[Senate Hearing 111-]
[From the U.S. Government Publishing Office]



 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2011

                              ----------                              


                         TUESDAY, MARCH 9, 2010

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:03 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Herb Kohl (chairman) presiding.
    Present: Senators Kohl, Dorgan, Pryor, and Brownback.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

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

                 OPENING STATEMENT OF SENATOR HERB KOHL

    Senator Kohl. Good morning. We'd like to welcome each of 
you to our annual hearing on the budget for the Food and Drug 
Administration (FDA).
    Dr. Hamburg, we thank you for being here today. We're 
pleased to have you testify in front of this subcommittee for 
the first time, especially now that you've had a little while 
to get settled in your position.
    We also appreciate the participation of your colleagues, 
Mr. Patrick McGarey and Mr. Norris Cochran.

                            BUDGET INCREASES

    The FDA has been at the receiving end of some fairly 
substantial budget increases over the past several years. 
Between fiscal years 2007 and 2010, the FDA budget, excluding 
user fees, went up by 50 percent. This funding was important. 
As we all know, the FDA is responsible for oversight of a wide 
array of consumer goods used by every American, often multiple 
times each day.
    In fact, about 20 cents out of every dollar spent is on a 
product regulated by the FDA. This includes foods, drugs, 
medical devices, cosmetics, dietary supplements, vaccines, 
animal drugs and foods, and most recently, tobacco.
    The FDA's budget, for a long time, had not been 
representative of the task before the agency. This 
subcommittee, in recent years, has been working in a bipartisan 
manner to reverse that trend. This year's budget request again 
includes increased funding for the FDA, although it's been--
about one-half of the increase provided in fiscal year 2010. 
While some believe this is a cause for alarm, it's a realistic 
reflection of the need for the government as a whole to slow 
down spending. As it is, even though the budget proposes a 
smaller increase for FDA than the past few years, it's still a 
larger increase than nearly all of the United States Department 
of Agriculture (USDA) and most of the Department of Health and 
Human Services (DHHS).
    A brief review of the FDA budget would show that it 
includes increases in three overarching themes, which are: food 
safety, protecting patients, and advancing regulatory science. 
There are also proposals to save money through contract savings 
and the enactment of new user fees.
    In food safety, increases are proposed for activities 
including the establishment of an integrated national food 
safety system, a modern import safety system, and additional 
and smarter surveillance and enforcement.
    For patient safety, increases are proposed to improve the 
safety of imports and high-risk products, expand partnerships 
with public and private entities, and to slightly increase 
FDA's capacity to review generic drug applications.
    The Advancing Regulatory Science Initiative includes 
proposed increases that will help strengthen the FDA's 
scientific leadership, staff, and scientific capacities in 
emerging technologies.
    The increases are important, but we have concerns. We're 
concerned that, without adequate funding levels to maintain FDA 
scientists, inspectors, and reviewers, the performance goals 
that you list are not realistic and achievable. I want to 
repeat something said last week. I believe the goals for this 
subcommittee this year will be to produce a bill that protects 
the important gains we have made over the last few years, 
ensure that programs vital to the health and safety of 
Americans are adequately funded, and to do so in a way that 
shows fiscal restraint and responsible austerity.
    The FDA is obviously vital to the health and safety of 
Americans, and it will be adequately funded this year. We won't 
allow the agency to lose the ground that we've made up in 
recent years. However, we all need to do more with less, and no 
one is exempt.
    Senator Brownback and I will be looking closely at the 
budget and working in a bipartisan manner to make funding 
decisions. It will not be an easy job, but it's one that we 
must do right. I'm sure that you agree, Dr. Hamburg; and in 
that spirit, we are looking forward to continuing our work 
together.
    We turn now to Senator Brownback.

                   STATEMENT OF SENATOR SAM BROWNBACK

    Senator Brownback. Thank you very much, Mr. Chairman.
    It's always a pleasure to work with you.
    Senator Kohl and I like to talk about basketball too. 
Kansas has two top-ten teams in the NCAA basketball tournament, 
so we're hopeful we can move forward. And next to the wheat 
harvest, this is kind of the big season in Kansas.
    Pleasure to have you here, Dr. Hamburg. It was good to 
visit with you last week in the office. I enjoyed that, and I 
look forward to your presentation here.

                      RARE AND NEGLECTED DISEASES

    I want to follow up on the visit we had, because I've got 
some suggestions. I hope you're willing to look at, and that 
your staff has been willing to consider, about rare and 
neglected diseases, in particular, in the United States and 
around the world.
    To help jumpstart this effort in rare and neglected 
diseases, I worked with the chairman to include a provision in 
the current year's appropriation bill that created two groups 
within FDA to review the agency's process for approving medical 
products for the treatment of rare and neglected diseases. When 
fulfilling the agency's requirements under this provision, I 
have some ideas that I hope you'll take into serious 
consideration, and I hope these teams will be meeting and 
reporting out fairly soon.
    To date, approximately 7,000 rare diseases have been 
identified. These diseases affect more than 30 million 
Americans, but there are only FDA-approved treatments for 
approximately 200 of these 7,000 rare diseases. So, if you 
happen to be one of the 200 that has a FDA treatment, you've 
got something to work with. Those other 6,800 rare diseases are 
without treatments at all and are not benefiting from the 
progress. This is totally unacceptable. And it's 30 million 
total Americans that are in this category.
    In addition to those suffering from rare diseases in the 
United States, there are billions of people worldwide suffering 
from diseases that are often ignored because there are no 
market incentives for engaging in the costly process of 
developing a product for FDA approval. According to the World 
Health Organization, one of every six people worldwide is 
affected by at least one neglected disease. One in six. This is 
particularly astonishing when you consider that only 1 percent 
of the drugs approved since 1975 were developed to treat such 
diseases that affect one in six people in the world. This, too, 
is unacceptable.
    Now, solving these problems will involve many government 
agencies, and the cooperation of the private sector. Today, 
however, I'd like to talk with you about--something I think FDA 
can do to substantially impact this category. Specifically, I 
believe, and a lot of people agree, that FDA should work to 
demystify and simplify the review process for products to treat 
deadly rare and neglected diseases.
    While it's my expectation that FDA always consider safety 
and efficacy while reviewing products, the agency must exercise 
flexibility when reviewing certain products. I believe the 
agency should establish a second track for product approval 
that takes into consideration the unique nature of the product 
being approved, including the ability of manufacturers to find 
large enough populations for clinical trials, the willingness 
of patient groups to knowingly accept certain risk, and the 
global public health benefit. Without doing these things, I 
think it is highly unlikely we find treatments for these 6,800 
rare diseases; I don't see how it happens. And I think we're 
probably stuck on this 1 percent figure of work in these 
neglected diseases that affect one in six people globally. That 
is completely unacceptable, and it doesn't need to be this way. 
And you are the person most well positioned to address this.
    So, I hope you'll be able to look at this category of 
products. You've got a lot of other issues at FDA. I think this 
is amongst the top tier of most important.
    Mr. Chairman, thank you for holding the hearing.
    Senator Kohl. Thank you very much, Senator Brownback.
    We turn now to Dr. Hamburg for your statement.

               SUMMARY STATEMENT OF DR. MARGARET HAMBURG

    Dr. Hamburg. Thank you very much, Chairman Kohl and Senator 
Brownback.
    I'm very pleased to present the President's fiscal year 
2011 budget for the FDA.
    And, as you note, Patrick McGarey, Budget Director for FDA, 
and Norris Cochran, Deputy Assistant Secretary for Budget at 
HHS, are with me this morning.

                             BUDGET REQUEST

    My testimony outlines the fiscal year 2011 budget request. 
It also includes a summary of recent developments related to 
our new responsibilities to regulate tobacco products and other 
important FDA initiatives.
    As you know, this is my first time before this 
subcommittee, and I look very much forward to working with you. 
I deeply appreciate the support that you've given to the FDA, 
and I know that you share my determination to make sure that we 
can count on, as a Nation, a strong, fully functional FDA. And, 
as you point out, FDA is a unique and important agency 
responsible for programs and activities that affect every 
American every day.
    The fiscal year 2010 appropriation reflects your commitment 
to FDA and the health of the American public. Those funds will 
allow FDA to make progress across a wide range of public health 
priorities which are essential to the health, quality of life, 
safety, and security of all Americans. So, again, I thank you.
    The proposed fiscal year 2011 budget includes 
$4,000,000,000 for FDA programs, which is an increase of 
$755,000,000, with $601,000,000 in user fees, and $154,000,000 
in budget authority.
    We're proposing three major initiatives in areas vital to 
our mission: transforming food safety, protecting patients, and 
advancing regulatory science. These initiatives are crucial for 
the modernization of the agency to the challenges presented by 
the 21st century.

                        TRANSFORMING FOOD SAFETY

    The Transforming Food Safety Initiative reflects President 
Obama's vision of a new food safety system to protect the 
American people. And it's based on the principles of the 
President's Food Safety Working Group: prioritizing prevention, 
strengthening surveillance and enforcement, and improving 
response and recovery.
    FDA proposes an increase of $326,000,000 for transforming 
food safety, with $88,000,000 in budget authority, and 
$238,000,000 for new user fees, including $200,000,000 for a 
food registration and inspection fee.
    The fiscal year 2011 resources would allow FDA to establish 
a foundation for an integrated national food safety system 
focused on prevention. Key elements include setting standards 
for safety, expanding laboratory capacity, piloting track and 
trace technology, strengthening import safety, improving data 
collection and risk analysis for foods, and increasing 
inspections. This initiative will allow FDA to make the kind of 
changes needed to deliver the promise of improved food safety 
and reduce illnesses caused by contamination of the food supply 
in years to come.

                          PROTECTING PATIENTS

    The Protecting Patients Initiative reflects FDA's pressing 
need to modernize our approach to patient safety and the safety 
of medical products. This is a time when science and technology 
offers new promise to improve disease prevention, diagnosis and 
treatment, as well as new protections for safety. This is also 
a time when an increasing number of drugs, devices, and 
biologics are being manufactured abroad. FDA must act as a 
strong and smart regulator, addressing medical product safety 
challenges in the years ahead.
    The budget proposes an increase of $101,000,000 for this 
initiative, including $49,000,000 in budget authority. The 
balance is for two new user fees, generic drugs fees and fees 
for reinspecting medical product facilities.
    The Protecting Patients Initiative focuses on four vital 
areas: import safety, high-risk products, partnerships for 
patient safety, and generic drug review. These activities will 
have a very significant impact on public health in the United 
States. This science-based strategy will build new and greater 
safety capabilities. The result will be fewer import safety 
emergencies and fewer serious adverse events with drugs, 
devices, and biologics.
    FDA is proposing, in our budget, a new focus on advancing 
regulatory science, which is very important and exciting. It 
includes an increase of $25,000,000 for this much-needed 
initiative. Regulatory science represents the knowledge and 
tools we need to assess and evaluate a product's safety, 
efficacy, potency, quality, and performance. It is fundamental 
to all of our work at FDA, from supporting the development of 
new food and medical technologies to bringing new treatments to 
patients. In many ways, it represents the gateway between 
discovery, innovation, and opportunity and actual products that 
people need and can count on. Building a strong, robust 
regulatory science capacity is vital to the health of our 
Nation--to the health of people, our healthcare system, our 
economy, and our global competitiveness.
    During the past two decades, research has dramatically 
expanded our understanding of biology and disease, yet the 
development of new therapies has been in decline and the costs 
of bringing them to market have soared. New approaches and 
partnerships in the emerging field of regulatory science are 
urgently needed to bridge the gap between drug discovery and 
patient care, and, I might add, to address some of the concerns 
that Senator Brownback just raised.

                      ADVANCING REGULATORY SCIENCE

    Investing in regulatory science will yield better tools, 
standards, and pathways to evaluate products that offer 
promising opportunities to diagnose, treat, cure, and prevent 
disease. It will also improve product safety, quality, and 
manufacturing, more broadly, including new opportunities to 
better protect the food supply and support the development of 
healthy foods and food choices.

                          TOBACCO CONTROL ACT

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act into law. The act grants FDA 
important new authority to regulate the manufacture, marketing, 
and distribution of tobacco products. I'm pleased to report 
that, so far, FDA has met or exceeded the statutory deadlines 
in the Tobacco Control Act.
    During fiscal year 2011, we will continue to implement the 
act, including overseeing and enforcing the reissuance of the 
1996 rule to prevent smoking and smokeless tobacco use among 
young people and proposing graphic health warning labels for 
cigarette packages and advertising.

                                  H1N1

    Finally, I'd like to take the opportunity to report to the 
subcommittee on FDA's response to the 2009 H1N1 influenza 
pandemic. During the past year, key FDA accomplishments include 
the licensure of five different H1N1 vaccines in record time. 
These H1N1 vaccines faced the same stringent manufacturing, 
quality, and oversight processes as seasonal influenza vaccine, 
and now more than 70 million Americans have been safely 
immunized.
    FDA also authorized the emergency use of antiviral drugs in 
circumstances for which they had not been licensed, but where 
they might save lives. These decisions were based on careful 
review of the scientific data for these products.
    FDA also conducted an aggressive proactive strategy to 
combat fraudulent H1N1 products. We issued more than 80 warning 
letters, covering about 150 different products, and we achieved 
a very high compliance rate in response to these actions.
    So, FDA's fiscal year 2011 budget contains important 
funding for vital public health priorities, including 
transforming food safety, protecting patients, and advancing 
regulatory science, as well as implementing the Tobacco Control 
Act and many other critical FDA programs and activities. 
Achieving all of this, and especially these identified 
priorities, is possible because of your support for the work of 
the Food and Drug Administration.

