Copyright 2000 Federal News Service, Inc.
Federal News Service
February 29, 2000, Tuesday
SECTION: PREPARED TESTIMONY
LENGTH: 10939 words
HEADLINE:
PREPARED TESTIMONY OF JANE E. HENNEY, M.D. COMMISSIONER, FOOD AND DRUG
ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG
ADMINISTRATION
BEFORE THE HOUSE APPROPRIATIONS
COMMITTEE HOUSE SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT,
FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES
SUBJECT -
FISCAL YEAR 2001 BUDGET REQUEST
BODY:
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
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 modem 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:
- We must strengthen our science; - We must address the highest priority
risks; - We must engage in effective collaborative and leveraged activities;
and, - We must design ever more predictable, timely and transparent regulatory
processes.
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 21 Century environment. You will see evidence throughout
our budget that the most serious problems are at the top of our list. To
illustrate:
- The medical error initiative in our FY 2001 budget
emphasizes FDA working with other agencies in the Department of Health and Human
Services and with Departments across the Federal government as part of the
President's new and comprehensive plan to improve health care through the
prevention of medical errors and enhancement of patient safety.
- Drugs
marketed and sold from illegitimate internet pharmacy sites
present real risk for the American consumer. These have been made a priority for
FY 2001. FDA will use prevailing Internet hardware and software to focus on
suspect web sites, and will convey a rapid response team to deal with these
sites. FDA also intends to work very closely with State authorities and other
Federal agencies in order to expedite the elimination of this fraudulent
activity. We also plan to step up our efforts to educate consumers about the
risks involved and what types of sites or practices they should avoid.
-
Again, we have addressed the most serious risks first as part of the Food Safety
Initiative. If provided the funding requested, we will be able to inspect the
high risk food firms at least once a year. We would continue the work supported
by the Congress in the past which focuses our efforts in the import arena by
targeting imported produce that contain microbiological pathogens. Your support
has also allowed us to invest in new science-based tools like PulseNet, a
collaborative project between CDC, FDA, USDA and state health departments, which
uses rapid analysis of bacterial DNA fingerprints to pinpoint the exact source
of food borne illness outbreaks. More of these detection tools will
revolutionize our ability to detect and prevent a wide range of adverse
experiences and to focus on the most serious ones first; but we need resources
to do this.
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:
- FDA scientists have developed a single rapid
technique (rapid screen) that identifies as many as 13 common foodborne
pathogens, including Salmonella spp., Shigella spp., and Escherichia coli 0157H7
from one sample in a test that takes only 8 hours to complete. This method is
permitting faster hazard detection and removal of potentially dangerous foods
from the marketplace.
- Our scientists also developed a test system that
would help to determine the extent of interference of cardiac pacemakers caused
by cellular telephones. This research has formed the basis of a standard for
implantable cardiac pacemakers and defibrillators that are being proposed by the
Association for the Advancement of Medical Instrumentation.
- FDA
scientists have developed a transgenic model that can be used to screen for
toxicities. By using this model, scientists are learning more about how specific
chemicals cause toxicity in humans, and how to extrapolate results from animal
species to the human. Some of our molecular epidemiologists have also worked
with academia and industry to develop and validate a microchip product designed
to identify individuals at risk for cancer and/or adverse drug interactions. The
significance of this chip technology is that it allows for researchers to screen
large numbers of people simultaneously for different types of biomarkers, or
potential disease vulnerabilities.- FDA has successfully launched the Product
Quality Research Institute Initiative (PQRI). PQRI is a non-profit corporation
whose mission is to conduct research to support science-based regulatory policy
regarding product quality.
- FDA has also taken action to assure that
our scientists keep pace with and effectively monitor products that are produced
by state-of- the-art manufacturing and quality control technologies. This past
fall FDA launched a new joint training program focused on emerging technologies
of relevance to the Agency. The training is conducted in cooperation with the
regulated industry. The first of these courses brought together more than 30 FDA
field investigators, Center scientists and field lab analysts to a Merck
manufacturing plant in Pennsylvania to address state-of-the-art sterilization
methodologies. Similar advanced courses are planned for the future.
