue I raised with the Committee last
year as a recently confirmed Commissioner, was my desire and intention to
restructure and streamline the Office of the Commissioner in order to realign
resources and functions. I appreciate
the Committee’s support of my plans.
The reorganization is now complete.
We are now undertaking an additional step to reinvent many of our
processes to make the Office of the Commissioner and the Agency programs which
it supports operate in an efficient and effective manner. During the course of this past year I
appointed two people to key leadership positions in the Agency. Dr. David Fiegel is our new Director of the
Center for Medical Devices and Radiological Health. He brings with him an extensive background in the academic sector
as well as managerial experience in two of our other product centers –
Biologics and Drugs; Dennis Baker is
our Associate Commissioner for Regulatory Affairs. Mr. Baker was Chief of the Bureau of Food and Drug Safety within
the Texas Department of Health…. and while he was in that position he
established a strong reputation for being a regulatory ‘reinventor.’ He will be a very valuable resource to me as
we work closely with the states to achieve our mutual public health and safety
goals.
Now, let me discuss our fiscal year 2001 request
before you for your consideration.
FY
2001 Budget RequestFY 2001 Budget Request
No matter how many or laudable our
accomplishments may be, there still is much to do. This year’s budget is reflective of the high priority areas where
we need your support to assure that strong science will guide our decisions and
ensure a strong safety net is in place for the American Consumer. The fiscal year 2001 President’s budget
request for FDA is $1,390,831,000 -- an increase of $176 million over
FDA’s fiscal year 2000 enacted
level. This budget targets improvements
that will:
By strengthening both of these areas, FDA is
assuring safety throughout the life cycle of the product.
In addition, the budget identifies major
initiatives of special note and interest to the President and the Congress
including Food Safety, Youth Tobacco Prevention and Bioterrorism. The budget also targets critically needed
improvements to FDA’s Infrastructure – specifically replacement of the Agency’s
Los Angeles regional laboratory facility, completion of the Center for Food
Safety and Applied Nutrition in College Park, Maryland and continued support
for the Arkansas Regional Laboratory.
Let me briefly highlight our major initiatives
in each of these areas:
Bringing
New Products to Market Through Strong Science
Assuring
A Strong Safety Net Through Strong Science
Initiatives
of Special Note and Interest to the President and the Congress
FDA
Infrastructure Improvements
In addition, the Agency is requesting $14.2
million in proposed existing user fees; and $19.5 million in proposals for new
user fees.
Each of these requests is described in more
detail which follows:
Bringing
New Products to Market Through Strong Science
New products entering the marketplace will
change the face of health care and will help us lead longer, healthier
lives. They will also bring enormous
economic benefits, both in lessening the cost of health care and in returning
profits on the investments that are being made in research.
We are requesting $42 million to enhance the
review of new health-giving products so that they can be considered in a timely
fashion for entry into the market place.
FDA efforts will focus on: direct food additive petitions; generic
drugs; animal drugs; children’s vaccines; the blood supply; pandemic flu; and
medical device re-use. The requested
funding for direct food additive petitions, together with funds provided in FY
2000, would provide full funding for this important program.
FDA will use new funding to develop a focused
effort in the rapidly evolving field of food biotechnology. FDA requires scientific expertise capable of
reviewing products developed through the tools of biotechnology and for
providing public assurance of their safety.
Assuring
a Strong Safety Net Through Strong Science
Medical Errors
($12.8 million). One of my first
initiatives as Commissioner was to establish a Task Force to evaluate the
system for managing the various risks of FDA-approved medical products. The task force issued a report in May 1999,
entitled, “Managing the Risks from Medical Product Use”. The report confirmed that the high standard
of premarket review has been maintained even as our reviews have become more
timely. However, several key areas were
identified where the safety net for consumers and patients could be
strengthened. This report has led to a
bold initiative in which FDA is a key participant along with other major health
agencies in the public sector as well as health practioners, hospitals, and
states. In a related study the
Institute of Medicine (IOM) estimates that close to 100,000 Americans may be
dying each year as a result of preventable medical errors because of failures
within the complex systems of modern health care. The aim of FDA’s initiative in response to its own report and the
IOM study is to aggressively deal with the medical errors and adverse events
that are reported annually in the U.S.
Patients, doctors, nurses
and other health professionals represent a key human component of our health
care delivery system. This same system also includes a vast array of drugs,
medical devices, blood and other biological products that are regulated by
FDA. While the causes of medical error
cover a broad spectrum, many involve the use of medical products. Preventing the errors can save people’s
lives and the health care system and society billions of dollars annually in
unnecessary costs. FDA is working with
agencies within DHHS and across the Federal government to develop and implement
strategies to prevent medical errors.
