[Senate Hearing 109-]
[From the U.S. Government Publishing Office]



 
AGRICULTURE, RURAL DEVELOPMENT, AND RELATED AGENCIES APPROPRIATIONS FOR 
                            FISCAL YEAR 2007

                              ----------                              


                        TUESDAY, MARCH 14, 2006

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:05 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Robert F. Bennett (chairman) 
presiding.
    Present: Senators Bennett, Craig, Kohl, and Harkin.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF HON. ANDREW C. VON ESCHENBACH, ACTING 
            COMMISSIONER
ACCOMPANIED BY:
        KATHLEEN HEUER, CHIEF FINANCIAL OFFICER AND ASSOCIATE 
            COMMISSIONER FOR MANAGEMENT
        RICHARD TURMAN, DEPUTY ASSISTANT SECRETARY FOR BUDGET, 
            TECHNOLOGY, AND FINANCE, DEPARTMENT OF HEALTH AND HUMAN 
            SERVICES
        STEVE SUNDLOF, DIRECTOR, CENTER FOR VETERINARY MEDICINE

             OPENING STATEMENT OF SENATOR ROBERT F. BENNETT

    Senator Bennett. The subcommittee will come to order.
    And this morning, we are happy to welcome Dr. Andrew von 
Eschenbach, who is the acting Commissioner of the Food and Drug 
Administration. And we also welcome Ms. Heuer and Mr. Turman. 
We appreciate very much your being here.
    This is the second subcommittee hearing we have convened 
since receiving the President's fiscal 2007 budget request, and 
it is the first time that Dr. von Eschenbach has appeared 
before the subcommittee.
    The FDA did pretty well under the President's budget 
process. The budget request, not including user fees and fiscal 
2006 supplemental funding, represents an overall increase of 
$70 million from the level of funding in fiscal 2006. Not all 
portions of this subcommittee's budget did as well in terms of 
the President's recommendations.
    The FDA budget includes increases for pandemic influenza 
preparedness, food defense, drug safety, tissue safety, animal 
drug and medical device review, and a new initiative, called 
the Critical Path Initiative, to speed development of medical 
products.
    But it does include more than $50 million in base funding 
reductions. We have been given very little information about 
the impact of these reductions, and I expect that we will 
discuss those in some greater detail in the hearing this 
morning.
    Now given the fact that we are competing with other 
subcommittees, had to fight your way down the hall to get 
around the corner to come in here, and we are in the midst of 
the budget discussions on the floor, we are going to keep 
members to 5-minute rounds.
    We will use the ``early bird'' rule. That is, Senators will 
be recognized in the order of their arrival, and members will 
be allowed to submit questions for the record. We want all of 
the questions to the subcommittee to be here by the close of 
business on the 24th of March.
    Senator Kohl and I will be the only two to give opening 
statements. And when we have finished with our opening 
statements, then we will go directly to Dr. von Eschenbach for 
his presentation and then begin the questioning rounds.
    So with that statement of the ground rules, Senator Kohl.
    Senator Kohl. I thank you, Mr. Chairman.
    Dr. von Eschenbach, it is good to see here you here today, 
and we also want to welcome Ms. Heuer and Mr. Turman as well as 
the rest of your staffs.
    There has been, as you know, lots of interest in your 
budget, which appears to receive the most robust increase in 
the entire agricultural appropriations bill. I am pleased to 
see additional funding for drug and tissue safety as well as 
avian flu and food defense.
    Also in the budget, though, there is a redirection of $52 
million and funding for some important activities and staffing 
levels actually decreases. These decreased activities, 
according to your budget, include generic drug contracts, 
analysis of food import samples, compliance and recall 
functions, certain safety activities in the biologics program, 
dietary supplement activities, and inspections of veterinary 
food and human drugs manufacturers.
    This is not at all a complete list. This is obviously a 
concern, and we are interested to know how the priorities in 
this budget were determined.
    We are hopeful that you will provide detailed information 
on this redeployment as well as your budgeted increases here 
today. And so, we look forward to your statement and the 
opportunity to ask questions.
    Thank you, Mr. Chairman.
    Senator Bennett. Thank you.
    Dr. von Eschenbach, your prepared statement has been 
received and will be included in the record at this point in 
its entirety. But we would appreciate it now if you would give 
us a summary and whatever introductory comments you may wish to 
make.

               STATEMENT OF DR. ANDREW C. VON ESCHENBACH

    Dr. von Eschenbach. Thank you, Mr. Chairman.
    Good morning, Senator Kohl. And good morning, Senator 
Craig, and other members of the staff.
    I am very honored to be here as the acting Commissioner of 
the Food and Drug Administration to present this 2007 fiscal 
year budget. But most of all, to also have the opportunity to 
thank you for the continued support and commitment that you 
have made to the FDA in helping to assure that it continues to 
be the gold standard around the world for the safety and 
effectiveness of the interventions that we provide to people.
    Our 2007 budget request proposes a total budget of $1.95 
billion, of which $1.54 billion is in discretionary budget 
authority and $402 million will be in user fees from the firms 
that we regulate. These funds are precious, and they are, in 
fact, essential to FDA's continuing effort to assure that 
Americans can go to bed each night confident that the food they 
ate is safe, the medical devices they use are reliable, and the 
drugs that they gave to their children and grandchildren were 
safe and effective.
    As we developed this 2007 proposal, the first thing we 
focused on was FDA's most precious asset, its people. The funds 
we are requesting are essential for us to continue to recruit, 
retain, and nurture a critical and diversified staff of highly 
skilled professionals and scientists who make it possible for 
the FDA to achieve the gold standard in regulating foods, 
drugs, and medical products.
    Our request includes $20 million for cost of living 
increases that are essential to meet payroll obligations and 
needed funds for the infrastructure to support our workforce 
and consolidate FDA operations in modern facilities at White 
Oak.
    In addition to the workforce-related issues, we have also 
focused on emerging urgent public health challenges and 
opportunities. The increase of $30.5 million over fiscal year 
2006 for pandemic preparedness is for a comprehensive program 
that is designed to safeguard Americans from the danger of 
avian flu by enhancing and integrating our programs across 
vaccine development, antivirals, enhancement of devices for 
detection as well as for human protection, and also include 
issues with regard to animal welfare and human health.
    The $20 million for food defense is to protect the Nation's 
food supply both from intentional terrorist attacks as well as 
to enhance our ability to safeguard the food supply from 
unintentional contamination.
    $4 million for human drug safety, plus an additional 
$700,000 in user fees, we believe will strengthen our capacity 
to recognize and act upon emerging drug safety concerns. And 
the $2.5 million for human tissue safety is in response to the 
dramatic growth that we are experiencing in the use of tissues 
for transplantation and the anticipation of the emerging 
challenges that will come from tissues obtained through 
bioengineering.
    With regard to the request for $6 million for the Critical 
Path to Personalized Medicine, this initiative is an essential 
investment, an investment in FDA's ability to respond to the 
explosion in molecular medicine that is responsible for and 
resulting in progress toward new treatments, diagnostics, and 
preventive interventions.
    By using the science and technology of the 21st century, 
Critical Path will help ensure that FDA can guide these new 
discoveries through the development process so that they are 
able to be delivered to patients in a rapid, safe, and 
effective manner.
    A modern, robust Critical Path will lead to solutions that 
will deliver on the promise of making our future health care 
personalized, predictive, preemptive, and, in fact, more cost 
effective.
    As you have indicated, to partially offset the cost of 
these initiatives and, most importantly, as good stewards of 
the resources that you have already provided, FDA has undergone 
a process to identify and an activities for opportunities for 
efficiencies and proposes to strategically redeploy $52 million 
in base funds.
    We have done this, first and foremost, with the principle 
to not undermine or impair our commitment to public health. But 
we believe by looking at opportunities within the portfolio to 
determine where there are programs that could be effectively 
carried out by alternative or other strategies, where there are 
opportunities to eliminate waste and maximize the impact of our 
investment, we believe that we can modernize and transform our 
business operations, as well as our programmatic operations, to 
address the emerging needs of the 21st century.
    We will accomplish this strategic redeployment while 
assuring you that we will maintain our century-old commitment 
to assuring the health and welfare of the American public.
    There are two new user fees that are being proposed. One 
covers the cost of re-inspecting facilities that fail to meet 
standards, and the second would cover the cost of issuing food 
and animal feed export certificates.
    As you have pointed out, the investment in the FDA in this 
budget is investment in the future of our country and our 
commitment to continue to ensure the health and safety of the 
American public. We propose to use these resources wisely and 
carefully as good stewards and, in doing so, assure a healthier 
America for generations to come.