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:
- FDA and the U.S. Customs Service
developed an Imported Foods Action Plan to further enhance border surveillance.
The Plan will be implemented this year.
- FDA conducted the second year
of seafood HACCP inspections, with priority to processors with implementation
problems. FDA found clear progress by most seafood processors, but also issued
warning letters to those firms with significant, unaddressed deficiencies.
- FDA issued two guidance documents to enhance the safety of sprouts,
including guidance for microbiological testing.
- FDA published a
proposed rule that would require refrigeration of shell eggs at retail and safe
handling statements on labels of shell eggs.
- In collaboration with
USDA, EPA and the Department of Commerce, FDA completed an Egg Safety Action
Plan that identifies the systems and practices that need to be implemented to
sharply reduce eggs as a source of human Salmonella enteritidis illness.
Implementation will begin in FY 2000.
- FDA completed revisions to the
Food Code to enhance the safety of food prepared outside the home, including
restaurants, nursing homes, hospitals, and day care centers. The Food Code was
adopted by agencies in 15 states.- FDA continued the expansion of the National
Antimicrobial Resistance Monitoring System (NARMS), a collaborative effort among
the FDA, USDA, and CDC that monitors susceptibility to 17 antimicrobial drugs in
food borne pathogens from human and animal clinical specimens, healthy farm
animals, and carcasses of foodproducing animals at slaughter. Important
augmentations of the NARMS were funded from the Food Safety Initiative during
fiscal year 1999.
- FDA also provided educational materials to farmers
regarding how to prevent future outbreaks and the spread of the multi-resistant
organism, Salmonella typhimurium DT104, among animals and to human beings. This
was accomplished through collection of information from a field study, several
farm-based efforts, and molecular genetic research on a Vermont dairy farm.
On-farm poultry studies were initiated in five States in collaboration with USDA
to determine the management, production, and drug use practices that influence
the development of resistant zoonotic pathogens. Studies examining the effect of
the prudent use of antimicrobials on chicken farms began in association with the
University of California and Michigan State University.
- FDA and USDA
collaborated with medical microbiologists from hospitals in Mexico and Guatemala
who are interested in initiating an antimicrobial resistance monitoring program.
This collaboration between the U.S. NARMS officials and the Mexican
antimicrobial surveillance group represents the beginning of the first
international human and animal monitoring system for food borne antimicrobial
drug susceptibility surveillance in the Americas. The collaboration will lead to
improvements in the Mexican Surveillance Program, which will reduce the
possibility that contaminated food products will be shipped to the U.S.
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
lifethreatening 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 carded 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:
- The Agency completed a systematic
update of the blood regulations. As a result of this update, obsolete blood
regulations were eliminated; and guidance documents are now focused on those
standards that are enforceable.
- Under the Blood Action Plan, FDA is
harmonizing its new Biologics License Application for blood products with its
New Drug Application. In addition, FDA, CDC, and NIH representatives have formed
an Emerging Infectious Diseases Committee that has developed plans for
responding to emerging infections that threaten the blood supply.
- The
Agency met its statutory requirement of inspecting all registered blood banks
and source plasma operations within the past two years. Compliance of these
establishments with current Good Manufacturing Practice requirements now exceeds
95%.
- Agency scientists responded to challenges by blood-borne
pathogens for which there are no vaccines or adequate therapies. Blood supplies
are often exposed to the dangers posed by such pathogens as HIV, Hepatitis B
& C, and Transmissible Spongioform Encephalopathies (TSE). Because these
pathogens have evaded known therapies, our strategy is to test and disqualify
donors and blood donations found to be contaminated with these pathogens.
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 the
enforcement area, FDA now has contracts in place with all 50 states and 3
territories to conduct compliance checks of retail establishments. This
establishment of a comprehensive compliance network exceeded all of our
expectations. As a result, in 1999 we achieved a 166% increase in the number of
compliance checks conducted. Existing contracts resulted in a total of 107,200
compliance checks completed.