                           PREPARED STATEMENT

    I thank you, and I'm happy to answer any questions you may 
have.
    [The statement follows:]
             Prepared Statement of Dr. Margaret A. Hamburg
                              introduction
    Chairman Kohl, Senator Brownback, and members of the Subcommittee, 
I am Dr. Margaret Hamburg, Commissioner of Food and Drugs. I am pleased 
to present the President's fiscal year 2011 budget request for the Food 
and Drug Administration (FDA or agency). Joining me at today's hearing 
is Patrick McGarey, FDA's Director of the FDA Office of Budget and 
Norris Cochran, Deputy Assistant Secretary for Budget at the Department 
of Health and Human Services.
    My testimony outlines FDA's fiscal year 2011 budget request and the 
policy initiatives that we are advancing in our budget. I will also 
summarize recent developments related to FDA actions to implement the 
Family Smoking Prevention and Tobacco Control Act, FDA's response to 
the 2009 H1N1 influenza pandemic, and other initiatives at FDA.
                        fiscal year 2010 budget
    The funding that you appropriated for fiscal year 2010 shows the 
depth of your commitment to FDA's public health mission and the health 
of the American public. On behalf of all Americans who benefit from the 
work of the FDA, thank you for your support.
    This funding allowed FDA to make progress in a wide range of areas.
    For example, in the Foods Program, we are hiring and training new 
inspectors, improving our scientific and technical capacity, initiating 
a wide range of new State and international partnerships and--working 
with industry, consumer advocates, and others--laying the foundation 
for a shift to a food safety approach focused on prevention. We also 
started critical work on front of package labeling, an effort that will 
help American families better understand the nutritional content of 
foods.
    Fiscal year 2010 funding allowed FDA to aggressively engage with 
our HHS partners and industry in the public health response to the 2009 
H1N1 influenza pandemic. We supported the effort to rapidly develop and 
deploy safe vaccines, antiviral medicines, and diagnostic tests that 
were so vital in the public health response.
    For drugs and biologics, we began the first phase of the Sentinel 
system, a distributed network of electronic health data that can track 
the safety of medical products once they reach the market and quickly 
investigate potential safety signals. For medical devices, we released 
key guidance defining a path for more efficient and effective clinical 
trials.
    In the Tobacco Program, we established the new Center for Tobacco 
Products, implemented a ban on cigarettes with characterizing fruit and 
candy flavors, and established a program of registration and listing.
    We also began a process that will make FDA much more transparent to 
the American public and to the industries that we regulate. The FDA 
Transparency Initiative responds to President Obama's Executive Order 
on open government and the transparency priorities that Secretary 
Sebelius is advancing.
    As part of our Transparency Initiative, FDA held two public 
meetings, launched a transparency blog, and opened a docket--efforts 
that received more than 900 suggestions from the public.
    In January, FDA launched ``FDA Basics,'' the first phase of the 
Transparency Initiative. As one observer of the agency commented, 
``[t]he initiative can go a long way toward educating the public about 
what FDA does--and how--and also provide industry with realtime answers 
to their daily challenges, ultimately improving product quality and 
patient safety.'' Another said, ``[i]t is really well put together, 
clear and works quite well. . . . The site is not only supportive of 
transparency, but is highly instructive and educational.''
    The next two phases of our transparency efforts are well underway, 
and our goal is to provide communication with the public and industry 
about FDA actions and the basis for FDA decisions.
    We are also developing a major performance management initiative, 
which will provide additional access to Congress and the public about 
the activities and progress on more than 50 FDA offices.
                        fda 2011 budget request
Overview
    The President's fiscal year 2011 budget includes $4,000,000,000 for 
FDA programs to protect and promote public health. This represents an 
increase of $756,000,000 for FDA programs, which includes $601,000,000 
for statutory increases for user fee programs in current law and four 
new user fees to support public health priorities.
                 details of the fiscal year 2011 budget
Transforming Food Safety Initiative
    For fiscal year 2011, FDA proposes an increase of $326,300,000 for 
Transforming Food Safety. This increase includes $87,800,000 in budget 
authority and $238,500,000 for three new user fees related to food 
safety: Food Inspection and Registration User Fees, Reinspection User 
Fees for food facilities and Export Certification User Fees for food 
and feed products. The funding for Transforming Food Safety includes 
the budget amendment of $8,000,000 that the Administration recommended 
on February 12, 2010.
    The Transforming Food Safety Initiative reflects President Obama's 
vision of a new food safety system to protect the American public. The 
initiative is based on three core principles announced in July 2009 by 
the President's Food Safety Working Group: prioritizing prevention, 
strengthening surveillance and enforcement, and improving response and 
recovery.
    The fiscal year 2011 resources for Transforming Food Safety 
demonstrate that food safety is a national priority. It reflects the 
consensus among consumers, industry and experts that our food safety 
system needs fundamental change to prevent illness and restore public 
confidence.
    With the fiscal year 2011 increases, FDA will set standards for 
safety, expand laboratory capacity and pilot track and trace 
technology. FDA will also strengthen import safety and improve data 
collection and food risk analysis. Most importantly, the fiscal year 
2011 resources allow FDA to establish a foundation for an integrated 
national food safety system focused on prevention.
    During fiscal year 2011, FDA will hire 718 additional full time 
equivalent (FTE) staff to expand programs that protect America's food 
supply. The hiring by FDA food safety programs includes more than 425 
new FTE in our field operations, of which 132 FTE will be new food 
inspectors in the field operations of our Office of Regulatory Affairs. 
Among those 132 FTE, 3 are funded by budget authority, 99 are funded by 
food registration and inspection user fees, and 30 are funded by 
reinspection fees.
    When fully trained and deployed, the 132 new inspectors will 
annually conduct the following additional field activities, based on 
budget authority and user fee funding proposed for Transforming Food 
Safety:
  --1,900 domestic food safety inspections;
  --150 foreign food inspections;
  --1,000 domestic food and animal feed program reinspections;
  --200 domestic tissue residue inspections for illegal drug residues 
        in meat and poultry; and
  --3,000 samples for analysis in FDA laboratories.
    The Transforming Food Safety Initiative will also allow FDA to fund 
the cost of living pay adjustment for FDA professionals that conduct 
food safety activities and pay higher rent and related facility costs.
    In addition to the priorities listed above, fiscal year 2011 
resources for Transforming Food Safety support the following domestic 
and foreign activities that implement Food Safety Working Group 
priorities.
            Prioritizing Prevention
    FDA will issue guidances and establish new, binding standards to 
help prevent foodborne illness and reduce food risks. The standards 
include new controls to prevent food safety risks associated with fresh 
produce and other commodities, standards for food inspections, and 
standards for collecting and analyzing food samples.
    FDA will conduct audits of its regulatory and public health 
partners. FDA audits will evaluate inspection, investigation, sample 
collection and analysis, enforcement, response, recovery, and outreach 
activities. The audits will measure performance against FDA food safety 
standards. FDA will also strengthen collaboration with foreign 
regulatory bodies to evaluate and leverage inspection data. FDA will 
begin to develop an updated inventory of foreign facilities to support 
more foreign inspections.
    FDA will begin to establish a modern import safety program. FDA 
will develop standards to evaluate food safety systems in foreign 
countries. FDA will also continue third party certification efforts and 
develop a registry of all importers. When fully implemented, FDA's 
import safety program will result in greater oversight of imported 
foods and provide greater assurance they meet safety standards 
comparable to those required for domestically produced foods.
            Strengthening Surveillance and Enforcement
    FDA State liaisons will communicate essential information on food 
safety standards and priorities throughout the integrated food safety 
system. FDA will also develop and implement a national food inspection 
and sampling work plan. Working with the States, FDA will increase 
surveillance and sampling of feed and feed ingredients. FDA will 
improve its analysis of inspection results by establishing a system to 
electronically exchange inspection data.
    FDA will improve risk analysis and research for food and feed 
safety. FDA will expand its ability to identify products at highest 
risk for contamination. FDA will use this information to better target 
and prioritize food and feed safety sampling and inspection. As one 
tool for food risk analysis, FDA will enhance the food registry used to 
report problems with foods.
    FDA will expand the National Antimicrobial Resistance Monitoring 
System (ARMS). Expanding NARMS means more surveillance and monitoring 
of commodities such as seafood and animal feed. Working with CDC and 
USDA, FDA will also adapt NARMS to monitor emerging pathogens in food 
animals and retail foods of animal origin.
    FDA will increase its laboratory capacity. FDA will establish a new 
forensic microbiological laboratory and conduct more food safety 
sampling and surveillance.
            Improving Response and Recovery
    FDA will conduct pilot studies with industry of track and trace 
technology.
    FDA will improve response and recovery with expanded lab capacity. 
FDA will develop technology to reduce the time needed to screen for 
pathogens. We will focus our energies on priority pathogens and work to 
reduce screening time to one to two days, compared to the current 5 to 
10 days.
    FDA will invest in enterprise information technology (IT) systems 
to transform food safety. Funding for IT systems will also allow FDA to 
establish, collect and support the proposed new Food Registration and 
Inspection User Fees Program.
    FDA will provide essential support to food program offices. This 
support will allow food safety programs to achieve priority public 
health objectives.
            Results for Transforming Food Safety
    Fiscal year 2011 funding for the Transforming Food Safety 
initiative will allow FDA to deliver the promise of improved food 
safety. With this fiscal year 2011 investment, FDA will steadily reduce 
illnesses caused by contamination of the food supply in the years to 
come. In summary, Transforming safety will allow FDA to:
  --Reduce the number of foodborne illnesses by heightening the focus 
        on preventing harmful contamination;
  --Identify sources of risk in the food safety system through expanded 
        data collection and analysis and collaboration with partners in 
        other Federal agencies and with, States, international 
        agencies, and industry;
  --Improve industry compliance with food safety standards through more 
        frequent inspection and expanded use of microbial testing and 
        other modern tools;
  --Reduce time to detect and respond to outbreaks through improved 
        staffing and procedures and collaboration with the Centers for 
        Disease Control and Prevention and State, local, and 
        international colleagues;
  --Establish stronger links between performance outcomes and resource 
        investments by developing and tracking appropriate measures of 
        progress on food safety;
  --Better integrate Federal, State, local, and foreign food safety 
        efforts by removing barriers to full collaboration, leveraging 
        of information, and expanding current partnership efforts.
Protecting Patients Initiative
    For fiscal year 2011, FDA proposes an increase of $100,800,000 for 
Protecting Patients. This increase includes $49,400,000 in budget 
authority and $51,400,000 for two new user fees: Generic Drug User Fees 
and Reinspection User Fees for medical product facilities.
    The Protecting Patients Initiative advances Obama Administration 
priorities for safe, quality healthcare for all Americans. The 
resources in this initiative support new tools and partnerships to 
enhance the safety of increasingly complex drugs, devices, vaccines, 
human tissues and America's blood supply.
    This initiative will modernize FDA's approach to the safety of 
medical products at a time when the number of drugs, devices and 
biologics manufactured abroad is increasing dramatically. With these 
resources, FDA can act as a strong and smart regulator and address 
medical product safety challenges in the years ahead.
    The Protecting Patients Initiative focuses on four vital areas: 
import safety, high-risk products, partnerships for patient safety, and 
generic drug review.
    During fiscal year 2011, FDA will hire 215 FTE staff for programs 
that protect patients and support the safety and effectiveness of 
medical devices, human and animal drugs, and vaccines, blood and other 
biologics. This includes hiring 85 FTE in FDA field operations, of 
which 40 will be new ORA medical product inspectors. Among those 40 
FTE, 13 are funded by budget authority, 21 are funded by reinspection 
fees, and six are funded by generic drug user fees.
    When fully trained and deployed, the 40 FTE will annually conduct 
more than 600 foreign and domestic risk-based inspections. This 
includes more than 225 inspections funded by budget authority and more 
than 380 inspections funded by reinspections and generic drug user 
fees. These include inspections of foreign and domestic drug, device, 
radiological health, and biologic manufacturers, as well as bioresearch 
monitoring inspections to protect patients and ensure data integrity in 
clinical trials. The Protecting Patients Initiative funds the cost of 
living pay adjustment for FDA professionals that conduct food safety 
activities. The Initiative also funds higher rent and related facility 
costs and provides essential support to allow medical product programs 
to achieve their public health priorities.
    In addition to the activities listed above, fiscal year 2011 
resources for Protecting Patients support the following priorities.
            Import Safety
    Thousands of critical medical products are manufactured outside of 
the United States. Increased funding for import safety will allow FDA 
to better understand and respond to the growing challenge of foreign 
manufacturing and globalization, including counterfeit products.
    FDA will launch an electronic drug registration and listing system 
to stop imports of illegal drug. FDA will also work more closely with 
trusted foreign regulators to monitor drug manufacturing facilities.
    FDA will increase foreign inspections. FDA will identify and 
inspect the highest risk foreign facilities. FDA will also protect 
patients through increased inspections of human subject trials.
    FDA will review and use third party International Organization for 
Standardization (ISO) audits of foreign device manufacturers. As a 
result, FDA will leverage device inspections conducted for foreign 
governments.
            Safety of High-Risk Products
    Drugs, devices and biologics are becoming increasingly complex. To 
protect the American public, FDA will develop additional capacity to 
assess the safety of these medical products.
    FDA will improve the safety of the blood supply, vaccines, human 
tissues, and cord blood. To counter threats to the blood supply, FDA 
will improve the ability to prevent, detect and monitor for infectious 
agents. FDA will also improve its ability to analyze and respond to 
manufacturing deviations. FDA will also build additional capacity to 
identify and respond to adverse events and adverse reactions associated 
with biological products. FDA will improve vaccine safety through 
guidance for industry and better understanding mechanisms of adverse 
events.
    FDA will begin to build a National Medical Device Registry. FDA 
will begin a pilot project to link unique identifiers for medical 
devices with electronic health data. The result will be improved 
patient safety by creating a National Medical Device Registry.
            Partnerships for Patient Safety
    To meet its public health responsibilities, FDA must interact and 
collaborate with many public and private entities in a medical system 
that is committed to safety.
    FDA will expand postmarketing surveillance systems for medical 
product safety. This investment includes support for the next stage in 
FDA's Sentinel Initiative. The goal of the Sentinel Initiative is to 
use large databases to fairly and quickly assess the safety of medical 
products.
    FDA will partner with public and private organizations to reduce 
unnecessary adverse events, with emphasis on special populations. FDA 
will also work with the private sector to reduce unnecessary medical 
radiation exposure.
    FDA will improve pediatric drug and device safety. Working with 
international and domestic partners, FDA will identify medical products 
that are safe for children and those that pose special risks.
    FDA will improve the safety of animal drugs. FDA will hire and 
train scientific staff to review adverse experience reports and require 
prompt corrective action.
            Generic Drug Review
    FDA will Increase its Capacity to Review Generic Drugs 
Applications: FDA will hire additional staff to support generic drug 
review.
            Results for Protecting Patients
    FDA's Protecting Patients Initiative will have a significant impact 
on public health in the United States. This science-based strategy will 
build new and greater safety capabilities, resulting in:
  --Reduced number of import safety emergencies;
  --Fewer serious adverse events linked to medical products; and
  --Early identification of major safety problems with drugs, devices 
        and biologics.
    This initiative will permit FDA to rise to the challenge of 
protecting patients in the 21st century. The initiative supports 
critical international efforts, upgrades to FDA capacity, and essential 
partnerships with the private sector. With the fiscal year 2011 
resources, the Protecting Patients Initiative will lead to:
  --improved import safety program for medical products;
  --increased capacity to conduct inspections;
  --improved safety of blood, tissue, and vaccines;
  --improved data collection and risk analysis for medical products; 
        and
  --enhanced assessments of postmarket safety.
Advancing Regulatory Science for Public Health Initiative
    For fiscal year 2011, FDA proposes an increase of $25,000,000 in 
budget authority for Advancing Regulatory Science. The Advancing 
Regulatory Science initiative is the backbone that supports all other 
FDA activities, including transforming food safety and protecting 
patients. At FDA, science is at the heart of everything we do from 
keeping the blood supply safe, protecting Americans from global and 
emerging infectious diseases, supporting the development of new food 
and medical technologies, to bringing new treatments to patients.
    Advancing Regulatory Science for Public Health reflects President 
Obama's commitment to harness the power of science to benefit America. 
In his April 2009 address to the National Academy of Sciences, the 
President declared, ``science is more essential for our prosperity, our 
security, our health, our environment, and our quality of life than it 
has ever been before.''
    During the past two decades, U.S. research investments have 
dramatically expanded our understanding of biology and disease. Yet the 
development of new therapies has been in decline, and the costs of 
bringing them to market have soared. As a result, we have experienced 
lost opportunities to improve the effectiveness of U.S. medicine and 
the success of the biotechnology industry.
    Today, FDA is relying on 20th century regulatory science to 
evaluate 21st medical products. Regulatory science is needed to provide 
better tools, standards, and pathways to evaluate products under 
development. It also serves to create efficiencies in the development 
process, and improve product safety, quality, and manufacturing. The 
Advancing Regulatory Science initiative represents the first 
comprehensive effort to modernize regulatory science at FDA.
    Stem cells and personalized medicine are two examples of areas that 
could change the way we treat many diseases. Stem cells offer hope for 
treating patients with neurodegenerative diseases, such as Parkinson's 
and Alzheimer's disease. For the promise of stem cells to come to 
fruition, FDA must develop standards for stem cell therapies so that 
they can be produced reliably and safely. In the area of personalized 
medicine, FDA must work collaboratively to identify markers that can 
predict whether a patient will respond to certain cancer therapies. FDA 
must use cutting edge science to validate these tests for use in 
clinical practice.
    In addition to helping patients benefit from biomedical advances, 
improvements in regulatory science will also support better assessment 
of drug and device safety, better tools for food safety, and better 
understanding of how to reduce the enormous public health harm of 
tobacco products.
    The Advancing Regulatory Science for Public Health initiative 
focuses on three broad themes: science leadership and coordination, 
core capacity, and modern standards for evaluating products.
            Science Leadership and Coordination
    FDA will strengthen scientific leadership. The Office of the Chief 
Scientist (OCS) will support FDA and its centers with dedicated and 
expert scientific leadership. OCS will work with the centers to 
prioritize, oversee, support and coordinate key scientific investments 
at FDA.
            Core Capacities: Infrastructure, Workforce, Collaboration
    FDA will build core scientific capacity in the field of 
nanotechnology.
    Nanotechnology holds great promise in many areas. Examples include 
targeting drugs to where they can do the most good and least harm and 
making improved material for medical devices. Yet, nanoscale materials 
may interact very differently with biological systems and require 
special methods to assess safety and effectiveness. FDA will support 
science focused on the sound evaluation of nanotechnology-based 
products. The goal is to realize their promise while protecting 
patients and consumers.
    FDA will support the development and evaluation of products from 
stem cell innovation. The FDA investment will support the transfer of 
stem cell discoveries from the bench to the bedside.
    FDA will recruit next generation scientific staff. FDA will begin 
targeted recruitment in essential areas of emerging science where FDA 
has an expertise gap.
    FDA will address science issues that support a National Medical 
Device Registry.
    FDA will begin a pilot project to link unique device identifiers 
with health-related electronic data to create a National Medical Device 
Registry. The Registry will improve our understanding of the risk 
benefit profile of higher risk devices.
    FDA will promote scientific collaboration through the Critical Path 
Initiative.
    Fiscal year 2011 investments in FDA's Critical Path Initiative will 
allow FDA to foster partnerships that transform product development and 
evaluation sciences, advance personalized medicine, support meeting 
unmet public health needs, and better predict and prevent safety risks 
early in development.
            Medical Product Regulatory Standards
    FDA will update review standards and provide regulatory pathways 
for biosimilars. FDA will establish regulatory guidance to provide a 
scientifically sound and safe pathway to characterize and develop 
biosimilars.
    FDA will increase its ability to regulate animal biotechnology 
products. FDA will hire and train staff to strengthen our knowledge 
base and thereby support the review and potential approval of animal 
biotechnology products.
    FDA will promote development of healthy foods and encourage healthy 
food choices. FDA will use data from well-designed studies to support a 
modernized food label to encourage Americans to eat healthier diets.
    The Initiative also funds rent and related facility costs to 
conduct initiative activities and provides essential support to allow 
medical product programs to achieve their public health priorities.
Tobacco Control Act
    On June 22, 2009, the President signed H.R. 1256, the Family 
Smoking Prevention and Tobacco Control Act (Tobacco Control Act), into 
law. The Tobacco Control Act grants FDA important new authority to 
regulate the manufacture, marketing, and distribution of tobacco 
products.
    FDA's goals for the tobacco program include:
  --preventing youth from using tobacco and helping adults who use 
        tobacco to quit;
  --promoting public understanding of the harmful and potentially 
        harmful constituents of tobacco products;
  --developing a science base for tobacco regulation; and
  --beginning meaningful tobacco product regulation to reduce the toll 
        of tobacco-related disease, disability, and death.
    In September 2009, after a national search, I selected Lawrence 
Deyton, M.S.P.H, M.D., as Director of the Center for Tobacco Products. 
Dr. Deyton is an expert on veterans' health issues, public health, and 
tobacco control and prevention. He also is a clinical professor of 
medicine and health policy at George Washington University School of 
Medicine and Health Sciences.
    During fiscal year 2010, FDA made substantial progress in 
establishing the tobacco program and implementing initial steps under 
the Act.
    To date, FDA has met or exceeded the statutory requirements of the 
Tobacco Control Act, including:
  --establishing the tobacco products user fee program to support FDA's 
        tobacco program;
  --issuing and enforcing a ban on cigarettes with certain 
        characterizing flavors, including fruit and spice flavors;
  --publishing a guidance document related to tobacco product 
        establishment registration and product listing and began 
        tobacco industry registration with FDA;
  --publishing a guidance document describing the requirements for 
        providing listings of all ingredients used in making 
        cigarettes, smokeless tobacco, and certain other tobacco 
        products and began accepting tobacco product ingredient and 
        constituent listings;
  --establishing an FDA program to assist small tobacco product 
        manufacturers; and
  --creating the Tobacco Product Scientific Advisory Committee.
    FDA is in the midst of an aggressive recruitment and hiring 
program, with a goal of hiring 370 FTEs in the tobacco program by 
fiscal year 2011. I am pleased to report that FDA has met or exceeded 
the statutory deadlines in the Tobacco Control Act. During fiscal year 
2011, FDA will continue to make progress in tobacco product regulation. 
We will learn from the successes of our international counterparts that 
also regulate tobacco. We expect to implement a number of key steps in 
the next year. These steps will include reissuing and enforcing the 
1996 rule to prevent smoking and smokeless tobacco use among young 
people and proposing graphic health warning labels for cigarette 
packages and advertising.
New User Fees
    The new user fees proposed in FDA's fiscal year 2011 budget will 
facilitate the review of generic drugs and enhance FDA's ability to 
register and inspect food and feed manufacturing and processing 
facilities. New user fees will also allow FDA to reinspect facilities 
that fail to meet good manufacturing practices and other safety 
requirements and allow FDA to collect fees when it issues export 
certifications for food and feed.
            fda response to the 2009 h1n1 influenza pandemic
    I would also like to take this opportunity to report to the 
committee on FDA's response to the 2009 H1N1 influenza pandemic. As we 
reported to you last year, FDA established an incident command approach 
that allowed us to work across government, internationally and with the 
private sector to rapidly mobilize emergency response.
    Key accomplishments include:
    Licensing Safe and Effective Influenza Vaccines.--FDA worked to 
facilitate development, production, and availability of vaccines. FDA 
licensed pandemic influenza vaccines from all five U.S. licensed 
influenza vaccine manufacturers. These pandemic vaccines were subject 
to the same stringent manufacturing and quality oversight processes in 
place for seasonal influenza vaccines. More than 70 million Americans 
have been immunized with these vaccines, based on CDC's coverage survey 
estimates. Extensive safety review involving active surveillance 
systems that have captured information from approximately 4 million 
patients has found the vaccine to have the same excellent safety 
profile as the seasonal influenza vaccines.
    Authorizing Emergency Measures.--Our physicians and scientists 
worked tirelessly to facilitate the availability of antiviral 
medications to patients. FDA authorized 13 laboratory tests, 3 drugs, 
and certain types or models of respirators, known as N95 respirators, 
to provide tools to doctors across the country to fight the novel H1N1 
influenza. For example, FDA authorized the emergency of use of an 
unapproved intravenous antiviral drug, Peramivir, to treat certain 
hospitalized patients. FDA's work on dosing of Tamiflu in children 
under the age of 1 year was adopted by countries around the world. In 
addition, FDA authorized the use of antiviral medications that 
otherwise might have been thrown away because they were beyond their 
labeled expiration dates. Our efforts on expiring drugs helped prevent 
shortages of essential medicines for patients.
    Cracking Down on H1N1 Fraud.--FDA established the 2009 H1N1 
Consumer Protection Team that conducted an aggressive, proactive 
strategy to combat fraudulent 2009 H1N1 products. To date, the team has 
sent more than 80 Warning Letters to more than 85 Web sites, covering 
about 150 different products purporting to be dietary supplements, 
medical devices, drugs or biologics. These Warning Letters have 
resulted in a compliance rate of about 80 percent.
    FDA is pleased to have worked so closely with its sister agencies 
under the leadership of the Department of Health and Human Services in 
the pandemic response. We will continue our work to pave the way for 
manufacturers to develop faster and more reliable vaccines, antiviral 
medications, and diagnostic test.
                               conclusion
    The FDA fiscal year 2011 budget of $4,000,000,000 contains 
important funding increases for important public health priorities: 
Transforming Food Safety, Protecting Patients, Advancing Regulatory 
Sciences and Implementing the Tobacco Reform Act. Achieving these 
priorities is possible because of your support for the work of the Food 
and Drug Administration.
    Thank you for the opportunity to testify. I am happy to answer your 
questions.

