[Senate Hearing 112-]
[From the U.S. Government Publishing Office]



 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2012

                              ----------                              


                        THURSDAY, MARCH 17, 2011

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 1:58 p.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Herb Kohl (chairman) presiding.
    Present: Senators Kohl, Pryor, Brown, Blunt, and Moran.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF DR. MARGARET A. HAMBURG, COMMISSIONER
ACCOMPANIED BY:
        PATRICK McGAREY, ASSISTANT COMMISSIONER FOR BUDGET, FOOD AND 
            DRUG ADMINISTRATION
        NORRIS COCHRAN, DEPUTY ASSISTANT SECRETARY FOR BUDGET, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

                 OPENING STATEMENT OF SENATOR HERB KOHL

    Senator Kohl. We will come to order right now and start 
this hearing.
    Today's hearing will focus on the fiscal year 2012 budget 
request of the Food and Drug Administration (FDA). We would 
like to welcome Commissioner Hamburg, as well as Mr. Patrick 
McGarey and Mr. Norris Cochran. It is very good to have you 
guys here with us.
    The FDA budget request for this fiscal year includes an 
increase of $385 million, or 14 percent, more than the funding 
level provided in fiscal year 2010. During a time when overall 
Government spending is declining, this budget request is an 
exception. Among other things, we are here to talk about why 
this increase is necessary.
    Some people have questioned the role of the FDA and the 
growth of the agency's budget over the past several years. 
These are fair and important questions. I have been and 
continue to be a very strong supporter of the FDA. At the same 
time, I understand how difficult it is to talk about deficit 
reduction while at the same time defending such a large 
increase in the budget. Justifying that increase, Dr. Hamburg, 
is your task and it is not an easy one.
    We have supported your work because we believe it is the 
job of the Federal Government to make sure that our food and 
drugs are safe, and we need to make sure that you have the 
funding that you need to make that happen. This is not 
something we can relegate to States, local government, or 
private industry. The world and the way our food and drugs are 
produced are becoming more complex every day, and it is 
important for the FDA to have the ability to adapt to these 
changes.
    Every $1 that we spend in this bill must be questioned, of 
course, defended, of course, and well thought out. The 
administration has proposed to increase this budget while other 
areas of the Government are being cut. I believe the FDA's 
mission is critical to the safety of American families, but we 
must be able to justify the budget increase at this time.
    So, we are looking forward to hearing from you, and first 
we will call on Senator Blunt.

                     STATEMENT OF SENATOR ROY BLUNT

    Senator Blunt. Thank you, Chairman Kohl, for holding this 
hearing on FDA and their budget request for fiscal year 2012. I 
know you have been a knowledgeable advocate for this work and 
look forward to your leadership on it.
    I want to thank our witnesses for coming today as well.
    The administration's request for FDA is an increase of 16 
percent more than the current funding level, and if the budget 
request is approved, the agency will grow by an astonishing 60 
percent since fiscal year 2008. This is one of the largest 
increases in the entire Department of Health and Human Services 
(HHS) and it is a higher percentage increase than in almost any 
agency in the U.S. Department of Agriculture (USDA).
    As I mentioned at last week's hearing with Secretary 
Vilsack and earlier this week in a meeting I am pleased the 
Commissioner was able to have with me in anticipation of this 
hearing, I am concerned about the fragmentation among the food 
agency inspection services and hope we can look for ways to 
streamline wherever we can. I think it was Einstein who said 
everything should be as simple as possible but no simpler. So, 
we do not want to streamline it to the point that it does not 
work, but we do want to look for those efficiencies that we are 
able to find. According to the Government Accountability Office 
report released earlier this month, 15 Federal agencies are 
responsible for oversight of 30 food-related laws. It is 
important we look for ways to do what we can about duplication 
where it occurs.
    The recent outbreak of salmonella in eggs showcased this 
fragmentation. Currently, the FDA has the responsibility of 
ensuring the safety of shell eggs, yet USDA oversees eggs that 
are processed into egg products. The Secretary himself used the 
example of a pepperoni pizza that is under the jurisdiction of 
one agency while cheese pizza is under the jurisdiction of 
another.
    With significant investments, Dr. Hamburg, comes 
significant responsibility. I know you want your agency to be 
accountable and we do too. We cannot look at this budget 
without understanding that the Federal Government is borrowing 
$4 billion every single day. Families all across America do not 
understand why their Government cannot operate with the same 
rules they face, and the Government must start living within 
its means. So, I am looking forward to what we can do together 
to address these issues.
    As we tackle funding decisions this year, we have to be 
mindful, of course, that the FDA touches the lives of every 
American every day, and amazingly around 20 cents out of every 
$1 spent in America is used to purchase an FDA-regulated 
product. Americans expect these products to be safe and 
effective. Dr. Hamburg, I look forward to working with you and 
your team and certainly with Chairman Kohl as we move down the 
path to doing the things that make the most sense for the job 
you have to do.
    And thank you, Chairman.
    Senator Kohl. Thank you very much, Senator Blunt.
    Commissioner Hamburg, we would love to hear from you.

              SUMMARY STATEMENT OF DR. MARGARET A. HAMBURG

    Dr. Hamburg. Thank you very much, Chairman Kohl, Ranking 
Member Blunt, and distinguished members of this subcommittee. I 
appreciate the opportunity to present the President's fiscal 
year 2012 budget for FDA and our priorities for the coming 
year.
    This hearing comes at a critical time for our Nation and 
for our agency. We must be prepared to meet and fully embrace 
the scientific challenges and global realities of our modern 
world, and the stakes for public health, for patients and 
consumers, and for our economic health have never been higher.
    Our agency is charged with an extremely significant task, 
to promote and protect the health of the American people. This 
includes ensuring the safety, effectiveness, and wholesomeness 
of products that Americans rely on, as you noted, in 
fundamental, sometimes lifesaving, ways--drugs, vaccines, 
medical devices, our Nation's food supply, and more. But it 
also includes working proactively to foster the scientific 
innovation that will lead to tomorrow's new breakthrough 
products. Both roles are essential to delivering progress for 
the American people and both roles impact our economy by 
encouraging consumer confidence, growing key industries, and 
creating jobs.
    Thanks to the support of the chairman and members of this 
subcommittee, FDA has been able to make forward progress on a 
wide range of vital priorities to improve the health, quality 
of life, safety, and security of all Americans. With the 
resources that you have appropriated, we have achieved tangible 
benefits for the people that we all serve.
    During the past year, we have approved dozens of new drugs, 
vaccines for seasonal and pandemic flu, and medical devices for 
hearing and vision loss, severe asthma, and to perform 3-D 
mammography screening. We applied cutting-edge whole genome 
sequencing to trace foodborne illness outbreaks. We have 
launched a new system that identified 100 food safety problems 
in the first months of operation. We have collaborated with the 
National Oceanic and Atmospheric Administration to develop and 
to perform screening tests to assure seafood safety and reopen 
the gulf coast fisheries after the Deepwater Horizon oil spill. 
Those are just a few of the things that the agency has 
accomplished in the past year.
    As you can see, FDA is charged with an enormous and unique 
set of tasks, and if we do not do our job and do it fully, 
there is no other agency or entity to backstop behind us. That 
is why I am here to ask for your support of the fiscal year 
2012 budget for the FDA.
    The proposed budget includes $4.4 billion overall and 
identifies four priority initiative areas: Transforming Food 
Safety and Nutrition; Advancing Medical Countermeasures; 
Protecting Patients; and Fostering FDA Regulatory Science and 
Facilities.
    Compared to the fiscal year 2010 budget, the fiscal year 
2012 budget represents an increase of almost $1.1 billion, $382 
million in budget authority, and $694 million in user fees. The 
amount of user fees includes $60 million for three new user 
fees that FDA is proposing.
    In addition, in an effort to contribute to deficit 
reduction, we will undertake nearly $30 million in contract and 
administrative savings across the agency.
    These four initiatives are critical to our mission of 
protecting and promoting the health of the public and they also 
represent important opportunities for our food and medical 
product industries to grow and to strengthen our economy. In 
other words, they will provide the significant return on 
investment that we all are looking for, for products, for 
people, and most importantly, for the public health. And let me 
just quickly explain how.
    First, the Transforming Food Safety and Nutrition 
Initiative contains an increase of $326 million to build a 
stronger, more reliable food safety system that will protect 
American consumers. We will use these resources to aggressively 
implement the Food Safety Modernization Act (FSMA) that the 
Congress passed in December. This landmark legislation provides 
FDA with the tools to establish a prevention-focused food 
safety system, placing the primary responsibility for 
prevention on the food producers and processors and leveraging 
the valuable work of FDA's State and local partners. FDA will 
also make sure that American families have the information that 
they need to make more healthful food choices through menu and 
vending machine labeling.
    Second, for the Advancing Medical Countermeasures 
Initiative, FDA proposes $70 million. Medical countermeasures 
include drugs, vaccines, diagnostic tests, and other medical 
equipment that are needed to detect and respond to deliberate 
chemical, biological, radiological, and nuclear threats, as 
well as emerging infectious diseases or other natural 
disasters, all of which threaten the lives and safety of the 
American people and I think weigh heavily on our minds right 
now given the tragic events in Japan. This investment will help 
accelerate the development of countermeasures to meet a set of 
critical national security and public health needs.
    Third, the Protecting Patients Initiative, for which we are 
proposing an increase of $123.6 million, will allow FDA to 
establish a pathway for approving lifesaving biosimilar 
products. This could offer substantial savings for the Federal 
Government and private-sector healthcare. This initiative also 
includes investments in scientific tools and partnerships to 
enhance the safety of increasingly complex drugs, medical 
devices, and biologics, and an increasingly complex foreign and 
domestic global supply chain.
    Fourth, the FDA Regulatory Science and Facilities 
Initiative contains an increase of $48.7 million to strengthen 
the core regulatory scientific capacity that supports all of 
FDA's missions and will enable us to truly streamline and 
modernize our regulatory work by applying the best possible 
science, especially as we address more advanced therapies, 
complex devices, and emerging technologies. It will also allow 
FDA to outfit and to occupy the Center for Biologics and Center 
for Drugs Life Sciences-Biodefense Laboratory complex which 
will play a critical role in shaping strategies in response to 
pandemics, emerging infectious diseases, and deliberate 
biological threats.
    So, even in these difficult times, the FDA's fiscal year 
2012 budget is essential to our ability to take meaningful, 
science-based action on behalf of the American people. With 
these investments and your support, I am confident that we can 
build on our past successes and better ensure our Nation's 
health.
    Thank you for the opportunity to testify and I am happy to 
answer your questions.
    [The statement follows:]

             Prepared Statement of Dr. Margaret A. Hamburg

                              INTRODUCTION

    Chairman Kohl, Ranking Member Blunt, and members of the 
subcommittee, I am Dr. Margaret Hamburg, Commissioner of the Food and 
Drug Administration (FDA). I am pleased to present the President's 
fiscal year 2012 budget request for FDA.
    For today's hearing, I am joined by Patrick McGarey, FDA's 
Assistant Commissioner for Budget and Norris Cochran, Deputy Assistant 
Secretary for Budget at the Department of Health and Human Services 
(HHS).
    In my testimony today, I will outline the important initiatives in 
FDA's fiscal year 2012 budget request to the Congress. My testimony 
also highlights FDA's unique role in protecting public health and the 
value that FDA delivers for American taxpayers.

                           UNIQUE ROLE OF FDA

    FDA is charged with ensuring the safety, effectiveness, and 
wholesomeness of products that Americans rely on in fundamental, 
sometimes lifesaving, ways--drugs, vaccines, medical devices, our 
Nation's food supply, and more. These are products that people need; 
products they care about; and products that are critical to their 
health, safety, and well-being. Our role is unique and if we don't do 
our job completely and responsibly, there is simply no other agency or 
entity to backstop us.
    Fulfilling our mission--to promote and protect the public health--
is a difficult task under any circumstances. But these are especially 
challenging times. Today, the powerful forces of globalization are 
reshaping our world. We face complex threats--both accidental and 
deliberate--that pose new risks to FDA-regulated products and the 
Americans who rely on them. And we have been forced to rethink the way 
we do our job.
    But we also live in a time of great advances in science and 
technology. Breakthroughs in the life sciences have provided industry 
with new opportunities to invest, innovate, create new markets, 
strengthen our economy, and most important, deliver new products and 
benefits for the American people.

              FDA INNOVATION, ACCOUNTABILITY, AND RESULTS

    My dedicated colleagues at the FDA are deeply committed to the 
health of American patients and consumers--and they recognize that 
innovation is essential to progress in public health.
    Innovation is the foundation of the successful industries we 
regulate, and innovation is responsible for remarkable advances across 
all of the product areas within FDA's jurisdiction--which is why we 
must work proactively to foster the scientific innovation that will 
lead to tomorrow's breakthrough products.
    Innovation is also critical to maintaining U.S. global leadership 
in many areas, including medical product development. Currently, most 
new drugs are approved in the United States before they are approved in 
Europe. And according to a recent industry study, we either are ahead 
of or tied with Europe for approval of medical devices that fall into 
the lower-risk category, which represents 90 percent of medical 
devices.
    In my testimony, I highlight some recent FDA actions that allow the 
food, drug, biologic, and device industries--all engines of 
innovation--to bring new products and technologies to market.
    We also recognize that just as FDA supports the ability of industry 
to innovate, FDA itself must innovate and become more efficient. In 
FDA's fiscal year 2012 budget, we highlight more than 100 examples in 
which FDA centers and offices are improving the efficiency of our 
programs, and in many of these examples, we are also supporting 
industry efforts to develop new products. Examples of FDA innovation 
include the recent launch of the Innovation Pathway, a program to 
stimulate new, breakthrough technology and advances for medical device 
manufacturers, as well as a scientific collaboration with industry to 
develop novel technologies to detect new and traditional foodborne 
contaminants and to develop safe food packaging. These efforts reduce 
the risk and expense of recalling products that fail to meet safety 
standards.
    FDA is also committed to accountability. During the past year, we 
developed and implemented FDA-TRACK, an agency-wide system to monitor 
key performance measures for more than 90 FDA programs. Through FDA-
TRACK, we are systematically monitoring FDA's progress as we work to 
achieve our performance measures and allowing stakeholders and the 
public to witness our progress through quarterly reports that we post 
on www.FDA.gov.
    But the best measure of the value that FDA delivers is the 
opportunity to reduce costs and achieve measurable savings in areas 
that are important to America's health. One example is FDA support for 
the generic drug industry, which markets drugs that save American 
patients and taxpayers $140 billion per year.
    A second example is FDA's food safety program, which is making 
significant progress to reduce foodborne illness that costs the U.S. 
healthcare system $88 billion annually. A third example is the fiscal 
year 2012 Generic Biologics Initiative, which will generate significant 
savings for the Federal Government and for private-sector health plans.

                          FDA ACCOMPLISHMENTS

    Thanks to the support of this subcommittee, FDA continues to 
achieve important public health milestones. Since early 2010, FDA has 
supported industry efforts to bring new products and technologies to 
market--and to think creatively about how to promote and protect the 
health of the American people in meaningful and sustainable ways.
    During the past year, FDA:
  --approved new drugs to treat diabetes, hypertension, osteoporosis, 
        bacterial infections, chronic pain, rheumatoid arthritis, 
        preterm birth, gout, immune deficiencies, schizophrenia, major 
        depressive disorder, and pulmonary disease;
  --approved five new therapies to treat rare diseases;
  --conducted four workshops to stimulate new orphan drug development;
  --tentatively approved the 126th anti-retroviral drug under the 
        President's Emergency Plan for AIDS Relief;
  --approved vaccines for seasonal and pandemic influenza;
  --approved new donor screening tests for HIV and Chagas disease;
  --cleared a new test to support kidney transplant patients;
  --approved new medical devices to treat hearing loss, severe asthma, 
        and vision loss, and to perform 3-D mammography screening;
  --cleared technology for physicians to view diagnostic images on 
        iPhones and iPads;
  --identified measures to prevent radiation overdoses during computed 
        tomography scanning;
  --permitted the marketing of the first test to identify norovirus, a 
        common foodborne illness;
  --applied genome sequencing to trace foodborne illness outbreaks;
  --collaborated with the National Oceanic and Atmospheric 
        Administration to develop tests to re-open gulf coast 
        fisheries;
  --formed public-private partnerships to improve produce safety; and
  --launched a new system that identified 100 food safety problems in 
        first 7 months of operation.

                    FISCAL YEAR 2012 BUDGET SUMMARY

    Although the President emphasized in his fiscal year 2012 budget 
message that the fiscal realities we face require ``hard choices,'' the 
5-year freeze on Federal spending announced in the fiscal year 2012 
budget is not an across-the-board cut. Although the overall budget 
represents a freeze in the aggregate, it also contains investments in 
areas critical to sustain and grow the American economy.
    FDA is one such area of critical investment. As you can see from 
FDA's fiscal year 2012 priorities--food safety and nutrition, medical 
countermeasures (MCMs), patient safety, and FDA regulatory science--an 
investment in FDA is an investment in the economic health of two of the 
largest segments of America's economy: our food and medical products 
industries.
    Our fiscal year 2012 budget is also an investment in health--in the 
health of individuals and the public health of our Nation. As a result, 
the budget includes $4.4 billion in budget authority and user fees to 
protect and promote the health of the American public every day, and 
through every stage of life.

                  CONTRACT AND ADMINISTRATIVE SAVINGS

    Although FDA's fiscal year 2012 budget is an overall increase for 
FDA, it also contains savings that contribute to the administration's 
deficit reduction goals. FDA is proposing $29.7 million in contract and 
administrative savings designed to achieve reductions and cut costs 
across all FDA program areas.
    To achieve these savings, FDA will reduce administrative staff by 
46 full-time equivalents, lower contract costs by increasing 
competition, and expand the use of blanket purchase agreements and 
other agency-wide approaches to reduce contract costs. Where possible, 
we will also save by using technology to improve how we manage our 
contracts and the contracting process. Finally, in some program areas, 
FDA will reduce the cost of employee training by replacing the 
traditional classroom model with online training.