                           PREPARED STATEMENT

    We really are grateful and appreciate your commitment and 
your interest to working together with us, as we will with you, 
to be sure that we fulfill that goal.
    [The statement follows:]

           Prepared Statement of Dr. Andrew C. Von Eschenbach

Introduction
    Good morning Chairman Bennett, Senator Kohl, and distinguished 
members of the Subcommittee. I am very honored to have been appointed 
by President Bush 6 months ago as Acting Commissioner of the FDA, and I 
consider it a privilege to present our fiscal year 2007 budget request 
on behalf of this extraordinary agency. I am joined today by Ms. Kathy 
Heuer, FDA's Chief Financial Officer and Associate Commissioner for 
Management, and Mr. Richard Turman, Deputy Assistant Secretary for 
Budget, Technology, and Finance of the Department of Health and Human 
Services (DHHS). I also have members of FDA's senior leadership with me 
at today's hearing.
    Last September, President Bush selected me to lead an agency to 
which I appreciate, we, as Americans owe a great debt of gratitude. 
Millions of Americans go to sleep each night, secure in the knowledge 
that the food they ate and the medicines they gave their child were 
safe and effective. They do so, thanks to the thousands of dedicated 
professionals at FDA who work to assure the safety, efficacy, and 
security of drugs, vaccines and biological products, medical devices, 
our Nation's food supply, and other consumer products.
    This year, the Food and Drug Administration will celebrate its 
100th birthday, marking a century as America's gold standard for safety 
and consumer protection. We began in 1906, when Congress passed and 
President Theodore Roosevelt signed the Food and Drugs Act. This 
statute entrusted the Bureau of Chemistry, an office in the U.S. 
Department of Agriculture, to implement the sweeping new law. The 
Bureau eventually became the FDA, an agency of the Department of Health 
and Human Services. As the first consumer protection agency in the 
United States, FDA has a distinguished record, established during its 
100 years of service to the American public.
    Today, the products we regulate represent almost 25 percent of U.S. 
consumer spending and include 80 percent of our food supply and all 
human drugs, vaccines, medical devices, tissues for transplantation, 
equipment that emits radiation, cosmetics, and animal drugs and feed. 
FDA takes great pride in its heritage and accomplishments, promoting 
and protecting the health and well-being of all Americans.
    I assure you that the precious resources you provide this agency in 
fiscal year 2007 will be used wisely and judiciously to ensure that we 
maintain this record of excellence, as well as work to respond to the 
growing challenges to advance the Nation's public health in a new era 
of rapidly developing science and individualized medicine.
    I want to thank the Subcommittee members for providing FDA with 
several key increases in the fiscal year 2006 appropriation. The 
Subcommittee demonstrated its commitment to FDA's mission by providing 
increases for drug safety, the Critical Path Initiative, review of 
direct-to-consumer advertising, Food Defense, medical device review, 
and the FDA consolidation project at White Oak, Maryland. In addition 
to the amounts in the annual appropriations bill, I also want to 
express my thanks to Congress for the supplemental appropriation of $20 
million to contribute to our Nation's preparedness for the threat of 
pandemic flu. FDA enters this appropriation cycle mindful of our 
responsibility and stewardship, and that all Federal agencies must 
operate in an environment where our dollars must go to the greatest 
need.
FDA's 2007 President's Budget Request
    In our fiscal year 2007 budget, the Administration proposes a total 
program level for the FDA budget of $1.95 billion, an increase of 3.8 
percent above the fiscal year 2006 amount. This includes $1.54 billion 
in discretionary budget authority and $402 million in current law user 
fees. Our budget also includes $25.5 million for two new user fees. Our 
budget request maintains critically important core functions and 
demonstrates that our programs meet a firm test of accountability. At 
the same time, we are heeding the President's call to assure continued 
progress by fostering innovation and focusing on emerging priorities. 
In fiscal year 2007, FDA will employ resources to advance its mission 
to protect the public health by assuring the quality of food and 
medical supplies and by implementing advanced technologies to monitor 
and speed innovations to market that will make foods safer and medical 
products more effective, safer, and more affordable. We will also 
implement advanced tools to ensure that the medical community can use 
molecular biology to improve outcomes for patients. We must accomplish 
these goals in a way that provides the public with the accurate, 
science-based information they need to use food and medicine to improve 
their health.
    The President's budget focuses on six emerging, and urgent 
challenges and opportunities. To address these challenges, the budget 
proposal increases funding in these targeted activities above the 
amount provided in fiscal year 2006: $30.5 million for Pandemic 
Preparedness, $19.9 million for Food Defense, $5.9 million for the 
Critical Path to Personalized Medicine, $4.0 million for Human Drug 
Safety (plus an additional $0.7 million in user fees), $2.5 million for 
Human Tissue Safety, and $7.4 million to meet the statutory triggers of 
the Animal Drug and Medical Device user fee programs. In addition to 
these high priority initiatives, the budget requests $20.3 million for 
inflationary cost-of-living increases that will enable the agency to 
recruit, nurture, and retain a critical mass of highly skilled 
professionals and scientists. This dedicated staff is necessary to 
respond to greater challenges in the regulatory process, including 
increased complexity of the sciences and technology and the need for a 
more rapid pace.
    FDA also seeks $1.2 million for the Unified Financial Management 
System, and an investment of $14.3 million for the agency's 
infrastructure needs. To partially offset the cost of these 
initiatives, the President's budget proposes to strategically redeploy 
$52.3 million in base funds. Even in an era of declining budgets, FDA 
recognizes the need to modernize and transform operations to address 
the emerging needs of the 21st century. Therefore, we engaged in an 
ongoing process to strategically redeploy resources to address high-
risk public health challenges while maintaining our century-old 
commitment to principles that have made us the world's ``gold 
standard'' for regulating food and medical products. In doing so, the 
proposed budget will permit FDA to meet its ongoing statutory and 
regulatory responsibilities, while allowing us to initiate new and 
expanded efforts in critical areas of our mission. Now I would like to 
provide you with greater detail on our proposed budget increases.
Pandemic Preparedness (+$30.5 million)
    To safeguard Americans from the danger of pandemic influenza, FDA 
requests a total base program of $55.3 million in fiscal year 2007. 
This amount is $30.5 million more than the fiscal year 2006 enacted 
level, which includes the $20 million in supplemental appropriations 
provided by Public Law 109-148. The supplemental will allow FDA to 
rebuild and enhance its infrastructure; provide personnel and expertise 
in the essential clinical, product and manufacturing areas necessary to 
support new vaccine development for pandemic influenza. With the fiscal 
year 2007 funds, we will conduct a more comprehensive program to 
prepare for and respond to the risks of a pandemic flu outbreak. The 
resources will build upon the program this Congress launched in the 
supplemental, and will allow FDA to:
  --Engage in public-private partnerships to select, prepare, and test 
        pandemic seed strains of variants of the H5N1 virus.
  --Develop reagents (used to assess vaccine potency) that are 
        essential for successful large-scale manufacturing.
  --Evaluate and license flu vaccines that rely on current egg-based 
        technology as well as encouraging the development of new 
        approaches such as cell culture-based vaccines, recombinant 
        vaccines, and vaccines that contain adjuvants--substances added 
        to vaccines to stimulate an immune response.
  --Provide essential technical support to vaccine manufacturers 
        throughout the vaccine development process, including support 
        throughout the manufacturing phase.
  --Develop analytical methods to detect, identify, and quantify 
        antiviral residues in poultry, so that these drugs do not 
        promote drug resistance in humans.
  --Develop and validate methods to detect avian influenza in foods and 
        advise American consumers about how to safely handle and cook 
        these foods.
    We make this request because public health experts tell us that the 