    Senator Kohl. Thank you, for your fine statement, Dr. 
Hamburg.
    You've been at the FDA for nearly a year now, and I assume 
that it has been fulfilling as well as challenging.

                             VISION FOR FDA

    After a year, what have you learned about the FDA? What's 
working? What would you change? What is your vision for the 
agency, and where do you want it to be in 5 years and beyond? 
How does the Performance Manage Initiative you discussed in 
your opening statement play into this, Dr. Hamburg?
    Dr. Hamburg. There's a lot of questions--very, very 
important questions. I have found, since being here--it's been 
only about 8 months, but who's counting--that FDA is an 
extraordinary agency, you know, with an array of professional 
scientists, lawyers, policy analysts and support staff that, 
you know, are dedicated to the mission of protecting and 
promoting health.
    I have been struck much more deeply, since I've been in 
this role, by how important and unique FDA is--that we are 
responsible for a vast array of regulated products, and 
products that affect every American every day, as you noted in 
your opening statement.
    If we cannot do our job, and do it well, there are not 
other parts of government or other sectors of society that can 
step in and backstop behind us. And that is why it is so 
important to have a strong, fully functional FDA.
    As the new FDA Commissioner, I feel a tremendous 
responsibility to lead this agency fully into the 21st century. 
I think I must be a strong advocate for the agency, explaining 
to policymakers and the public about what we do, how we do it, 
and why. I believe that I must work to ensure trust and 
confidence in the work of the agency, and that includes being a 
responsible steward of the resources given to us, and tracking 
to make sure that we are using them widely and for the benefit 
of the American people.

                                SCIENCE

    I believe that now is the time for us to act aggressively 
to strengthen science within the FDA, in partnerships with 
external partners, so that we can bring the best possible 
science to bear on our regulatory decisionmaking. And I believe 
we have to respond to the globalized world we live in, and 
recognize that products regulated by the FDA are coming in from 
all over the globe, and that we have to effectively extend our 
foreign presence, so that we can ensure safety.
    Senator Kohl. Have you made any trips to any of these 
foreign countries?

                          INTERNATIONAL TRIPS

    Dr. Hamburg. I have made one international trip, so far, 
and we are planning additional--I've made two international 
trips--planning additional trips, as well. I've met with many 
of my counterparts from other countries on their visits here, 
as well, and have really made this area of strengthening our 
presence internationally a very high priority, because the 
world we live in is so increasingly complex and globalized. And 
the supply chains, whether it's food products or medical 
products, go around the globe, and we know that this, 
potentially, entails serious safety concerns.

                           FUNDING INCREASES

    Senator Kohl. Dr. Hamburg, as I said in my opening 
statement, and I'm sure you're fully aware, we have provided 
FDA with very large funding increases over the past several 
years. Your budget this year again includes one of the largest 
increases in our bill, but it's only about one-half of the 
increase that the Department has been receiving recently. How 
would you respond to concerns that this budget reflects a 
decrease in the priority the administration places on 
modernizing and improving the FDA?
    Dr. Hamburg. Well, I think we all recognize that these are 
very difficult economic times and we have to operate in that 
environment. I do think it's very, very important that we 
continue sustained investments in the FDA for the reasons I 
cited earlier, that we have a unique role to play, and it is 
one that matters deeply to every American. So, you know, we 
will continue to work, in every way possible, to perform the 
programs and activities that are on our plate and to address 
emerging new priorities. We hope that we will have the 
opportunity, in the fiscal year 2011 budget, to continue to 
expand in some key areas, as the budget reflects. And I'm eager 
to work with you and with others to ensure, in the upcoming 
fiscal year and in the years beyond, that we continue to 
support FDA in its crucial mission.
    Senator Kohl. Thank you.
    Senator Brownback.
    Senator Brownback. Thank you, Mr. Chairman.
    Dr. Hamburg, let me show you a chart--and I think we've got 
one laid out in front of you--for what I was talking about in 
my opening statement of a bifurcation on the review process. 
It's what we visited about it in my office, and we went and 
took the liberty to give a couple of examples.

                             RARE DISEASES

    I mentioned in my opening statement, there are some 7,000 
rare diseases affecting nearly 30 million Americans, only 200 
of which have any treatment at all. And what I'm suggesting to 
you is that your standard process which is well established; 
it's very expensive, I might add. I saw a 2005 review of it, 
and said that, by FDA's own report, it costs somewhere between 
$800 million to $1.7 billion to develop a new product. This is 
a 2005 FDA report.
    Diseases like Tay-Sachs disease affects approximately 1 in 
112,000 live births. There are no treatments for it. A child 
who's born with this--it's a genetic lipid storage defect--
usually dies by age 4. No treatment, whatsoever. Small market 
potential for it.
    Leigh's disease affects 1 in 36,000 live births. 
Individuals typically live anywhere from a few years to the 
mid-teens; and no treatment for it, whatsoever. The symptoms 
associated with this are usually a loss of early control--head 
control, walking, talking--becoming other problems, such as 
irritability, loss of appetite, vomiting and seizures, and 
there may be periods of sharp decline or temporary restoration 
of some function. Eventually, the child may also have heart, 
kidney, vision, breathing complications. These are tough 
things, when they grab a family.
    We all, as members, get people coming by our offices, 
representing these rare and neglected diseases, and they're 
always saying, ``Look, we want you to put more money into the 
process,'' and we all want to do it, because you don't want to 
hear of anybody having to face any sort of struggle or 
circumstance like that. But, then the truth of the matter is, 
we develop very few products for them, even if we pump a bunch 
of money from here into it, because it's going to take $800 
million to $1.7 billion to bring the product to market, and 
that market is this thin; it's just not going to happen.
    And that's why I would ask you to seriously consider 
something that the FDA has done, on an ad hoc basis previously, 
but instead, let's make this a separate category of review so 
it's not just done on an ad hoc, ``Well we like this one, we're 
not going to do that one. This one's important to us, or this 
one has political impetus to us, that one doesn't.'' Just 
create a separate category. Work with the disease population 
groups to see if they're willing, as groups, to consider going 
into this. Do a thorough review of it, and then set this 
truncated category up. And it's known, going into it, this 
isn't the same review that we're going to take on a common 
disease--arthritis, diabetes, something where there's a large, 
clear population.
    I think you would get a huge amount of support for doing 
something like this. I think you would get a lot of people 
behind it. And I think it would stretch our dollars out to a 
point where you would get action in 6,800 categories that have 
no action now.
    So, I'd ask how you would respond to that, please.
    Dr. Hamburg. Well, thank you very much for this proposal, 
and we will certainly look at it very seriously. And, you know, 
the issues you raise are ones that are very meaningful to me, 
personally and professionally, as well as to the agency. As I 
mentioned to you when I met with you at an earlier time, I 
shifted, in my career, from a career in academic medicine to 
public service, because of watching the AIDS epidemic develop 
while I trained as a medical student and became a resident in 
internal medicine. And at that time, we had no treatments to 
offer AIDS patients. And then new treatment options began to 
emerge, and I went to work at NIH--National Institute of 
Allergy and Infectious Diseases--to be part of that process of 
trying to develop new therapies and trying to get them to 
people who needed them.
    You know, the opportunity that we have right now, in terms 
of advances in science, combined with the growing public health 
need for both rare and neglected diseases, I think, demands 
that we take action and that we be innovative, if not 
transformative, in how we approach it.