                 TRANSFORMING FOOD SAFETY AND NUTRITION

    For fiscal year 2012, FDA proposes an increase of $326 million for 
the Transforming Food Safety and Nutrition Initiative to build a 
stronger, more reliable food safety system that will protect American 
consumers. This increase includes $225.8 million in budget authority 
and $100.2 million for user fees, including the four new user fees 
enacted in the FDA Food Safety Modernization Act (FSMA).
    With this increase, FDA will begin to implement the landmark food 
safety legislation, which the Congress enacted last December. Under 
this initiative, FDA will also ensure--through menu and vending machine 
labeling--that American families have the information they need to make 
more healthful food choices.
    FDA Food Safety Investment.--The passage of FDA FSMA, the first 
major overhaul of our food safety law in more than 70 years, will 
transform FDA's food safety program. Through FFSMA, the Congress 
enacted new safeguards and enhanced tools to protect America's food 
supply by preventing food safety problems rather than reacting to 
problems after they occur.
    Regrettably, foodborne illness is pervasive across America. Each 
year, nearly one of every six Americans gets sick due to foodborne 
illness. Some cases are severe--128,000 require hospitalization, and 
3,000 Americans die from foodborne illness.
    FFSMA closes significant and longstanding gaps in FDA's food safety 
authority. For example, FFSMA gives FDA important new tools to ensure 
that imported foods are as safe as domestic foods and directs FDA to 
build an integrated national food safety system in partnership with 
State, local, and tribal authorities.
    FDA will use these resources to establish a prevention-focused food 
safety system that leverages the valuable work of FDA's State and local 
food safety partners. In addition to yielding profound public health 
benefits, the FFSMA focus on prevention offers the opportunity for a 
dramatic return on the resources that this subcommittee invests in food 
safety. According to recent studies and the latest estimates of 
foodborne illness, the healthcare cost of foodborne illness--not 
including costs to the food industry--exceeds $88 billion each year.
    The combined result of these actions will be a stronger, more 
reliable food safety system that protects the American people.
    In its fiscal year 2012 budget, FDA is organizing its food and 
animal feed safety programs and investments to implement FFSMA. Our 
detailed budget documents display the specific dollar amounts that FDA 
will allocate to implement the 22 separate sections of the law.
    Nutrition.--As part of the Transforming Food Safety and Nutrition 
Initiative, FDA will also begin an $8.8 million program to improve 
nutrition labeling on restaurant menus and vending machines so that 
consumers can adopt healthier diets. This small but significant 
initiative offers powerful return on investment. A fiscal year 2009 
analysis estimated the medical costs of obesity at $147 billion per 
year (Finkelstein, et al., Health Affairs), which means that 
controlling obesity goes hand-in-hand with controlling healthcare costs 
and reducing a significant burden on our economy.
    The investments in this initiative will empower consumers to make 
better nutritional choices and will motivate food producers to develop 
healthier foods.

                   ADVANCING MEDICAL COUNTERMEASURES

    For fiscal year 2012, FDA proposes $70 million for the Advancing 
MCMs Initiative. MCMs include drugs, vaccines, diagnostic tests, and 
medical equipment and supplies to respond to deliberate chemical, 
biological, radiological, and nuclear (CBRN) threats and emerging 
infectious diseases, such as pandemic influenza.
    The Advancing MCM Initiative will strengthen FDA's ability to 
respond to these national security threats by supporting the 
development of MCMs as well as enhancing review by allowing FDA to work 
interactively with product developers and Government partners from 
early in the development process. With this investment, FDA will be 
better able to anticipate and resolve bottlenecks in MCM development 
and accelerate development of MCM products for pressing public health 
and national security needs.
    MCM Gap.--Today, our Nation lacks the range of MCMs required for 
emergency response. For example, there are no countermeasures to treat 
acute radiation syndrome, which would afflict millions in the aftermath 
of a nuclear event.
    Moreover, no FDA-cleared, rapid, point-of-care diagnostics exist 
for any of the biothreat agents of greatest concern. Such diagnostic 
tests are essential to guiding the public health response; ensuring 
that patients receive the most appropriate treatment; and promoting 
appropriate use of the limited supplies of MCMs available during a 
public health emergency.
    Analysis of the Need for MCMs.--In December 2009, on the heels of 
the influenza pandemic, HHS Secretary Sebelius called for a 
comprehensive review of the Nation's readiness to defend against CBRN 
threats. The HHS review was prompted by recognition that influenza 
vaccine became available only after pandemic influenza was already 
widespread across the United States. The HHS review called on the 
expertise of the scientific leadership of all Federal agencies that 
work with MCMs, as well as State and local health departments, the 
National Biodefense Science Board, and the Institute of Medicine.
    The review, released on August 19, 2010, identified the barriers to 
MCM development as well as significant opportunities to improve the 
path for successful MCM development. The review identified FDA as 
critical to the success of the MCM Enterprise, primarily because FDA 
evaluation of product safety and efficacy can significantly affect the 
course of product development.
    The report further recognized that robust FDA engagement from the 
earliest stages of product development can substantially increase the 
odds of successful approval. In other words, increased support for 
FDA's MCM activities is one of the most critical steps the Federal 
Government could take to transform the larger MCM Enterprise.
    Threat Assessment.--Dozens of reports since September 2001 and the 
October 2001 anthrax attack have affirmed the risk of terrorist groups 
wielding biological weapons and the suffering, death, and social and 
economic disruption that would result in the case of an attack. 
Therefore, the fiscal year 2012 investment in FDA medical 
countermeasure development and review offers the potential for a strong 
return on investment.
    The analysis of the National Security Strategy warns that the 
effective dissemination of a lethal biological agent within a U.S. 
population center would endanger the lives of hundreds of thousands of 
people and have unprecedented economic, social, and political 
consequences. The National Security Council warned in 2009 that the 
economic cost of a well-executed bioterrorist attack on American soil 
could exceed $1 trillion.
    Clearly, such an attack would have profound consequences on our 
social and political order, and more broadly, our way of life. Without 
this investment, America's public health and national security will 
continue to be at risk.

                          PROTECTING PATIENTS

    For fiscal year 2012, FDA proposes an increase of $123.6 million 
for the Protecting Patients Initiative. This increase includes $64.8 
million in budget authority and $58.8 million from three new user fees. 
FDA is proposing new fees for reviewing generic drug applications, 
paying the cost of medical product reinspections, and inspecting 
imports that arrive by international courier.
    Generic Biologics.--With the fiscal year 2012 increase in budget 
authority, FDA will establish a pathway for approving generic 
biologics. Generic biologics are biological drugs shown to be highly 
similar to an FDA-approved biological product. In some cases, generic 
biologics may also be interchangeable with the FDA-approved biological 
product.
    Biological products include therapies to treat certain cancers, 
rheumatoid arthritis, age-related macular degeneration, and HIV. These 
therapies cost $15,000 to $150,000 or more per patient per year--and 
represent a significant share of Federal Government and private-sector 
pharmaceutical costs.
    Approving biosimilar versions of these products offers the 
potential for substantial savings for the Federal Government and 
private-sector health plans. However, these savings will not 
materialize unless FDA has the resources to implement a clear 
regulatory pathway for approving generic biologics. FDA is requesting 
these funds for fiscal year 2012 because the sooner we make this 
investment the sooner we will see savings from generic biologics.
    Other Medical Products.--In addition to investing in generic 
biologics, the Protecting Patients Initiative also invests in new 
scientific tools and partnerships to enhance the safety of increasingly 
complex drugs, medical devices, vaccines, and other biological 
products. For example, the Protecting Patients Initiative will 
strengthen FDA efforts to modernize and improve safety throughout the 
supply chain of medical products at a time when the number of medical 
products manufactured abroad is increasing dramatically, which presents 
real challenges for medical product and manufacturing safety.
    Safer medical products not only benefit patients, but also benefit 
the manufacturers of drugs, biologics, and medical devices. Safer 
products reduce healthcare costs and allow manufacturers to avoid the 
expense of product recalls.
    With the resources in this initiative, FDA will modernize its 
approach to ensure safety across the supply chain for medical products. 
The initiative will also expand FDA's capacity to conduct medical 
product safety assessments and strengthen the safety of vaccines and 
the blood supply.
    The proposals in this initiative offer a high rate of return for 
the investment of Federal dollars. They can reduce the cost of care and 
promote safe, high-quality, and accessible healthcare that Americans 
deserve. In addition, the administration is proposing additional 
measures for fiscal year 2012 designed to reduce costs and increase the 
availability of generic drugs and biologics.

                 FDA REGULATORY SCIENCE AND FACILITIES

    For fiscal year 2012, FDA proposes an increase of $48.7 million for 
the FDA Regulatory Science and Facilities Initiative.
    The FDA Regulatory Science and Facilities Initiative will 
strengthen the core regulatory scientific capacity that supports all 
elements of the FDA mission. Regulatory science focuses on developing 
the knowledge and tools to properly assess the safety, effectiveness 
and quality of products that are being developed or are already on the 
market. Specifically, this initiative will help modernize and 
streamline the regulatory pathways that industry relies on to bring 
new, innovative products to market.
    It will also modernize the FDA review and approval process for 
products that rely on new and emerging technologies. The result will be 
promising new opportunities to diagnose, treat, cure, and prevent 
disease.
    Finally, the resources in this initiative will also allow FDA to 
outfit the Center for Biologics Evaluation and Research-Center for Drug 
Evaluation and Research Life Sciences-Biodefense Laboratory complex. On 
August 18, 2010, the General Services Administration awarded the 
construction contract for the new laboratory complex at White Oak, and 
construction work is currently underway. Without this investment, FDA 
must pay double the rent: the first for a new lab we cannot occupy and 
second for the old lab we cannot vacate.
    The new laboratory complex will help FDA fulfill our scientific 
responsibilities to promote drug and biologic safety and MCM 
development and prevent threats, including annual influenza. FDA must 
make this investment in fiscal year 2012 to ensure that the laboratory 
is operational and ready for occupancy in fiscal year 2014.

                       FDA CURRENT LAW USER FEES

    For fiscal year 2012, FDA proposes an increase of $634.5 million 
for 12 current law user fee programs.
    FDA user fee programs support safety and effectiveness reviews of 
human and animal drugs, biological products, medical devices, and other 
FDA-regulated products. Fees also allow FDA programs to achieve timely 
and enhanced premarket review performance. Finally, fees support the 
programs and operations of the FDA Center for Tobacco Products.
    Existing user fee laws authorize fee increases for many FDA user 
fee programs. The increases expand the available options for treating 
and curing diseases and addressing other important public health needs.

                               CONCLUSION

    The FDA budget for fiscal year 2012 contains important investments 
for critical public health priorities. With these resources, FDA will 
transform food safety; support the development of urgently needed MCMs; 
protect patients by assuring that the drugs and other medical products 
they rely on are safe; and advance regulatory science, which serves as 
the foundation for all science-based decisions at FDA.
    Thank you for the opportunity to testify. I am happy to answer your 
questions.

    Senator Kohl. Thank you very much, Dr. Hamburg. We will now 
embark on a round of questions from the panel.

                          FOOD AND DRUG SUPPLY

    Your statement highlights what FDA can do with additional 
funding, but what happens if you do not get the full amount you 
are asking for like, for example, can you still tell us that 
you will be able to ensure a safe food and drug supply with 
your present budget?
    Dr. Hamburg. Well, as you know, FSMA, which just went into 
law, gives us a historic opportunity to really transform the 
food safety system in our country into one based on prevention 
and one that will really make a difference in preventing costs 
in terms of illness and death of people, consumers, and 
preventable costs to our healthcare system and to the food 
industry.
    If we cannot get additional resources to support the 
implementation of this bill, we will, of course, continue to 
pursue important aspects of what is contained in that 
legislation, but we will only really be able to put forward 
regs. We will be able to put ideas and programs on paper, but 
we will not be able to fully implement all that needs to be 
done. We will not be able to pursue the ambitious inspection 
program domestically and internationally that enables us to 
have a hands-on look at how food production and processing is 
being done to ensure safety.
    Importantly, we will not be able to work with manufacturers 
and producers to really put in place the prevention-based 
strategies, the risk-based approaches that are really so vital 
to what we need to be doing so that we are not scrambling after 
outbreaks occur but actually preventing them in the first 
place. That will save lives. That will save money.
    And we will not be able to address the increasing challenge 
of import safety. More and more of the food we eat in this 
country is actually grown, produced, manufactured, distributed 
overseas in an increasingly complex supply chain, and we really 
have a responsibility to enhance our efforts to ensure the 
safety of that global food supply as well.
    And at the end of the day, it is very, very important to 
industry that we have and maintain the reputation of a strong 
food supply. We do, at the present time, have one of the 
strongest food safety systems in the world. That is very, very 
important. It matters to people and it matters to the health of 
the industry, their ability to have markets that people have 
confidence here at home, and export markets depend on the 
confidence of the public at large in the work of the FDA 
working with industry.

                        MEDICAL COUNTERMEASURES

    Senator Kohl. The budget for fiscal year 2012, Commissioner 
Hamburg, proposes an increase of $70 million to help develop 
new therapies that could be quickly used in the event of a 
chemical or biological attack or a natural disaster of another 
sort. The tragedy in Japan where they are confronting so many 
challenges right now including, of course, radiation exposure, 
does focus our attention on the importance of preparedness.
    Can you tell us a little bit about this initiative of 
yours? What will we be getting with this investment? What can 
we tell the American people about our present state of 
preparedness with respect to something comparable to what 
happened in Japan?
    Dr. Hamburg. This is a very important initiative, and as 
you say, it is underscored by recent events. As a Nation, we 
must be prepared and we must be resilient in the face of a 
range of potential threats, both naturally occurring and 
deliberately caused. And at the present time, we have more work 
to do, and this Medical Countermeasures Initiative at FDA is 
part of a broader administration-wide initiative to ensure that 
we as a Nation are prepared for the kinds of potential threats 
to our Nation's security that can occur.
    If we cannot move forward with this Medical Countermeasures 
Initiative, we will not be able to ensure that we have the 
drugs, the vaccines, the diagnostics, the medical equipment 
that is necessary to respond to an event. We need to be 
developing, for example, with respect to radiation safety, 
state-of-the-art therapies that will enable us to treat both 
acute radiation syndrome, such as, sadly, workers in the 
nuclear plant in Japan are potentially being exposed to, and 
other forms of radiologic exposures, both the threat of a dirty 
bomb or an intentional nuclear event, or a catastrophic, 
unexpected event, such as what has occurred in Japan.

                         RADIATION PREPAREDNESS

    Senator Kohl. Are we prepared at this time to deal with the 
fallout of a nuclear meltdown such as they have had in Japan? 
Are we prepared?
    Dr. Hamburg. There are many aspects of preparedness, and 
actually FDA is involved in a number of them. There is the 
issue of ensuring that any imported products from Japan are 
screened and safe for consumption, and we are actively involved 
in addressing that. At the moment, there are not imports from 
that region coming in.
    Senator Kohl. I was referring to something akin to what 
happened in Japan. Are we prepared today to deal with it here 
in the United States?
    Dr. Hamburg. Oh, an event in--you know, we have many 
systems of preparedness in place, but we are lacking some 
critical elements of preparedness, including these important 
medical countermeasures. We need to make sure that we have the 
medical treatments necessary. We do not have treatments for 
acute radiation sickness. We need to develop those treatments 
and we need to make sure that they are available for the 
American people and potentially available for people around the 
world.
    Senator Kohl. Before I turn this over to Senator Blunt, I 
believe I hear you saying that we could not assure the American 
people here today that in the event of something similar to 
what happened in Japan, we would be in a position to take care 
of the needs of the people in the areas where the nuclear 
disaster occurred. We are not prepared to take care of them.
    Dr. Hamburg. We have systems for response and we have some 
acute measures that we could provide, but we do not have, for 
example, as I said, the treatment of acute radiation sickness 
that we would need to be able to benefit people exposed to very 
high levels of radiation exposure. We do not have the 
treatments to address a range of potential nuclear exposures. 
We would be able, in the case of a nuclear reactor event, to 
provide potassium iodide for limited protection of the thyroid 
organ. There are other potential exposures, and we are working 
to develop, as a Government, interventions that will make a 
difference.
    But we need to make targeted investments today to be 
prepared for tomorrow. That is what this Medical 
Countermeasures Initiative is about. In the field of radiation 
exposure absolutely, yes, we have other gaps in preparedness 
that we need to address whether it is naturally occurring 
infectious disease threats or the potential for biological, 
chemical, nuclear terrorism. We really have a responsibility to 
make sure that we make these investments today, and I think it 
is something that we all, for our Nation's security, need to 
work on together.
    Senator Kohl. Senator Blunt.

                          RADIATION TREATMENTS

    Senator Blunt. Thank you, Chairman.
    Commissioner, are you saying on this area of radiation 
problems, that we do not have a stockpile of the treatments or 
that the treatments do not exist?
    Dr. Hamburg. The treatments do not exist for many aspects 
of radiation exposure.
    Senator Blunt. And are you saying that under this program 
you are talking about, one of the FDA's goals would be to 
develop those treatments?
    Dr. Hamburg. Would be to work with industry and Government 
scientists to, yes, develop and also to get them reviewed and 
approved for safety and effectiveness so that they could be 
available to the American people.