risks of being unprepared for a pandemic could mean the death of up to 
200,000 Americans (based on a medium-level pandemic scenario) and 
economic losses of up to $160 billion. In the near term, our pandemic 
initiative will stimulate broader interest among vaccine manufacturers, 
as they recognize that FDA will provide consistent technical support to 
overcome vaccine development hurdles. We have already seen results in 
this area. In the longer term, our fiscal year 2007 investment will 
yield essential seed strains and reagents, and allow us to transfer 
this technology to manufacturers, while we also perform our regulatory 
responsibilities of evaluating and licensing pandemic influenza vaccine 
products. Over the next 2-4 years, we will also fulfill our public 
health responsibilities related to foods and veterinary products, by 
delivering methods to detect antiviral residues and by educating 
Americans about safe food practices.
Food Defense (+$20 million)
    FDA seeks an investment of an additional $20 million in fiscal year 
2007 to protect the Nation's food supply from terrorist attack, by 
developing and deploying improved methods to screen food and feed 
imports and expanding the Food Emergency Response Network (FERN).
    FERN is a network of Federal and State laboratories designed to 
ensure that we have the analytic surge capacity to respond to an attack 
on the food system. By the end of fiscal year 2006, we plan to have an 
operational FERN system of 10 Federal and 10 State labs. The fiscal 
year 2007 funds ($13 million) will allow FDA to expand the current 
network by six additional labs, located at existing State facilities, 
and we will work to bring these on-line before the end of the fiscal 
year. We will fully equip these new labs, and provide operational 
funding and technical assistance so that they can conduct food defense 
activities. Our technical assistance will include proficiency testing 
on the new equipment and training to validate their ability to conduct 
food testing in response to an emergency. The result of this investment 
will be a more robust and more geographically diverse capability to 
provide the essential surge capacity to test contaminated food samples 
and allow us to warn the public about threats to the food supply. By 
working cooperatively with State facilities, we can stretch our Federal 
dollars and strengthen food defense at the Federal and State level.
    Within the $20 million increase, we will also:
  --Conduct food defense research ($1 million) to fill in gap areas 
        that we identified in the vulnerability assessments we 
        conducted on 23 major food products such as baby food, infant 
        formula, dairy products, soft drinks, and bottled water.
  --Strengthen the Electronic Laboratory Exchange Network (eLEXNET), an 
        Internet based data exchange system used by Federal, State, and 
        local government food safety laboratories. Using fiscal year 
        2007 funds, we will use eLEXNET to provide food sector-specific 
        information to sister agencies and build a secure interface so 
        that we can exchange data with DHS. Finally, we will purchase 
        essential reagents and test kits to conduct biomonitoring 
        surveillance. In fiscal year 2007, we will spend $2 million of 
        the Food Defense increase for these activities.
  --Improve our Emergency Operations Network ($1 million) to allow FDA 
        to conduct more sophisticated incident tracking for food-
        related emergencies.
  --Continue Field support of food defense operations ($3 million), 
        including the targeting of potentially high-risk imported foods 
        through Prior Notice Import Security Reviews based on 
        intelligence, FDA inspection reports, discrepancies in prior 
        notice reporting and sample collection and analysis.
Critical Path to Personalized Medicine (+$5.9 million)
    FDA requests an increase of $5.9 million in fiscal year 2007 for 
the Critical Path to Personalized Medicine initiative. This will allow 
us to increase the predictability and efficiency of developing new 
medical products, and deliver greater benefits to patients as we 
accelerate the field of personalized, predictive, preemptive, and 
participatory medicine. Our goal is to stimulate a new generation of 
scientific tools that will enable product sponsors to evaluate and 
predict the safety and effectiveness of drugs. This will permit 
physicians to tailor therapies to individual patients and avoid 
potentially dangerous adverse events. The Critical Path to Personalized 
Medicine Initiative also fulfills the Congress' expectation under the 
Food and Drug Administration Modernization Act, when it charged FDA to 
work collaboratively with partners in government, academia, and 
industry to advance medical product development. A modern, robust 
Critical Path will lead to solutions that will deliver on the promise 
to make our future health care, personalized, predictive, preemptive, 
and more cost effective.
    The fiscal year 2007 investment will support:
  --Imaging Initiative.--Our Critical Path investment will support 
        efforts to accelerate an understanding of the use of positron 
        emission tomography (PET) and other advanced imaging 
        technologies as surrogate endpoints for developing new cancer 
        drugs. A surrogate endpoint helps to predict the benefit that a 
        patient may experience from therapy. In fiscal year 2007, we 
        will participate in developing technical standards for PET 
        imaging--the tools that will enable drug developers to evaluate 
        and improve the effectiveness of new products.
  --Improving Stent Design.--Cardiovascular disease is a significant 
        cause of morbidity and mortality in the United States, and drug 
        eluting stents have become a standard therapy to address 
        cardiac disease in many patients. Today, most vascular stents 
        eventually fail and alternative designs are difficult to test 
        in humans. Our objective is to improve stent performance and 
        safety by predicting and avoiding product failures. In fiscal 
        year 2007, we will develop the preliminary components of a 
        simulation model of drug eluting stent behavior in adults and 
        children. Also in fiscal year 2007, we will work to develop 
        open source imaging software to assess stent performance and 
        begin to develop guidance for industry on using the simulation 
        model to predict stent performance.
  --ECG Warehouse.--We will invest funds to develop the tools to permit 
        searches of electrocardiogram (ECG) data submitted with drug 
        applications so that we can identify cardiovascular risk 
        patterns associated with unsafe drugs. We will also partner 
        with academia and the public sector in fiscal year 2007 to 
        conduct additional ECG analyses. This will improve our ability 
        to identify cardiac safety concerns before we approve a drug 
        for marketing and also detect post market safety signals. 
        Through these activities, we will help ensure that therapies 
        are safe and effective, and we will improve outcomes for 
        patients who are using products that are already on the market.
    The need for new medical treatments and the investment of billions 
of dollars in basic biomedical research led many in the medical 
community to anticipate a new wave of medical products capable of 
dramatically saving and extending lives. Yet the recent slowdown in the 
rate of new medical treatments actually reaching patients is a 
significant concern at FDA. Products fail before they reach the market 
because clinical trials fail to demonstrate safety or efficacy, or they 
cannot be manufactured at a consistently high quality. Despite recent 
innovations, many serious and life-threatening diseases still lack 
effective treatments.
    At FDA, we witness the full spectrum of drug, device, and biologic 
product development. From this unique perspective, it is clear that the 
development of evaluative scientific tools to utilize in medical 
product development has not kept pace with the rapid advances in basic 
sciences. The path from cutting-edge medical discovery to the delivery 
of safe and effective treatments is long, arduous, and uncertain--and 
it does not yield extensive information on product performance. To 
correct this imbalance, FDA initiated the Critical Path to Personalized 
Medicine, a program designed to modernize medical product development 
to ensure more efficient and more informative product development and 
clinical use. FDA considers the Critical Path Initiative to be its top 
scientific policy initiative for at least the next 5 years.
    FDA's Critical Path Initiative will stimulate research community 
efforts to identify the essential biomarkers and improved clinical 
trial designs that will accelerate product development. Biomarkers are 
measurable characteristics that reflect physiological or disease 
processes. Medicine can use biomarkers to predict or monitor response 