                        NEW REGULATORY PATHWAYS

    So, I'm eager to work with you. I think that the program 
that you've already helped to establish within FDA in response 
to past legislation--section 740--has already gotten us on 
track, in terms of beginning to really, in a focused way, to 
look at: How do we develop new regulatory pathways? How do we 
leverage advances in science and technology to make our 
regulatory oversight as efficient and effective as possible? 
And how do we think creatively, building on activities already 
underway, such as the Orphan Drug Program, to look at various 
incentives that exist or could be developed to try to, you 
know, really catalyze activity in areas where there are limited 
markets.
    It's something that I know is of the highest priority 
within the White House, as well. President Obama spoke to this 
issue in his recent State of the Union Address, briefly, but he 
did talk about the importance of developing new products to 
address unmet public health needs.
    So, we will work with you with enthusiasm. We will make 
sure that the group--that the groups within FDA working on 
implementing section 740 look very seriously at your proposal 
here, and continue to work with you and your staff and others 
to make, you know, real, meaningful, and sustainable progress 
in this important area.
    Senator Brownback. I can't think of anything you could do 
that would give more hope to a large group of people that don't 
have a whole lot of it right now. And it affects a lot of 
people.
    I've got several other questions I'd like to ask, but, 
chairman, that's the primary issue, and I really hope--this is 
my last year in the Senate--I really hope we can make some 
progress on this. And I think it's within your power to move 
this forward, in developing a proposal, putting it forward. I 
think you would get a lot of support, and I'd love to be one 
right there with you to try to move that forward, to give hope.
    Dr. Hamburg. If I could just add, I think there's also a 
huge opportunity here to work with sister regulatory agencies 
around the world, because these are issues that do crosscut, 
clearly. And, you know, if we can bring new, innovative 
regulatory strategies and the best possible science to bear, 
and also, you know, fully define the markets that do exist and 
the incentives to bring the pharmaceutical and biotech industry 
into developing products in these areas, you know, we can make 
additional progress with that approach.
    Senator Brownback. Thank you.
    Thank you, chairman.
    Senator Kohl. Thank you, Senator Brownback.
    Senator Mark Pryor.
    Senator Pryor. Thank you, Mr. Chairman.
    And thank you for being here today, Dr. Hamburg. I 
appreciated our visit on the phone last week.

                             NANOTECHNOLOGY

    Let me talk a little bit about nanotechnology, and I'd like 
to get your thoughts. I know that the FDA has proposed a $7.3 
million line item to build core scientific capacity for 
nanotechnology. I actually have a bill here that would do a 
total of $25 million. And I guess my question for you--on that 
$25 million--is, if we are able to get that bill passed and 
make that money available, could you all spend it wisely?
    Dr. Hamburg. Well, I have not seen that piece of 
legislation, but, you know, clearly nanotechnology is an 
emerging technology that holds great promise, in terms of 
products--medical products, as well as cosmetics and food-
related issues. It's one where we want to fully explore the 
opportunity, but we also want to study it carefully to ensure 
that safety issues are adequately surfaced and addressed.
    We have a program that is moving forward in the 
nanotechnology area. As you may well know, the National Center 
for Toxicological Research in Arkansas is a very important hub 
in our nanotechnology research activities.
    But, it cuts across every aspect of FDA work, in terms of 
our product centers. So, I think that, yes, you know, there--
it's a very, very important emerging technology. We need to 
deepen our understanding. And it's key to many areas of FDA 
activities, so we would welcome the opportunity to work more 
with you to see what we can do and how we should best do it.
    Senator Pryor. Does FDA currently have the physical 
infrastructure it needs--the physical labs, buildings, space, 
and equipment, whatever that may be--to really, thoroughly 
study nanotechnology, or is that still a work in progress?
    Dr. Hamburg. You know, I think that we are always having to 
evolve our capabilities as emerging technologies also evolve. 
We do have a solid technical capability for nanotechnology, but 
I would hesitate to try to address whether we have all of the 
infrastructure that we need for our nanotechnology efforts. I 
can certainly tell you that we need to bring on board more 
expertise in the nanotechnology area. We also are working in 
partnership with outside experts in this important arena to 
strengthen our capacity. But, I think it's probably fair to say 
that one always needs to be dynamic in these kinds of programs, 
because the science itself is so dynamic.

                               SALMONELLA

    Senator Pryor. Let me change subjects on you, if I can.
    In the last few weeks, there's been a salmonella outbreak, 
and apparently it was related to hydrolyzed vegetable protein. 
And my understanding is, the administration's budget adds money 
for--to identify such outbreaks. But, does FDA--are you--do you 
feel like you have the right resources and the right 
capabilities in place to monitor things like salmonella and 
these other type of outbreaks that you see in the food system?
    Dr. Hamburg. Strengthening food safety is a huge priority 
for FDA and for the administration and for the Nation. We have 
experienced the real-world implications of gaps in food safety 
and a food safety system that's oriented toward addressing 
problems once they occur, rather than preventing them in the 
first place, and that's what we are dedicated to doing.
    Senator Pryor. And not to interrupt you, but, as I 
understand, there's a President's Food Safety Working Group? Is 
that----
    Dr. Hamburg. Yes. That is--the Food Safety Working Group is 
very active. It was established by the President, I think 
actually at the same time that he announced my nomination. And 
they've identified a number of critical activities and also a 
focus on prevention, strengthening surveillance and 
enforcement, and response and recovery.

                              FOOD SAFETY

    There is a piece of legislation that's pending, on the 
Senate side, to strengthen food safety, which we are very 
supportive of, because it would bring additional authorities 
and resources for the FDA to continue to develop our food 
safety programs and to truly transform our food safety system 
as it needs to be to address the challenges before us. But, 
even without that legislation, we are moving forward in key 
ways to reorient the system toward prevention, to enhance 
inspection, to try to really get a better handle on how to 
track and trace food-borne outbreaks, and working, importantly, 
in partnership with our counterparts at the State and local 
level, and also, again, working internationally, because import 
safety is such a concern. But, we do look forward to the 
consideration by the Senate of the food safety bill, because 
that would really dramatically enhance our position with 
respect to making the kinds of meaningful and enduring changes 
that we need for food safety.
    Senator Pryor. The last question I have, really, is about 
the National Center for Toxicological Research (NCTR). And I 
know that you've attempted to come down there previously, but--
I don't remember if it was a snowstorm or whatever, but you 
couldn't make it, and we certainly would love for you to come 
down and see that again, whenever it works in everybody's 
schedule.

                                  NCTR

    But, is the FDA doing everything possible to assure that 
the high quality science at NCTR is relied upon by other FDA 
labs rather than duplicating the capabilities elsewhere?
    Dr. Hamburg. NCTR represents a very unique resource for 
FDA, and one that we rely on, and one that I certainly value. 
It enables us to build fundamental research capacity that has 
implications that cut across our various product centers and to 
do, you know, really cutting-edge scientific work in some key 
areas, whether it's the establishment of a genomics lab that's 
really helping us think about how we can use a deepened 
understanding of genetics and genetic traits to target 
therapies better and to understand the interaction of lifestyle 
factors and genetics as we think about medical products; some 
of the bio-imaging capabilities that have been developed there 
that can help us develop new kinds of markers to assess product 
effectiveness and to support activities across a range of 
programs at FDA--the activities that they're doing in terms of 
toxicology research, per se, and safety that are so important, 
especially as we're looking more deeply at a range of 
environmental exposures, issues like BPA; and, of course, you 
know, what we talked about with nanotechnology--they represent 
a key hub in those efforts. So, it's really a unique, highly 
valued resource.
    I'm looking forward to my visit down there. But, in the 
meantime, I've been working closely with members of the NCTR 
staff and its director, and they are very much, while at a 
distance, integrated into our work at FDA.
    Senator Pryor. Thank you.
    Thank you, Mr. Chairman.
    Senator Kohl. Thank you very much, Senator Pryor.
    Senator Byron Dorgan.
    Senator Dorgan. Mr. Chairman, thank you very much.
    Dr. Hamburg, welcome, and----
    Dr. Hamburg. Thank you.
    Senator Dorgan. Dr. Hamburg, I want to visit with you about 
the issue of importation of prescription drugs, perhaps not a 
surprise to you.

                              IMPORTATION

    Last December, I and Senator Snowe, along with 30 other 
cosponsors, after working for a number of years, were preparing 
to have a vote on the importation of FDA-approved prescription 
drugs--only FDA-approved prescription drugs. And the day before 
the vote, you sent a letter to Senator Brownback and Senator 
Carper; and, in the letter, you indicated some concern about 
the legislation. You indicated, however, that the 
administration supports a program to allow Americans to buy 
safe and effective drugs from other countries, and you're 
beginning working with stakeholders to accomplish that.
    This has been a long and tortured trail, probably 10 years, 
in which the pharmaceutical industry has prevented the American 
people from accessing FDA-approved identical drugs that are 
sold for a fraction of the price in most other countries in the 
world.
    So, this is an issue, I think, of freedom for the American 
people. They don't want to buy tainted drugs or counterfeit 
drugs, but if Lipitor is made in Ireland and put in a sealed 
container and sent various places in the world, why should the 
American consumer be paying triple the price? Why should they 
not have access to that FDA-approved drug made in a plant 
inspected by the FDA, and so on?
    So, I guess the first question is--you indicate you support 
a program to allow Americans to buy safe and effective drugs. 
Are you working to make that happen? And if so, what kind of 
work is underway at FDA to assure that that could be the case?
    Dr. Hamburg. Well, we do very much care about helping 
Americans get access to important drugs for their health, and 
we also care very much about ensuring safety. And, with you, we 
want to work toward finding better strategies. As I think you 
know, in fiscal year 2010, and again in the proposed fiscal 
year 2011 budget, money has been put aside--$5 million each 
time--for developing strategies and examining and analyzing the 
safety issues with a broadened drug importation strategy. There 
are genuine safety concerns, and that's what we're trying to 
address.
    Many of the drugs that we're talking about, in terms of 
importation, are not drugs that are identical. They're----
    Senator Dorgan. Let's deal with identical drugs, however. 
Let's just talk about identical drugs.

                                LIPITOR

    Dr. Hamburg. Well, Lipitor is one example where it really 
is the same product, as I understand it. But, many of the drugs 
are not necessarily bioequivalent. They may have the same 
product name and be the same product class, but the formulation 
may not be bioequivalent, the dosing formulation may be 
different.
    Senator Dorgan. I understand----

                                LABELING

    Dr. Hamburg. There are labeling issues. There are issues 
about our being able to really assure proper manufacturing 
practices. All of those things really matter, and so we need to 
have a program that is doable, that will enable us to able to 
assure those kinds of issues for the American people.
    Senator Dorgan. Dr. Hamburg, but in the second paragraph of 
your letter last December, you talked about, ``Importing non-
FDA-approved drugs represents four potential risks.'' No one is 
talking about importing non-FDA-approved drugs. And the things 
you've just raised, labeling and so on--our staffs met with the 
FDA and the FDA staff and said, ``Identify any concerns and 
technical issues you've had.'' We dramatically changed our bill 
to address all of those issues.
    And if you will just bear with me for a moment, let's take 
the drug that is identical. Let's reintroduce the bill, with 
only an identical drug, made, in this case, by an American 
manufacturer in an Irish plant and sent in various places of 
the world, and the American consumer has the opportunity to 
spend double or triple the price in order to access it.
    Is there a way for us--in our legislation, we have batch 
lots, we have pedigree, things that don't now exist, even in 
today's drug supply. You're familiar with the Heparin issue, 
right? The tainted medicine----
    Dr. Hamburg. Of course.

                                HEPARIN

    Senator Dorgan [continuing]. With Heparin that's made in 
pig farms in China that no inspector has ever visited. So, I 
understand all of the scare stuff that the pharmaceutical 
industry raises about this, but I'm talking about an identical 
drug made in an FDA-approved plant, with batch-lot and pedigree 
attached, and so on. Couldn't we agree that, at least in those 
circumstances, we could at least do a pretty good job that 
would assure the American consumer that they are--what they are 
buying is exactly what everyone else is purchasing, for a 
fraction of the price?
    Dr. Hamburg. You know, we share your concerns. We want to 
work to try to establish programs that can assure safety of 
drugs and medical products that are imported into this country. 
It's a hugely important issue and a high priority. There are, 
you know, real logistical concerns, very resource-intensive 
strategies that are outlined in the legislation that, you know, 
would be very, very difficult for the FDA to actually--to 
implement. But, I think that there are ways that we can 
approach these issues, and I think, you know, we need to work 
with you and others in order to really--as we pursue this 
planning effort, this----

                        PROGRAM TO IMPORT DRUGS

    Senator Dorgan. Is there an end date on this effort? I 
mean, do you have a time by which you want to accomplish the 
goal--the administration's goal of allowing Americans to buy 
safe and effective drugs in other countries?
    Dr. Hamburg. Well, I think that we are moving forward, in 
terms of the work that we're doing--the analyses and the 
development of different types of strategies, and modeling 
those options for how much they would assure safety--trying to 
get a better sense of what are the issues, in terms of drugs 
that are being--while the drug may be approved for use in the 
United States, the drug that's coming in to people ordering 
these drugs on the Web site are not those drugs that are 
necessarily the FDA-approved drugs. That's----
    Senator Dorgan. Well, that's a----
    Dr. Hamburg [continuing]. One of the huge concerns that we 
have.
    And we know--you know, I was----
    Senator Dorgan. Yeah, that----
    Dr. Hamburg [continuing]. Recently up at the border offices 
at JFK and saw, you know, the products coming in from all over 
the world, some of them with a Canadian maple leaf, you know, 
to suggest that they were coming from Canadian pharmacies, but 
they were not. And the quality cannot be assured.
    So, it's a big issue. It's complicated. We ultimately 
want--our mission is to be able to provide Americans with 
access to safe and effective drugs in as timely and low-cost 
way as possible.
    Senator Dorgan. Mr. Chairman, let me ask if we might--if 
the subcommittee might request of Dr. Hamburg that she submit 
to us what they are doing, with respect to this planning, and 
what the timeliness might be.
    And let me say this. I--look I supported your nomination. 
I'm glad you're where you are. I think you are a terrific 
public servant, and you offering yourself to serve this country 
is an important thing. So, I--but I was upset in December, 
because, even in the last answer, you deftly changed the 
subject, and I don't want to lose an argument we're not having.
    We're not having a debate about medicine that's coming in 
that might or might not be counterfeit. We're having a 
discussion about whether--and I'm using Lipitor just as an 
example--whether the company that produces Lipitor in a plant 
in Ireland, with a batch lot and a pedigree and the safety that 
ought to exist now for American consumers--whether those 
consumers ought to have the freedom to access that FDA-approved 
drug made in an FDA-approved plant--same pill, put in the same 
bottle, sent to three places, except the American consumer pays 
triple the cost.
    This is not rocket science. Europe has done it for 20 
years. If Europe can do it, we can do it. And I would hope that 
we--you and I and others--can approach this on the basis of 
saying, ``How do we accomplish this with complete safety--which 
I think exists in our bill--for the American people?''
    So, I'm very anxious to engage with you and your staff, and 
Senator Brownback and anybody else that has questions about 
this, so that we can support the American consumer, here, to be 
able to access FDA-approved drugs that are being sold around 
the world--in some cases, for one-sixth the price; in Lipitor, 
it's one-half to one-third of the price. And I just think it's 
an important issue.
    So, thanks for indulging this discussion. You do a lot of 
other important things. It's very--and I appreciate the 
chairman's work and the subcommittee's work with the FDA. We 
want to get you the funding you need. We want you to succeed.
    Thank you very much.

                           SAFETY AND ACCESS

    Dr. Hamburg. Well, I appreciate that, and I do look forward 
to working with you and others on this important issue of 
safety and access.
    Senator Kohl. Just to pursue that, are there powerful 
political interests and lobbying interests involved here that 
prevent us from bringing these drugs to the American public at 
prices that are being paid around the world--much, much less 
than what we're paying here? And, as you know, I'm sure, and as 
Senator Dorgan has said, and which he has pursued so well over 
the years, we're paying double and triple and quadruple the 
price for some of the most popular drugs here in the United 
States than people are paying all around the world. Now, I'm 
sure that that causes you great concern and arouses your strong 
interest. And as the head of the FDA, of course, you can play a 
pivotal role in helping us bring these drugs to the American 
consumer for the equivalent price that are being paid around 
the world. Is that one of your missions?