                       RESPONSIBILITY DUPLICATION

    Senator Blunt. Well, I am going to get to review and 
approval here in 1 minute. Let me go through things with some 
quickness, if I can.
    On the duplication issues that I talked about earlier and 
that we talked about the other day, is there any ongoing effort 
in the food and drug safety agencies to try to figure out how 
we can do that in a more focused way?
    Dr. Hamburg. It is an important area of focus. Soon after 
the President was inaugurated, he initiated the Food Safety 
Working Group to bring together the different agencies of the 
Federal Government that have responsibilities for food to 
really look at how they could coordinate better and to develop 
key cross-cutting strategic priorities as well.
    It is the case that FDA and USDA have the major 
responsibilities for food safety in this country, and we, of 
course, do work closely together and we are examining ways to 
work more closely going forward. Certainly, in FSMA 
implementation, we are working closely with USDA in order to 
take advantage of their expertise and experience working in 
farming communities, to take advantage of the resources that 
they already have on the ground. We are also talking with them 
about how to more effectively share information around 
inspections and other food safety-related activities.
    The partnership is also very important, and the integration 
working with State and local authorities as well, and that is 
an important component of FSMA, and it is a very important 
component of how we do business and need to do business more 
efficiently going forward.
    Within the FDA itself, we have looked hard at how to make 
our work more efficient and integrated as well because we had 
components of the FDA working on food safety issues and we have 
now created an Office of Foods with a Deputy for Foods in 
charge of all of those activities and are integrating our food 
safety activities across both the human and the animal food 
safety arenas to make our program more robust, more integrated, 
and more efficient. And there is lots more work to be done.

                     FOOD SAFETY MODERNIZATION ACT

    Senator Blunt. Well, I encourage you to pursue all of that 
work as vigorously as we can. We need to be able to defend the 
things we do and to argue with justification that we are trying 
to do those things better and not duplicate our effort.
    On the duplication of effort, one of my big concerns about 
FSMA was yet another on-farm presence of another Government 
regulator. What are you doing there, as you look at those new 
responsibilities, and are you working with agencies like USDA 
that are already there to see how you can work with the 
information and structure they have?
    Dr. Hamburg. Yes. No, very much so. We have been working 
hard to really make sure that we understand the challenges and 
the concerns of the farming community as we move towards 
implementing FSMA. We, of course, have been on farms in the 
past when there are food-borne outbreaks around BSE issues and 
tissue residue issues. So, it is not completely new territory 
to us. But we recognize that we are now undertaking a new set 
of roles and it is very important that we work constructively 
with the farming community and with other partners that 
interact with the farming community.
    I have been out to visit quite a number of farms and my 
Deputy for Foods even more, have learned a lot about the full 
range of different types of farms and their different issues 
and have listened hard and will continue to try to work with 
the farming community. And USDA has been very helpful to us and 
the Extension Service is a critical component of our ability to 
do outreach to farmers and to consumers.
    We recognize that nobody wants more people in their farming 
communities telling them what to do. We view this as a 
collaboration. We view this as an opportunity for us to pursue 
a common goal of ensuring that the food supply is safe, doing 
what I think every farmer and food producer wants to be able to 
do, which is to make sure that the food they produce is safe 
and wholesome and that consumers can count on it and trust it.

                           FOOD TRACEABILITY

    Senator Blunt. And do you have new responsibilities for 
food traceability in this law?
    Dr. Hamburg. It is an important component of what we need 
to do as part of FSMA, and it will certainly prove to be of 
value if we can put that kind of a program in place because it 
will enable much more rapid identification of a problem and its 
source when it should occur so that we can identify and respond 
rapidly, control the problem, and mitigate the effects, and get 
those companies back up and running, producing the food with a 
robust market for the food that they produce.
    Senator Blunt. Would that be across the board? This is a 
question I do not know the answer to. Is that across the board 
for your agency? Does that include livestock as well?
    Dr. Hamburg. No. We regulate about 80 percent of the food 
supply, but we are not responsible for meat, poultry, processed 
eggs, and catfish.
    Senator Blunt. And particularly catfish.
    Dr. Hamburg. Right.
    Senator Blunt. Mr. Cochran will be glad to know that you 
are not going to get involved in catfish. Probably Mr. Pryor as 
well.
    But you will have new traceability requirements or 
obligations on the things you do regulate on the farm.
    Dr. Hamburg. We are going to be starting to have those 
discussions about what such a system should look like. Industry 
has an important voice and a lot of experience in these issues 
because it is so important in terms of being able to rapidly 
identify problems and address them.

                             REVIEW PROCESS

    Senator Blunt. Let me ask just a couple of quick questions 
on review processes, particularly since you mentioned you might 
have some other ways to try to get these products that Chairman 
Kohl was talking about to the market quicker.

                            USER FEE REVIEWS

    Two of your largest fee programs, prescription drugs and 
medical device review, are up for reauthorization in this 
fiscal year. How do you intend to approach those fee 
negotiations with industry?
    Dr. Hamburg. Well, these are very important activities, and 
the user fee programs that were introduced in the 1990s have 
demonstrated their value on the drug side and on the device 
side in terms of helping to give us the resources that we need 
to be able to ensure the best possible review in the most 
timely way possible. The negotiations are underway. We have 
actually just begun negotiations with the generic industry as 
well, which currently does not have user fees. We are 
optimistic that we are going to be able to achieve a good 
proposal for the next user fee legislation that will come 
before you. And I think both the industries we regulate that 
provide user fees and certainly our agency feel that these are 
critical programs that help to enable us to be able to do our 
job. And I think that overall we have been performing well in 
response to the introduction of the user fees and meeting the 
targeted goals both on the drug side and the device side.
    Senator Blunt. I do not know what the fiscal year 2010 
numbers were. I think the fiscal year 2009 numbers--and 
clearly, this is the first 9 months of this administration, so 
numbers that may be even less than fiscal year 2009. But I 
think in fiscal year 2009, the agency failed to meet one-third 
of its drug review goals and approximately 20 percent of its 
device review goals.
    Dr. Hamburg. Well, those are different numbers than I have 
seen. On the drug side, it is the case that in recent years we 
have not met all of the goals, although in the first 15 years 
of the program, we met and surpassed the goals. In 2007, the 
FDA Amendments Act (FDAAA), gave FDA quite a comprehensive set 
of additional new responsibilities mainly focused on drug 
safety, and it is the case because our resources are fairly 
limited, we had to target resources that might have gone into 
drug review into responding and implementing the requirements 
of this new and important Amendments Act. So, we saw some drop-
off in our review times as we began to implement those 
components of FDAAA. We are getting right back up to the 
performance levels prior to that though. But we have had a lag. 
That is true.
    On the device side, most of the device program is focused 
on the premarket notification program, what is called the 
510(k) process. About 95 percent, I think, of the devices that 
we review are part of that program. And we have been meeting 
the targets agreed to with industry in that program.
    Senator Blunt. And they should expect you to do that.
    Dr. Hamburg. And they should expect us to do that.
    In the premarket approval area, which is a more rigorous 
approval mechanism and has more requirements, we can and will 
do better. We have put forward, under the leadership of our new 
center director, Dr. Jeffrey Shuren--he has led a very serious 
review of our regulatory pathways, how we can make them more 
effective and efficient, how we can bring the best possible 
science to bear. He put forward in January of this year 25 
recommendations that reflected a lot of public comment, 
discussions with industry, stakeholders, patient advocates, and 
others. He put forward these 25 recommendations for how we can 
do better.
    We have also asked the Institute of Medicine of the 
National Academies of Sciences to take a look at some of the 
regulatory issues in the device area to make broader 
recommendations about how we can modernize and improve our 
regulatory pathways.
    Senator Blunt. Good.
    Dr. Hamburg. So, we want to keep working on it.
    Senator Blunt. if my figures are wrong here, would you 
please get back to me and let me know? But my notes here 
indicate that FDA failed to meet one-third of the drug review 
goals and approximately one-fifth of the device review goals. 
And if that is not right, just tell me at some future time.
    Dr. Hamburg. We will get back to you.
    [The information follows:]

                      Drug and Device Review Goals

    In fiscal year 2008, we met or exceeded the 90-percent performance 
levels for 33 percent--or 4 of 12 goals--of the drug review performance 
goals. In fiscal year 2009, we demonstrated significant improvement in 
regaining stability in meeting our performance goals and met or 
exceeded the 90-percent performance levels for almost 60 percent--or 7 
of 12 goals--of the drug review performance goals.
    The Food and Drug Administration (FDA) agreed to more stringent 
device performance goals as part of the Medical Device User Fee 
Amendments of 2007, also known as MDUFA II. For fiscal year 2009, FDA 
is on track to meet or exceed 7 out of 10 device performance goals for 
which we have reportable results, including the goals relating to 
510(k) devices, which represent more than 90 percent of the devices FDA 
clears or approves for marketing. The goals not met by FDA in fiscal 
year 2009 represent less than 3 percent of the submission volume FDA 
reviews, and performance has been steadily improving for these goals. 
The Center for Devices and Radiological Health has undertaken a number 
of steps to continue making improvements towards meeting these goals, 
including drafting clinical trial guidance, identifying, and recruiting 
needed staff expertise, strengthening its external experts program, and 
improving its premarket information management systems.

    Senator Blunt. I would also be pleased to see the numbers 
for fiscal year 2010, if they are available now, the data that 
ended September 30.
    [The information follows:]

                Fiscal Year 2010 Drug and Device Reviews

    It is too early to determine the overall performance for fiscal 
year 2010, given the current number of pending applications. While drug 
review performance numbers for fiscal year 2010 are still preliminary, 
it appears that the Food and Drug Administration (FDA) is on track to 
meet or exceed 11 of the 12 drug review performance goals called for 
under the Prescription Drug User Fee Act. Preliminary data as of the 
fiscal year 2010 Medical Device User Fee Amendments of 2007 (MDUFA II) 
performance report indicates that FDA is meeting or exceeding 5 of the 
goals for which there are sufficient results to reliably estimate 
current performance, and has the potential to meet or exceed all 12 
performance goals.

    I have got a couple other questions, but I think I will try 
to do those a little later, chairman, and let others ask 
questions. Thank you.
    Senator Kohl. Thank you.
    Senator Brown for 5 minutes.

                                 MAKENA

    Senator Brown. Thank you, Mr. Chairman. I will take less 
time. My Governor from Ohio is coming in and I have a meeting 
with him in a few minutes.
    But just one brief line of questioning, Dr. Hamburg. And 
thank you for joining us.
    As you know, after the FDA-approved Makena, which was the 
version of a longstanding medicine that had been produced by 
compounding pharmacies for years given to women who were at 
high-risk of low birth weight, early birth babies, K-V 
Pharmaceutical announced that the price for the product would 
jump from about $10 to $20 per injection and typically a woman 
would take 20 doses of it, I guess, over 20 weeks. It would 
jump from $10 to $20 per injection to $1,500 per injection, 
which by my calculations is from $10 to $1,500 is a 14,900-
percent increase.
    Since the drug plays such a critical role in reducing the 
incidence of premature birth and the associated deaths and 
disabilities and costs, this price increase marks a dramatic 
setback for public health, to insurance carriers, to 
businesses, to taxpayers, to anyone and to the individuals 
trying to pay them going from $10 times 20 injections to $1,500 
times 20 injections.
    What can the FDA do to stop manufacturers from exploiting 
this existing approval process? Even though K-V has admitted 
that the price increase does not derive from R&D or from 
production costs, all they did was--my understanding--they say, 
pay $200 million for the clinical trials, but they did not do 
the R&D. In fact, taxpayers did most of the R&D here. So, 
taxpayers, in the end, get a good drug, but it looks a lot like 
blackmail to me. Seat belts serve an important purpose too, but 
they are not priced in the stratosphere to reflect the fact 
they save lives. But they are pricing it in a way that they 
will make huge profits and it will compromise the public 
health.
    What can you do? Administrative, legislative strategies? 
What do we do about a drug that has been used for decades and 
prevented an awful lot of low birth weight baby births and 
instead will become so, so, so prohibitively expensive?
    Dr. Hamburg. Well, it is such an important concern, and 
like you, I was very surprised when I learned about the price 
increase. I think it is important and an advance that we have 
an FDA-approved drug to prevent preterm pregnancy and all of 
its consequent serious medical concerns for both mother and 
infant. And while the drug had been available through 
compounding, compounding as a practice has been associated with 
serious health risks, contamination----
    Senator Brown. I am not in any way questioning that FDA did 
the right thing here. But my understanding is under Bayh-Dole 
enacted decades--three decades--25, however many years ago, I 
think in the 1980s. Under Bayh-Dole, you in fact do have the 
power to do something about this price and do something about 
K-V Pharmaceutical's actions. And if you do not, it is so 
important that we figure out something to do here.
    This price increase in my understanding started this week, 
and it is only going to get worse. And if K-V is not willing to 
back down, I would hope the embarrassment of doing this to 
America's families would cause them to want to back down, at 
least try to price it a little more reasonably. But if you 
cannot use Bayh-Dole, you need to figure out a strategy what to 
do here.
    Dr. Hamburg. I am not as expert on these issues as I 
perhaps should be. I am told that Bayh-Dole does not fall under 
FDA's jurisdiction.
    Senator Brown. It is HHS with Bayh-Dole. You are suggesting 
that to them. You are writing a letter. You are weighing in 
with them, as we are doing and some other Senators are starting 
to now, as we worked on this.
    Dr. Hamburg. This is an issue that, as you know, has arisen 
recently. It did come as a surprise to us, very surprising, 
especially in that the National Institutes of Health, as you 
indicated, did the original clinical trials on which this 
approval was based. I think it is a very important issue to 
raise. FDA does not make its approval decisions with pricing 
considerations.
    Senator Brown. Nor should you.
    Dr. Hamburg. So, I think our role is a different one, but I 
think that the issue that you are raising about the 
accessibility to this important drug is a critical one.
    Senator Brown. I made clear I am not blaming FDA. FDA did 
the right thing. This company acted I guess you cannot say 
criminally, but immorally and any other string of adverbs you 
might want to choose. I am just looking for FDA to take 
leadership with HHS in finding a way, a strategy, or a path 
quickly to get this company to price its drug more reasonably 
for American women. Fair enough. Thank you.
    Dr. Hamburg. Thank you.
    Senator Kohl. Thank you very much, Senator Brown.
    Senator Moran.

                           FOOD FROM THE FARM

    Senator Moran. Chairman Kohl, thank you very much.
    Thank you, Dr. Hamburg, for joining us.
    In a broad sense, I was pleased to hear you indicate that 
you are working to understand the challenges of the farm 
community. In a broad sense, a broad question that I would ask 
you is what does that mean within FDA. Have you hired people as 
a result of the passage of the legislation who have farm 
experience--agronomists, actual farmers, or ranchers who 
produce food for our country?

                         LIVESTOCK ANTIBIOTICS

    And then in a very narrower, more specific way, I want to 
raise concerns that I have raised previously in regard to your 
draft guidance No. 209 issued June 28, 2010, ``The Judicious 
Use of Medically Important Antimicrobial Drug in Food-
Processing Animals.'' We are very much a livestock-producing 
State, and I generally would tend to avoid commenting on what I 
would hope would be scientific-based decisions by FDA, but I 
continue to raise significant concerns about FDA's proposal in 
that draft guidance document.
    It appears, from reading that draft, that FDA did not 
engage in rigorous review of current research in regard to 
antimicrobial resistance and is attempting to ban the use of 
those antibiotics for growth promotion, feed efficiency, and in 
some instances preventive treatment based upon uncertain 
evidence. In fact, if you read the report, the analysis uses 
the phrases like--when you cite reports in that draft, they 
fail to establish a direct link between antibiotic use and the 
risk to human health, not adequate epidemiological evidence, a 
very limited amount of that research unable to find a 
substantial body of evidence. And so there is, in my view, 
great uncertainty about the specific risk posed by antibiotics 
shown in your draft. And it also appears that the most recent 
scientific evidence was completed 10 years ago.
    And so I am asking what has changed, other than personnel 
at the FDA, that now causes the FDA to have a significant 
interest in regulating antibiotics.
    Also in that draft you state, in fact, that before 
withdrawing a drug that is for--a labeled use of an approved 
drug, Federal law requires the FDA to demonstrate that new 
evidence shows that a drug is not shown to be safe under 
approved conditions. And I am interested in knowing what that 
new evidence is and how you are proceeding with this draft, 
what time frame, have you read the comments, and the direction 
that you are going.
    Dr. Hamburg. As you well know, antibiotics are an essential 
and vital tool for the health of animals and the health of 
people. It is a limited resource. There is a serious and 
growing problem with antibiotic resistance, and that is well 
documented in human populations and in animal populations. And 
that is the concern that we are trying to address. We do not 
want to go back to an era of pre-antibiotics because the 
antibiotics that we have no longer work. And in some areas of 
serious medical disease, we have begun to see that kind of a 
circumstance occurring.
    We are a science-based agency. It is our mission, our 
orienting purpose to make data-driven science-based decisions. 
So, it is very, very important to us that we do that rigorous 
review of the scientific literature and really look at what the 
data tells us about these important questions. There is broad 
scientific literature in this area. There is a lot of data to 
support the concerns about the use of antibiotics in food-
producing animals for growth promoting or feed enhancement 
purposes. Many, many of the public health, medical, and 
scientific societies have reviewed the science and have made 
recommendations that such use should not be considered 
judicious, therapeutic use. We, of course, are doing our own 
internal reviews.
    But this guidance is voluntary guidance. We are working on 
it with industry and other stakeholders. When we proposed our 
framework, which was to limit medically important antimicrobial 
agents in food-producing animals to the circumstances that are 
necessary for assuring health and to also have those 
antibiotics used under the supervision or oversight of a 
veterinarian, that was done as guidance. It was put forward 
over the summer. We have received a lot of comments from a 
range of stakeholders, all with very different and very hard-
held perspectives. We are analyzing those comments and 
continuing to look at the data. We will be coming forward with 
a revised guidance and we will continue to have that open for 
comment from the public. We want to move towards something that 
benefits the health of animals and humans.
    Senator Moran. Mr. Chairman, I have follow-up, but I notice 
they have just called the vote and I would not want to prevent 
Mr. Pryor from having his opportunity to question.
    But I would say that the draft proposal that you have put 
forth does not demonstrate the things that you said about the 
broad scientific evidence. It lacks the connection. And I also 
still continue to believe that the scientific research that you 
announced or indicated in your draft proposal is still 10 years 
old. And so if there is more to come or you have additional 
scientific-based evidence, I would welcome that.
    Thank you, Mr. Chairman.
    Senator Kohl. Thank you, Senator Moran.
    Senator Pryor.

               NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

    Senator Pryor. Thank you.
    Thank you for joining us today, Commissioner. It is always 
good to see you.
    Let me start with something that you know is near and dear 
to my heart. It happens to be located in my State. It is the 
National Center for Toxicological Research (NCTR). NCTR focuses 
on technological research so that the FDA can make science-
based decisions, and this includes an emphasis on regulatory 
science. The decisions that the FDA makes based on this 
research range from food safety to safety devices used in the 
medical community to safety of basic cosmetics.
    The House has proposed a very significant cut--I believe it 
is 43 percent--in their continuing resolution, and my 
understanding is that might even lead to the closure of NCTR. I 
guess the first question is, do you have any idea why the House 
targeted NCTR?
    Dr. Hamburg. No, I really do not, but it is a grave concern 
to me what that will mean.
    Senator Pryor. If you do not mind, tell the subcommittee 
what NCTR is and what it does and what its unique role is at 
the FDA.
    Dr. Hamburg. Well, it is a unique resource for FDA and for 
the Nation. It is a center for toxicological research really 
focused on strengthening our understanding of a set of safety 
concerns that cut across drugs and cosmetics and food, dietary 
supplements, a range of issues that FDA regulates. It is 
helping us to really understand emerging new technologies in 
terms of the scientific promise that they hold, things like 
nanotechnology. They have been a leader in nanotechnology 
research which offers applications in so many areas. But also, 
we need to understand what are the implications in terms of 
near-term and long-term safety issues, and they are a leader in 
research in that area.
    They undertake important research in areas that are very 
much on the minds of Americans these days, issues like 
bisphenol-A (BPA), a chemical in plastic and the lining of food 
containers, really trying to sort out what are the risks and 
benefits of a substance like that and really understand and 
trying to modernize the underlying science of toxicology so 
that we can get important answers for consumers and to support 
industry in key areas and to make sure that we have the 
innovative products that Americans are counting on.
    Senator Pryor. Is there another facility that does all this 
type of research?
    Dr. Hamburg. It is really quite a unique resource, a whole 
center really focused on toxicology research and doing this 
research in the service of product evaluation for safety and 
efficacy.

                             NANOTECHNOLOGY

    Senator Pryor. You mentioned a few moments ago about 
nanotechnology and research in that area at NCTR. There are 
more and more products that are coming onto the market that 
claim to be nanotechnology products. I am sure a lot of them 
are.
    What steps is FDA taking to ensure the American public that 
nano products are safe?
    Dr. Hamburg. Well, there is a broad research agenda that 
needs to be undertaken to really understand the effects that 
these very, very small nano-sized materials have when they are 
introduced into the human body, often with chronic exposures, 
and they can be used to deliver drugs in exciting ways to get 
targeted therapies to people. They can be used in food 
products, in cosmetics. They are used in non-FDA-regulated 
products as well, including fabric and clothing.
    But NCTR is really helping to develop and undertake 
important areas of research to examine how these nano particles 
work under different circumstances, how the human body 
responds, and to look at it under different conditions, 
different models, different products, and of course, working in 
partnership with others, but it is a unique resource.
    Senator Pryor. And my last question on nanotechnology--
maybe my last question because I am out of time--is should the 
FDA have a regulatory science program on nano-toxicology.
    Dr. Hamburg. I think that we are undertaking important 
experiments in that arena. I think it probably needs to be 
developed as a full-fledged area of focus, and FDA clearly 
should be at the center of those activities in that as we see 
more and more products using this technology, we need to be 
able to fully assess the risks and the benefits and we need to 
have a strong, sound science base to enable us to make the most 
informed decisions possible.
    Senator Pryor. Thank you.
    Thank you, Mr. Chairman.

                             GENERIC DRUGS

    Senator Kohl. Thank you very much, Senator Pryor.
    Dr. Hamburg and I talked about this issue before. Over the 
years, we have provided funding to speed approval of generic 
drugs because, as everybody knows, they save the consumer tons 
of money. Unfortunately, the backlog of applications awaiting 
approval continues to grow and at this point, we have no 
indication that it will slow down. The budget proposes a very 
slight increase for generic drugs, not enough to keep up with 
the increased workload and again proposes to create a user fee 
for generic drugs in order to offset the costs, which would 
speed up our ability to get these generic drugs approved.
    Research shows that it is the first and second generic 
drugs coming to the market that save consumers the real money, 
and of those at FDA awaiting approval, how many of the pending 
applications, if approved, would be the first or second generic 
of their kind on the market?
    Dr. Hamburg. Of the pending applications, I believe that 
about 365 or so are first generics. I would be delighted to 
give you more specifics on the numbers of second generics. I do 
not have that information at hand. But it is the case that with 
the additional dollars that you have helped us get in recent 
years and what we hope to get going forward through a 
combination of budget authority and user fees, that we will be 
able to make a significant dent in the pending applications and 
be able to continue to get these important products to people 
as quickly as possible.
    You correctly note that they have had a huge impact. I was 
told that over the last decade, it has been about $284 billion 
saved, and of course, people getting access to these drugs. So, 
it is a hugely important area.
    [The information follows:]

                     First and Second Generic Drugs

    It is not possible to immediately determine which pending generic 
applications would be the first or second generics on the market. 
Whether a generic is first or second is based on the order in which it 
is approved and marketed. A number of factors can affect which drug is 
marketed first, making it difficult to identify which pending 
applications will ultimately become first or second generics. However, 
FDA makes every effort to ensure that generics are available to 
consumers as soon as possible. In most cases, a first generic is 
approved shortly after all relevant exclusivities have expired, and all 
relevant patents have expired or are successfully challenged.

                         GENERIC DRUG USER FEES

    Senator Kohl. Yes, as you point out, it has been a 
tremendous savings, if we can just get these drugs to market. 
And the reason I say first and second, if a standard drug from 
a brand name company is priced at $10, maybe the first generic 
comes out at $8, but then the second generic might come out at 
$4 or $2 in order to get their share of markets. So, oftentimes 
it is the second generic that comes to market that really 
impacts the price of that product to consumers.
    Do you support user fees?
    Dr. Hamburg. I do support user fees. I think that the user 
fees will enable our generic program to be much stronger and I 
think that it is increasingly important that we have a robust 
generic review program both because of the importance of these 
drugs to the American people, as we have been discussing, but 
also because our ability to review them is getting harder and 
harder. In a way, we are a victim of our own success. Number 
one, because the industry has really taken off, we are getting 
more and more applications. Believe it or not, we actually 
approve about two generic drugs per working business day at the 
FDA. So, it is a huge volume that comes before us.
    And many of the generic drugs are part of this more 
globalized supply and manufacturing chain that we have touched 
on briefly. So, increasingly, in order to do the approvals, we 
have to go overseas to do inspections of the manufacturing 
plants, and that takes more time and money as well.
    So, as we are seeing the generic industry really expanding 
and the challenge of the review process increasing because of 
this globalization--and in some cases, because of the 
complexity of the drugs that are coming before us, but mainly 
we are facing growing challenges and we need to meet them. I 
think that both industry and the public benefit. So, I think it 
is appropriate to have the program funded by budget authority 
and user fees.
    Senator Kohl. Thank you.
    Senator Blunt, go ahead.
    Senator Blunt. Well, we do have votes, and I may have some 
written questions. I would be interested in how big these user 
fees are for generics compared to the original certification of 
drugs.
    Dr. Hamburg. Well, we are just----
    Senator Blunt. If you had them, what are we talking about 
here?
    Dr. Hamburg. We are beginning to sit down at the table for 
the negotiations. The President's budget proposes, sort of 
targets a $40 million user fee for generic drugs in fiscal year 
2012.
    [The information follows:]

                         Generic Drug User Fee

    The fiscal year 2012 budget proposal calls for a generic drug user 
fee program of about $40 million. In relation to the market for generic 
drugs, estimated at $58 billion, according to the Generic 
Pharmaceutical Association, this represents a modest expense.
    The economics of the generic drug market make it difficult to 
determine precisely what impact this $40 million would have on the 
price of generic drugs. We note that this $40 million is significantly 
less than the $250 million user fee program which members of the 
generic drug industry have outlined in public meetings; any impact from 
the $40 million user fee would therefore be significantly less than any 
impact resulting from the $250 million user fee proposed by industry.

    Senator Blunt. If you have any studies on what impact that 
has on the prices of these drugs, and maybe it is over such a 
large number of drugs it is varied, but I would like to see 
that if you have that information. You know what I am asking? 
What impact do you think $40 million of user fees would have on 
the price of drugs, and is there a way to differentiate that 
out?
    Dr. Hamburg. Okay. Well, we will take our best stab at 
doing that.
    [The information follows:]

                       Generic Drug Price Impacts

    The Federal Drug Administration and the generic drug industry have 
only recently begun negotiations to discuss generic drug user fees. At 
this time, FDA does not know what type of fee structure will be 
established, let alone the amount of each fee. FDA's goal is to work 
with the industry trade associations to establish a program that 
promotes the timely review and inspection of the growing number of 
generic drug applications. Members of the generic drug industry 
outlined proposals at a public stakeholders meeting that would equate 
to about $250 million in annual user fees. Given that sales of generic 
drugs are about $58 billion, from the GPHA, such a user fee would 
represent less than 1 percent of sales.
    By contrast, the prescription drug industry paid approximately $459 
million in fiscal year 2008, on 2008 sales of $234 billion, according 
to a report by the Kaiser Family Foundation in 2010, also less than 1 
percent of sales.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Blunt. I would think that would be something we 
would want to know as part of the whole evaluation of what 
impact this has on the generic marketplace.
    And I may have some other written questions, Mr. Chairman.
    Dr. Hamburg. Okay, delighted to take them.
    Senator Blunt. Commissioner, thank you for your 
knowledgeable answers today.
    Dr. Hamburg. Thank you very much.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

                Questions Submitted by Senator Herb Kohl

                             OVERALL BUDGET

    Question. Please provide a priority list of the increased funding 
items you are requesting in the budget.
    Answer. The Food and Drug Administration (FDA) is responsible for 
protecting Americans many times each day and through every stage of 
their lives. Our role in protecting public health is unique, and there 
is no one to backstop us.
    With these principles in mind, the FDA fiscal year 2012 budget 
supports many urgent public health priorities. It contains the 
resources to achieve fundamental public health responsibilities 
entrusted to FDA. The budget recommends new resources for FDA to 
transform America's food safety and nutrition, speed the development of 
medical countermeasures to meet critical national security priorities, 
protect American patients, and advance the regulatory science that 
serves as the foundation for FDA public health decisions.
    The initiatives and resources that FDA recommends for fiscal year 
2012 will allow us to act more quickly and strategically to protect 
consumers from food safety threats and help deliver safer, more 
effective medical therapies to the American people. Fulfilling our 
responsibilities to the American public requires additional resources, 
as recommend in the fiscal year 2012 budget, across all of these 
priorities.
    Like many Government executives, I am carefully watching the 
progress of the ongoing bicameral, bipartisan discussions between the 
administration and congressional leadership on the Nation's long-term 
fiscal picture. These discussions will likely affect the overall 
funding for Federal programs, the scope of many programs and the size 
of individual budgets. We look forward to working with you and others 
in the Congress as this process moves forward.
    The administration is committed to making the difficult decisions 
necessary to reduce the deficit. However, we must do so in a way that 
safeguards the public health of Americans now and in the future. That 
is what FDA and its employees strive to do every day.

                        MEDICAL COUNTERMEASURES

    Question. The budget for fiscal year 2012 proposes an increase of 
$70 million for advancing medical countermeasures (MCMs). This is on 
top of a fiscal year 2011 request to use $170 million in unspent 
pandemic flu money for these activities.
    Can you talk a little bit about this initiative--it's a lot of 
money. What, specifically, will we be getting with this investment? Is 
the initiative scalable, and to what degree?
    Answer. FDA plays a key role in facilitating development and 
availability of the Nation's MCMs. To successfully contribute and keep 
pace with the multibillion-dollar investments being made in MCM 
development by the National Institutes of Health (NIH), the Biomedical 
Advanced Research and Development Authority (BARDA) of the Office of 
the Assistant Secretary for Preparedness and Response, and the private 
sector, FDA needs funding to support its MCM Initiative. The fiscal 
year 2012 investment of $70 million in the MCM is critical to 
successfully developing innovative, safe, and effective MCMs to counter 
identified chemical, biological, radiological, and nuclear (CBRN) 
threats and emerging infectious disease threats. The $70 million 
investment is also essential to develop the capacity to rapidly develop 
MCMs in the face of new threats.
    The fiscal year 2012 investment in the MCM will help to accelerate 
the pace and increase the probability of successfully developing MCMs 
for these threats. FDA will use the fiscal year 2012 funds in a number 
of ways. FDA will create and maintain a highly qualified workforce with 
the appropriate technical training, scientific skill, and subject-
matter expertise to fully support FDA's MCM responsibilities. FDA will 
also improve the MCM infrastructure at FDA, such as laboratory 
equipment and information technology, so that our researchers and 
reviewers have the tools they need. FDA will establish 
multidisciplinary Action Teams that will work to establish clear, 
science-based pathways for evaluating and approving MCMs. FDA will 
expand FDA's regulatory science program to help overcome existing 
hurdles in MCM development and to facilitate the translation of 
scientific discoveries into MCMs. And, FDA will modernize agency 
regulations and policies to make the FDA evaluation and review process 
more efficient and to ensure that MCMs can be made readily available to 
the public when needed.
    Regarding the question about whether the MCM is scalable, we 
recognize the budget challenges that the Congress and the Federal 
Government face. The FDA investment has been carefully designed and 
balanced to fulfill the resource needs for the activities that FDA must 
conduct and the performance that FDA must deliver. It has also been 
designed to sustain the MCM infrastructure and programs already under 
way and to continue and build on this critical work. If the Congress 
must scale its investment in MCM, FDA will determine how to make 
adjustments.
    Question. Are there specific threats that you are working on that 
are greater than others?
    Answer. Yes, FDA is fully engaged with its MCM Enterprise partners 
throughout the Federal Government to establish and maintain MCM 
programs and activities based on MCM Enterprise partner priorities 
based on anticipated.
    The Department of Health and Human Services (HHS) prioritizes both 
the threats and the MCM programs to counter those threats. The highest 
priority threats include CBRN threats for which a Material Threat 
Determination has been issued by the Department of Homeland Security. 
Examples include anthrax, smallpox, botulinum toxins, and radiological 
nuclear threats. These have been determined to present a material 
threat against the United States population sufficient to affect 
national security. Pandemic influenza is also a high-priority threat.
    The HHS review, ``The Public Health Emergency Medical 
Countermeasures Enterprise Review'', released in August 2010, 
envisioned the Nation's MCM Enterprise evolving from its current 
threat-specific approach to a flexible capability that can produce MCMs 
rapidly in the face of any attack or threat, known or unknown. As a 
result, FDA is also focusing on supporting the development of broad-
based platform technologies in support of MCM Enterprise priorities 
that can offer scalable and flexible advantages over agent-specific MCM 
programs for high-priority threats.
    Question. I know you've started working on some of this in 
earnest--what happens if you don't get the money you are requesting in 
fiscal year 2011 or fiscal year 2012?
    Answer. HHS provided FDA with the funding to launch and begin 
implementing the MCM by allocating $170 million from previously 
appropriated funds for pandemic influenza activities. The $70 million 
budget request for fiscal year 2012 is designed to provide base funding 
for the MCM.
    As already noted, the $70 million fiscal year 2012 budget request 
for the MCM is designed to sustain the MCM and to enable it to keep 
pace with the multibillion-dollar investments ongoing at NIH and BARDA. 
If FDA receives less than the amount requested, the agency must limit 
its investment in the MCM, regulatory science program, and the full-
time equivalents (FTEs) necessary to support the enhanced review 
process for MCMs. The risks of receiving a reduced amount include an 
inability to adequately implement FDA's MCM, which will ultimately 
degrade the ability of the MCM Enterprise to achieve its mission to 
protect the Nation from these threats.
    The HHS review, ``The Public Health Emergency Medical 
Countermeasures Enterprise Review'', stressed that improving the 
regulatory environment for MCMs is critical to the success of the MCM 
Enterprise and is among the challenges the U.S. Government must address 
if it is to successfully develop MCMs. Moreover, investments in the MCM 
have implications for improving the health and security of the U.S. 
population beyond countering CBRN threats and emerging infectious 
disease threats. Investments to advance regulatory science to support 
development of MCMs will contribute directly and indirectly to 
development of products to treat other diseases and conditions and help 
improve the safety and efficacy of and access to FDA-regulated 
products.