Features that contribute
to errors in actual product use are not always identifiable before FDA
approval. Once products are widely used
in today's complex and fast-paced healthcare delivery system, these "human
factors" can emerge as safety risks.
The Agency has a number of surveillance systems to identify harm
resulting from use of FDA-regulated products.
We receive problem reports from hospitals, other health-care facilities
and individual health care professionals.
When the FDA is alerted to problems with a medical product, we conduct a
thorough safety analysis using medical and scientific experts to identify
critical factors causing the problem, and to identify problematic product
features and safety procedures. To prevent further harm to patients, FDA takes
actions necessary to minimize problems including communicating with doctors,
other health professionals, and patients and requiring changes to the medical
product. The "lessons
learned" about safe product features are incorporated into the Agency's
review of future products.
Recent and dramatic
increases in the complexity and numbers of newly-approved medical products, the
trend toward their increased patient use, and increased time and cost pressures
on health care providers, have raised the level of risk for human error in the
use of medical products. While FDA
receives over 300,000 reports each year, it is known that the vast majority of
incidents are not reported.
The estimated costs for
these medical errors are as high as $29 billion a year. Increased resources will allow the agency
to elicit more complete reporting as well as analyze report data in a timely
manner and to invest in information technology to develop more effective
systems. The Administration has set the goal to reduce preventable medical
errors by 50% within the next 5 years.
FDA’s request includes an additional $12.8 million. If provided these funds we will:
Adverse Event Reporting Systems ($3.1 million). In addition to the
adverse events discussed as part of medical errors, FDA monitors adverse events
related to dietary supplements and
animal drugs. The dietary supplement
industry is one of the fastest growing industries in the world. Dietary
supplement sales have nearly doubled in the past five years and one study
estimates that sales will increase by over 90 percent over the next six
years. Surveys show that over half of
the US population now uses some type of
dietary supplement, spending over $12 billion per year for these products. FDA estimates that the industry markets
approximately 29,000 of these products which are sold under 75,000 distinct
labels.
The number of adverse event reports related to
animal drug products has risen from about 1,000 per year in the early nineties
to over 12,000 for 1999. Because FDA does not have the resources to process
these reports in a timely manner, they must be triaged and only those showing
the most serious health hazards are evaluated.
Consequently, a substantial backlog exists in
reviewing adverse event reports in both of these important areas. This budget request will improve our
Adverse Event Reporting System (AERS) for animal drugs and dietary
supplements. This will enable us
to provide greater assurances to
consumers that problems will be identified and action taken promptly.
Inspectional
Activities ($13.5 million). FDA inspections, laboratory analysis,
and related surveillance activities are the primary means of assuring industry
compliance and thus consumer safety once products are in use. New technologies, international regulatory
commitments, and increasing coordination with State partners require new and
challenging expansions of FDA’s traditional inspection role.
FDA’s ability to physically verify the safety of
domestic and imported products has eroded considerably in all product areas,
even as consumer expectations continue to rise. We are falling significantly short of the minimum inspection
obligations required by the FDC Act.
Import entries alone increased 14 percent in FY
1999, and over all, less than one percent of import entries are physically
examined. Even in conjunction with its
State regulatory partners, FDA is able to annually inspect less than a third of
the domestic firms within its purview.
The number of foreign and domestic inspections for foods, drugs, and
devices (excluding mammography), has decreased from 28,000 to 22,000 between
1991 and 1999. This decrease of 6,000
inspections, or 21 percent, is due to the impact of the time required to
perform the increasingly complex science based inspections, the almost static
level of investigative personnel in the past eight years, and the increases in
imports. The total volume of
FDA-regulated imports is estimated to exceed $50 billion per year and imports
continue to grow in volume, complexity, and diversity of sources.
FDA requests $13.5 million in additional funding
to improve statutory inspection coverage for Human Drugs, Biologics, Animal
Drugs and Medical Devices, where the law requires specific inspection
frequency. The requested funds will
keep the FDA from falling behind the fiscal year 2000 level of inspectional
effort. Through the use of leveraging and expanding existing state contracts,
FDA will make modest gains in inspection coverage. Specific performance improvements are identified in FDA’s FY 2001
Performance Plan. These funds will also
allow FDA to enhance laboratory testing for pesticides, chemical contaminants
and dietary supplements.