to therapy. The initiative will generate essential information to 
identify patients likely to benefit from a treatment and patients more 
likely to respond adversely to a product. Without clinically proven 
biomarkers and innovative trial designs, we cannot modernize medical 
product development and realize the potential of personalized medicine. 
The subcommittee recognized this need when it appropriated funds for 
FDA in fiscal year 2006 to study cardiovascular biomarkers predictive 
of safety and clinical outcomes, and the funds that we request in 
fiscal year 2007 will support broader efforts to achieve personalized 
medicine.
Drug Safety (+$4.7 million in budget authority and user fees)
    FDA will build on recent improvements to its drug safety activities 
with an fiscal year 2007 increase of $4.7 million (a $3.96 million 
increase in budget authority and $0.74 million in PDUFA user fees). The 
proposed fiscal year 2007 budget will provide a significant increase to 
our base resources for drug safety and will allow FDA to continue to 
strengthen our capacity to recognize and act on emerging drug safety 
concerns.
    As we plan for fiscal year 2007, we must continue to focus on the 
needs of the patient. We must constantly ask ourselves--how can we 
achieve the proper risk/benefit balance while speeding patient access 
to safe and effective products? U.S. pharmacies fill approximately 3.7 
billion prescriptions per year and consumers make more than 5 billion 
over-the-counter drug purchases annually. The effect of these medicines 
on the full spectrum of our population causes unforeseen problems to 
surface that may not have appeared during the sometimes-lengthy drug 
review process.
    Our fiscal year 2007 drug safety request will permit us to launch a 
web-based system that provides agency analysts faster access to adverse 
event reports. Known as AERS II, this system will allow FDA to more 
easily evaluate potential safety issues, and improve our ability to 
take follow-up actions to protect patients. Fiscal year 2007 funding 
will also allow us to analyze valuable drug safety information housed 
in CMS and other population-based databases and to conduct studies of 
high priority safety issues in the Medicare population. Studies 
conducted on these types of databases will provide more supporting 
evidence about drug use under a broader range of conditions, and more 
detailed evidence about drug safety in subgroups of patients, such as 
the elderly, and in patients with multiple medical conditions. This 
will provide FDA with many of the tools necessary to formulate and 
communicate safety information to health care practitioners, consumers, 
and the research community in a more timely and user-friendly way.
    We have made important drug safety enhancements during the past 
year, and I would like to highlight these activities for your now. The 
members of this Subcommittee provided an increase of $9.9 million in 
FDA's fiscal year 2006 budget. We will bolster premarket and postmarket 
drug safety functions by using these funds to:
  --Increase the professional staff in FDA's Center for Drug Evaluation 
        and Research (CDER) who perform high priority drug safety 
        reviews.
  --Increase the number of staff with expertise in critical areas, such 
        as risk management, risk communication, and epidemiology.
  --Expand our information technology infrastructure for monitoring 
        post-marketing data by increasing access to a wide range of 
        clinical, pharmacy, and administrative databases.
  --Hire additional experts to enhance use of multidisciplinary, multi-
        office teams to interpret drug safety data.
  --Access external population-based ``linked'' databases to identify 
        drug safety signals.
    Other important drug safety accomplishments during the past year 
include:
  --Establishing a Drug Safety Oversight Board to provide independent 
        oversight and advice on drug safety and disseminating safety 
        information. The Board conducted 5 meetings in 2005 to discuss 
        17 drug products with potential risks.
  --Appointing a new director of CDER's Office of Drug Safety.
  --Conducting a public meeting of experts to assess risk communication 
        about drugs and to plan future communication efforts.
  --Unveiling a major revision to the format of prescription drug 
        information, commonly called the package insert, to give 
        healthcare professionals clear and concise prescribing 
        information.
    These efforts emphasize our commitment to providing the American 
public with safe and effective medical products.
Tissue Safety (+$2.5 million)
    FDA requests an increase of $2.5 million to provide the essential 
resources to support a human tissue safety, including our role in 
monitoring the expanding field of tissue transplantation and the 
emerging challenges of bioengineering. These funds will allow the 
agency to:
  --Commence a comprehensive risk-based approach to assure the safety 
        and quality of human cells, tissues and cellular and tissue-
        based products used for transplantation. Examples include 
        corneas, heart valves, ligaments, joints, skin, or other 
        tissues.
  --Promptly monitor and investigate adverse events and tissue product 
        problems.
  --Take early action to improve tissue practices and prevent tissue-
        related injuries and deaths.
  --Educate industry, the medical community, and the public about human 
        tissue safety.
  --Support promising new technologies that use cells and tissues, 
        including therapies for diseases such as cancer, AIDS, 
        Parkinson's disease, hemophilia, diabetes, and other serious 
        conditions.
    This program will provide guidance and predictability to more than 
2,000 registered establishments that process and distribute tissue 
products used in medical procedures that save or enhance the lives of 
recipients. FDA has seen its workload in the area of human tissue 
transplants rise dramatically as transplants have increased from 
approximately 350,000 in 1990, to more than 1,000,000 annually. The 
number of transplants will continue to rise in the years ahead.
    With these resources, FDA will conduct 75 additional tissue 
inspections in fiscal year 2007 and thereby increase our annual 
inspection coverage to 325 facilities. Through inspection and 
monitoring activities, we can ensure that establishments demonstrate 
safety and efficacy of their products. These funds will also permit FDA 
to rapidly review, track, and analyze tissue deviation reports. 
Finally, we will issue guidance for industry on emerging issues 
relating to the eligibility of donors and good tissue practices. The 
goal of these efforts is to ensure safe outcomes for patients when they 
receive tissue transplants.
    FDA's announcement in early February that we ordered a New Jersey 
company to cease operations is evidence that we will take action to 
protect the public health against tissue manufacturers that fail to 
follow safety requirements. This is an example of the targeted 
enforcement action we will conduct to protect the public health when we 
have evidence unsafe tissue practices.
Budget Authority in Support of User Fee Programs--MDUFMA and ADUFA 
        (+$7.4 million)
    To achieve more timely and cost-effective review of new medical 
devices and animal drugs, we continue to implement Medical Device User 
Fee and Modernization Act (MDUFMA) and the Animal Drug User Fee Act 
(ADUFA). Congress enacted these statutes to allow the agency to collect 
user fees from companies that submit medical device and animal drug 
applications.
    In fiscal year 2007, we are requesting a total increase of $7.4 
million in new budget authority ($4.9 million for medical devices and 
$2.5 million for animal drugs) to ensure that we meet statutory 
requirements, known as triggers, and fulfill the fiscal year 2007 
performance commitments under these programs. If we do not receive 
sufficient budget authority to meet the statutory triggers, FDA will 
lose the right to collect $55.3 million in user fees. The flow of 
potentially life saving medical devices will decline and the use of 
unapproved drugs in food-producing animals will likely rise.
    Under both these user fee programs, we pursue a complex and 
comprehensive set of product review goals. Each year brings additional 
goals, and the goals become more aggressive. FDA provides a complete 
report on its performance on under these programs at the end of each 
year.
    The proposed increase will permit FDA to maintain its highly 
skilled scientific and professional review staff and conduct speedier 
review and approval of safe and effective medical devices. Under 
MDUFMA, FDA is meeting, or is on track to meet, nearly all of the 
performance goals for fiscal year 2003, fiscal year 2004, and fiscal 
year 2005. We will continue to make program improvements to ensure we 
meet the goals for fiscal year 2006 and fiscal year 2007. Under ADUFA, 
FDA expects to meet or exceed all performance goals.
Cost of Living--Paying our People (+$20.3 million)