                             BIOEQUIVALENTS

    Dr. Hamburg. You know, very much front and center is--a 
mission--is to be able to assure access to safe and effective 
medicines for the American people. You know, this is a very, 
very challenging area, though, in terms of being able to assure 
safety. And for the FDA, that is, honestly, the issue that 
motivates our actions and concerns. I am not the first FDA 
Commissioner to raise these issues. FDA Commissioners, 
regardless of administration, over, you know, many years now, 
have echoed these same concerns. And it does reflect the 
complexity of trying to assure, especially in the world of 
Internet sales, that the products that are being purchased are 
what they purport to be, and being able to assure that, while a 
product may be FDA-approved for use in the United States, when 
that same product is actually manufactured elsewhere, it is not 
manufactured with the exact same specifications that it's 
manufactured for use in the United States, and that can have 
very important implications for patients. If it's a different 
formulation, it may have different bioequivalence, it may 
require a different dosing schedule, it may be formulated even 
with other components. And, of course, the labeling for use may 
be different from what FDA reviews and approves.
    So, we need to have a program that can really get into that 
level of analysis to assure that patients get what they need, 
that their healthcare providers, as well as the patients, 
understand what may be different about these drugs, even though 
they have the same name, so that they're used properly.

                           COUNTERFEIT DRUGS

    And then there's the problem of outright counterfeit drugs, 
which is an enormous problem, and it is growing. And so, I 
think, you know, that this whole arena of import safety could 
not be more important and pressing to the work of the FDA and 
to the safety and security of the American people, and I hope 
that we can work on all of this together, because it is such a 
huge and urgent challenge.

                          STATE COLLABORATION

    Senator Kohl. Dr. Hamburg, I was happy, last August, that 
you were able to come to Wisconsin and visit with folks in my 
own State about food safety efforts, including people in 
Wisconsin government as well as academia. I believe it was a 
day that was well spent by you; and a major theme of that day, 
as you know, was collaboration.
    States inspect millions of food establishments each year, 
and investigate thousands of food-borne illness outbreaks, and 
they are really our first line of defense. You talk about 
collaboration often in your statement, specifically mentioning 
State liaisons and working with States to increase 
surveillance. Could you expand on this? What additional roles 
do you see the States playing, in collaboration with the 
Federal Government, in the integrated national food safety 
system?
    Dr. Hamburg. Well, thank you very much for that question 
and for the opportunity to say how much I enjoyed that visit, 
and that I've never eaten so much cheese and ice cream in one 
day before. But, it was a wonderful day, and I was told if I'd 
stayed for another, I would have had an equal amount of beer 
and sausage.
    But, you know, the partnership with States and localities 
is absolutely key to achieving our success in food safety, and 
I feel that very personally, having served for 6 years as New 
York City's health commissioner. I know, you know, that it's 
the States and localities that are on the ground from the time 
that a first case of food-borne illness appears until the last 
case goes away, and that the burden, in many ways, is borne at 
that level. And the opportunities to extend the reach of 
government and these important programs is so enhanced through 
collaboration.
    We see working with the States as key. We see strengthening 
training as an important part of that, we see strengthening 
laboratory capacity as an important part of that. We need to 
really improve the IT infrastructure for better communication 
of information--outbreak results, et cetera.
    And I really do think that--going back to some of your 
early questions and remarks--especially at this time of 
economic constraints--the need for partnership, the need to 
make sure that we're really utilizing the sources as best we 
can, and that we are sort of mutually supporting the whole 
spectrum of activities that are needed to support food safety--
and especially, to put a focus on prevention is absolutely key. 
So, this is a priority. We work well with the States on our 
food-borne outbreaks, but there's, I think, room to grow, in 
terms of strengthening those working relationships. And, of 
course, we work with our partner, the Centers for Disease 
Control and Prevention (CDC) and the Department of Agriculture, 
as we address important food-safety issues, as well. So, it's a 
very important Federal-State-local partnership.
    Senator Kohl. Thank you.
    Senator Brownback.
    Senator Brownback. Thanks, Chairman.
    If you're going to go to Wisconsin, you got to come to 
Kansas. We'll feed you bread and steaks. Really good.
    The other thing I would like to invite you there to see is 
University of Kansas' Pharmacy School is one of the top rated. 
It's rated top one, two, or three in the country. And they've 
developed this high-throughput model to test drugs at an early 
stage. And they're starting to work more and more in Second and 
Third World disease category areas for review, as well. And I 
think it'd be interesting to you to be able to see how they're 
doing this now, on trying to review these products at a much 
faster pace with the process that they're using.
    They're also at a point of being able to get a National 
Cancer Institute designation, with the Pharmacy School being 
one of the key aspects of it. So, it's drug delivery on cancers 
that they're working on. And I think it'd be an interesting 
thing for you to look at and to see as you think of ways to get 
more drugs to market--safe, efficaciously--but try to get this 
cost curve down, which is so important for us to be able to get 
some more of these categories covered. So, I hope you can--hope 
you come out and can take a look at that.

                       PARTNERSHIPS WITH ACADEME

    Dr. Hamburg. Well, I'd love to. And what you're describing, 
I think, fits very much with our strong new focus on advancing 
regulatory science, and that critically involves partnership 
with academe. We want to bring the best and the brightest minds 
to addressing these important issues of, how can we make the 
regulatory pathway more effective and efficient? How can we use 
the best possible science to help us rapidly identify 
products----
    Senator Brownback. Right.
    Dr. Hamburg [continuing]. With promise, and those that will 
fail, so that we can really focus our efforts on moving 
products through the pipeline to people who need them.
    So, I'd be delighted to come out there. A few other people 
in the Department of Health and Human Services that care about 
Kansas, too. So.
    Senator Brownback. Good, good. There's a secretary there 
that cares about it, yes.
    Thanks, Chairman.
    Senator Kohl. Thank you very much, Senator Brownback.
    Senator Pryor.
    Senator Pryor. No further questions, Mr. Chairman.
    Senator Kohl. Senator Dorgan.
    Senator Dorgan. Mr. Chairman, I would just repeat the 
previous discussion we had, so I think I'll--we'll do this at 
another time, but----
    Dr. Hamburg. All right.
    Senator Dorgan [continuing]. Telephone or perhaps in 
person.

                           FOODBORNE ILLNESS

    Senator Kohl. Dr. Hamburg, one the outcomes you hope to 
achieve with fiscal year 2011 funding is to reduce the time it 
takes to detect and respond to outbreaks of food-borne illness. 
You talk about collaboration with CDC. State, local, and 
international partners have long felt that, after prevention, a 
quick response to any outbreak of food-borne illness is the 
most important way to prevent its spread.
    Several years ago, we actually put funding in this bill for 
the FDA to create rapid-response teams throughout the country 
in order to do that. I understand that you have increased the 
number of these teams--hopefully, because you believe that they 
have been successful. Could you talk a little bit more about 
these teams and other collaborative efforts you use to respond 
to food-borne illness outbreaks in this country?

                             RAPID RESPONSE

    Dr. Hamburg. Well, the rapid-response teams have been an 
important success. And thank you for your leadership in making 
those happen. We have nine rapid-response teams, at present, 
and I think they have demonstrated their value, in terms of, as 
you say, being able to rapidly identify a problem and respond.
    I think that, even beyond these nine teams, they provide a 
useful model as a strategy for how to achieve a more integrated 
approach to responding to outbreaks of food-borne illness, and 
the need to have a team that reflects a range of different 
disciplines and expertise so that you can understand, in a 
systematic way, the outbreak and what's needed to respond.
    In addition to those rapid-response teams, we have been 
able to put in place a network of laboratories to enhance our 
emergency response, because you need to identify the food 
source, and confirm it, in order to really pursue the 
investigation and the appropriate response. And so, that's been 
very, very important, as well.
    But, there--the elements of an integrated system, I think, 
are really starting to be put in place. You know, part of what 
I hope to be able to achieve is to continue to extend those 
important elements of our system--to institutionalize them, 
because, you know, one of the things that I have seen since 
I've been in this role is that the FDA has a sort of 
unfortunate history of sort of gearing up after there's been 
some kind of a crisis, and then the resources recede, and then 
there's another crisis, and we gear up again. I'd like to see 
us just continue with sustained support for key programs, such 
as the rapid-response teams, that do make a difference and 
matter to us all.

                             GENERIC DRUGS

    Senator Kohl. Dr. Hamburg, I've been a strong supporter of 
the generic drug program for many years now. As you know, we've 
consistently provided increased funds for the Office of Generic 
Drugs, and yet, because of the number of applications, which 
are rising so quickly, we can't keep up, and the backlog is 
continuing to rise.
    As you know, generic drugs provide an important opportunity 
to lower healthcare costs, which Senator Dorgan was referring 
to, and to which he is so much dedicated; and getting these 
drugs to market as quickly as possible is important, to respond 
to the high-priced drugs that we have on the market today.
    The budget includes a proposal for user fees for generic 
drugs that would result in hiring nearly 80 new reviewers and 
inspectors of generic drug applications. Have you been talking 
with the industry about these user fees, which they have 
opposed in the past? Can you give us an update on this? How 
soon can we hope to decrease, if not eliminate, the backlog in 
generic drug applications?
    Dr. Hamburg. Well, as you point out, generic drugs are 
very, very important in being able to get lower-priced, safe 
and effective drugs to people who need them. And thanks to the 
work of this subcommittee, you know, we have been able to 
increase our staffing and our opportunities in the Office of 
Generic Drugs and the review process. But, getting those 
generic user fees will make an enormous difference.
    I, just a few weeks ago, addressed the Generic 
Pharmaceutical Association's annual meeting, and had the 
opportunity to meet with and speak with their leadership. I am 
optimistic that this time we're going to be able to sit down 
and work something out, in terms of the generic drug user fees. 
I certainly hope so. I think, you know, this is one of those 
arenas where industry and FDA both recognize that the present 
situation is unacceptable, and not serving the American people 
well, and that, you know, together we have to find a meaningful 
and real solution. So, we are starting to roll up our sleeves, 
and we're going to be working hard on that. And, as I said, I 
am optimistic.
    Senator Kohl. What's your level of priority on this issue?

                               PRIORITIES

    Dr. Hamburg. On this issue, very high priority. Very high 
priority. You know, one of the challenges of this job is that 
I'm always juggling a lot of high-priority concerns, but this 
is very, very fundamental to what--we're trying to achieve with 
the President has set out to achieve through healthcare reform 
and other activities, what the Secretary wants to achieve--and 
certainly very fundamental to the mission of the FDA.
    Senator Kohl. Could you talk a little bit about some of the 
foreign offices that you've opened. I understand you have one 
in Jordan. What have these foreign offices accomplished, and 
how have they increased the level of food safety for American 
consumers? And are you intending to pursue that by opening 
additional foreign offices?

                            FOREIGN OFFICES

    Dr. Hamburg. We do have a number of foreign offices, at the 
present time. Actually, Jordan hasn't opened yet, but it's 
slated to open in the upcoming year. This is very important to 
extending our foreign presence and our ability to really ensure 
the safety of imports, both food and medical products. We, 
importantly, have offices in China and India now; we also have 
offices in Mexico, Costa Rica, and Chile. We have a presence in 
Brussels, to work with our counterparts in the European Union 
and in London, our counterpart agency, the EMEA, which is the 
European Union's FDA. We're planning an office in Jordan, as 
indicated, and also one in Parma, Italy, where EFSA, the 
European Union's food safety agency is located.
    And, you know, these offices are very, very important, 
working to extend our reach, in terms of international 
presence, working with sister regulatory agencies in those 
countries and in those regions, providing technical assistance 
to national regulatory authorities to try to boost regulatory 
capacity in other nations, that have less sophisticated systems 
than we do, so that we can have greater confidence that 
products being developed in those countries are being developed 
in accordance with international standards and with the 
standards that we would apply.
    So, I think, as we think about extending our global reach, 
we need, really, to have a very new approach, where our job 
isn't simply to inspect things at the border as they come over, 
but really to push back and try to assure safety; and again, 
you know, a preventive approach, to have standards and systems 
that are institutionalized, whatever country is producing the 
product, to enhance the safety of these products when they come 
into this country. And I think, you know, in many areas, we can 
provide an additional benefit by working with other countries 
to help them strengthen their regulatory capacity that will 
accrue to the people of those nations, as well as to the people 
of this country.
    Senator Kohl. Thank you.

                        MEDICAL DEVICE REGISTRY

    Could you talk a little bit about the medical device 
registry that you're working with?
    Dr. Hamburg. Well, this is an effort to try to really 
achieve a unique identifier system for medical devices, and a 
system that will allow us to link information about medical 
devices to electronic health records and to a overarching 
system where we can better monitor how medical devices are 
working in the real world, better track adverse events that may 
occur in relation to medical device use in the marketplace, 
and, if problems do emerge, to more swiftly and effectively 
respond.
    Senator Dorgan. All right.
    Well, I'd like to thank you so much for being here this 
morning.
    Dr. Hamburg. Thank you.
    Senator Kohl. There are multiple votes that are starting on 
the floor, so we'll have to wrap this up.
    You've done a great job.