                             PREGNANCY RULE

    Question. An estimated 75 percent of all pregnant women use 4-6 
prescriptions or over-the-counter drugs at some time during their 
pregnancy. It's widely acknowledged that information provided to 
pregnant women on drug labels is confusing at best. I know FDA has been 
working on this issue and even proposed a rule in 2008.
    I understand that 73 comments were received on this proposed rule. 
Even if they are extremely complex, I can't see why I would take 
several years to go through 73 comments. Can you tell me the reason for 
the delay?
    Answer. FDA staff have been reviewing the comments, identifying and 
considering the issues raised by the comments, determining whether any 
revisions should be made to the proposed regulation and preparing the 
final rule. FDA staff are continuing to work on the final rule. Because 
of the importance of this public health issue, FDA wants to proceed 
with the appropriate care and judgment.
    Question. Is it a priority for FDA, and when do you think it will 
be finalized?
    Answer. Publication of the final rule regarding prescription drug 
labeling for pregnant and lactating women remains a strong priority 
within FDA. FDA staff are actively working on the rule. Please be 
assured that FDA is committed to finalizing this rule as promptly as 
feasible and practical.

                             GENERIC DRUGS

    Question. Dr. Hamburg, I ask about this every year. Over the years 
we have provided funding to speed approval of generic drugs. We do it 
because they save consumers and the Government significant money. 
Unfortunately, the backlog of applications awaiting approval continues 
to grow. And at this point, we have no indication that it will slow 
down. The budget proposes a slight increase for generic drugs--not 
enough to keep up with the increased workload, and again proposes to 
create a user fee for generic drugs in order to offset the costs. These 
user fees would allow you to collect more than $40 million in fiscal 
year 2011.
    To put the question in context, how many generic drug applications 
are pending at FDA right now?
    Answer. There are approximately 2,400 generic drug applications 
pending. These pending applications include applications that are 
awaiting FDA's original assessment or review, applications that FDA 
found were not ready for approval and the company is preparing a 
resolution or response to address the FDA concerns, and applications 
awaiting re-review where companies submitted responses to deficiencies 
previously identified by FDA. This last category of applications is 
known as amendments.
    Question. Research shows that it's the first and second generic 
drugs that save consumers the most money. Of those in the backlog, how 
many, if approved, would be the first or second generic of their kind 
on the market?
    Answer. Our current tracking system does not allow us to identify 
pending generic applications as first or second generics. Whether a 
generic is first or second is based on the order in which it is 
approved and marketed. A number of factors can impact this order and 
factors can cause the order to shift with the passage of time. In 
addition, a first generic might be only one of the dosage strengths 
that the brand manufacturer makes, so the actual definition of first 
generic is not always clear. The Food and Drug Administration makes 
every effort to ensure that generics are available to consumers as soon 
as possible. In most cases, a first generic is, as with multiple 
generic drugs, approved shortly after all relevant patents and 
exclusivities have expired or the relevant patent is successfully 
challenged.
    Question. And within those, how many could go on the market 
tomorrow, as opposed to those being delayed due to lawsuits, etc.?
    Answer. As explained earlier, we cannot specify the number of 
pending first and second generic applications, and therefore, we cannot 
specify how many of those applications are not blocked by patents or 
exclusivities.
    However, of the approximately 2,400 abbreviated new drug 
applications currently under review, about two-thirds are currently 
blocked from approval by patents or other exclusivities. Please note 
that applications waiting for expiration of patents or exclusivity to 
expire may be tentatively approved. A tentatively approved application 
has been found to meet FDA's rigorous approval requirements, and is 
ready to be marketed as soon as the innovator patent expires, the 
patent is successfully challenged, or all exclusivities expire. As a 
general matter, all patent or exclusivity issues related to the brand 
product or reference listed drug must be resolved before the generic 
product can be approved. Currently, there are 309 tentatively approved 
applications.

                     FOOD SAFETY MODERNIZATION ACT

    Question. The Food Safety Modernization Act (FSMA), passed last 
year, was the largest expansion of FDA's authorities in 70 years. 
Obviously, the way food is produced, transported, stored, and consumed 
has changed since then, so this updated law was long overdue.
    The Congressional Budget Office has estimated that it will cost 
$1.4 billion over 5 years to fully implement this law. Your budget 
proposes an increase of around $225 million for your Transforming Food 
Safety and Nutrition Initiative, which includes $183 million for you to 
begin implementation. Will this amount fully fund FDA's first year 
costs for the new food safety law, and how much additional funding do 
you think you'll need over the next few years?
    Answer. With the requested increase of $183 million to implement 
FSMA, FDA expects to make substantial progress in building the science-
based, prevention-oriented, and efficient food safety system mandated 
by the Congress. FDA plans to issue the key regulations required by 
FSMA, including produce safety standards, preventive controls in food 
facilities, and standards for preventing intentional adulteration. In 
addition, we would strengthen the scientific basis for the Foods 
Program, including the ability to make the design and implementation of 
our prevention standards more risk-based and effective in preventing 
food safety problems.
    FDA plans to train FDA investigators in the latest inspection 
techniques that take advantage of the preventive controls regulatory 
framework. FDA will also build State capacity and create a national 
inspection work plan so that State inspections can be leveraged to meet 
FDA's domestic inspection frequency requirements.
    FDA plans to design and implement a new import safety framework for 
carrying out the FSMA mandates. The new framework will include stronger 
importer accountability through the foreign supplier verification 
program, an accredited third-party certification program, comparability 
assessments to determine if foreign governments have food safety 
systems comparable to that of the United States, a voluntary qualified 
importer program to expedite review and importation of food by 
qualified importers, and expansion of the foreign inspection program. 
Finally, FDA will need to rely on better information technology to 
support more efficient domestic inspection and effective oversight of 
imports.
    In future years, FDA will need to continue to invest in 
implementing these programs, including increasing FDA science capacity, 
strengthening the integrated food safety system, and implementing the 
import safety framework. We hope to work with the Congress to ensure 
that FDA has adequate resources to achieve our shared food safety 
goals.
    Question. There have been statements made that this law isn't 
really necessary. Some people point to the recent decreases in the 
Centers for Disease Control and Prevention (CDC) estimates of the 
numbers of deaths and illness from food-borne illnesses. Particularly 
at a time when Federal spending is declining, how would you respond to 
those criticisms? Why do we need to spend this additional money right 
now, when we continue to have one of the safest food supplies in the 
world?
    Answer. The revised CDC estimates still demonstrate a significant 
public health burden due to foodborne diseases with an estimated 48 
million illnesses, affecting one in six Americans each year and 
resulting in 128,000 hospitalizations, and 3,000 deaths each year. It 
is true that the United States has one of the safest food supplies. For 
the most part, the food industry does a good job of providing abundant, 
safe food to American consumers. However, there has been a continuing 
series of food safety problems--major recalls, outbreaks, and 
illnesses--most of which are preventable. FDA FSMA, which gives FDA new 
tools to prevent foodborne illness, received the support of industry 
and consumer groups, as well as the Congress, and represents a 
consensus that improvements in the current system are necessary.
    Question. How will these efforts help our economy? What is our 
return on investment?
    Answer. Efforts to improve food safety through the prevention-
focused framework envisioned in FSMA will result in fewer outbreaks of 
foodborne illness and more rapid response when they do occur. Outbreaks 
are costly to all involved--to consumers, to the food and feed 
industries, and to the healthcare industry. A 2007 study estimated the 
average hospital stay at 5.8 days for each case of foodborne illness 
requiring hospitalization. The same study estimated the average cost 
per case of foodborne illness at between $16,100--for an adult--and 
$26,700--for a child. In the case of the 2006 spinach recall, the 
Institute of Food Technologists estimated the cost of recalled spinach, 
lost sales, lost productivity, and other costs at $129 million. 
Likewise, in the case of the 2008 Peanut Corporation of America (PCA) 
peanut product recall, one major manufacturer--Kellogg--estimated its 
costs to recall peanut-containing products at $65 million to $70 
million. FDA expended more than 100 staff years--full-time 
equivalents--to protect consumers and conduct PCA-related inspection 
and recall activities. In the aggregate, the costs of foodborne 
illnesses and outbreaks are in the billions of dollars.
    Question. How can you ensure that the produce safety regulations 
you are drafting will not follow a one-size-fits-all approach, which 
would harm small and organic growers?
    Answer. FDA is aware of the tremendous diversity in farming 
operations and that a one-size-fits-all approach to produce food safety 
will not be practicable. Over the past year, FDA and U.S. Department of 
Agriculture (USDA) technical experts, scientists, and other staff 
participated in listening sessions and meetings in 13 States. In some 
of those States, we were able to tour large and small farms and speak 
with people who have the on-the-ground knowledge that FDA realizes must 
be reflected in the proposed rule. FDA is committed to providing 
operators with flexibility and innovation in their approaches to on-
farm food safety for their operations.

                    FOOD SAFETY DUPLICATION EFFORTS

    Question. The Government Accountability Office (GAO) recently 
issued a report on duplicative Government programs. Duplication in food 
safety across Federal agencies was a major theme in the report. Of the 
15 agencies with oversight over food safety activities, the FDA is in 
charge of 80 percent of domestically produced and imported food.
    Since your agency has responsibility for the vast majority of the 
food we eat and in light of the fact that we just passed a massive food 
safety overhaul bill, can you please respond to the findings of the 
report regarding overlap in food safety activities?
    Answer. The GAO report, ``Federal Food Safety Oversight--Food 
Safety Working Group Is a Positive First Step but Governmentwide 
Planning Is Needed to Address Fragmentation,'' highlighted the positive 
steps taken by the Federal food safety agencies under the auspices of 
the Food Safety Working Group (FSWG) to coordinate and collaborate on 
cross-cutting food safety issues, such as produce safety, salmonella 
contamination, and food safety performance measures. The report 
contained one recommendation for the Office of Management and Budget 
(OMB) to develop a Governmentwide performance plan for food safety. FDA 
continues to work through FSWG with its food safety partners to address 
a coordinated agenda of food safety issues as appropriate within our 
statutory frameworks.
    Question. How often and how well do you work with the Food Safety 
and Inspection Service and other Federal, State, and local food safety 
agencies during an outbreak that would affect both agencies, and how 
can you improve?
    Answer. FDA works with its State and local food safety partners 
during every outbreak of foodborne illness. FDA and its State and local 
counterparts are striving to improve how they work together on 
outbreaks. Efforts include cooperative agreements with States to form 
rapid response teams (RRTs). The RRT agreements allow the selected 
recipient to build State program infrastructure and rapid response 
capabilities for food and feed emergencies and implementation of the 
Manufactured Foods Regulatory Program Standards. This project engages 
partners to develop innovative programs and tools, both within each 
individual program and jointly among the nine pilot teams.
    During the past 2 years, there have been three specific 
investigations in which FDA and USDA have had close, very positive 
collaborations--salmonella enteritidis in shell eggs, salmonella 
montevideo in spices used in deli meat, and salmonella enteritidis in 
liquid-/pasteurized eggs. In these investigations, FDA and USDA senior 
level and field level staff have planned the investigation, worked side 
by side in the field, shared laboratory resources, and coordinated 
closely on messages to consumers. Also, senior outbreak staff from FDA, 
CDC, and USDA now participate in 1- to 2-week orientation visits within 
each agency to better understand policies and procedures, and allow 
networking outside of emergency events. In addition, through FSWG, the 
Federal food safety agencies recently formed a group to improve how 
they work together during outbreaks. The agencies have formed a 
standing Multi-Agency Coordination Group for Foodborne Illness 
Outbreaks (MAC-FIO). MAC-FIO is comprised of a designated 
representative from each of the Federal agencies with food safety 
responsibilities, which allows for rapid coordination and communication 
during an outbreak that involves multiple Federal food safety agencies.

                      ADVANCING REGULATORY SCIENCE

    Question. The budget includes an increase of $49 million for your 
regulatory science initiative. Of this, nearly $24 million is to pay 
for FDA staff to occupy a new lab.
    What specifically will these funds be used for? Please provide a 
breakout of spending. Is this a top priority?
    Answer. The Advancing Regulatory Science funding relating to White 
Oak are required to ensure that the new Life Sciences-Biodefense 
Laboratories and supporting facilities on the White Oak Campus are 
outfitted and operational to support critical FDA biologic and human 
drug research programs. Since these laboratories use select agents, 
they must undergo a highly specialized certification process before we 
can conduct research in these facilities to advance FDA's mission. 
These funds will allow the testing and commissioning of state-of-the 
art laboratory equipment required for FDA science operations to support 
the following programs: annual and pandemic influenza, nonpandemic 
MCMs, blood and other biological products, biosimilars, and regulatory 
science. System testing and commissioning includes building automation 
system operation and monitoring, air flow tests, HEPA air filter tests, 
primary bio-containment device effectiveness, room pressurization 
control, and power tests. Funding will also allow FDA to provide for 
cabling and telecommunications equipment to support lab operations.
    This is a top priority as the funding will allow FDA to demonstrate 
that all systems and standard operating procedures will provide 
environmental and biological safety. We will be severely hampered in 
our ability to protect national security and world-wide public health 
if funding is not received as our existing laboratories are outdated 
and filled to capacity. In addition, FDA lab facilities would not be 
able to move to White Oak from National Institutes of Health and other 
locations and FDA would continue to pay approximately $20 million in 
annual rent for existing facilities.

                              DRUG SAFETY

    Question. Drug recalls have increased significantly since 2009, and 
there have been several high-profile cases of tainted drugs reaching 
the market. There have been many potential causes discussed for these 
increases. Some point to the high cost of manufacturing drugs, and 
cost-saving measures taken by manufacturers that lead to problems. 
Others point to manufacturers rushing too quickly to be the first 
company to submit an application, especially in the case of generic 
drugs. Another obvious concern is that 40 percent of drugs consumed in 
the United States are imported, while 80 percent of the ingredients 
used in U.S. drugs come from other countries, and these numbers 
continue to rise. Both you and your senior staff have said very 
recently that we continue to be at risk, and another drug safety 
problem is all but unavoidable. The budget includes an increase of $56 
million for the Protecting Patients Initiative, of which $12 million is 
for import safety.
    Can you talk specifically about this increase, and more generally 
about how you begin to address problems like this when increased 
funding is not a certainty?
    Answer. The increased funding will be used to strengthen our 
multifaceted approach for leveraging different opportunities for 
additional knowledge of imported products and foreign manufacturers. As 
resources allow, we will continue to pursue our efforts to conduct 
additional foreign inspections, enhance our working relationships with 
international regulatory counterparts, and strengthen our foreign 
presence. FDA conducts inspections of foreign facilities that offer 
FDA-regulated products for import into the United States, and in some 
cases supplements information gathered during inspections with 
knowledge gained from foreign regulatory counterparts. In this regard, 
we continue to enhance working relationships and information-sharing 
with our international regulatory partners which, in turn, help FDA 
identify problem products before they are offered for import and enter 
U.S. commerce. Another important opportunity is FDA's acceptance into 
the Pharmaceutical Inspection Cooperation Scheme, whose primary goals 
are to foster the international development, implementation, and 
maintenance of harmonized Good Manufacturing Practice standards, and 
further the development of a quality system of inspectorates in 
medicinal products.
    FDA is also participating in a pilot program with the European 
Medicines Agency on the coordination and performance of joint 
inspections. The overall objective is to see whether greater 
international collaboration can better distribute inspection capacity, 
allowing more sites to be monitored and reducing duplication. In 
addition, FDA's Office of International Programs has opened several 
foreign offices to further enhance FDA's ability to protect U.S. 
consumers from unsafe foreign-sourced products. Establishing a foreign 
presence reflects the evolution of FDA's regulatory strategy and its 
responsiveness to U.S. consumers in meeting its mission of public 
health protection.
    An additional example of international collaboration includes the 
FDA's memorandum of understanding with the Health Products and Food 
Branch of Health Canada. This allows FDA and Canada to develop specific 
procedures for sharing of regulatory, emergency management, and public 
health information related to drug products. This can include 
information on quality defects or product recalls of therapeutic 
products manufactured or distributed in Canada, inspection reports, 
product samples, enforcement activities, product investigations, as 
well as information on facilities registered or authorized to market 
products.