- We also provided retailers with a
mediation procedure to resolve civil monetary penalty complaints and avoid
litigation. Many of the violators were small businesses such as convenience
stores or gasoline stations. During a mediation conference call, the mediator
offers the retailer suggestions for preventing future violations. This process
has resulted in almost all cases being settled to the satisfaction of the
retailer. They have been very favorably impressed.
FDA has also
capitalized on information technology by designing and installing a computer
system to automate the program's processes and to develop and maintain a list of
retailers selling tobacco in each state. This is of tremendous benefit to the
states because it gives them a way of tracking up to 1.5 million retailers who
may be selling tobacco. It also provides the States with the legal record that
may be necessary for later civil monetary penalty proceedings.
- FDA has
also been active in attempting to reach retailers through a broad scoped
advertising and education campaign. In addition to reminding retailers and sales
clerks not to sell to minors and to check young peoples' photo identification,
the campaign also urges customers to cooperate with retailers to help keep young
people tobacco-free. Last year, FDA received the marketing industry's highest
honor for effective advertising, the EFFIE Award, for its advertising and
education campaign.
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 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:
1) bring new products to market
through strong science; and
2) assure a strong safety net for products
on the market through strong science.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
- $42 million to enhance the
science-based review of new health- giving products so that they can more
rapidly enter the market place.
- Improving pre-market review of
products submitted and accelerating the process of generic drug review thereby
reducing the cost of medical care to the public;
- Expanding the
scientific expertise to meet increasing demands while maintaining FDA's high
standards.
Assuring A Strong Safety Net Through Strong Science
-
$15.9 million to reduce the number of Americans who die
annually from medical errors, currently estimated at 100,000. We would
significantly upgrade and make more comprehensive our adverse event report
systems, including those for dietary supplements and animal drugs. With our
labeling initiative we would also be able to reduce the errors made because
names of drugs sound similar.- $13.5 million to better ensure
the safety of products on the market by conducting more inspections to support
statutory compliance; - $10.0 million to protect consumers from
illegitimate Internet pharmacies that inappropriately prescribe
medications, increase the risk of dangerous drug interactions or sell
potentially counterfeited or contaminated drugs. Our rapid response team would
be supported with upgrades to our computer technology used to identify,
investigate, and prosecute illegitimate Internet pharmacies. In
addition, we would enhance our public education campaign on safe ways to
purchase pharmaceuticals over the Internet.
Initiatives of Special Note
and Interest to the President and the Congress
- $30.0
million to enhance the safety of the food supply through strengthening key
elements of the President's Food Safety Initiative by increasing inspection
frequency for high risk food firms; implementation of an Egg Safety Action Plan;
developing nation-wide standards for food safety; and expanding the research
activities necessary to support the entire initiative.
-
$11.5 million to ensure expeditious development and licensure
of vaccines to be used in response to possible bioterrorist attacks; and to
respond to foodborne contamination.
- $5.0 million to
promote and protect the health of our nation's youth by reducing the number of
young people who begin to use tobacco products. Compliance checks and
compliance-based outreach efforts would increase with these funds.FDA
Infrastructure Improvements
- $20.0 million to replace
our outdated and unsafe Los Angeles laboratory facility. This facility is the
site that must test many of the products imported from foreign countries,
particularly food products.
- $5 million in one-time
costs to move the Center for Food Safety and Applied Nutrition into a new
facility at the University of Maryland in College Park.
-
$3 million to continue the next phase of the plan for the
Arkansas Regional Laboratory.
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 fastpaced 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:
1)
Improve the reporting systems for blood errors and accidents;
2)
Implement Phase II pilot of the Medical Device Surveillance Network (MeDSuN) to
address under-reporting and incomplete user facility reporting of medical device
errors. To accomplish this, FDA will recruit over 150 hospital reporting sites
into a national reporting network. This system has the potential to be extended
to drugs and other areas in future years.