                     ADDITIONAL COMMITTEE QUESTIONS

    We're going to keep the record open until next Tuesday, for 
any questions, and I hope that you will respond to them by 
April 13----
    Dr. Hamburg. Okay.
    Senator Kohl [continuing]. If you can.
    Dr. Hamburg. Certainly.
    [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
                               pay costs
    Question. The amount proposed to keep up with inflation for all of 
FDA's salaries and expenses is just under $11,000,000, approximately 
$30,000,000 below what was requested last year, although staffing 
levels have increased.
    Will this amount fully fund all of the salary and benefit increases 
you will have to fund this year in order to retain staff?
    Answer. The $10,896,000 pay increase for FDA for fiscal year 2011 
is not intended to cover the cost of higher benefits and other 
increases in payroll costs other than the annual pay adjustment. In 
addition, although the $10,896,000 pay increase for FDA supports 
increased costs for the annual pay adjustment, it will not cover all of 
the FDA costs for the pay adjustment.
    Question. If not, how much is necessary, and where will the 
additional dollars come from?
    Answer. The Summary of Changes table on page 56 of the FDA fiscal 
year 2011 budget displays the fiscal year 2011 estimate for higher pay 
costs of $66,382,000. This amount is based on the most recent PDUFA pay 
analysis. The August 2009 pay analysis for PDUFA determined that the 
average change in FDA cost for compensation and benefits per FDA FTE 
was 5.54 percent. The table on page 56 also shows the fiscal year 2011 
pay change of $10,896,000 and the estimated pay absorption of 
$55,486,000. FDA will cover any shortfall during fiscal year 2011 due 
to the annual pay adjustment and other pay and benefit costs through a 
combination of strategies, including reducing operating costs and 
adjusting when it conducts hiring.
                               user fees
    Question. If food safety legislation is passed and includes 
authorization of user fees as proposed in the budget, will there be any 
discretionary start-up costs? If so, how much?
    Answer. The President's fiscal year 2011 budget includes 
$220,200,000 for user fees to register food facilities, conduct 
additional inspections of both domestic and foreign facilities, and 
conduct expanded import review and product sampling. In addition, the 
budget proposes $13,900,000 in food and feed reinspection fees and 
$4,400,000 for food and feed export certification services.
    If food safety legislation is passed and includes authorization of 
user fees as proposed in the budget, FDA could use existing resources 
to support the start up costs of setting up the new food safety related 
fees. Examples of startup activities include establishing a process to 
calculate the new food user fees, expanding FDA billings and 
collections capacity, and developing and implementing the new 
manufacturer and importer registration requirements In addition, FDA 
would enhance its capacity to hire the new employees funded by the food 
user fees by expanding FDA efforts to develop, classify, and recruit 
the new positions in the foods program and efficiently bring the new 
employees on board to FDA.
    Question. If legislation is passed to authorize any of the 
remaining proposed new user fees (including generic drugs), will 
additional budget authority be required to fund start-up costs?
    Answer. In this scenario FDA could use existing resources to 
support the start up costs of setting up both fees.
    Question. If a food safety bill isn't passed this year, and 
proposed registration fees can't be collected by FDA, how will this 
affect the agency? Do you have a contingency plan to allow FDA to keep 
moving forward without those additional dollars?
    Answer. For fiscal year 2011, FDA proposes an increase of 
$220,200,000 for food registration and inspection user fees. FDA also 
proposes an increase of $87,800,000 in budget authority to support 
transforming food safety priorities. If Congress does not enact 
legislation for fiscal year 2011 that contains food registration and 
inspection user fees, FDA will have to rely on the $87,800,000 budget 
authority increase to begin to transform food safety. Without the 
proposed fees, FDA will have a greatly reduced ability to implement the 
priorities announced by the President's Food Safety Working Group.
    The affect on FDA will be a significantly reduced ability to 
implement President Obama's vision of a new food safety system to 
protect the American public. For example, FDA will not be able to hire 
479 FTE to conduct important food safety priorities, including 99 
consumer safety officers to perform food safety inspections. The result 
will be a reduction of the following food inspection activities 
compared to the level supported with proposed user fees: 1,900 domestic 
food safety inspections, 150 foreign food inspections, 200 domestic 
tissue residue inspections for illegal drug residues in meat and 
poultry and 3,000 samples for analysis in FDA laboratories.
    Not receiving these fees will significantly undermine FDA's ability 
to implement the major activities to Transform Food Safety, beginning 
in fiscal year 2011. FDA will have a greatly reduced ability to set new 
standards for safety, expand laboratory capacity, pilot track and trace 
technology, strengthen import safety, improve safety data collection, 
conduct food risk analysis and most importantly establish a foundation 
for an integrated national food safety system focused on prevention.
                              food safety
    Question. I understand that FDA has entered into cooperative 
agreements with more than 30 countries to share inspection reports and 
other information, so if they discover a problem, we can be on the 
lookout for it here. How long have these agreements been in place and 
are you working with additional countries for more?
    Answer. FDA currently has 43 confidentiality arrangements with 39 
agencies, including the World Health Organization and specific 
Directorates General of the European Commission. These confidentiality 
arrangements involve 20 countries. The first arrangement was signed 
with our counterpart in Switzerland in September, 2003.
    Under these arrangements, FDA is not only able to share critical 
information with public health counterparts in other countries, but is 
also able to receive from our counterpart agencies important 
information about emerging safety and other issues and about foreign 
regulatory actions. These arrangements allow FDA to share otherwise 
non-public information, with the exception of trade secret and personal 
privacy information, with counterpart agencies. We believe we have 
arrangements now with most countries that are able to enter into and 
perform the tasks required in a confidentiality commitment, and which 
deal with public health and regulatory issues similar to ours. However, 
we continue to monitor our needs and add countries and agencies as the 
need arises. Most recently, we have added arrangements with counterpart 
agencies in Austria and Italy.
    Question. In Dr. Hamburg's statement, she mentioned the importance 
of expanding data collection and analysis and removing any barriers to 
full collaboration with State, local and foreign food safety efforts. 
What specific barriers was she referring to, and what proposals do you 
offer?
    Answer. Barriers to full collaboration with our State, local and 
foreign counterparts are predominantly barriers to data sharing between 
entities because of regulatory and technology constraints. To address 
these constraints, FDA has developed a new regulatory procedure 
designed to leverage more effectively the public health inspection data 
gathered by our State partners. Under this initiative, FDA will begin 
issuing Warning and Untitled Letters on the basis of State-gathered 
evidence. As a result of this enhanced cooperation, both FDA and our 
State partners will reap the benefits of translating State regulatory 
work directly into FDA regulatory action. FDA is also pleased that 
pending food safety legislation which passed the House of 
Representatives last year, H.R. 2749, would grants new legal 
authorities to allow more information sharing with our State, local and 
foreign counterparts.
    The technology constraints to data sharing are being addressed in 
working groups that are part of the Integrated National Food Safety 
System efforts. FDA, the United States Department of Agriculture, and 
the Centers for Disease Control and Prevention are participating in 
those discussions with the States to seek out opportunities to make 
their respective data systems interoperable.
                 united states pharmacopia partnership
    Question. Was FDA's recent partnership with the non-profit 
organization United States Pharmacopia to update standards for heparin 
and glycerin a successful one? Is this a model that can be replicated?
    Answer. Yes, the recent partnership with the United States 
Pharmacopia, also known as USP, has been successful. At the request of 
FDA, USP has revised the monographs for heparin, glycerin, and 
propylene glycol to test for known contaminants. FDA hopes to continue 
working with the USP to evaluate the current monograph system and 
determine methods to ensure that monographs are modernized as 
manufacturing changes or technology improves.
    Question. The FDA budget includes proposed funding to develop a 
standard for front of package labeling. Is FDA working with USDA in 
that effort?
    Answer. FDA has been coordinating with the United States Department 
of Agriculture (USDA) on front-of-pack labeling in numerous areas. Our 
coordination includes, design, research and science to ensure that the 
resulting symbols are noticeable, understandable and useable. The USDA 
has supported FDA's research by providing design support for the food 
label formats that are being tested by FDA. Additionally, USDA and FDA, 
with the Centers for Disease Control and Prevention (CDC), are 
supporting the Institute of Medicine, also known as IOM, on issues 
related to panel on front-of-pack labeling. Jointly, USDA and FDA 
provided input to the IOM panel on the Federal goals for front-of-pack 
labeling, information on existing front-of-pack symbols and direction 
for the IOM activities. FDA will continue to collaborate closely with 
USDA to ensure that the resulting front-of-pack symbols provide 
consumers with the information they need to consume healthy diets.
                          vaccine development
    Question. Recently, Secretary Sebelius announced a major evaluation 
of our efforts to respond to pandemics and other health threats, 
including vaccine development. What will FDA's role be in this, and 
what was learned from the H1N1 outbreak?
    Answer. A successful public-private partnership that preceded the 
2009 H1N1 influenza pandemic facilitated the availability and approval 
of safe and effective H1N1 vaccines in record time. This success 
reflects years of preparedness efforts and a significant investment by 
the Federal Government to counter the pandemic threat.
    However, we might not have been so fortunate if the public health 
emergency resulted from a pathogen other than influenza. Currently the 
Administration is conducting a comprehensive review of the HHS medical 
countermeasures development and distribution process, and FDA is 
actively working with others in HHS to provide input to this review. 
There is increasing awareness that the current approaches to developing 
and evaluating vaccines, diagnostics and other treatments needed to 
respond to the range of potential public health threats should take 
advantage of the latest scientific innovations. Reaping the benefits of 
our Nation's investment in biomedical research requires a 
complementary, strategic investment in regulatory science. FDA plays a 
central role to advance this type of science, which focuses on the 
tools to properly assess the safety, efficacy, and quality of medical 
products and to get them from concept to people efficiently. In fiscal 
year 2011, FDA seeks to enhance its own critically needed scientific 
infrastructure and augment its scientific collaborations to advance 
regulatory science, and to continue collaborating with our Federal 
partners and industry to transform public health preparedness.
                     prescription drug advertising
    Question. I have become increasingly concerned with the lack of 
standards regarding direct-to-consumer advertising of prescription 
drugs and medical devices via the Internet. Specifically, I am 
concerned that the limited amount of drug information provided in 
advertisements on social networking forums or ``microblogs'' may pose a 
risk to consumers. I am hopeful that increased oversight of this issue 
will make Internet-based advertising safer and more reliable, but 
remain concerned about any attempt to reduce the safety and labeling 
information that consumers receive.
    What restrictions does FDA currently place on Internet direct-to-
consumer advertising by drug and medical device manufacturers? What 
information must be included in ads or ``microblogs'' about advertised 
treatments?
    Answer. FDA's regulates all prescription drug promotion that drug 
companies issue or caused to be issued. FDA regulations require that 
such promotion be accurate, non-misleading, and present balanced 
information about both the risks and the benefits of the advertised 
product. FDA regulations do not specifically address Internet promotion 
of prescription drugs separately from the other types of promotion, but 
we have been regulating Internet promotion since drug companies first 
began using this medium. For example, we have sent numerous enforcement 
letters citing promotion on the Internet that failed to comply with the 
regulations, including promotion on company brand Web sites as well as 
promotion on search engine sites such as Google, third party sites such 
as cnn.com, and on newer social media sites such as YouTube.
    FDA regulates promotional labeling of all medical devices but only 
the advertising of restricted medical devices. FDA regulations do not 
specifically address Internet promotional labeling or advertising for 
medical devices, as applicable, separately from other types of 
promotion or advertising. FDA has sent numerous enforcement letters 
based on promotional labeling, where statements made are not consistent 
with the FDA approved or cleared labeling, including statements about 
the intended use of the device. FDA has also sent enforcement letters 
in situations where it has considered statements made in advertisements 
for medical devices to be evidence of an intended use for which the 
device has not been approved or cleared.
    Question. Are you concerned that incomplete drug advertising 
information on social networking sites like Facebook or Twitter may 
pose a risk to consumers, especially if the FDA logo is included in the 
ad?
    Answer. Yes, we are concerned about drug advertising on social 
network sites and are committed to ensuring that prescription drug 
promotion accurately conveys product risks and benefits, regardless of 
the medium used for such promotion. We are also concerned about FDA's 
logo being used in any drug promotion. FDA held a Part 15 Public 
Hearing in November 2009 to obtain public input on ``Promotion of FDA-
Regulated Medical Products Using the Internet and Social Media Tools.'' 
Social media tools, as well as their expansion to applications such as 
mobile technology, have raised questions regarding how to apply 
existing regulations to promotion in these newer media. We are 
currently evaluating the information and data obtained during our Part 
15 Hearing and in the related docket and plan to ensure that FDA has 
optimal policies in place for oversight of drug promotion using social 
networking tools.
    Question. Does the Division of Drug Marketing, Advertising, and 
Communications have adequate resources to properly oversee this type of 
marketing? If not, what additional resources are necessary?
    Answer. The Division of Drug Marketing, Advertising, and 
Communications, also known as DDMAC, has approximately 53 full-time 
employees. Currently, there are 24 staff in DDMAC focused on the review 
of direct-to-consumer advertising, including 13 reviewers. To get a 
sense of their workload, we note that DDMAC received 76,631 promotional 
pieces at the time of their first use during calendar year 2009. Of 
these, 15,998 were consumer-directed promotional pieces, which includes 
both direct-to-consumer ads and DTC promotional labeling pieces. 
Another 14,970 were ``mixed'' pieces. These are pieces directed to both 
consumer and professional audiences, which are typically Internet-based 
materials intended for all audiences. DDMAC can only review a fraction 
of these promotions. To most effectively address the increasing number 
of prescription drug promotional pieces that are produced each year, 
including the extremely rapid growth of Internet promotion, FDA has 
adopted a comprehensive risk-based strategy for triaging its 
substantial workload. This risk-based approach is designed to have the 
most impact in addressing misleading promotion and fulfill its goal of 
protecting consumers and healthcare professionals from misleading 
promotion of medical products.
                              antibiotics
    Question. The Agriculture Appropriations Subcommittee last year 
encouraged FDA's Center for Veterinary Medicine to conduct a focused 
reassessment of Guidance Document No. 152 to review and update the 
current ranking of antibiotics according to their importance in human 
medicine as a framework for approving antibiotics for use in animals. 
What is the status of this reassessment?
    Answer. FDA intends to update its guidance on the ``Potential 
ranking of antimicrobial drugs/drug classes based on identified 
relevant factors'' included in Guidance For Industry Number 152, 
``Evaluating the Safety of Antimicrobial New Animal Drugs With Regard 
to Their Microbiological Effects on Bacteria of Human Health Concern.'' 
At this time, FDA is planning to seek expert advice and public input on 
any updates to this existing drug ranking.
    Question. What is FDA's timeframe for issuing regulations to 
implement the animal antibiotic use data collection provision that was 
included in the Animal Drug User Fee Act (ADUFA)?
    Answer. Section 105 of the Animal Drug User Fee Amendments of 2008, 
also known as ADUFA, established additional requirements regarding the 
submission of sales and distribution data for antimicrobial active 
ingredients in new animal drugs approved for use in food-producing 
animals. The sponsors of such products are required by statute to 
submit the first report including this additional information by March 
31, 2010. The issuance of regulations is not required to implement the 
new ADUFA Section 105 requirements. However, independent of 
implementing these new statutory requirements, FDA intends to pursue 
rulemaking in the near future to incorporate the new Section 105 
requirements into the existing regulations regarding the preparation 
and submission of records and reports for new animal drugs.
    Question. The FDA has been authorized for several years to review 
the non-therapeutic use of antibiotics in farms. In 2004 letters were 
sent from the FDA to manufacturers of drugs requesting more information 
related to resistance, but there is uncertainty regarding whether FDA 
received a response. To date, it appears FDA is still attempting to 
gather data on this issue.
    At what point will this data gathering be completed? Will there be 
a point prior to that when FDA will have enough data to make an 
assessment?
    Answer. FDA continues to be concerned about the use of medically 
important antimicrobial drugs, antimicrobial drugs that are important 
for therapeutic use in humans, in food-producing animals for non-
therapeutic, production purposes. FDA does not believe that it is 
judicious to use these important drugs for such purposes in animals. 
Therefore, FDA is developing a strategy to address this important 
public health issue. Moving forward with the strategy to address this 
important public health issue is a priority for FDA. FDA is completing 
an initial review of the issue and intends to publish a document 
describing its current thinking in the near future.
                         regulation of tobacco
    Question. Recently the FDA began implementation of the Family 
Smoking Prevention and Tobacco Control Act. How is FDA working with 
interested parties, including the tobacco industry, consumer groups, 
and other agencies that have jurisdiction over tobacco products, in 
developing and implementing the regulatory process to ensure 
compliance?
    Answer. FDA, through its Center for Tobacco Products, or CTP, is 
working in a number of ways with interested parties to implement the 
Family Smoking Prevention and Tobacco Control Act, or more simply, the 
Tobacco Control Act. In July 2009, FDA opened a public docket seeking 
input from the public and various stakeholders on the implementation of 
the new statute and subsequently extended the comment period from 
September 29, 2009 to December 28, 2009. Since then, public dockets 
have been opened for comment on a number of issues, including marketing 
descriptors to convey modified risk and product registration and 
labeling requirements.
    FDA has developed a CTP Web site, located at www.fda.gov/
TobaccoProducts. This Web site contains information about CTP's efforts 
to implement the Tobacco Control Act, a list of frequently asked 
questions and answers about the Tobacco Control Act, tobacco-related 
regulatory documents such as guidance documents and regulations, 
contact information, and other information about tobacco use and 
prevention.
    In early August 2009, the Assistant Secretary for Health, the FDA 
Commissioner, and the Director of the Centers for Disease Control and 
Prevention hosted a conference call with more than 200 State and local 
officials to discuss collaboration in carrying out the Tobacco Control 
Act.
    In September 2009, FDA held a series of listening sessions with a 
variety of stakeholders, including national tobacco control groups, 
State and local government organizations, Federal partners, and tobacco 
manufacturers, distributors, importers, and retailers to hear comments 
and concerns regarding implementation of the Tobacco Control Act.
    In October and November 2009, FDA held two listening sessions to 
provide industry additional opportunities to make comments and raise 
concerns about the registration, product listing, and ingredient 
submission requirements.
    Question. As of June 22, tobacco packaging will no longer be 
allowed to include phrases such as ``Light'' and ``Ultra-Light''. When 
will final guidance on this be issued to ensure maximum compliance?
    Answer. Section 911 of the Tobacco Control Act prohibits the use of 
the descriptors ``light,'' ``mild,'' or ``low'' in the label, labeling, 
or advertising of tobacco products without an FDA order in effect. This 
statutory provision takes effect on June 22, 2010. In advance of the 
effective date of this prohibition, FDA intends to conduct outreach to 
retailers and manufacturers, reminding them of their responsibilities 
under the statute. FDA also plans to initiate a public education effort 
to increase public understanding about the prohibition of these terms. 
Once this provision takes effect, FDA intends to enforce it through a 
variety of means.
    Section 911 also prohibits the use of ``similar descriptors,'' such 
as descriptors similar to ``light,'' ``mild,'' or ``low,'' without an 
FDA order in effect. FDA opened a public docket in January 2010 to 
solicit public input on how to define ``similar descriptors,'' 
specifically requesting input on the use of numbers, colors, healthy 
images and terms like ``smooth,'' ``silver,'' and ``natural.'' FDA is 
in the process of assessing the input received from the public, 
including comments from tobacco control advocacy organizations and 
tobacco companies and trade organizations.
                     standards of identity for milk
    Question. Please provide an update on FDA's response to a petition 
filed last year regarding amending the standards of identity for milk 
as they relate to artificial sweeteners.
    Answer. FDA received a citizen petition from the International 
Dairy Foods Association, also known as IDFA, and the National Milk 
Producers Federation dated March 16, 2009. The petitioners requested 
FDA to amend the standard of identity for milk in 21 CFR 131.110(c), to 
provide for the use of any safe and suitable sweetener in the optional 
characterizing flavoring ingredients and to similarly amend 17 other 
standards of identity for milk and cream products, including yogurts. 
Such a change to the milk standard would permit the use of non-
nutritive sweeteners in flavored standardized milk. Currently, the 
standard of identity for milk provides for the use of only nutritive 
sweeteners under optional ingredients in 21 CFR 131.110(c)(2) in the 
characterizing flavor for flavored milks. FDA issued an interim 
response to IDFA on August 24, 2009 explaining that FDA had not reached 
a final decision on the petition due to other priorities. FDA is 
currently considering how it will respond to the petition.
                       state contract inspections
    Question. During fiscal year 2009, what percentage of food and 
medical product inspections were carried out by State inspectors 
through a contract?
    Answer. In fiscal year 2009, State inspectors carried out 23,913 
unique food and medical product establishment inspections. These State 
contract inspections total 62 percent of domestic inspections carried 
out by FDA and the States.
                              state audits
    Question. Funding was provided in fiscal year 2010 to enhance FDA's 
audit program for State inspection programs. Please provide an update 
on how this funding was used, and whether State program audits have 
increased.
    Answer. Of the 26 States currently enrolled in the Manufactured 
Food Regulatory Program Standards, also known as MFRPS, FDA completed 
program audits of five States during fiscal year 2009. These States are 
Missouri, North Carolina, New York, Oregon and Wisconsin. FDA expects 
to complete program audits in Massachusetts, Florida, Minnesota, 
Michigan, California and Washington during fiscal year 2010. These 
audits include a review of the States' self-assessment of their own 
programs against the standards described in FDA's MFRPS. The audits 
focus on a review of all manufacturing inspections accomplished by the 
States--both FDA contract and routine State inspections. The audits 
include reviews of the States' regulatory foundation, education and 
training files maintained for field investigators, inspection reports, 
self-audit procedures, compliance and enforcement actions, response and 
preparedness within the State, sample collection procedures, community 
outreach and the program's relationship with a regulatory lab.
    In addition to creating the infrastructure to perform robust 
program audits and improve our performance in auditing State 
inspections performed under FDA contract, FDA is also creating the 
critical infrastructure to provide support, guidance and technical 
assistance to our State regulatory partners to better enable them to 
establish and sustain conformance to the MFRPS. The funding provided by 
Congress is being fully and effectively used to support our States' 
successful implementation of the MFRPS, a key component of an 
effective, integrated national food safety system.
                                 ______
                                 