    Soon after the President appointed me Acting Commissioner, I told 
my FDA colleagues that the well-being of our agency's employees was one 
of my top priorities. The talented and dedicated FDA employees are the 
agency's most precious asset and are the primary reason for our 
success.
    The proposed increase of $20.3 million to meet inflationary pay 
costs is essential to FDA's ability to accomplish its public health 
mission. Payroll costs account for more than 60-percent of the FDA 
budget, and the Agency is not able to absorb inflationary increases on 
such a significant portion of its resources. These funds will allow FDA 
to maintain its world-class workforce and achieve the promise of a 
healthier America.
    FDA's diverse portfolio of pubic health responsibilities demands 
that we maintain a large cadre of scientists and professionals with the 
training and experience to respond to complex and escalating public 
health challenges. This workforce is directly engaged in both 
developing the science of regulation as well as administering 
regulatory functions.
    FDA professionals are increasingly challenged by evolving food 
defense responsibilities as well as growing responsibilities in 
regulation of vaccine, drug, and device, development. Within the past 
year, they have addressed threats such as BSE (Mad Cow Disease), 
Salmonella, West Nile Virus, and pandemic flu. The FDA workforce 
reviews, approves, and continues to ensure the safety and effectiveness 
of products to manage cancer, diabetes, and heart disease, as well as 
oversee products intended to preserve health. FDA principally expends 
its budget for payroll that allows us to recruit and retain a skilled 
workforce dedicated to safeguarding the public using advanced tools to 
preempt public health threats.
Unified Financial Management System (UFMS) (+$1.2 million)
    In fiscal year 2007, FDA seeks an increase of $1.2 million to fully 
utilize the Unified Financial Management System (UFMS) for all of our 
financial transactions. These funds will allow FDA to achieve a major 
program milestone in the implementation of a new centralized financial 
management system under the Department of Health and Human Services 
(HHS). These additional funds would bring the fiscal year funding level 
to $14.1 million.
    UFMS is changing the way HHS agencies do business at it improves 
efficiencies in business processes and technology It will replace five 
redundant and outdated accounting systems in use at the National 
Institutes of Health, the FDA, the CDC, the Centers for Medicare and 
Medicaid Services, and the DHHS Program Support Center. The requested 
increase and the base funds in our budget will support dual functions. 
First, as a component of the Department-wide system, FDA resources will 
support testing and integration of the UFMS system, as well as regular 
operation and maintenance of UFMS. Second, fiscal year 2007 funding 
will support FDA-specific functions such as the purchase of reporting 
tools and software licenses, essential system upgrades and new software 
releases, and training to support FDA users of this new system. This 
will ensure that we satisfy financial requirements and provide timely 
financial information to executives and managers to support better 
decision making. As FDA fully integrates UFMS into our systems and way 
of doing business throughout fiscal year 2007, we expect to witness the 
projected efficiencies for this vital enterprise and be able to use 
UFMS' full financial management capability.
Infrastructure (+$11.3 million)
    In fiscal year 2007, FDA submits a modest request to fund three 
fundamental components of our physical infrastructure:
  --An increase of $10.5 million for rent payments to the General 
        Services Administration (GSA).
  --An increase of $3.8 million in budget authority to maintain 
        progress on the White Oak Consolidation project.
  --A reduction of nearly $3 million below the fiscal year 2006 
        appropriated level for our Buildings and Facilities account.
    In total, these proposals would result in a net increase of $11.3 
million for fiscal year 2007.
    We also plan to commit $8.2 million in PDUFA carryover funds to the 
White Oak project and $1.9 million for GSA rental payments. FDA 
continues to seek support for the White Oak project with the goal of 
eventually housing over 7,700 staff in 2.3 million square feet of 
space. As of the end of calendar year 2005, we have approximately 1,850 
staff on site at White Oak, in three buildings with almost 700,000 
square feet. The new buildings will eventually replace all 40 existing, 
fragmented facilities in 16 locations that support the Office of the 
Commissioner, and all of our Centers and the Field headquarters, other 
than the Center for Food Safety and Applied Nutrition and the National 
Center for Toxicological Research.
Proposed User Fees: Reinspection and Food/Animal Drug Export 
        Certificates ($25.5 million)
    In addition to those user fees authorized by statute, the FDA is 
proposing two new user fees. The first, estimated at $22.0 million, 
would pay the full cost of reinspection and other FDA follow-up work if 
a manufacturer fails to meet important FDA requirements such as Good 
Manufacturing Practices, which help ensure high quality and safety of 
FDA regulated products. When a firm fails an inspection, FDA must 
conduct a reinspection and perform associated laboratory analysis to 
verify the firm's corrective measures.
    The reinspection user fee will ensure that facilities that fail to 
comply with established health and safety standards bear the cost of 
FDA follow-up inspection. We are asking Congress to assess the cost of 
follow-up inspections on those who fail to comply, rather than on the 
American taxpayer, who bears the cost today. The natural consequence of 
this change will be that manufacturers will work to ensure that they 
meet established standards.
    The second proposed new user fee will cover the cost of issuing an 
approximately 37,000 food and animal feed export certificates. We have 
estimated the cost of this user fee program at $3.5 million. Although 
the agency's effort to issue these certificates benefits industry 
exports, FDA must support this function at the cost of other vital 
public health activities. FDA's proposal for user fees would establish 
a source of dedicated funding for this activity and allow the agency to 
better perform this function. The domestic food and animal feed 
industry would benefit from the agency's enhanced ability to facilitate 
the exportation of their products.
    The Federal Food, Drug, and Cosmetic Act (the Act) authorizes FDA 
to collect user fees for export certificates for human drugs, animal 
drugs, and devices. However, this authority does not extend to 
collecting user fees for export certificates for foods and animal feed. 
FDA expends significant resources annually to issue these certificates, 
and the agency needs to focus its resources on activities that are 
central to its public health mission. The Administration has asked that 
Congress fund these two user fee programs with mandatory budget 
authority.
Current Law User Fees (+$20.2 million)
    We are also requesting an increase of $20.2 million for user fees 
that support prescription drug review, medical device review, animal 
drug review, mammography inspections, export certification, and color 
certification fees, for a total fiscal year 2007 user fee level of $402 
million. These fees enable FDA to review medical products in a timely 
manner and reimburse FDA for two services (color certification and 
export certification for human drugs, animal drugs, and devices) that 
we provide to industry. All of these requested fee increases are 
authorized under current law. In fiscal year 2007, FDA will work with 
Congress on the reauthorization of the PDUFA, MDUFA, and ADUFA user fee 
programs.
Closing
    Mr. Chairman, I look forward to working with you, members of the 
Subcommittee, and your staffs to maximize FDA's resources in the best 
interest of the American people and our country as we move into fiscal 
year 2007. The agency's program level request of $1.95 billion is 
necessary to perform our mission--established by Congress a Century 
ago--to protect and promote the health and safety of the American 
public. At the Food and Drug Administration, we work tirelessly to 
fulfill these public health responsibilities. Our goal is to maximize 
the benefits and minimize the risks from the products we regulate.
    Among my highest priorities as Acting Commissioner--for as long I 
am privileged to serve at the helm of FDA--will be to foster the 
development of the FDA of the 21st Century. Building on the success of 
the past, we will maintain our ``covenant of trust'' with patients and 
the public. We will assure they have safe, effective, modern, and cost 
efficient solutions for the challenges to their health and well-being, 
and the health and well-being of their children and grandchildren. A 
well managed and adequately funded FDA will mean a healthier America 
for many generations to come.