Internet
Sales of Drugs ($10 million). The number of people who use the Internet
for the purchase of medical products is growing rapidly. Many consumers, including those in rural or
remote areas, those that can not leave their homes because of disabilities or
who are elderly, greatly benefit from the access and convenience features of
this option. However, on-line sale of
prescription drugs also poses risks for the consumer. When buying from a brick and mortar pharmacy, a corner drug
store, a strong safety net of State and
Federal laws exists. Prescription drugs
are to be dispensed only with a valid prescription, because they are not safe
for use without the supervision of a licensed health care practitioner and
dispensed from a licensed pharmacy. The availability of pharmaceuticals from
the Internet can greatly disrupt this safety net. Patients who buy prescription drugs from Internet websites
operating outside the law are at increased risk. During fiscal year 1999, illicit or illegal operated sites grew
dramatically and we anticipate this trend to increase. This initiative will enable us to track down illegitimate operations and
educate consumers by coordinating efforts with the states.
For fiscal year 2001, FDA seeks $10 million
primarily to conduct investigations and to carry out a public education
campaign on safe ways to purchase pharmaceuticals over the Internet. FDA would use part of this request to
support a rapid response team and to upgrade our computer technology to
identify, investigate and prosecute illegitimate Internet pharmacies.
INITIATIVES OF SPECIAL NOTE AND
INTEREST TO THE PRESIDENT AND THE
CONGRESS
Food
Safety Initiative ($30 million). The world of food has changed significantly
over the past 50 years. Consumers’
diets are more varied and include foods that are more susceptible to foodborne
pathogens. A much larger percentage of
meals are prepared and consumed outside the home. Vulnerable populations have increased by as much as 25 percent of
the U.S. population to include pregnant women, children, the elderly, and
immuno-compromised persons. Finally,
the number of identified pathogens found in food has more than tripled. More to the point, these pathogens are more
deadly.
The Food Safety Initiative represents a
multi-year, inter-agency effort to respond to these changes and to improve food
safety for the Nation. This initiative
has successfully built a strong foundation for a state-of-the-art,
science-based food safety system, and has promoted partnering among the key
Federal agencies (FDA, USDA, and CDC), States, academia, industry, and
consumers. A total of $218 million,
representing a $30 million increase, is requested for FDA for fiscal year
2001. With this $30 million increase in
funding we will:
Food Safety Initiative investments for the past
three years have paid tremendous dividends.
Foodborne outbreaks have been shortened. The risk of foodborne illness and death related to
microbiological contamination of both domestic and imported foods has
decreased. With the resources requested
in fiscal year 2001, we will continue to provide the U.S. with a consistent,
uniform system to respond to foodborne illness that will contribute
significantly to shortened outbreaks and reduced incidence of illness and
death.
Countering
Bioterrorism ($11.5 million). Preparing for and responding to an attack
involving biological agents is critical.
Our task is made more complex by the large number and characteristics of
many of the potential agents, many of which are rarely encountered naturally
and have the ability to remain undetected for long periods of time. There is often potential for secondary
transmission as they could be genetically engineered to resist current
therapies and evade vaccine-induced immunity.
While there is a clear and unquestionable need to develop specialized
vaccines for these biological agents, there are limited commercial interests or
market incentives addressing this problem. Thus, it falls upon the Federal
government to ensure that such vaccines are developed.
FDA is
an important contributor to the Nation’s capability to respond to potential
chemical and biological threats from bioterrorism. The FDA’s critical role in bioterrorism includes assuring that new vaccines and drugs are safe and
effective, safeguarding the food supply, and conducting research for diagnostic
tools and treatment of disease outbreaks. Whether the issue is the development
and use of rapid diagnostics to quickly identify a suspected biological agent
or the capability to make available and administer large quantities of a vaccine,
immune globulin, or drug to counter the effects of a bioweapon, FDA’s research
is the linchpin that makes it possible for the Centers for Disease Control and
Prevention (CDC), the National Institutes of Health (NIH), the Office of
Emergency Preparedness (OEP), the Department of Defense (DOD), and others to
effectively respond.
FDA’s research includes the development of new
analytical approaches and methodologies to determine if new products provide
needed benefits without causing adverse side effects that would outweigh those
benefits. This research includes both
laboratory and non-laboratory investigations to address FDA’s regulatory
responsibilities.
Due to the highly toxic nature of the agents
identified as potential bioterrorist agents, specialized equipment and
facilities are necessary and needed in the FDA to understand these agents to
prevent, diagnose and treat outbreaks.
Other Bioterrorism activities that support FDA’s
efforts are:
The fiscal year 2001 request is $11.5 million.