                     PATIENT MEDICATION INFORMATION

    Question. I understand that FDA has been working on a new process 
for producing consumer and patient medication information (PMI) that is 
included with patient prescription medication. This is due to a general 
belief that the current format can be confusing, and too much 
information can be included, which makes it less useful to consumers. 
This information is currently produced by private publishing companies. 
My understanding is that the current proposal would require each 
manufacturer to provide a consumer/PMI insert with each drug they 
produce, and the information would be limited to one page.
    Concerns have been brought to my attention that requiring every 
drug manufacturer to independently produce this information could lead 
to inconsistent information being provided to patients, and limiting 
the documents to one page could lead to the omission of important 
information. I have further been informed that FDA has stated they will 
not be able to provide oversight of these documents.
    What is the current plan for modernizing the consumer and PMI? What 
was the thought process behind requiring each manufacturer to publish 
this information independently?
    Answer. FDA's ongoing analysis of and plans for modernizing 
consumer and PMI are intended to achieve the goals of Public Law 104-
180, enacted in 1996, which included specific targets regarding the 
distribution and usefulness of PMI. FDA-commissioned studies subsequent 
to the enactment of Public Law 104-180 have indicated that those 
statutory goals are not being met by current private sector efforts, 
and we are considering next steps.
    Currently, documents are developed by drug manufacturers, other 
private organizations, or individuals and patients may receive several 
different types of information, developed by different sources. PMI may 
be duplicative, incomplete, inconsistent, or difficult to read and 
understand, and distribution is voluntary for certain types of PMI. The 
distribution of Medication Guides, in accordance with 21 CFR part 208 
and some patient package inserts in accordance with 21 CFR 310.501 and 
310.515 is mandatory as described in the regulations.
    FDA has determined that the current system is not adequate to 
ensure patients receive essential medication information needed to 
safely use drugs. Based on recommendations from FDA's Risk 
Communication Advisory Committee and other stakeholder input, FDA sees 
merit in adopting the use of a single document with standardized 
content and format. FDA is working with all relevant parties, such as 
patients, healthcare providers, drug manufacturers, interested 
professional organizations, and PMI developers and publishers, to 
determine the appropriate regulatory path forward. For example, the 
Engelberg Center for Health Care Reform at the Brookings Institution is 
working with key stakeholders, including FDA, to conduct initial 
demonstration pilots, designed to evaluate feasibility of various PMI 
distribution channels and assess patient and provider PMI preferences.
    FDA does not intend to limit production of PMI solely to drug 
manufacturers. Our goal is to establish standards regarding the content 
and format of PMI in order to increase the overall quality of the 
documents patients receive and hopefully enhance patient care through 
proper medication use. FDA is still considering how best to accomplish 
this goal, and has not finalized requirements for the procedural 
aspects surrounding the creation of PMI or the single page limitation. 
When making any determinations, FDA will consider all stakeholder 
input, including the comments received in your statement.
    Question. Can you please address the concerns that have been 
brought to my attention?
    Answer. We understand that concerns have been voiced that requiring 
every drug manufacturer to independently produce PMI could lead to 
inconsistent information being provided to patients, and limiting PMI 
documents to one page could lead to the omission of important 
information. To address those concerns, FDA is seeking public input and 
taking a scientific approach, including conducting research, as part of 
our decisionmaking process. FDA has developed three draft PMI 
prototypes to be used in consumer testing. The results of the consumer 
testing will inform FDA of the usefulness and various format options 
for PMI documents. FDA recognizes that FDA review and approval of all 
PMI documents prior to distribution may not be feasible given our 
resource constraints and the potential volume of products that may 
require PMI, perhaps as many as 22,000 products. FDA is considering 
developing standardized content and format requirements, which should 
enhance quality and accessibility of information in PMI, similar to the 
standardized labels on over-the-counter drugs and many food products, 
and should lead to improvements in patient care due to safer use of 
medications.
    Question. Will there be rules regarding updating and streamlining 
information to make it easily understandable for consumers, which 
providing an appropriate amount of information? Will FDA provide 
oversight on these publications?
    Answer. Yes, FDA intends to develop rules or guidance based in part 
on the outcomes of our testing and pilot projects. FDA has developed 
three draft PMI prototypes to be used in consumer testing. Based on 
public comment and expert panel input, FDA is also finalizing the 
design of the consumer testing study of the prototypes. Consumer 
testing will begin when the final study design is approved by OMB. The 
results of this study will inform FDA of the usefulness and various 
format options for PMI documents.
    FDA intends to provide oversight of PMI documents, and is 
considering the best approach for doing so. Although one approach to 
oversight could involve FDA review and approval of all PMI prior to 
distribution, we recognize that this may not be feasible given FDA's 
resource constraints and the potential volume of products that may 
require PMI--perhaps as many as 22,000 products when including all 
innovator and generic products.
    Question. What is the timeline for this change?
    Answer. Before implementing changes to PMI, the plan is for FDA to 
first study and test the utility of PMI prototypes. Approval by the 
White House OMB for this research is expected by July 2011 and results 
of the study are expected in 2012.
    One option for implementing changes to PMI might be to develop a 
new rule. The timeframe for developing and finalizing a new rule at FDA 
varies, but the process can take a 5 years. Thus, implementation of a 
PMI rule would likely not occur prior to 2015/2016. During FDA's 
decisionmaking process, FDA plans to continue to study prototypes, 
research potential processes, and discuss and evaluate the impact of 
those potential procedures. FDA intends to continue to involve all 
interested stakeholders in these activities.

                          GENERIC FOR LIPITOR

    Question. I understand that later this year, a generic for the 
blood pressure drug Lipitor will be eligible to enter the market due to 
patent expirations. The entry of generic competition to Lipitor has the 
potential to save consumers as much as $6.7 billion.
    Are you working to try to reach a decision as to whether to approve 
a generic drug application for Lipitor in a timely fashion?
    Answer. Lipitor, which has the chemical name atorvastatin, is a 
drug used to treat high cholesterol. The FDA recognizes the benefits 
and value of making safe, effective, high-quality generic drugs, such 
as Atorvastatin, available to the American public. FDA is fully 
dedicated to doing so as quickly as possible within the framework of 
the law and applicable regulations.
                                 ______
                                 
            Questions Submitted by Senator Dianne Feinstein

                 PROGRESS ON RESEARCH INTO BISPHENOL-A

    Question. I remain particularly concerned about the use of 
bisphenol-A (BPA) in food containers, particularly those used to 
provide food and beverages to infants and children. Mounting scientific 
evidence demonstrates a link between BPA exposure, even at low doses, 
and a host of harmful health effects such as cancer, diabetes, 
behavioral disorders, and heart disease. This is why I have introduced 
legislation in the 112th Congress that would ban the use of BPA in baby 
bottles, sippy cups, infant formula, and baby food.
    In January 2010, the Food and Drug Administration (FDA) released an 
``Update on Bisphenol A for Use in Food Contact Applications'' (update) 
to explain your current perspective on BPA, including support for 
additional research and interim recommendations for public health.
    In this update, you agreed with the National Toxicology Program 
(NTP) at the National Institutes of Health (NIH) and expressed ``some 
concern about the potential effects of BPA on the brain, behavior and 
prostate gland in fetuses, infants, and young children.'' You also 
cited additional research being pursued by the FDA's National Center 
for Toxicological Research (NCTR), and the interim steps you would take 
to reduce exposure.
    What progress have you made in your consideration of the low-dose 
toxicity studies and peer-reviewed studies of BPA?
    Answer. FDA announced the availability of updated review documents 
on low-dose studies in a Federal Register Notice published on April 5, 
2010. Since that notice published, FDA has continued to incorporate new 
published information and information from studies conducted at FDA's 
NCTR into our review of the safety of BPA in FDA-regulated products.
    Question. What is the status of the research being conducted by the 
FDA's NCTR, including those studies being conducted in collaboration 
with NTP?
    Answer. FDA's NCTR is conducting studies characterizing the 
toxicities of BPA in several animal models in partnership with NTP. 
Study designs are using both oral and intravenous routes of exposure. 
The results with oral studies are used to model dietary exposure while 
intravenous studies are used to model neonatal and infant exposure in a 
medical setting.
    To date, the results of several studies have been published in the 
peer-reviewed scientific literature. Four studies were published that 
characterize systemic distribution and excretion patterns following 
oral and intravenous administration of BPA using rat and nonhuman 
primate models. Human biomonitoring data are also being collected in 
conjunction with research partners, including FDA's Center for Devices 
and Radiological Health; the Centers for Disease Control and Prevention 
(CDC); and the Pacific Northwest National Laboratory. The animal study 
data and the human biomonitoring data will be combined into 
mathematical models to minimize uncertainties in estimates of human 
tissue exposures.
    Several additional, longer-term exposure studies with BPA 
evaluating effects of in utero and neonatal exposures are in progress 
in rats, which include the effects on the brain structure and behavior. 
Additional long-term exposure studies are scheduled to begin in fiscal 
year 2012. These studies include a lifetime cancer bioassay, and an 
evaluation of factors related to diabetes and heart disease. All the 
studies have been designed to fill data uncertainties identified by FDA 
and NTP in order to assess potential impact of BPA on human health.
    Question. What is the status of your consultations with other 
expert agencies including the NIH, the Environmental Protection Agency 
(EPA), the Consumer Product Safety Commission (CPSC), and CDC?
    Answer. FDA included scientists from several other agencies 
including NIH, EPA, and CPSC in an external review of our most recent 
memorandum on low-dose studies of BPA. We continue to interact with 
Government scientists from all these agencies to better inform our 
safety assessment process. For example, FDA's on-going studies at the 
NCTR are being performed in collaboration with the National Institute 
for Environmental Health Sciences (NIEHS), as mentioned previously and 
FDA scientists have attended NIEHS BPA grantee meetings. In addition, 
in November 2010, FDA scientists participated with other U.S. 
Government scientists as well as international experts in a Food and 
Agriculture Organization (FAO)/World Health Organization (WHO)-
sponsored consultation regarding the safety of BPA in food contact 
applications. One conclusion of the FAO/WHO consultation was that it 
would be premature to initiate public health measures based on current 
data.
    Question. You cite support for the industry's actions to stop 
producing BPA-containing bottles and infant feeding cups in the U.S. 
market. What specific actions, if any, have you taken to express this 
support?
    Answer. FDA announced its support for these actions in a January 
10, 2010, announcement posted on FDA's Internet site. At that time, FDA 
announced that major manufacturers had stopped selling new BPA-
containing baby bottles and infant feeding cups for the U.S. market 
since early 2009. FDA's contact with these industry members over the 
past year continues to confirm that BPA is not being used for the 
manufacture of infant feeding articles.
    Question. You also cite the FDA is facilitating the development of 
alternatives to BPA for the linings of infant formula cans by working 
with manufacturers, giving technical advice on the approval of 
alternatives, and expeditiously reviewing new applications for 
alternatives. Please provide details of the efforts you have taken in 
this area.
    Answer. FDA has worked with industry to increase our understanding 
of the different packaging materials currently used for infant formula 
and the types and quantities of infant formula packaged in these 
materials. At the present time nearly 90 percent of infant formula--
primarily those that are powdered--sold in the United States is 
packaged in materials that are not manufactured using BPA. Over the 
past year, FDA has actively worked with industry on a wide range of 
alternative materials for liquid infant formula packaging. Because of 
the complexities in this market and the higher potential exposures to 
infants to these materials, FDA has provided substantial individualized 
guidance regarding the development of appropriate safety data to ensure 
safe use of replacement products. These efforts have been the subject 
of over a dozen presubmission applications, a tool FDA uses to 
communicate with industry prior to the formal submission process. Once 
an applicant submits a complete premarket submission is made to FDA, 
the review time is 120 days. We continue to work with the infant 
formula and packaging industries to bring safe alternative materials to 
the market.

          NUCLEAR RADIATION AND ITS EFFECT ON OUR FOOD SUPPLY

    Question. The tragic events that continue to unfold in Japan are 
having extraordinary consequences even within our own society. In 
addition to the earthquake's much publicized effect on gas prices and 
the price of consumer electronic goods, there is substantial concern 
about the safety of food produced in regions affected by the nuclear 
radiation emitting from the damaged power plants.
    What extra precautions is the FDA taking to ensure that all food 
that has been exposed to high levels of radiation is either destroyed 
or decontaminated before it enters the U.S. market?
    Answer. From the earliest days of the situation in Japan, FDA has 
been actively protecting United States consumers from potentially 
contaminated products; instituting import controls to ensure such 
products do not enter the United States marketplace, and adjusting 
those controls as circumstances warranted. These controls include the 
detention of specific products from prefectures reported by the 
Japanese Government as being found to contain radionuclides; and 
increased examinations and FDA analysis of other FDA-regulated 
products. These controls provide a blanket of coverage for FDA-
regulated products from Japan. As this situation evolves, our targeted 
coverage is evolving.
    As of today, March 17, 2011, FDA-activated electronic screening 
criteria to hold all lines of products manufactured or shipped by 
Japanese firms. This screening provides instructions to FDA's field 
offices when encountering shipments from Japan. The instructions 
include documenting review and disposition of all shipments from Japan 
based upon when the shipment left Japan. For those shipments that left 
Japan prior to March 11, no further action is required. Admissibility 
is determined as per normal procedures. For all lines shipped on or 
after March 11, if the shipment originated from an area outside of our 
areas of concern, admissibility is determined as per normal procedures. 
If the shipment originated from within the affected area, FDA 
investigators are instructed to check with local Customs and Border 
Protection (CBP) to determine if the shipment went through CBP's 
radiation screening. CBP will contact FDA if CBP has not screened the 
line or if CBP screening indicates adverse readings for the presence of 
radionuclide contamination.
    If the importer of contaminated product does not voluntarily 
destroy or decontaminate the product, we will rely on CBP's seizure 
authority to take control of the product and ensure it is properly 
disposed.
    Question. What steps is FDA taking to ensure that the elevated 
levels of radiation in the United States does not impact food 
production in California and across the rest of the country?
    Answer. EPA is monitoring atmospheric radiation levels and collects 
environmental samples, such as rainwater, to monitor radiation and any 
increases that may occur due to the tragedy in Japan. Monitoring allows 
FDA to react swiftly in the unlikely event of significant amounts of 
radionuclides reaching our shores. So far, EPA's monitoring has 
detected only very low traces of radionuclides characteristic of a 
power plant accident. These levels do not present a public health 
concern. FDA has had a sampling program in place domestically for many 
years collecting samples of food products from areas around nuclear 
facilities to monitor any potential problems, including California and 
other States across the country. There have been no sample results from 
this program indicating harmful levels of radionuclides. We continue to 
keep abreast of EPA's monitoring to ensure that there is no threat to 
our domestic crops.

                    FOOD SAFETY BILL IMPLEMENTATION

    Question. I strongly supported the passage of FDA FSMA last 
Congress because I believe that the FDA needs to move towards 
preventative model when it comes to protecting the safety of our food 
supply. I believe that all processors should have in place a Hazard 
Analysis and Critical Control Point (HACCP) plan, and I believe that we 
must fully enforce the requirement that these plans are in operation 
any time food is being produced.
    However, produce farmers in my State that are concerned that FDA 
will take a one-size-fits-all approach when it comes to the 
implementation and approval of these food safety plans. I do not think 
that this would be in the best interest of safety, and it certainly 
would not be in the best interest of the food production industry.
    What are you doing to ensure that HACCP plans will be product 
specific? What assurances can I give farmers in California that the FDA 
will not treat spinach HACCP plans, like almond or dairy HACCP plans?
    Answer. We understand your question to relate to the produce safety 
standards required by section 105 of the FDA Food Safety Modernization 
Act. FDA is aware of the tremendous diversity in farming operations and 
that a one-size-fits-all approach to produce food safety will not be 
practicable. FDA is committed to providing operators with flexibility 
and innovation in their approaches to on-farm food safety for their 
operations. FDA intends to propose a rule containing requirements that 
will be commensurate to the hazards and risks associated with any 
particular operation.

                     ANTIBIOTIC IS FOOD PRODUCTION

    Question. I remain concerned about the overuse of antibiotics in 
food animal production and FDA's slow response to address this critical 
public health matter. While I was encouraged to see the FDA proposal in 
guidance for industry (GFI) No. 209 in June of last year, I have not 
seen or heard of any definitive progress since. I cannot underscore the 
importance of swift action in addressing this concern--in the last 10 
years antibiotic resistant E. coli infections have risen by 16.5 
percent, antibiotic resistant P. mirabilis infections have risen by 19 
percent, and MRSA infections rose by 22.4 percent.
    When will FDA offer a definitive plan of action on how to reduce 
the over- and misuse of antibiotics in food animal production?
    Answer. FDA's action plan for promoting more judicious use of 
medically important antimicrobial drugs in food-producing animals began 
in 2010 with the publication of draft GFI No. 209. GFI No. 209, which, 
for the first time, lays out FDA's policy on the use of these drugs in 
animal agriculture provides two definitive guiding principles. The 
first principle is that medically important antimicrobial drugs should 
be used in food-producing animals only when necessary for assuring 
animal health. The second, that such use should include veterinary 
oversight or consultation. We believe that by communicating these key 
principles we have identified a clear pathway forward as we work with 
the animal health and animal agriculture industries to reduce the 
overuse and misuse of antibiotics in food animal production. FDA is 
close to completing review of comments received regarding draft GFI No. 
209 and plans to finalize the guidance later this year.
    However, while this was an important first step, the goal now is to 
put these principles into action. Since publication of GFI No. 209, we 
are very encouraged by the interactions we have had to date with key 
stakeholders, including the animal health industry, on plans for 
implementation. Sponsors of some of our most important antimicrobial 
drugs have already initiated discussions with FDA about updating their 
animal drug products in a manner consistent with the principles of GFI 
No. 209.
    To further support implementation of GFI No. 209 principles, FDA 
intends to issue additional guidance which will provide more specific 
information for animal drug sponsors. In addition, FDA has initiated 
the rulemaking process to streamline the Veterinary Feed Directive 
System to facilitate the transition to veterinary oversight of the use 
of medically important antimicrobial drugs in feed. Work has already 
begun on both of these tasks and related publications can be expected 
sometime within the next year.
    Question. If you intend to follow the general principals laid out 
in GFI No. 209, how will you define the term ``nontherapeutic use of 
antibiotics''? Will the definition include prophylactic use of these 
drugs?
    Answer. The intent of GFI No. 209 was to make a distinction between 
those uses of medically important antimicrobial drugs in food-producing 
animals that FDA considers judicious and those we consider injudicious. 
In this context, FDA believes those uses that are considered necessary 
for assuring animal health are judicious uses and those uses for 
production purposes in healthy animals, such as to promote growth or 
improve feed efficiency, represent injudicious use. As noted in the 
GFI, FDA considers uses that are associated with the treatment, 
control, or prevention of specific diseases to be uses that are 
necessary for assuring the health of food-producing animals. However, 
while FDA does believe that some prevention uses are necessary and 
judicious, we also believe it is imperative that such uses include 
veterinary oversight or consultation. Veterinary involvement in the 
decisionmaking process associated with the use of medically important 
antimicrobial drugs is an important aspect of assuring appropriate use, 
including judicious preventive use.
    Question. It is also my understanding that the FDA intends on 
revisiting the Veterinary Feed Directive (VFD) program and the approval 
of new animal drugs under FDA GFI No. 152. What revisions to these 
documents are you considering and by when do you plan on making these 
recommendations public?
    Answer. In March 2010, FDA published an Advance Notice of Proposed 
Rulemaking (ANPRM) regarding the VFD program. This action was taken in 
response to informal comments received by FDA that characterize the 
current VFD process as being overly burdensome. FDA is concerned that 
the VFD process in its current form may be difficult to administer in 
the future as the number of approved VFD animal drugs increases. 
Therefore, the goal will be to streamline the regulatory requirements 
where possible while still protecting public and animal health. The 
target date for publishing of specific proposals based on the comments 
we received on the ANPRM is planned for sometime during 2012. Of 
course, FDA's publication date can be affected by issues that emerge 
during the review and clearance process.
    FDA believes that GFI No. 152 has provided an effective mechanism 
for evaluating antimicrobial resistance concerns as part of the new 
animal drug approval process. This GFI includes a table that ranks 
antimicrobial drugs with respect to their importance to human medicine. 
FDA has acknowledged that this listing may need to be periodically 
updated so that it reflects current conditions regarding antimicrobial 
use in humans. FDA intends to seek public comments on any updates to 
the GFI prior to implementation.
                                 ______
                                 