             Question Submitted by Senator Byron L. Dorgan
                           drug reimportation
    Question. Please provide us with your timeline for setting up the 
process for drug reimportation.
    Answer. The Administration supports a program to allow Americans to 
buy safe and effective drugs from other countries. The Administration 
has included $5,000,000 in our fiscal year 2010 and 2011 budget 
requests for the Food and Drug Administration to begin working with 
various stakeholders to develop policy options related to drug 
importation and addressing some of the implementation challenges such 
as improving supply chain security.
    FDA is currently conducting assessments of different drug 
importation approaches to inform legislative proposals and identify 
initial infrastructure needed to implement a program that assures 
patient safety. This work includes, among other things, conducting an 
economic and implementation analysis, evaluating policy options, 
identifying and enhancing IT infrastructure associated with drug 
importation, identifying and developing training programs, increasing 
sampling and laboratory capacity, enhancing collaboration with 
regulatory counterparts, and developing track and trace standards for 
supply chain security. Although we have not established a specific 
timeline for setting up the process for drug importation program we 
remain committed to ensuring that Americans have access to safe and 
effective drugs.
                                 ______
                                 
            Questions Submitted by Senator Richard J. Durbin
    Question. Some individuals and interest groups have raised concerns 
that S. 510, the FDA Food Safety Modernization Act, expands the 
jurisdiction of the Food and Drug Administration into areas 
traditionally overseen by the United States Department of Agriculture. 
Please provide the FDA perspective on how, if at all, legislation would 
expand FDA jurisdiction into areas traditionally overseen by the USDA?
    Answer. FDA believes that these concerns are unfounded. The 
legislation makes it clear that the new provisions do not affect USDA's 
jurisdiction and, in many places, explicitly requires FDA consultation 
with USDA. With regard to new requirements, such as the produce safety 
standards, FDA is already working closely with USDA as we develop those 
standards. USDA also will be involved in the implementation of such 
standards, including an extensive outreach program to help the affected 
industry comply with the new standards. FDA recognizes the importance 
of working with USDA, with its expertise in agricultural production and 
its significant workforce, to help inform and implement the standards. 
FDA and USDA also are working together to ensure that our produce 
safety and quality activities are complementary and consistent and take 
into account the diversity of farming operations.
    Question. The adverse event reporting (AER) system for dietary 
supplements created by the Dietary Supplement and Nonprescription Drug 
Consumer Protection Act (Public Law 109-462) has been in effect for 
over 2 years. The intent of the AER system was to assist FDA in 
enhancing its surveillance capability by authorizing it to collect data 
regarding illnesses related to the consumption of dietary supplements. 
How has data collected through the AER system been used by FDA to 
identify meaningful trends and aid in recalls?
    Answer. The implementation of Public Law 109-462 resulted in a 
substantial increase in the number of adverse event reports about 
dietary supplements submitted to FDA. Additionally, the law mandated 
that product labels accompany mandatory serious adverse event reports. 
These factors have assisted FDA in two ways. First, the higher number 
of reports received enables FDA's clinical reviewers and statisticians 
to better detect unusual reporting patterns from clusters of adverse 
event reports, possibly providing evidence to better determine 
associations between products and adverse health effects. Second, 
product labels allow for better characterization of the products and 
their ingredients than may result from voluntary reports--typically 
from consumers--where the product may not be as clearly characterized 
and a label may not be included. Better description and 
characterization of the product helps FDA target specific products in 
support of FDA enforcement efforts. Analysis of adverse event reports, 
for example, led to FDA's warning to consumers and healthcare 
professionals about certain Hydroxycut-branded products because of 
serious reports of liver disease. The company producing the affected 
Hydroxycut-branded products--Iovate Health Sciences U.S.A., Inc.--
voluntarily recalled those products in 2009.
    Question. In January 2009, GAO issued a report on FDA's oversight 
of dietary supplements. In that report, GAO recommended that FDA issue 
guidance to clarify when an ingredient is considered a new dietary 
ingredient, what evidence is needed to document the safety of new 
dietary ingredients, and appropriate methods for establishing 
ingredient identity. In its comments on this recommendation, FDA said 
that it had developed draft guidance which was undergoing internal 
review. Can you provide me on an update on the status of this guidance?
    Answer. FDA is developing a draft New Dietary Ingredient, also 
known as NDI, guidance that is under internal FDA review. We expect the 
draft guidance to discuss, among other issues, when FDA considers an 
ingredient to be an NDI, FDA's current thinking on the evidence needed 
to document the safety of NDIs, and recommendations on appropriate 
methods for establishing the identity and composition of NDIs.
    In addition, FDA is developing a proposed rule to better define 
what a manufacturer or distributor must include in a NDI notification. 
Establishing more precisely the information that must be included in an 
NDI notification would improve the quality of the notifications being 
submitted to FDA and would expedite the review of NDI notifications. 
The amendments FDA intends to propose would also enable staff to 
evaluate the safety of new dietary ingredients in a more efficient 
manner with its limited resources. Both the draft guidance and the 
proposed rule are currently under review within FDA and appear to raise 
a number of complex issues.
    Question. There have been numerous notification delays that 
resulted in schools unknowingly serving beef, peanut products and 
canned vegetables that have been recalled. For the last 5 years, the 
Food and Drug Administration and the United States Department of 
Agriculture have been drafting a Memorandum of Understanding related to 
the safety of food served in schools. The Memorandum of Understanding 
would set forth detailed notification procedures during the FDA's 
investigation of commodities intended for school meal programs. Have 
the two agencies finalized this memorandum of understanding? If not, 
what is causing the delay and what is the anticipated timeline for 
doing so?
    Answer. FDA and the Food and Nutrition Service, also known as FNS, 
has collaborated with FDA to develop a Memorandum of Agreement, or MOA. 
Specifically, the MOA is between the Department of Health and Human 
Services, FDA and the following agencies within the United States 
Department of Agriculture: the Agricultural Marketing Service, FNS, and 
the Farm Service Agency. It is intended to strengthen and facilitate 
the exchange of information among the participating agencies during 
investigations and recalls that may involve USDA commodities such as 
those offered through the National School Lunch Program, and the Woman, 
Infants, and Children (WIC) Program.
    The basic framework of the Memorandum of Understanding is complete 
and it is under review by the agencies. Final clearance will follow 
with a targeted completion date of summer 2010.
    Question. In June 2010, several provisions of the Family Smoking 
Prevention and Tobacco Control Act (Public Law 111-31) will take 
effect, including new restrictions on cigarette advertising; new 
stronger warning labels for smokeless tobacco products; and a 
prohibition of terms such as ``light,'' ``low,'' and ``mild'' on 
cigarettes and smokeless tobacco products. How is FDA planning to 
educate the public about these changes, and ensure that industry 
complies with both the letter and spirit of the law?
    Answer. Concurrent with the reissuance of the 1996 Final Rule, 
``Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents,'' published in 
the Federal Register on March 19, 2010, FDA began educating the public. 
FDA has made available a variety of materials directed to retailers and 
consumers about the regulations. This effort includes information about 
what the regulations require, how to comply with them, and how to 
report violations. A dedicated Web page, www.fda.gov/
protectingkidsfromtobacco, was created and will be updated with the 
latest information. As of now, it includes fact sheets to both 
retailers and consumers, a letter to retailers, and frequently asked 
questions. FDA has also used social media, such as YouTube, badges, and 
buttons to reach out to consumers. Additionally, FDA has established a 
call center to respond to questions from the public.
    The Tobacco Control Act also directs the Secretary to contract with 
the States and Territories, to the extent feasible, to carry out 
tobacco retailer inspections and investigations to enforce the 
provisions of the reissued 1996 Rule. The goal is to enter into 
contracts with 75 percent of States and territories in fiscal year 
2011.
    In advance of the effective date of the provision prohibiting the 
use of terms such as ``light,'' ``low,'' or ``mild,'' FDA intends to 
conduct outreach to retailers and manufacturers, reminding them of 
their responsibilities under the statute. FDA also plans to initiate a 
public education effort to increase public understanding about the 
prohibition of these terms.
    FDA is currently assessing what additional public education and 
outreach efforts would be appropriate in order to adequately inform the 
public when these provisions become effective on June 22, 2010.
                                 ______
                                 
              Questions Submitted by Senator Arlen Specter
    Question. Last year, the FDA responded to the H1N1 threat with 
appropriate speed and while the process was not without challenges it 
was, in general, fast and efficient. I am concerned that this same 
urgency is not being applied to medical countermeasures being developed 
to prevent or mitigate threats that have been identified as critical 
national security priorities but have not yet materialized. The release 
of biological, chemical and radiological agents or the detonation of a 
nuclear device will come with little or no warning, we as a nation must 
have already developed and stockpiled safe and effective 
countermeasures if we are to respond to these types of threats. Does 
the FDA have the resources that it needs to prioritize responses to 
regulatory inquires and submissions from companies that are under 
contract with the Federal Government to develop products the United 
States has identified as critical unmet needs?
    Answer. Currently the Administration is conducting a comprehensive 
review of the HHS medical countermeasures development and distribution 
process, which has been a coordinated interagency effort by HHS' 
Assistant Secretary for Preparedness and Response and includes the 
Centers for Disease Control and Prevention, the National Institutes of 
Health, and FDA. As part of this review, there have been discussions 
about the U.S. Government's ability to ensure that medical 
countermeasure development is appropriately prioritized and resourced, 
and whether FDA has the resources and staff to robustly engage with 
partners throughout a product's developmental life-cycle. The 
Administration will be briefing Congress of its findings and 
recommendations once this comprehensive review is complete. Using 
existing resources and within the applicable regulatory framework, FDA 
prioritizes regulatory inquiries and submissions from sponsors and U.S. 
Government partners that are engaged in developing products that have 
been identified as meeting a critical unmet need.
    Question. How extensively has the leadership of the FDA and the 
staff responsible for reviewing medical countermeasures been briefed on 
the national security threat assessments for CBRN agents? How many FDA 
employees that are involved in the review of medical countermeasures 
being developed under contract with BARDA, NIH or DOD have the 
appropriate security clearances necessary to allow them to receive 
classified threat briefings?
    Answer. FDA leadership has been briefed and is very aware of the 
national security threat assessments for CBRN agents. FDA leadership is 
briefed by the HHS Office of Security and Strategic Information, and 
FDA has an employee assigned to that Office. In addition, FDA's Office 
of Criminal Investigations, within the Office of Regulatory Affairs, 
works with the Intelligence Community to obtain information and briefs 
FDA's leadership as needed. Across FDA's three centers that review 
medical countermeasure products, 106 employees that have been or in the 
future may be involved in medical countermeasure-related reviews have 
received special clearances to review classified documents related to 
product review submissions.
                                 ______
                                 