This funding will allow the Agency to
expeditiously review and approve every drug, therapeutic, vaccine, and
anti-toxin to be administered to humans; complete the FDA review process for
safety and efficacy of the pharmaceuticals, rapid diagnostics, and vaccines that
are needed in the event of a bioterrorist attack; and, to educate vaccine
manufacturers on the information needed for FDA approval.
Preventing
Tobacco Use Among Children ($5 million).
Tobacco products are responsible for more than
400,000 deaths annually due to cancer, respiratory illness, heart disease, and
other health problems, representing five million years of potential life lost
each year. Each day, nearly 3,000 young
people across the country begin smoking regularly. Of these 3,000 young people, 1,000 will die prematurely because
as a child they decided to smoke.
Conservative estimates are that children and adolescents illegally
purchase tobacco products 250 million times each year.
The Agency has devised a three-pronged approach
of enforcement and evaluation, compliance outreach, and product
regulation. The $5.0 million in this
request will be used to increase leveraging contracts with State and local
tobacco stakeholders to allow more compliance checks of age and ID
restrictions, and 100 percent re-checks of violators. It will also be used to develop a reliable, national list of
tobacco retailers and complete installation of an information technology system
to automate the program’s business and communications processes, as well as
increase the scope of the media campaign aimed at increasing retailer awareness
of, and compliance with, the tobacco regulation.
Our overall goal -- to reduce young peoples’ use
of tobacco – is a goal upon which we can all agree. We will continue to work with other organizations within the
Department of Health and Human Services, other agencies, the States, and other
stakeholders.
FDA Infrastructure
Los
Angeles Laboratory ($20 million). FDA’s field laboratories provide critical
laboratory and analytical support to the domestic and import inspection effort
and are a key element in the science base of FDA. The Los Angeles District annually reviews nearly 1.2 million
import line entries, almost 24 percent of the Agency total. In FY 1999 alone, the Los Angeles laboratory
analyzed 22.9 percent of the imported Foods samples taken by FDA. This
laboratory facility is over 40 years old, outmoded and unsafe.
FDA simply cannot remain in the present Pico
Boulevard facility in Los Angeles. We have the land and construction plans to
relocate the laboratory to Irvine, California.
This will assure that products are safe, provide the ability to partner
more effectively with State laboratory personnel, and provide a safe working
environment for FDA employees.
FDA requests $20.0 million to fund a portion of
the construction of the Los Angeles Laboratory and Office project. The request also includes $23.0 million as
an advance appropriation in fiscal year 2002 to complete the project. This construction will consolidate all three
Los Angeles district sites into one location, replacing three existing leases
totaling $2 million annually. The new
construction will concentrate the scientific talent available to permit better
management of the analytical workload and will provide significant improvement
in operational efficiency, especially during emergencies.
If funding is not provided, the Agency will be
forced to shift work to labs in other states, further from the point of
entry. This will obviously have an
impact on FDA’s import surveillance capability, the southern California food
import industry and our consumers.
College
Park Relocation ($5 million) and Arkansas Regional Laboratory ($3
million). In
2001, the Center for Food Safety and Applied Nutrition (CFSAN) will be moving
to a newly constructed facility in College Park, Maryland. Funds are needed to pay for one-time costs
associated with equipping and occupying this facility. The FY 2001 funding will support:
telecommunications equipment and necessary network connections, files
consolidation and moving costs. We will
also continue construction of the next phase of the Arkansas Regional
Laboratory.
Conclusion
In summary, Mr. Chairman, fiscal year 2001 is
the year in which FDA must cope with the maturation of two of the most massive
and significant change forces the agency has ever faced. In 2001, the increasing impact of molecular
science--genomics in particular—and the information revolution—especially the
internet and its linkage to an array of real-time data that was unimaginable
only a few years ago—will combine their forces to change how many FDA regulated
products are discovered, researched, manufactured, distributed, marketed and
advertised. When the world around us changes this much, we must be prepared to
respond in order to assure that products are still safe for American consumers.
Our credibility to provide valid assurance is at risk without strong science,
effective collaborations and consultation, and even greater openness and
transparency in our processes.
I wish to thank the members of this Committee,
their staff and the staff of the individual subcommittee members for their
support this year. This subcommittee
has many legacies, from improved agricultural production to safer consumer
products to protection of the American farmer.
I ask that you add another critically important one to the list –
bringing forth the technological promise of the 21st century. If you will give FDA the resources to do the
job I will commit to you that those funds will be used wisely. I look forward
to discussions with this committee to ensure that we are able to fulfill our
mission in this challenging environment.
Edited 3/8/2000
Posted 3/8/2000
Issued 2/25/2000
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