                Questions Submitted by Senator Roy Blunt

           USE OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS

    Question. The international body that establishes standards for 
food safety, known as Codex Alimentarius, is playing an increasing role 
in the facilitation of market access for U.S. agricultural products to 
a growing number of countries and customers around the globe. Standards 
set by Codex should be established based on scientific merit and be 
used to improve trade, not hinder it.
    Specifically, the Codex Committee on Residues of Veterinary Drugs 
in Foods (CCRVDF) has had a maximum residue standard for a Food and 
Drug Administration (FDA)-approved veterinary product, ractopamine, 
pending for the past 3 years. The adoption of this standard should move 
forward.
    FDA chairs this particular Codex committee, what are your thoughts 
on the current process as it relates to this particular situation?
    Answer. An FDA employee chairs the CCRVDF and another FDA employee 
serves as the U.S. delegate to this committee. Proposed ractopamine 
maximum residue levels (MRLs) for cattle and swine have been advanced 
from this committee to the Codex Alimentarius Commission (CAC) for 
adoption. Adopting MRLs is pending at the CAC level. The U.S. 
Government is part of a small group of countries that have been meeting 
at the CAC level to resolve the ractopamine issue before the next CAC 
meeting. The U.S. delegation remains hopeful the deliberations will be 
successful and the recommended ractopamine MRLs will be finalized and 
adopted by the CAC as a Codex standard.
    The U.S. delegation is committed to moving forward to adopt MRLs 
for ractopamine on the merits of the scientific evidence presented to 
Codex, without exemptions that would undermine the international Codex 
standard. The ractopamine MRLs have been recommended as safe after 
extensive review by the Joint Expert Committee on Food Additives 
(JECFA), an independent Food and Agricultural Organization/World Health 
Organization scientific body of recognized world experts. Adopting 
Codex MRLs for ractopamine is especially important for countries that 
do not have the resources to carry out their own risk assessments and 
rely on Codex MRLs. Other countries that do not have an MRL, but want 
to import from countries that enforce Codex MRLs can do so with 
confidence in the safety of the product.
    Some countries are trying to block adoption of the ractopamine MRLs 
using arguments that include national interests, national laws, or 
preferences regarding product use. Blocking the ractopamine MRLs after 
they have been evaluated and deemed safe by JECFA undermines the 
ability of Codex to establish international food safety standards, and 
may set a precedent for discounting the advice of its scientific 
experts.
    Question. How is FDA engaging within with our trading partners to 
ensure a science-based outcome of Codex meetings?
    Answer. The FDA works very closely with the U.S. Codex Office in 
the U.S. Department of Agriculture (USDA) on all matters related to 
Codex. The U.S. Chair of CCRVDF, and the U.S. Delegate to CCRVDF are 
FDA employees and have been actively engaged with the U.S. Codex 
Office, the Foreign Agriculture Service, and the U.S. Trade 
Representative to reach out to other countries on this issue.

                       FOOD MARKETING GUIDELINES

    Question. In December 2009, the Federal Trade Commission (FTC), 
FDA, USDA, and the Centers for Disease Control and Prevention (CDC) 
released a proposal for voluntary guidelines for food advertising to 
children and teens. These guidelines applied certain nutrition criteria 
to advertising during television programs that are viewed by children 
and teens. Some have complained that the proposal would prohibit the 
marketing of products that clearly fit within USDA and FDA's dietary 
guidelines.
    To what extent was FDA involved in the development of these 
guidelines?
    Answer. The committee reports that accompanied the 2009 Omnibus 
Appropriations Act included a provision calling for the establishment 
of an Interagency Working Group on Food Marketed to Children, made up 
of members from FDA, CDC, USDA, and FTC. The FDA representative to this 
working group was the Director of the Office of Nutrition, Labeling, 
and Dietary Supplements, at the Center for Food Safety and Applied 
Nutrition.
    In 2009, the working group met and held conference calls. The FDA 
representative worked to ensure that the working group understood the 
FDA nutrition labeling requirements and policies, and the FDA 
representative drew upon the technical expertise of FDA staff as 
necessary.
    The working group's discussions in 2009 on nutrition principles led 
to the development of the guidelines that your question refers to. 
Developing the tentative guidelines was the first phase of preparing a 
report to the Congress containing the working group's final findings 
and recommendations, as required by the committee reports that 
accompanied the 2009 Omnibus Appropriations Act. These guidelines were 
a tentative set of recommendations for voluntary nutrition principles. 
The voluntary principles were designed to guide industry self-
regulatory efforts to improve the nutritional profile of foods that are 
most heavily marketed to children.
    These tentative guidelines were made public at a forum hosted by 
the FTC in December 2009, entitled ``Sizing Up Food Marketing and 
Childhood Obesity.'' At the forum, the FDA representative joined 
representatives from the other participating agencies to discuss the 
standards that the working group had tentatively agreed to. Throughout 
2010, the working group met to refine the voluntary nutrition 
principles based on comments provided at the public forum and based on 
newly issued nutrition reports. Once again, the FDA representative and 
staff worked to ensure consistency with existing nutrition labeling 
requirements and current Federal nutrition policy. The continuing 
discussion of the working group has led to the development of a report 
on a set of proposed nutrition principles published for comment on the 
FTC Web site on April 28, 2011.
    Question. Are you aware of any scientific study that directly links 
television advertising to obesity?
    Answer. The Interagency Working Group evaluated research related to 
associations between television viewing, including advertisements, and 
childhood obesity. At the forum hosted by FTC in December 2009, the CDC 
representative to the working group, from CDC's Division of Nutrition 
and Physical Activity, provided data in his presentation from research 
on television viewing and links to childhood obesity. The CDC 
representative noted that although there is some evidence to suggest an 
association between television viewing and childhood obesity, the 
Institute of Medicine, part of the National Academies of Science, has 
concluded in a report entitled ``Food Marketing to Children and Youth'' 
that there is insufficient evidence of a causal relationship between TV 
advertising to obesity. The primary objective of the Working Group has 
been the promotion of children's health through better diet, with 
particular, but not sole, emphasis on reducing the incidence of 
childhood obesity. The proposed recommendations are therefore designed 
to encourage children, through advertising and marketing, to choose 
foods that make a meaningful contribution to a healthful diet and 
minimize consumption of foods with significant amounts of nutrients 
that could have a negative impact on health or weight.
    Question. Would these guidelines prohibit the marketing of foods 
that you would define as healthy?
    Answer. Neither the tentative guidelines on the recommendations for 
voluntary nutrition principles issued in December 2009 nor the report 
on the proposed nutrition principles that issued in April 2011 prohibit 
the marketing of any foods. The nutrition principles in each document 
contain recommendations related to advertising practices to guide 
industry efforts to improve the nutritional profile of foods marketed 
directly to children and to tap into the power of advertising and 
marketing to support healthful food choices. Such recommended 
principles should not be interpreted as a substitute or a replacement 
for any of FDA's food labeling regulations or a change in Federal 
dietary guidance for industry (GFI).
    The final product of the working group will be a report to the 
Congress containing recommendations for voluntary nutrition principles 
for industry to consider in advertising practices and not regulations 
promulgated by the agencies. Therefore, any guidelines from the working 
group would not prohibit the marketing of any foods.

                          GENERIC DRUG REVIEW

    Question. Since the fiscal year 2008 appropriation, funding for the 
Office of Generic Drugs (OGD) has increased by 23 percent. However, 
during this same time period, the median approval time for generic 
drugs has gone from 18.89 months to more than 26 months.
    How do you explain this decline in performance?
    Answer. FDA used the increased resources to hire more reviewers. 
However, it takes several months to train new reviewers and even longer 
before new reviewers become fully productive.
    In addition, the new and experienced reviewers are dealing with 
more complex new drugs that are becoming eligible for generic 
competition. Therefore, more time is required to review and approve the 
generic drug versions. Also, more resources are required to develop 
recommendations and GFI to address complex products.
    The number of new generic drug applications submitted to FDA 
remains at a high rate of more than 800 per year, compared to just more 
than 300 per year a decade ago. Complicating the review is an increase 
in the number of new companies, often relying on overseas manufacturing 
and bioequivalence testing sites. Approval of applications from new 
companies often takes longer as the new companies are less familiar 
with FDA requirements.
    This review effort makes up only part of the median approval time. 
The other part is time that the applications are with the firm to 
address deficiencies raised during review. More than 90 percent of the 
original generic drug submissions are found deficient. The companies 
must address these deficiencies before they can gain approval. The 
responses from companies are not always timely due to the companies' 
own priorities. Furthermore, there may be multiple review cycles before 
approval.
    Finally, other postapproval activities compete with FDA's efforts 
to review generic drug applications. There are many more marketed 
generic drugs products now than ever before. These products must be 
monitored to assure the safety of American patients. For example, any 
change to an already-approved generic drug must be reported to FDA's 
OGD. The growing workload to evaluate these changes competes with the 
workload of new generic drug application review.
    Question. Specifically, what have we been getting for our 
investment in generic drug review?
    Answer. The following is a brief summary of just a few of the 
benefits of the generic drug review program. For the decade 2000 
through 2009, according to a publication from the Generic 
Pharmaceutical Association, the use of generic prescription drugs in 
place of their brand-name counterparts saved the Nation's healthcare 
system more than $824 billion. In fiscal year 2009 alone, the use of 
FDA-approved generics saved $139.6 billion.
    It is estimated that more than 20 percent of all the drugs products 
on the market are only available in generic form. Therefore, generic 
drugs play a role in augmenting the supply and sources of drug products 
for national emergencies.
    In fiscal year 2010, 565 generic drugs were approved or tentatively 
approved. In fiscal year 2010, the OGD took 2079 actions on original/
new generic drug applications. These exceeded estimates for the 
program.
    As of March 2011, OGD has posted more than 800 product-specific 
bioequivalence draft GFI documents, including more than 150 that have 
been finalized after considering public comments. Approximately 15-30 
new GFI documents are posted every quarter. The information that FDA 
posts has been responsible for an approximately 75-percent reduction in 
the number of bioequivalence inquiries during the past 3 years. This 
timely and transparent provision of bioequivalence recommendations 
allows all interested parties equal access to information, and OGD 
believes the overall quality of submissions has improved.

                         MEDICAL DEVICE REVIEW

    Question. Recently, medical device manufacturers have complained 
that FDA's review process is expensive and unpredictable which leads to 
costly delays in approval. Many United States-based device companies 
have indicated that it makes far more financial sense to apply for 
approval and market new medical devices in Europe than in the United 
States. This has led some to worry that this sector would relocate to 
other countries and focus more intently on developing new products for 
marketing in other countries.
    Given that FDA missed 30 percent of its device review goals for 
fiscal year 2009, I wonder if there is any credence to this concern.
    What is your response to this industry complaint?
    Answer. Overall, FDA is meeting or exceeding the Medical Device 
User Fee Act (MDUFA) performance goals for more than 95 percent of the 
more than 4,000 annual device applications subject to these goals. For 
example, under the 510(k) program--the pathway used by 90 percent of 
the devices we examine each year--FDA completed 90 percent of our 
reviews in 90 days or less, which met the applicable goal. FDA also 
completed 98 percent of our reviews in 150 days or less, just as we 
committed to under MDUFA. For most of the goals FDA is not yet meeting, 
our performance has been steadily improving. FDA published more 
detailed performance information in FDA's fiscal year 2010 MDUFA 
Performance Report to Congress.
    The model of the European Union (EU) has important limitations. 
Unlike the United States, the EU does not require that a device be 
shown to be effective. Moreover, decisions to approve a device in the 
EU are made by private companies, called Notified Bodies. There are 
more than 70 from which a manufacturer can select and to whom it pays a 
fee. Notified Bodies are subject to variable amounts of oversight. The 
information on which Notified Bodies make an approval decision is not 
made available to the public. In addition, it is difficult to compare 
the United States and EU systems because, unlike in the United States, 
the EU does not have a centralized, publicly available database of 
review performance, summaries of approval decisions, or important 
measures of safety, such as adverse event reports.
    The European Commission has recognized that the EU model does not 
always offer a uniform level of protection of public health. As a 
result, it has sought comment on proposals to change the EU model. FDA 
believes that the best approach is not to replace the U.S. model, which 
has served the American public well, but rather to make the U.S. model 
more robust. With this goal in mind, in January 2011 FDA announced 25 
actions we will take this year to make our premarket review programs 
more predictable, consistent, and transparent. As a further effort to 
make the U.S. model more robust, in February we announced our 
Innovation Initiative to help bring breakthrough technologies to 
patients more quickly.
    Question. Could you be doing more outreach with device 
manufacturers during the review process to increase review certainty?
    Answer. FDA currently conducts interactive reviews on many 
submissions. As part of the Medical Device User Fee Amendments of 2007 
(MDUFA II) negotiations, FDA agreed to continue to incorporate an 
interactive review process. The commitment letter for MDUFA II states:

    ``The agency will continue to incorporate an interactive review 
process to provide for, and encourage, informal communication between 
FDA and sponsors to facilitate timely completion of the review process 
based on accurate and complete information. Interactive review entails 
responsibilities for both FDA and sponsors.''

    In response to this commitment, FDA has developed GFI titled, 
``Interactive Review for Medical Device Submissions: 510(k)s, Original 
PMAs, PMA Supplements, Original BLAs, and BLA Supplements.'' \1,\ \2\ 
We also added an interactive review log in the Center Tracking System 
database and trained Center for Devices and Radiological Health and 
Center for Biologics Evaluation and Research staff on interactive 
review with sponsors.
---------------------------------------------------------------------------
    \1\ PMA refers to premarket approval.
    \2\ BLA refers to biologics license application.
---------------------------------------------------------------------------
    In addition, as reflected in the public meeting minutes, FDA has 
proposed to industry during the Medical Device User Fee Amendments of 
2012 (MDUFA III) negotiations to further enhance interactive review by 
making mandatory the tracking of interactive review and by establishing 
interaction goals for premarket notification, or 510(k), submissions 
and for premarket approval submissions. The proposal also included 
identifying best practices and incorporating them into a Good Review 
Management Practices GFI.

                           COUNTERFEIT DRUGS

    Question. This week, you were on 60 Minutes discussing the $75 
billion counterfeit drug industry. During this interview, you stated 
that the agency does not know the extent to which counterfeit drugs 
have entered the domestic drug supply, but that you are aware that 30-
50 percent of important drugs for public health in certain countries 
are counterfeit.
    What would it take to get a handle on counterfeit products in the 
domestic drug supply?
    Answer. Addressing the challenge of counterfeit drugs is an 
important challenge and FDA uses a multifaceted approach to address 
this challenge. Counterfeiters take steps to avoid detection so it is 
very challenging to determine the prevalence of counterfeit drugs in 
the domestic drug supply. FDA can only quantify those events that we 
discover. FDA believes the U.S. drug supply is one of the safest in the 
world due to the closed distribution system and we rely on global 
estimates and reports to gauge the relative risk to U.S. consumers.
    FDA uses a multilayered approach to minimize the risk of 
counterfeit drugs entering the United States and to protect the U.S. 
drug supply. FDA works closely with supply chain stakeholders to secure 
the product, the supply chain, and distribution of the product by 
engaging in public outreach and education, coordinating regulatory 
actions with State and other Federal agencies, cooperating 
internationally, conducting criminal investigations, and enhancing 
enforcement.
    A robust track and trace system could help decrease the 
opportunities for diversion and counterfeiting by allowing distributors 
and pharmacies to authenticate product origin and supply chain by 
ensuring that a drug was handled only by legitimate entities. FDA is 
working to develop such a system, but implementation by the drug supply 
chain is essential to its success.
    FDA collaborates with many State and Federal agencies, in addition 
to international law enforcement and regulatory bodies to combat 
counterfeit drugs. FDA's Office of Criminal Investigations (OCI) works 
to identify counterfeit drug manufacturing locations, and prosecutes 
those responsible for the manufacturing and distributing of counterfeit 
drugs.
    Drug counterfeiting is a global problem so FDA is tackling this 
issue internationally by actively working with the World Health 
Organization and other private and public sector partners to develop 
tools, implement strategies, and take action to prevent and detect 
counterfeits that threaten the global marketplace and U.S. consumers.
    Question. Do you work with industry to find these products?
    Answer. FDA collaborates with industry to identify counterfeit drug 
products and warn the public once the products are identified. FDA's 
OCI collaborates with industry on a regular basis regarding illegal 
drug products, including counterfeit drugs. An example of this 
collaboration occurred last year when GlaxoSmithKline (GSK) received 
several reports of suspected counterfeit over-the-counter weight-loss 
product from consumers and GSK notified OCI. GSK worked with FDA to 
quickly identify the counterfeit product, warn the public about the 
danger of the counterfeit since it contained the wrong active 
ingredient, and educate consumers on how to distinguish counterfeit 
products from the authentic products. FDA issued two press releases 
with important information for consumers which assisted them in 
protecting themselves from buying or taking a counterfeit product. 
Additionally, OCI successfully identified and prosecuted those 
responsible for manufacturing and distributing the counterfeit product.
    FDA also has a Counterfeit Alert Network (CAN) a coalition of 
health professional and consumer groups. This network also includes 
associations that represent distributors and pharmacies. Participants 
in the network agree to develop educational information and to rapidly 
disseminate important information about confirmed counterfeit products 
to their members. The CAN is another way for FDA to engage other parts 
of the drug supply chain and share information with healthcare 
professionals and consumers so they can identify counterfeit products.
    Question. Would you agree that before we move forward with any 
proposal to allow Americans to buy drugs from other countries, we 
should demonstrate that we can do so safely and do so without 
increasing the chances that Americans may get a contaminated or 
potentially dangerous or counterfeit medication?
    Answer. FDA's main concern with the importation of prescription 
drugs is patient safety. Many of the drugs currently being illegally 
imported are not FDA-approved and come from unknown sources and foreign 
locations that may not be manufacturing the products in accordance with 
FDA regulations. In addition, these products may be counterfeit or may 
contain potentially harmful ingredients. FDA does not have the same 
information for drugs produced and approved for foreign markets or that 
are manufactured in foreign facilities not inspected by FDA as we do 
for products approved and manufactured for the U.S. market.
    Expanding the purchase of drugs from other countries would provide 
additional opportunities for counterfeits and other substandard or 
contaminated products to enter into the U.S. supply chain. FDA 
continues to identify appropriate compliance, enforcement, and 
information technology tools to monitor and address unapproved or 
otherwise illegally imported drugs. FDA is also developing a risk-model 
associated with importation to identify and minimize the risks to 
consumers, drug quality, and the supply chain. In addition, FDA is 
analyzing and assessing potential policies and operations that could 
reduce the risks from allowing foreign-approved drugs into the United 
States. This assessment includes exploring policy options that strike a 
balance between providing adequate safety measures and reducing costs 
to patients.