3) Increase FDA's capacity to
conduct multi-factor analyses to correctly identify the sources of safety
problems and potential solutions. This includes establishing links to safety
databases maintained within community healthcare delivery systems and regional
safety surveillance systems as well as augmenting our expertise in medical
epidemiology and statistical analysis.
4) Develop new standards to
ensure that pharmaceuticals are packaged and labeled in a manner that promotes
patient safety.
5) Increase FDA's capacity to act on safety findings,
through better risk communication to providers and patients who use medical
products; and partnerships with other health agencies and health care
organizations.
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 comer 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:
- Expand research and risk assessment activities that
provide the cornerstone for a science-based food safety system. Food safety
research is critical for the rapid and accurate identification of foodborne
hazards; for regulatory enforcement; for the development of effective
intervention techniques; and for better detection of antibiotic resistance. Risk
assessment activities provide the information necessary to allocate food safety
resources to the highest risks in the food supply.
- Develop consistent
nationwide food safety standards. Standards development includes technical
standards for particular products or processes, as well as product and/or
process-specific guidance documents and regulations. Such standards provide
consumers with increased assurance regarding the uniformity and safety of the
food they consume. In addition, by providing current, clear and understandable
expectations for industry, food safety standards provide a "level playing field"
for food producers and processors.
- Begin implementation of the Egg
Safety Action Plan to sharply reduce eggs as a source of human Salmonella
enteritidis (SE) illness in the U.S. While eggs are an important source of
protein in the diet, an estimated 1 in 20,000 eggs in the U.S. contain the SE
bacteria and can cause illness if eaten raw in food or not thoroughly cooked
before consumption. The Egg Safety Action Plan presents a comprehensive
nationwide strategy to address this important food safety and public health
concern.
- Expand domestic inspections to ensure annual inspection of
all establishments producing food that is at high risk of microbiological
contamination or high risk of causing severe disease. There are approximately
6,250 such firms. By "high risk" we mean: infant formula; ready-to-eat foods;
heat and serve products; seafood; and low acid canned foods and acidified foods.
The new resources would also be used to enhance FDA's oversight of state
inspection programs, as well as to enhance laboratory capabilities for the
analytical support associated with these inspections.
- Complete the
National Antimicrobial Resistance Monitoring System (NARMS) by adding national
and international data collection sites. At this fully operational level, NARMS
will provide an effective early warning system to detect the emergence of
antimicrobial resistance among foodborne pathogens. Also, develop new methods
for routine surveillance of fluoroquinolone resistant Salmonella and
Camploybacter to gather the data needed to make informed risk decisions
concerning the use of quinolonebased antimicrobials in poultry and antibiotic
resistance.
- Develop new methods for routine surveillance of
fluoroquinolone resistant Salmonella and Campylobacter to gather the data needed
to make informed risk decisions concerning the use of quinolone-based
antimicrobials in poultry and antibiotic resistance.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, them 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 throats from bioterrorism. The FDA's critical
role in bioterrorism includes assuring that new vaccines and drugs am 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:
- Vaccine
development in collaboration with NIH, CDC, DOD, academia, and private industry
to ensure expeditious development and licensure of vaccines for smallpox,
anthrax, plague, tularemia, Q-fever, encephalitis-c using alpha viruses, and
botulinum; Coordination of vaccine, drug and device stockpiling and preparation
for emergency response including rapid detection and decontamination procedures;
- Development of new diagnostic products, rapid methods development, and
comprehensive reviews for new drugs, therapeutics, and vaccines including new
uses of existing products; development and stockpiling of specialized immune
globulins; expansion of research to identify toxicity indicators associated with
biological warfare agents; and, initiation of a monitoring system for chemical
and biological agents in feed for food-producing animals.
- In
collaboration with NIH, CDC, DOD, academia and private industry, ensure that
rapid methods are developed to detect biological agents that may contaminate the
food supply.
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.
END
LOAD-DATE: March 1,
2000