              Questions Submitted by Senator Sam Brownback
                               access act
    Question. Dr. Hamburg, during our meeting last week we discussed a 
bill I've been working on since 2005 to create a new conditional 
approval system for drugs, biological products, and devices that is 
responsive to the needs of seriously ill patients. This effort, called 
the Access, Compassion, Care and Ethics for Seriously-ill Patients Act, 
or ACCESS Act, offers a new compassionate investigational approval 
system for treatments showing efficacy during clinical trials, for use 
by the seriously ill patient population. Under this new approval 
system, seriously ill patients who have exhausted all alternatives and 
are seeking new treatment options would be offered access to these 
treatments with the consent of their physician. I plan to reintroduce 
the bill during this session.
    After our meeting, my staff provided a copy of this bill to FDA. 
Have you had a chance to review this legislation? Do you have any 
thoughts on the bill?
    Answer. I appreciate your interest in providing treatments to 
seriously ill patients and am committed to working with you on this 
important issue. We recognize the importance of providing access to 
patients who may benefit from an investigational drug and of providing 
seriously ill patients with a measure of autonomy over their healthcare 
options. My staff is continually engaged in efforts to increase the 
awareness of clinicians and patients about FDA's expanded access 
mechanisms. We are currently in the process of reviewing the 
legislation your staff provided and will give you feedback on the bill 
as soon as our review is complete.
    Question. Would you be willing to work with me to find common 
ground on this issue?
    Answer. I welcome the opportunity to work with you to find common 
ground on this issue. Once we have reviewed your bill, my staff will 
contact your staff to determine how we might continue to work together 
on this important issue.
                        cost of developing drugs
    Question. In March 2004, FDA released a report, called ``Innovation 
or Stagnation: Challenge and Opportunity on the Critical Path to New 
Medical Products'', that addressed the challenges facing the drug 
industry in bringing a new medical product to market. In this report, 
FDA raised concerns about the high cost of product development, 
estimated in the report to be $800,000,000 to $1,700,000,000 per 
product, and the high failure rate of products before they reach FDA 
for review. This was particularly concerning to the agency given the 
government and private sector's increased investment in research and 
development over the same period of time.
    It has been 6 years since FDA released this report and launched a 
new initiative to address this problem. What progress has the agency 
made in its quest to reduce the cost of drug development and provide 
more certainty that products will be viable beyond the research phase?
    Answer. Development of a drug takes many years, so it is too early 
to provide any specific metrics on cost and viability. However, I can 
certainly report progress in many Critical Path areas, some of which 
will have serious cost impacts. We have a series of fairly advanced 
efforts under way that will ultimately make the collection, submission, 
and management of the data FDA receives totally electronic. This effort 
will bring significant cost savings for industry and FDA because it 
will make the collection and analysis of this data much more efficient.
    An especially notable Critical Path success is the enormous support 
it has among industry, academia, and the public. There has been 
considerable enthusiasm to partner with us on Critical Path projects. 
In 2008 alone, Critical Path collaborations involved 84 government 
agencies, universities, industry leaders, and patient groups from 28 
States and 5 countries on a raft of groundbreaking research projects. 
Critical Path has also stimulated the creation of numerous 
collaborations that are leveraging outside resources, with FDA serving 
in an advisory capacity. These collaborations are reporting substantial 
successes as well.
    We are also making great strides in personalizing therapy. 
Increasingly, pharmaceutical developers are using pharmacogenetics and 
genomics data in drug development and submitting more of this type of 
data to FDA as part of their marketing applications. Since 2008, we 
have seen a 250 percent increase in the submission of genomic data 
included in marketing applications. To modernize our review process, 
FDA created a Genomics Group that uses an integrated review process, 
including discussions of genomics, pharmacometrics, and clinical 
pharmacology in the scoping meetings for all application submissions, 
including pediatric supplements. We are learning more and more about 
how to personalize treatments, making them safer and more effective.
                          generic drug review
    Question. Since the fiscal year 2008 appropriation, funding for the 
Office of Generic Drugs 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. The number of new generic drug applications submitted to 
FDA remains at a high rate of over 800 per year. Increased resources 
recently provided by Congress enabled FDA to hire more scientific 
review staff members. As the complexity of applications increases, 
however, more time is required for review and approval of each 
application. There are a significant number of pending applications. 
However, in most instances, applications are approved when relevant 
patents or exclusivities expire. Even if the currently pending 
applications were otherwise approvable, over one-half of them could not 
be approved immediately because they are currently blocked by patents 
or exclusivities. Further, some applications are of lower quality and 
these take longer to review. In addition, the total time to approval 
includes time that the application is with the firm after the 
application has been reviewed and deficiencies have been communicated 
for the firm to address. Sometimes the firm does not respond to the 
deficiencies in a timely manner because of the firm's own priorities or 
perhaps lack of resources to address the deficiencies.
                         third party inspection
    Question. Many States have implemented ``inspect the inspector'' 
programs to help find efficiencies in their inspection budgets. FDA 
calls this third party inspection, and I understand that the agency has 
been looking into this kind of inspection program to augment FDA's 
foreign food inspections. Would you update me on FDA's efforts in this 
area?
    Answer. In fiscal year 2009, FDA initiated a pilot program for 
aquacultured shrimp, under which it has audited more than 56 shrimp 
processors in six countries in an effort to evaluate the utility of 
third party programs to prevent problems with shrimp before export to 
the United States. Under the pilot, third parties will be certifying 
compliance of aquaculture shrimp with FDA's Seafood Hazard Analysis 
Critical Control Point (HACCP) regulations. If FDA finds that it can 
have confidence in such certifications, it may alter the import 
monitoring for those processors, freeing up resources to focus on 
higher risk processors.
    FDA has been working with foreign regulators and third party 
certification bodies to enhance monitoring and oversight of processing 
sites. FDA expects that these activities will enhance FDA's regulatory 
oversight by leveraging resources and a shared mission with foreign 
regulators. These activities also have an educational outreach 
component that promotes foreign industry standards that are in line 
with FDA's expectations for imported food. In addition, the evaluation 
of the aquacultured shrimp pilot will provide valuable insight into the 
feasibility of using third party certification programs for foreign 
inspections.
    Question. Have you considered a third party inspection program for 
domestic food inspections?
    Answer. FDA is currently in the evaluation stage of our Voluntary 
third party certification pilot for imported aquacultured shrimp pilot. 
The goal of the shrimp pilot is to assist FDA to determine the 
infrastructure needs for managing third party systems and the process 
for evaluating third party certification programs, including evaluating 
the utility and feasibility of third party voluntary programs.
    The pilot evaluated six participants--U.S. Government agency, 
foreign government, and private certification bodies--using the 
Guidance for Voluntary Third Party Certification Programs, published in 
the Federal Register in January 2009. The guidance was drafted in 
alignment with other existing benchmark attributes such as the 
Manufactured Food Regulatory Program Standards to ensure the same 
attributes are used for all third parties--States, foreign governments, 
and private certification bodies. The evaluation of the aquacultured 
shrimp pilot will provide valuable insight into the feasibility of 
using third party certification programs for both foreign and domestic 
inspections.
    In the domestic arena, we are working with our State partners to 
build an integrated food safety system. This includes developing 
standards and training and auditing to those standards. With this 
approach, Federal and State inspections, sample collections and 
analyses will support an integrated food safety system that will result 
in more coordinated coverage of the domestic food industry.
                         medical product safety
    Question. In December 2009, FDA notified healthcare facilities to 
discontinue the use of or transition away from using the STERIS System 
1 sterilization device. The agency described this product as 
``misbranded and adulterated'' in this notice, but proceeded to allow 
the product to be in use in healthcare facilities for over a year and a 
half. Is it common procedure for the agency to notify healthcare 
facilities of safety concerns and then allow the product to be in use 
for a long period of time?
    Answer. The decision to allow the continued use of a product of 
concern is determined by several factors, including the availability 
and cost of alternate products and the time required for providers to 
safely put these alternative products in place. Other factors include 
the impact that a delay of treatment caused by transitioning to 
alternative products man have on patients.
    For some devices, the immediate removal of the device may result in 
a device shortage or cause a delay in necessary medical procedures. In 
these situations, FDA works with distributors and healthcare providers 
to avoid shortages that might result in postponement of care.
    FDA performed a shortage assessment for the STERIS System 1 
Processor, also known as SS1, and determined that a sudden removal of 
the SS1 could disrupt operations at healthcare facilities, and that the 
risks of such a disruption would outweigh the risk of a measured 
transition to legally marketed alternative products.
    FDA provided general information to healthcare facilities on steps 
to mitigate the risk associated with continued use of the SS1, 
including a document identifying FDA-cleared products available to 
sterilize or disinfect medical devices.
    Question. Are healthcare providers required to notify patients that 
they are using a product that FDA has asked them to discontinue?
    Answer. Unless healthcare providers are serving as medical device 
manufacturers or distributors, which would fall outside the practice of 
medicine, FDA typically does not ask them to notify patients that they 
are using product that FDA has asked them to discontinue. FDA 
communicates regularly with patients and healthcare providers about 
products of concern. For example, FDA has made a broad range of 
information available on its Web site that details FDA concerns with 
the STERIS System 1 Processor. FDA also looks to device manufacturers 
and distributors to provide notifications about their products to 
healthcare providers and patients.
                             critical path
    Question. I have followed with a great deal of interest the 
agency's critical path public private partnerships that were authorized 
in the Food and Drug Administration Amendments Act. I have been 
particularly impressed with how the Critical Path Institute has been 
able to leverage its relatively modest partnership funding from FDA by 
bringing additional funding from Arizona-based foundations and in-kind 
effort from the pharmaceutical industry to improve the methods used to 
test new drugs. I recently learned that the Critical Path Institute has 
been able to engage the Gates Foundation to work with the FDA on 
developing Tuberculosis drug combinations. As you know, the fiscal year 
2010 appropriations bill included $2,000,000 to address this serious 
global health threat. What do you think can be accomplished with the 
Tuberculosis funding and how does it fit into your priorities for 
regulatory science?
    Answer. The tuberculosis funding is a critical first step in 
generating a program to accelerate the development of products for the 
diagnosis, treatment, and prevention of tuberculosis. The effort we 
envision is completely in line with FDA's new regulatory science 
initiative, planned for fiscal year 2011, which is designed to get 
better products to patients faster and more safely.
    Under this initiative, FDA seeks to rebuild its own critically 
needed scientific infrastructure and capacity to meet the demands of 
the 21st Century and to enhance its scientific collaborations. We will 
use the TB funding to establish partnerships that can leverage the 
relevant expertise and resources to develop TB diagnostics and 
biomarkers, the lack of which is a critical obstacle to TB drug 
development. We will also focus on developing the scientific principles 
for selection of new drug combinations as well as approaches for 
identifying new compounds and existing drugs that have activity against 
TB. With regard to clinical trials, it will be important to identify 
and validate endpoints that can be used in the conduct of vaccine 
trials, as well as build a stronger clinical trial infrastructure for 
conducting high-quality studies where the disease is endemic.
                                 ______
                                 
            Questions Submitted by Senator Robert F. Bennett
    Question. As you are aware, the user fee agreement negotiated 
between the FDA and the medical device industry and passed into law by 
Congress includes a series of goals that the FDA commits to meeting in 
return for the funds provided to the FDA by the industry. The FDA holds 
quarterly meetings with the device industry to report on the user fee 
program, funds being collected, and how goals are being met. However, 
it has come to my attention that for the first time in the history of 
the medical device user fee program, the FDA has failed to meet its two 
goals for PMA applications: 60 percent of applications have a decision 
in 180 days and 90 percent have a decision in 295 days. Neither goal is 
being met for 2008 applications and also will likely not be met for 
2009 applications. Can you explain why FDA is not meeting these goals?
    Answer. The goal to which you refer applies to non-expedited 
original premarket approvals or PMA and panel-track supplements. Our 
data currently indicates that FDA can still meet the 180-day decision 
goal, both for 2008 and 2009 applications. Our staff is striving to do 
so. You are correct that the 295-day decision goal was not met for 2008 
applications and is unlikely to be met for 2009 applications, despite 
strong efforts by our staff.
    It is important to recognize that the goals for 2008 and beyond are 
more challenging than for previous years. For example, the required 
performance level for the 180-day decision goal increased from 50 
percent for 2007 applications to 60 percent for 2008 applications. 
FDA's performance on this goal for 2008 applications has already 
surpassed performance for 2007 applications, but the 2008 goal has not 
yet been met. Had the goal remained unchanged, FDA's performance would 
have already satisfied it.
    Another contributing factor may be growth in the premarket review 
workload. The number of expedited and non-expedited PMA applications 
and panel-track supplements filed in 2009 was 15 percent greater than 
in 2007. Similarly, the number of 510K submissions was 12 percent 
greater. The same technical staff who review PMA applications also 
review 510K submissions, so it is important to consider the total 
review workload. In addition, the complexity of medical device 
technology is continually increasing.
    FDA recognizes the importance to public health of promoting the 
rapid introduction of safe and effective medical devices. The user fee 
performance goals remain a high strategic priority, and the Center for 
Devices and Radiological Health, or CDRH, is taking steps to improve 
performance. The staff at CDRH are developing improvements to their 
review processes to increase efficiency, consistency, and transparency, 
such as the new ``iReview'' system--an electronic interactive review 
system for 510Ks. They have implemented intensified internal tracking 
and reporting procedures for submissions subject to user fee goals. 
They are also gathering information on missed goals to better 
understand the underlying causes and develop effective solutions.
    Question. In your budget justification document you discuss a 
Medical Device Registry. As I'm sure you know, a provision to amend the 
FDCA to establish a medical device registry appeared in the House 
healthcare reform bill. This provision relied on manufacturer's 
proprietary sales data and certainly had the potential to be used for 
purposes unrelated to the FDA's mission. The concept was never 
discussed at any hearings in the committee of jurisdiction. 
Manufacturers raised a number of concerns about the intent behind the 
provision and answers to questions about its purpose were not 
forthcoming from the Administration. Now your proposal seems 
straightforward and I just have a few questions:
    What assurances can you offer that your proposal will not rely on 
manufacturers' sales information or other confidential data?
    Answer. We do not anticipate that the effort to establish the 
National Medical Device Registry, also known as NMDR, will require 
manufacturer proprietary sales information or other confidential data. 
Rather, the aim is to develop and implement a national strategy for the 
best public health use of health-related electronic data that 
incorporates unique device identifiers (UDIs) and leverages existing 
procedure and device registries. To the extent any confidential 
commercial information is submitted to FDA, we can assure you that we 
will protect it in accordance with applicable disclosure statutes and 
regulations.
    Question. What assurances can you offer that the purpose of this 
registry is to gather meaningful denominator data in an effort to 
improve the usefulness of the FDA's post market safety efforts?
    Answer. The incorporation of UDIs into health-related electronic 
data will provide FDA with long-needed exposure--or denominator--
information that is critical to the assessment of device safety. The 
purpose of the NMDR is to use the variety of disparate healthcare data 
sources, which will incorporate UDIs, to significantly augment FDA's 
postmarket safety efforts.
    Question. How will you ensure that the registry and the information 
in it will not be used by CMS or other third party payers to make 
coverage and payment determinations?
    Answer. The purpose of the registry is to develop and implement a 
national strategy for the best public health use of health-related 
electronic data that incorporates unique device identifiers (UDIs) and 
leverages existing procedure and device registries. FDA can not control 
how others use this data.
    Question. As you know we have tried to support the Critical Path 
Initiative in your appropriations but we have not been able to come 
close to the amount the European Union has given to their Innovative 
Medicines Initiative, which I am told was created to directly compete 
with the FDA's critical path program. As the critical path initiative 
is very closely related and complimentary to your regulatory science 
program, how will you continue to support critical path?
    Answer. The European Commission has committed large amounts of 
funding to the E.U. program, which is modeled on FDA's Critical Path 
Initiative, but the funding you have given FDA to support Critical Path 
Initiative, also known as CPI, has been put to excellent use. In 2006, 
2007, and 2008, FDA reported on 40 to 60 specific CPI projects 
involving FDA and numerous collaborators. During fiscal year 2008, the 
year that Congress allocated $8,000,000 to fund CPI projects, CPI 
collaborations involved 84 government agencies, universities, industry 
leaders, and patient groups from 28 States and 5 countries on a raft of 
groundbreaking research projects.
    In 2009, we received $16,000,000 in appropriations to support CPI. 
That year, we conducted an informal survey of CPI projects under way, 
including the congressionally funded projects, and found that numerous 
CPI projects are being worked on all across FDA to support regulatory 
science. CPI has been the prime engine driving much of the scientific 
work at FDA since 2006.
    Advancing Regulatory Science is a broad, FDA initiative, with many 
cross-agency components, that is building on the Critical Path 
Initiative. Advancing Regulatory Science seeks to develop FDA's 
scientific infrastructure, enhance scientific collaborations with 
academia and other government agencies, and increase our Critical Path 
partnerships. With a focused agenda and a greater, more targeted 
investment of human and financial resources, we can expand our work 
with partners to transform the culture and science of product research, 
development, and evaluation. We plan to use these resources to continue 
efforts that speed therapies to patients, address unmet public health 
needs, protect our food supply, work toward modernizing toxicology and 
hazard assessment. With support from the Center for Tobacco Products, 
we hope to meet the many challenges to regulating tobacco.

                          SUBCOMMITTEE RECESS

    Senator Kohl. Once again, we thank you and your colleagues 
for being here today.
    And this hearing is now recessed.
    [Whereupon, at 11:10 a.m., Tuesday, March 9, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]
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