                           FDA MODERNIZATION

    Question. In February, The Financial Times reported that, ``Barack 
Obama has warned that the U.S. Food and Drug Administration is a 
candidate for a sweeping revamp amid complaints that it is ill-equipped 
to handle biotechnology and advances in medicine. `I've gotten a lot of 
commentary about the fact that . . . essentially their model was 
designed for the kind of medical devices you see in museums,' the 
president said in remarks before a new panel on jobs and 
competitiveness. While he was short on details, Mr. Obama singled out 
the FDA as an agency that ought to be modernized''.
    What changes has the President specifically asked you to initiate?
    Answer. The President has directed agencies to review regulations 
and other procedures to see if they can withdraw or modify regulations, 
or otherwise improve procedures, to reduce regulatory burden and 
improve competitiveness, innovation, economic growth, and jobs, while 
assuring safety. FDA has identified improvements to regulatory science 
as well as other initiatives--such as its Medical Device Innovation 
Initiative, the 510(k) Plan of Action, and the voluntary pilot program 
by FDA and the Centers for Medicare & Medicaid Services--also referred 
to as Parallel Review of Medical Devices--that will help it and the 
industries it regulates innovate and remain competitive.
    FDA has also identified regulations for revision and is continuing 
its review of its rules and procedures to identify additional 
opportunities. For example, FDA recently revised its biologics 
regulations to permit approval of exceptions or alternative to the 
regulation of constituent materials. This action recognizes advances in 
the development and manufacture of safe, pure, and potent biological 
products that, in some instances, render the existing constituent 
materials regulation too prescriptive and unnecessarily restrictive. 
FDA will maintain its ongoing review of device classifications to 
determine whether devices can be classified to a lower level, which 
reduces burdens on industry while maintaining product safety and 
efficacy. FDA is also revising its device adverse event reporting 
requirements to convert to a more efficient paperless, electronic 
system. In addition, FDA is pursuing initiatives to permit electronic 
submission of clinical trial data and other information related to 
drugs and medical devices, which will create efficiencies for both 
industry and FDA.

                            ADVISORY PANELS

    Question. At advisory panel meetings, FDA reviewers often instruct 
the panel on the standards that apply for assessing the safety and 
effectiveness of the product at hand. It appears that in the context of 
certain advisory panel presentations, FDA reviewers have put forward 
standards that differ from regulations and applicable binding 
agreements.
    What procedures are in place to ensure that FDA review teams' 
presentations to panels comply in every respect with the regulations 
and applicable binding protocol agreements?
    Answer. FDA presentations at panel meetings undergo multiple levels 
of review by scientific and supervisory staff to ensure that statements 
made by FDA are factually correct. FDA provides information that will 
be presented at the meeting to the sponsor of the product under review. 
Sponsors may suggest corrections, clarifications, or edits to these 
materials in advance of the meeting.
    Question. Does a product sponsor have any recourse if the review 
staff's presentation to an advisory panel provides incorrect 
information to the panel regarding the standards of safety, 
effectiveness, or the terms and obligations under a binding protocol 
agreement?
    Answer. In advance of a panel meeting, the product sponsor has the 
opportunity to comment on the review staff's presentation if they have 
any concerns. During the meeting, the sponsor may make a request to 
address the panel with any concerns it may have related to the material 
presented by FDA.

                             BLOOD TESTING

    Question. I understand FDA is considering whether to require all 
blood donations for human transfusion be screened for hepatitis B virus 
(HBV) using nucleic acid testing (NAT). The last public discussion on 
this issue took place at the April 2009 meeting of FDA's Blood Products 
Advisory Committee (BPAC).
    What is the agency's current thinking is regarding an HBV NAT 
mandate?
    Answer. FDA is evaluating and considering the required testing of 
blood for transfusion using HBV NATs. FDA currently requires that blood 
for transfusion be tested for HBV surface antigen and antibody to HBV 
core antigen. FDA brought the issue of testing of human blood for 
transfusion by HBV NAT to BPAC on April 1, 2009. The committee 
discussed scientific issues related to the risk of HBV transmission by 
blood for transfusion. The committee supported routine HBV NAT for 
blood donations, and establishment of a minimum sensitivity standard 
for the test. Currently, multiplex nucleic acid assay systems that 
simultaneously detect human immunodeficiency virus (HIV), hepatitis C 
virus (HCV), and HBV are in widespread use for testing blood donations. 
Therefore, because HIV and HCV NAT are required by FDA for testing 
blood donations, HBV NAT is also already widely performed to test blood 
for transfusion.
    Question. Is FDA preparing to issue GFI regarding this topic?
    Answer. FDA is considering issuing draft GFI for public comment on 
the use of HBV NAT to test both blood for transfusion and Source Plasma 
for further manufacture into derivatives.

                       DIABETES AND OBESITY DRUGS

    Question. I understand FDA is now requiring additional clinical 
trials, including cardiovascular (CV) studies, for new diabetes and 
obesity drugs.
    What is the agency doing to ensure that changing product 
requirements do not get in the way of making better therapies available 
to patients?
    Answer. For diabetes drugs, new concerns have recently been raised 
regarding the CV safety of drugs to treat diabetes. In May 2007, a 
meta-analysis of clinical trials of the diabetes drug, Avandia, also 
referred to as rosiglitazone, was published that suggested an increased 
risk of heart attacks in patients taking this widely used drug. The 
controversy surrounding the meta-analysis and other data on the CV 
safety of diabetes drugs were discussed at several public advisory 
committee meetings. In July 2008, FDA held a 2-day advisory committee 
meeting to seek advice from a panel of experts in the field of 
endocrinology, cardiology, statistics, and drug safety on the extent of 
assessment of CV safety that should be required of new therapies to 
treat type-2 diabetes mellitus (T2DM). The panel, by a majority of 14-
to-2, voted in favor of requiring a prospective assessment of CV safety 
prior to approval, Subsequently, in September 2010, FDA announced that 
it would restrict the use of Avandia in response to data suggesting an 
elevated risk of cardiovascular events by requiring a restricted access 
program under a risk evaluation and mitigation strategy. In December 
2008, FDA issued GFI titled, ``Diabetes Mellitus--Evaluating CV Risk in 
New Anti-diabetic Therapies to Treat T2DM.'' This GFI articulates FDA 
expectations for CV safety assessment of new drugs to treat T2DM. Under 
this GFI, collection of controlled data of new anti-diabetic therapies 
for at least 2 years is anticipated.
    Regarding obesity drugs, in February 2007, FDA issued a draft GFI 
entitled, ``Developing Products for Weight Management.'' The 
recommendations provided in the 2007 draft GFI document continue to 
guide the development of novel obesity drugs. Significant safety issues 
with three recently reviewed obesity drugs--Qnexa, Lorqess, and 
Contrave--led FDA to request that the drug sponsors conduct additional 
studies. In one case, FDA requested that a cardiovascular safety study 
to provide for a more complete benefit-risk assessment.
    Question. What has FDA's performance, in terms of months to review 
and number of review cycles, been for diabetes and obesity drugs?
    Answer. Since the diabetes GFI was issued in December 2008, FDA has 
approved three new molecular entity new drug applications (NDAs), 
submitted for the treatment of T2DM. Of these three NDAs, two were 
approved within their Prescription Drug User Fee Act goal dates for FDA 
to complete its review and take an action. All three NDAs were approved 
during their first review cycle.
    Since 1999, four NDAs for prescription obesity drugs have been 
submitted to FDA. Qnexa, Lorqess, and Contrave were all reviewed within 
one review cycle and were acted upon within 10 months of submission. In 
addition, the drug Rimonabant was reviewed within 10 months of initial 
submission in 2005 and was undergoing a second review cycle when the 
sponsor withdrew the application.
    The prescription obesity drug, orlistat, was approved in 2007 for 
use without a prescription. The nonprescription application was 
approved following an initial 10-month review cycle and a subsequent 6-
month review cycle.
                                 ______
                                 
               Questions Submitted by Senator Jerry Moran

                     ANTIBIOTICS IN FOOD PRODUCTION

    Question. As discussed by the Food and Drug Administration (FDA) in 
draft guidance for industry (GFI) No. 209, ``The Judicious Use of 
Medically Important Antimicrobial Drugs in Food-Processing Animals,'' 
antibiotic drugs, and the drugs' labeled uses, are approved on an 
individual basis, utilizing a drug-specific risk assessment. In the 
draft GFI, the FDA states that before withdrawing a previously approved 
use of an approved drug, Federal law requires the FDA to demonstrate 
that ``new evidence . . . shows that a drug is not shown to be safe 
under the approved conditions of use.'' Then, once the FDA meets this 
initial burden, under Federal law, the drug sponsor is entitled to 
demonstrate the drug is still safe for its intended use. Despite this 
Federal mandate, it appears that FDA is trying to generally ban the use 
of antibiotics for growth promotion, feed efficiency, and certain types 
of preventive treatment through the draft GFI. However, the draft GFI 
makes no finding in regard to a specific animal drug. Furthermore, the 
studies cited by the draft GFI are dated and generally confirm no 
direct link between antibiotics used for growth promotion, feed 
efficiency, and certain types of preventive treatment and risk to human 
health. Has FDA made any specific findings on individual, previously 
approved drug applications that demonstrate that animal ``production 
uses'' of a specific drug should be withdrawn based on new evidence 
that the drug is no longer safe under the approved conditions for use? 
If so, how many and for which drugs has it made such a finding?
    Answer. No, FDA has not yet made such a finding regarding any 
individual, previously approved new animal drug application.
    Question. In draft GFI No. 209, ``The Judicious Use of Medically 
Important Antimicrobial Drugs in Food-Processing Animals,'' the FDA 
states that rather than follow statutory procedures to withdraw an 
approved drug use, the FDA will sometimes address issues through an 
informal process where it convinces a drug sponsor to voluntarily 
withdraw an approved use.
    Which drug sponsors of animal antibiotic drugs is the FDA, through 
an informal process, currently trying to persuade to withdraw approved 
uses of antibiotics for animal growth promotion, feed efficiency, and 
preventive treatment? Of these drug sponsors, which approved animal 
antibiotic drugs are implicated in the informal withdrawal process?
    Answer. As discussed in draft GFI No. 209, the focus of FDA's 
concerns are on the use of medically important antimicrobial drugs in 
food-producing animals for production purposes, such as to promote 
growth or improve feed efficiency. FDA considers uses that are 
associated with the treatment, control, or prevention of specific 
diseases, including administration through feed and water, to be uses 
that are necessary for assuring the health of food-producing animals.
    Currently, FDA is conducting outreach to the animal health industry 
on this issue. Since publication of draft GFI No. 209, we have been 
very encouraged by the interactions we have had to date with key 
stakeholders, including the animal health industry, on plans for 
implementation. Sponsors of some of our most important antimicrobial 
drugs have already initiated discussions with FDA about updating their 
animal drug products in a manner consistent with the principles of 
draft GFI No. 209. Regarding which specific animal drug products are in 
most need of updating, FDA intends to issue additional GFI, which will 
provide more specific information on this topic and allow stakeholders 
the opportunity to comment on it.
    Question. Once draft GFI No. 209 is finalized, which drug sponsors 
is the FDA, through an informal process, planning to persuade to 
withdraw approved uses of antibiotics for animal growth promotion, feed 
efficiency, and preventive treatment? Of these drug sponsors, which 
approved animal antibiotic drugs are implicated in the informal 
withdrawal process?
    Answer. As previously noted, the focus of FDA's concerns are on the 
use of medically important antimicrobial drugs in food-producing 
animals for production purposes, for example, to promote growth or 
improve feed efficiency. FDA considers uses that are associated with 
the treatment, control, or prevention of specific diseases, including 
administration through feed and water, to be uses that are necessary 
for assuring the health of food-producing animals. Also as noted 
previously, FDA intends to issue additional GFI, which will provide 
more specific information on this topic including identifying which 
specific drugs or drug classes are subject to the recommendations 
outlined in draft GFI No. 209.
    Question. What is the FDA's timeline for publication of the final 
GFI for draft GFI No. 209, ``The Judicious Use of Medically Important 
Antimicrobial Drugs in Food-Processing Animals''?
    Answer. Once review of the comments received on draft GFI No. 209 
is complete, FDA plans to issue final GFI implementing draft GFI No. 
209. FDA is still developing a timeline for issuance of the final GFI 
No. 209. In addition, FDA continues to work collaboratively with other 
agencies and FDA stakeholders to develop sound strategies for 
implementing the recommendations outlined in the draft GFI.
    Question. Has the FDA reviewed and responded to all of the 
submitted comments to draft GFI No. 209, ``The Judicious Use of 
Medically Important Antimicrobial Drugs in Food-Processing Animals''?
    Answer. FDA is nearly finished reviewing the comments received 
regarding draft GFI No. 209. FDA is using the comments to assist in 
development of the final draft GFI No. 209.
    The FDA has requested an increase of nearly $326 million to fund 
its Food Safety and Nutrition activities associated with implementation 
of the FDA Food Safety Modernization Act (FSMA). I am concerned about 
how FDA plans to use these funds to create on-farm production standards 
and traceability rules.
    Question. First, I would like to know whether the FDA will abide by 
the law's exemption from on-farm production standards and traceability 
rules for grain commodities and livestock and not interfere with on-
farm decisions made by producers of these agricultural products.
    Answer. FDA FSMA contains numerous provisions requiring FDA to 
develop more than 50 new regulations, GFI documents, and reports to the 
Congress. As FDA is in the process of developing the required 
regulations, it is too soon to be able to provide specificity about the 
new requirements. However, I can assure you that, as we move forward, 
we will certainly be mindful of any exemptions contained in the 
statute. We also are committed to continuing to engage all our 
stakeholders to gain the information needed to inform our rulemaking 
activities and to help the affected industry implement the new food 
safety requirements.
    Question. Second, I would like the FDA to explain how it plans to 
set on-farm production standards for fruits and vegetables. Is FDA 
planning on promulgating broad, flexible standards that defer to the 
expertise of the individual producer or is FDA planning to promulgate 
specific production standards that restrict producer flexibility and 
ultimately hamper on-farm innovation?
    Answer. FDA is aware of the tremendous diversity in farming 
operations and that a one-size-fits-all approach to produce food safety 
will not be practicable. FDA is committed to providing operators with 
flexibility and innovation in their approaches to on-farm food safety 
for their operations. FDA intends to propose a rule containing 
requirements that will be commensurate to the hazards and risks 
associated with any particular operation.
    Question. During the hearing on March 17, 2011, Commissioner 
Hamburg noted that she recently appointed a new director for the FDA 
Office of Foods and plans to hire additional personnel to assist in 
implementation of on-farm production standards and traceability under 
the new authorities granted by FDA FSMA. Does FDA plan to hire 
individuals with production agriculture experience and education? For 
instance, does FDA plan to consider hiring personnel with a degree in 
agronomy or other applied agricultural science degrees?
    Answer. The authorities granted to FDA under FSMA cover many 
disciplines in the area of food safety, including production 
agriculture. FDA currently has staff whose expertise is production 
agriculture and with degrees in agronomy. FDA is committed to hiring 
subject matter experts from any field relevant to its needs, which 
would include consideration of individuals with degrees in applied 
agricultural sciences.

                         CONCLUSION OF HEARINGS

    Senator Kohl. Thank you very much, Senator Blunt.
    And Commissioner Hamburg, you have been great. You have 
been very informative. We have had a good discussion on many 
issues. I am sure you are looking forward to following it up 
with us.
    Dr. Hamburg. Yes. Thank you so much.
    Senator Kohl. Thank you very much.
    The hearing is recessed.
    [Whereupon, at 2:58 p.m., Thursday, March 17, the hearings 
were concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]