                         STRATEGIC REDEPLOYMENT

    Senator Bennett. Thank you very much.
    You talk about reprogramming and redirecting the $52 
million. Would you please provide for the record more specific 
information on each program that you plan to either reduce or 
eliminate and the impact this will have?
    Dr. von Eschenbach. Yes, sir. We will be very pleased to 
provide that for the record in significant detail.
    [The information follows:]

    
    
    Senator von Eschenbach. We have gone through the entire 
portfolio across the various centers and offices with the FDA, 
worked extensively with the staff within those offices to look 
for those opportunities and those efficiencies where we could 
leverage, synergize, and partner, and we will provide the 
detail for each of those particular parts of the portfolio for 
you.

                           PANDEMIC INFLUENZA

    Senator Bennett. All right. Thank you.
    Last night, as I was watching television, which I don't 
often do--the news programs on television strike me as being 
more fictional than the sitcoms in many cases--running across 
the bottom of one of them was constant reference to Secretary 
Leavitt's warning with respect to pandemics.
    And you discussed pandemic influenza preparedness at some 
length in your testimony, and we provided $20 million for 
pandemic preparedness in fiscal 2006. Now you are asking for an 
additional $30 million.
    For those who do watch television and the streamer that 
runs across the bottom, could you discuss FDA's overall role in 
preparing for a pandemic and kind of tell us what you see in 
that whole area coming ahead for us?
    Dr. von Eschenbach. Thank you, Mr. Chairman.
    I believe your question points out a very essential and 
critical element in our overall plan for a pandemic, and that 
particular element is the essential role that the FDA must play 
across a large portfolio of opportunity.
    The role being to make certain that we are proactively 
helping to develop and to approve vaccines, antivirals and, 
devices that could be used for diagnostic purposes as well as 
devices that may have to be used ultimately with regard to 
human protection and support. And the important area that needs 
to be included in the portfolio, and that is the attention that 
needs to be paid to food animal.
    In each of these areas, FDA plays and must continue to play 
a critically important role in that process. We are engaged, 
for example, in working proactively with companies in the 
industry to help stimulate the development of vaccines, to help 
them improve current vaccine production capabilities, including 
the utilization of cell-based techniques in addition to the 
traditional egg-based techniques that have been used.
    Senator Bennett. Let me interrupt you there quickly because 
I have been contacted by an American company that works on the 
issue of cell-based techniques as opposed to egg-based. And I 
want to call your attention to the fact that there are American 
companies that are in this field, and there has been concern 
raised about contracts being given overseas that are primarily 
to egg-based fixes, while there are American companies that 
complain that they are being overlooked.
    And I would ask you to pay personal attention to that as we 
go forward because it has to do with volume.
    Dr. von Eschenbach. I certainly will continue to look into 
that, as will the rest of the agency, and pay very close 
attention to that. Because our commitment is to broaden the 
portfolio as widely as possible to make as many opportunities 
and options available with regard to the development of new 
vaccines, specifically directed to H5N1.
    With regard to antivirals, just as an example of the FDA's 
commitment, we are actively looking at opportunities to enhance 
shelf life of antivirals such as Tamiflu, which would 
significantly increase and enhance our abilities with regard to 
stockpile.
    In devices, we work collaboratively with the CDC and 
recently approved in a very rapid period of time a diagnostic 
device, which can be used in processes of screening and looking 
for the first and earliest signs of H5N1.
    And one of the areas I have pointed out which we needed to 
include into the FDA's commitment, and where a significant 
amount of the new funds are being directed, has to do with 
issues with regard to animal welfare, including the ability to 
regulate how animals will be used and making sure that we check 
and look for residue or traces of antivirals because we are 
concerned about the development of resistance in animals and 
humans.
    But also should there be an outbreak or pandemic of avian 
flu within our bird population, the destruction of those food 
animals places the FDA in a critically important role with 
regard to regulating the processes of destruction and assuring 
that there is no contamination and risk for human health.
    So it is a very broad portfolio, and we initiated after I 
arrived at FDA an integrated task force within FDA so that all 
these parts and pieces are now being coordinated and integrated 
into a cohesive effort so that FDA contributes appropriately to 
the larger initiative being carried out at the Department of 
Health and Human Services and in other agencies.
    Senator Bennett. Thank you very much. I would note that the 
company that contacted me is not located in Utah.
    Senator Kohl.
    Senator Kohl. Thank you, Mr. Chairman.

                             GENERIC DRUGS

    Dr. von Eschenbach, the FDA plans to spend over $400 
million to approve approximately 88 new brand-name drugs and 
just $65 million to approve over 400 new generic drugs in 
fiscal year 2007. There are currently over 800 generic drugs 
waiting to be reviewed at FDA, and the generics waiting list is 
expected to grow, as you know.
    Now I understand the importance of reviewing and approving 
new drugs. They are often breakthroughs in the treatment of 
disease. However, according to the Congressional Budget Office, 
generic drugs on the market now save consumers an estimated $8 
billion to $10 billion a year at retail pharmacies, and this 
doesn't include the money saved when they are used in 
hospitals.
    As you know, they bring a big bang for the buck. And while 
the backlog continues to grow, your budget doesn't seem to make 
any effort to reduce that backlog. It seems that a relatively 
small increase, especially in relation to the money you spend 
to approve brand-name drugs, could make a big dent with respect 
to generics. How do you answer that?
    Dr. von Eschenbach. Thank you very much, Senator Kohl, for 
addressing what we believe is a very important and critical 
issue.
    As you point out, we do want to continue to be sure that we 
are nurturing and supporting the innovative opportunities to 
continue to bring new solutions to patients, especially based 
on the progress that is being made in biomedical research and 
molecular medicine. At the same time, however, we are equally 
committed to being certain that we can provide access to 
patients to a wide portfolio of these drugs, including the 
availability of generics.
    Over a period of time, we have a commitment to the generic 
program using all of the dollars that have been authorized for 
that purpose and have seen a continuous increase in the number 
of generics being approved each year. It is also true that the 
number of applications have also continued to increase.
    We are attempting to address this problem in a variety of 
ways. First, we are giving priority to the first generic 
available. That is enabling us to assure that at least across 
the entire portfolio, Americans have access to one alternative 
to the innovator drug.
    In fact, we believe that program has been successful, to 
the extent that we are approving first generics almost 
simultaneously with patent issues having been resolved. We have 
narrowed any gap between the legal barriers and the regulatory 
barriers making those drugs available to patients.
    With regard to volume, we are at a point now where we are 
approving more than one generic drug on the average every day. 
Having said that, we also recognize the need for continuous 
improvement in the process, to continue to expand our ability 
to grow the portfolio to alleviate the backlog.
    We are directing more people to the effort of the approval 
process. We are working with manufacturers to enhance the 
quality of their submissions in order to reduce cycle time to 
approval.
    Most importantly, we are improving our own internal 
processes, especially by moving from paper-based regulatory 
approval processes to electronic based. And we believe this 
electronic infrastructure will be a significant step forward in 
enhancing the rapidity of our ability to process these 
applications and eliminate the backlog.

                          GENERIC DRUG BACKLOG

    Senator Kohl. In spite of all of that, there are 800 
generic drugs waiting to be reviewed and approved at the FDA, 
and that waiting list is expected to grow. So why don't we find 
a way, understanding how important these generic drugs are in 
helping people save money, why don't we find a way to more 
quickly address this backlog?
    Do you see that as a high priority that you want to get at, 
or is it business as usual?
    Dr. von Eschenbach. No, sir.
    Senator Bennett. If I could just do the math? If they have 
800, and they are doing one a day, and they don't work 
Saturdays and Sundays, that is about 3 years of backlog.
    Senator Kohl. Thank you.
    Dr. von Eschenbach. Senator, let me approach the question 
in the following way. We are committed, as you are, to being 
able to expand the portfolio of access to various solutions for 
the American people. And to do that, I believe really requires 
a process improvement. It is a way of looking at this entire 
continuum and looking for places in which we can improve cycle 
time, where we can improve the ability to move larger volumes 
of these applications more effectively through the system.
    And as I indicated, the strategies that we are embarking 
upon are more people, more effective means of processing 
applications, including electronic submissions and electronic 
review, and working more collaboratively and proactively with 
the manufacturers of these generics in order for them to be 
able to enhance their applications and improve the application 
process.
    We believe that by a multi-pronged effort, we will find 
incremental benefits along the entire process improvement 
continuum. The end result being more generic drugs coming, 
being made available to the American people.
    Senator Kohl. Of course, you understand the American people 
want every generic drug that can be approved to be approved 
because it is an immediate tremendous saving in their pocket, 
right? And that is why we are here. That is a basic reason why 
we are here.
    I just make that comment, and I turn it back to you, Mr. 
Chairman.
    Senator Bennett. Yes. I mean, a 3-year backlog, and you add 
in holidays, you get to 3.5.
    Senator Kohl. Thank you again.
    Dr. von Eschenbach. Well, I think----
    Senator Bennett. That is more significant than I had 
realized.
    Dr. von Eschenbach. Well, I think one of the important 
things I would like to also emphasize--and apologize if I 
didn't make it as clear as I should have--is that in looking at 
the large volume of generics and what is available to the 
American people, we are looking at this in a hierarchical 
fashion.
    First and foremost, we want to be sure that across the 
continuum of drugs that there is at least one generic available 
for any one of those particular drugs or solutions. Then there 
are follow-on generics after that or additional generics that 
are complementary or perhaps identical to that same generic.
    Now the entire portfolio will always continue to grow, but 
there is a point where we believe that at least being sure that 
there are available drugs, generic drugs for every condition 
and in every situation and circumstance will be our first 
priority.
    Senator Bennett. So you are saying you are prioritizing 
them so that the generic that would benefit the greatest number 
of people will get moved up in the----
    Dr. von Eschenbach. Exactly, sir. In order to put the 
backlog into perspective, it would be one thing if we had a 
backlog in which there was an innovator drug for which there 
was no alternative generic. That would be a backlog that would 
have a critical impact on the health and welfare of the 
American people.
    But if the backlog is one in which we already have three or 
four generics available for that particular drug, and there is 
a backlog of three or four other applications, that is going to 
get less priority in the hierarchical system.
    Senator Bennett. Well, I encourage you to continue to do 
that, and that is prudent management. But it would be helpful 
if the total number could come down and the total backlog could 
shrink a little.

                 CRITICAL PATH TO PERSONALIZED MEDICINE

    Let me focus for a minute on your new initiative called the 
Critical Path to Personalized Medicine. That is an intriguing 
title, and this is obviously a long-term investment on your 
part.
    Tell us what the ultimate goals are and how long you think 
it will take to achieve those goals. Or is this something that 
the goals will always be coming up, so this is a long-term 
program that will continue?
    Dr. von Eschenbach. Well, Mr. Chairman, I have benefitted 
greatly from my previous experience in being able to witness 
firsthand the tremendous progress that is being made in 
biomedical research and the literal explosion in our ability to 
understand diseases and even human health and nutrition from a 
genetic and molecular perspective.
    And that discovery is really opening up for us the 
opportunity to develop new solutions, new products that are 
very different and unlike the products and solutions that we 
have seen in the past. We need a new bridge between that 
discovery to the delivery of those new solutions to patients, 
and that bridge of development is the bridge that the FDA is 
responsible for and is nurturing.
    And it is the critical path from that discovery to that 
delivery that we are committed to by bringing to the regulatory 
process the science that has been involved in the discovery and 
the development of these new interventions and the science and 
technology that will be necessary in order to regulate and 
approve these new solutions and new products with regard to 
their safety and their efficacy.
    So, in that context, with regard to that vision of what we 
are trying to accomplish, it will be an ongoing iterative 
process. We will continue to develop it as the science and 
technology continues to develop it.
    But our goal is to make certain that these new solutions 
that we are experiencing by virtue of our investment in 
biomedical research at the NIH and in other areas will, in 
fact, translate into solutions that can and will be delivered 
rapidly, effectively, and safely to the American people.
    Senator Bennett. Well, one of the frustrations that I have 
had since I have been in the Senate is that almost none of the 
discussion about health care has anything to do with health. It 
is always focused on acute care or after the fact kind of care.
    And if I hear correctly what you are saying, FDA is making 
a commitment for keeping people healthy prior to the time when 
they would need acute care and taking advantage of the science 
that is being developed at NIH and elsewhere.
    And if we are successful and keep people healthy at the 
front end, we presumably save money at the back end. Is this a 
fair summary of what it is you are aiming for?
    Dr. von Eschenbach. It is an absolutely insightful summary, 
and I appreciate you framing it in that way. We believe that 
the opportunities that are now available to us, the 
opportunities that the FDA can make possible for the American 
people, and for the rest of the world, by virtue of this 
critical path from discovery to delivery is the fact that 
medicine will be more preemptive or preventive.
    We will have the tools to be able to understand the 
earliest stages in the development of many diseases and be able 
to then have products that will be able to be delivered to 
preempt that process. Being able to develop and regulate 
approval of those products will require a new FDA, the FDA of 
the 21st century.
    And so, we will see cost benefits to that by moving out of 
a model that is predominantly focused on the treatment of 
established disease to a model in which we will have the 
solutions and tools to detect diseases much earlier in their 
development and then to be able to intervene and preempt them.
    It will also be personalized. We are seeing increasingly 
opportunities to be able to define the right intervention for 
the right patient based on our understanding of these 
fundamental molecular mechanisms. And we are seeing new 
targeted drugs becoming available and coming to the FDA for 
regulatory approval.
    If we get the right drug to the right patient, we eliminate 
the waste that occurs in the old system, the empiric system, 
where we are giving patients an intervention based on a 
statistical probability of success, but not knowing whether it 
will work in that patient or another patient. Just the fact 
that we can eliminate waste will have significant implications 
for our total expenditures in health care.
    Senator Bennett. I would like to pursue that with you in 
some detail because I think, ultimately, that is the only 
solution to our spiraling increase in Medicare and private 
health care costs.
    Dr. von Eschenbach. I would look forward to that, Senator.
    Senator Bennett. Yes. Senator Kohl.

                             GENERIC DRUGS

    Senator Kohl. Thank you very much.
    Just to add a final word on generics, you stated that you 
prioritized to be sure that we have at least a generic, if not 
two, available for every brand-name drug. I would like to ask 
my staff to work with your staff to satisfy me that, in fact, 
we are doing a good enough job in meeting at least that minimum 
kind of a condition which, as you point out, is very important, 
and I would agree.
    Dr. von Eschenbach. We would welcome that, Senator.
    Senator Kohl. Thank you.
    Dr. von Eschenbach. And look forward to working with your 
staff.

                            AVIAN INFLUENZA

    Senator Kohl. Dr. von Eschenbach, I was recently looking at 
some news reports on avian flu, and these two reports seemed to 
summarize, I think, what many people are feeling.
    The first report quoted Dr. Gerberding of the CDC as saying 
that our current situation is not a good one. Secretary 
Johanns, on the other hand, was quoted that same day as stating 
that bird flu is coming to America, but he said that we are 
ready and ``know how to deal with it, and we will deal with 
it.'' And just last week, he testified to us that, ``We are 
well prepared for bird flu.''
    It is understandable why many people are confused and 
uncertain and concerned about how to react. So from your 
perspective, are we prepared for a bird flu outbreak? How much 
vaccine do we have on hand now? And please talk about our 
ability to obtain or make more vaccine.
    Dr. von Eschenbach. Well, Senator----
    Senator Kohl. Do you think we are well prepared?
    Dr. von Eschenbach. Pardon me, sir?
    Senator Kohl. How would you summarize our situation with 
respect to the possibility of a bird flu outbreak?
    Dr. von Eschenbach. One of the things that I have 
appreciated is the fact that, as Secretary Leavitt has 
indicated, we are in a race. We are in a race with regard to 
our ability to mobilize and prepare all of the particular 
interventions and solutions that will be necessary to deal with 
an avian flu outbreak in humans.
    And that race to prepare is in contrast to the race that 
the virus is engaged in with regard to its mutations. We don't 
know and can't predict exactly how long it may take for the 
virus to undergo the mutations that might be necessary for 
human-to-human transmission. We certainly have seen enough with 
regard to the virus to be alarmed and concerned that that 
ultimately might occur.
    Having witnessed the mobilization that is occurring with 
regard to not only our own infrastructure within the United 
States, but around the world, I believe that we are engaged now 
in a very positive and very constructive and productive effort 
to bring all of the components to bear. As I indicated, the FDA 
is taking its role in a very integrated and comprehensive way 
to look across this continuum, to accelerate the ability to 
develop vaccines.
    We cannot develop a vaccine for the human-to-human virus 
until that virus occurs, but we are developing vaccines for the 
H5N1 that has already occured. And we are also developing seed 
strains so that we have in place variations of the virus so 
that we would be already prepared to move to the next step to 
mass production of vaccines once we got the right match.
    So I use that as an example to point out that it is a 
problem that requires a comprehensive, integrated, 
collaborative solution. It is one in which we will look across 
the wide portfolio of interventions, and it will go beyond just 
vaccines to also include, as I have indicated before, 
antivirals, and diagnostic devices.
    Senator Kohl. But just last week, the United Nations stated 
that bird flu could arrive in the United States between 6 and 
12 months from now, which is imminent. So if these predictions 
are correct, the virus could arrive in the United States before 
we have the capability to make mass quantities of vaccines.
    What advice do you have for people all across our country 
who are concerned about this imminence, this possibility within 
6 to 12 months?
    Dr. von Eschenbach. Well, I think, as Secretary Leavitt has 
indicated, we need to be aware of the threat. We need to not 
panic, but we need to prepare in the sense of anticipating and 
being aware of the fact that this is a threat that could strike 
us.
    It has not happened at this point in the sense of having 
the avian form of the disease in the United States, but that is 
expected to occur. It has not happened with regard to a strain 
that has human-to-human transmission capabilities.
    But I think as far as the public is concerned, the 
continued support of the efforts that are being made across the 
public health continuum--not only in the Department of Health 
and Human Services, but throughout the rest of the academic 
world and in conjunctions with WHO--as you pointed out, I think 
it is a commitment to prepare and to prepare as rapidly as 
possible is the most important contribution we could make at 
this point.
    Senator Kohl. Thank you, Mr. Chairman.
    Senator Bennett. Senator Harkin.

                    BOVINE SPONGIFORM ENCEPHALOPATHY

    Senator Harkin. Thank you very much, Mr. Chairman. And I 
apologize for being late. We had an authorizing committee 
hearing prior to this, not the appropriations.
    But I thank you, Mr. Chairman, and welcome our witnesses 
here, especially Dr. von Eschenbach, whom I have worked with a 
great deal at NIH over the years.
    I will get right to the point. Maybe this has been asked 
before, but I don't know if anything has been brought up about 
the recent case of BSE that was just discovered in Alabama.
    Senator Bennett. It hasn't been asked. So go ahead.
    Senator Harkin. Thanks, Mr. Chairman.
    Well, as you know, it is in the press now that it was 
confirmed that we have another animal, a 10-year-old cow in 
Alabama tested positive for BSE, and now they are looking at 
the herd and the feed and everything else to try to figure out 
if there were other animals contaminated or where this 
contamination may have come from.
    Now FDA recently proposed several changes to the feed ban 
rule that it first adopted in 1997. The main adjustment 
proposed is that brain and spinal cord from cattle would be 
banned from all animal feed, not just from cattle feed, okay? 
So far, so good.
    However, the loophole that currently exists of allowing 
poultry litter--yes, you heard me right--poultry litter to be 
fed to cattle would continue.
    So we have a situation where you can take some of the SRMs, 
specified risk material, from cattle, a ruminant animal, feed 
it to chicken. Some of that gets into the litter. The litter is 
then fed to a ruminant animal. The prions exist, and they may 
exist in the SRMs from the slaughtered, go into chicken feed, 
fall into the litter, and be fed back to a ruminant animal.
    Canada is in the process of strengthening its feed ban rule 
to prohibit all, all specified risk materials from all animal 
feed, including pet food. That is, Canada is going beyond just 
the brain and spinal column. Canada has already banned poultry 
litter and plate waste from cattle feed.
    Now FDA clearly acknowledges that the main cause of BSE in 
cattle is from contaminated feed. In fact, the feed rules are 
routinely cited by USDA and FDA officials as our first line of 
defense against BSE. But in this case, FDA, with these new 
proposed rules, appears to be preparing to come out with a 
weaker feed rule than Canada, weaker than has been called for 
by experts on BSE.
    In other words, it would still be permissible to feed 
cattle byproducts with a high risk of BSE back to cattle 
through poultry litter. Now, again, I don't know what the 
reasons for allowing that are, but I am just wondering with 
this proposed rule, FDA proposed rule, FDA will only prohibit a 
partial list of SRMs from all animal feed, a partial list.
    In addition, FDA is not closing the loophole that currently 
exists by allowing poultry litter to be fed to cattle. This 
leaves a clear circle of transmission wide open, where the SRMs 
that are not prohibited by the proposed rule could be fed to 
poultry, and then the poultry litter fed back to cattle. How 
does the FDA justify not closing the poultry litter loophole?
    Dr. von Eschenbach. Senator, let me first begin by saying I 
appreciate the question and thank you for it because it is 
addressing an issue that, as you pointed out, with the recent 
awareness in the press of another cow being detected with BSE, 
it has raised concerns. And it is important that we address 
them.
    The feed ban that was put in place in 1997 was done in a 
way to be able to ban high-risk materials and to be able to 
over a period of time, continue to monitor and inspect and be 
sure that processes were being appropriately applied. So FDA 
has been working closely with USDA. As it has been responsible 
for the issues with regard to cattle, FDA has been approaching 
the issues with regard to animal feed.
    Throughout that period of time, and as you have pointed 
out, the processes that we put in place have, as we have gone 
through looked for compliance with regard to the processes, we 
have found in all the inspections over 99 percent compliance 
with the rules. And during that period of time, over 800,000--
or at least at this point with regard to 650,000 high-risk 
animals that the FDA has identified, there have only been 2 
cases of BSE, and those 2 cases have been in animals that were 
born before the feed ban was put in place.
    Now I emphasize that because I think it is important to 
point out that the processes that have been in place since 1997 
have had a high degree of compliance, and in fact, the risk of 
BSE in the cattle population at this point in time has only 
involved 2 animals, and both those animals were born before 
this ban was put in place.
    Having said that, as you have pointed out, the FDA recently 
went a step further to further strengthen the feed ban rule and 
put in additional bans, as you have indicated.
    Now with regard to the specifics of the transmission of BSE 
in prions in the droppings from poultry, if I could permit--
with your permission--to have Steve Sundlof, the head of our 
Center for Veterinary Medicine, who is responsible for this 
area, he may be able to give you a much more precise scientific 
answer with regard to the risk of that particular aspect of 
possible transmission of BSE.

                  POULTRY LITTER AND BSE TRANSMISSION

    Senator Harkin. It is up to the Chairman.
    Senator Bennett. We could follow up.
    Senator Harkin. It is up to the Chairman. Yes, that is 
fine.
    Senator Bennett. Do you want to follow up quickly?
    Senator Harkin. If that would be okay with you, Mr. 
Chairman?
    Senator Bennett. Sure. Go ahead.
    Mr. Sundlof. Thank you, Senator Harkin.
    I am Steve Sundlof, the Director of the FDA Center for 
Veterinary Medicine, and it is my center that regulates the 
safety of all animal feeds, including pet foods.
    To get to your precise question regarding poultry litter, 
first of all, we have evaluated the potential risk of poultry 
litter to spread BSE among cattle, and we find that to be very 
low for a number of reasons. First of all, the amount of animal 
protein in that poultry litter is very small. Secondly, it 
comprises a small part of the cattle diet. Thirdly, when we put 
it through some of our risk assessment models, it appears that 
that risk presently, as the rule is written, represents an 
extremely low risk.
    By proposing that all brains and spinal cords from cattle 
over the age of 30 months be eliminated from all animal feeds, 
you have taken 90 percent of whatever remaining infectivity 
there exists out there, and you have taken that out of any 
poultry diet. So now with the new proposed rule, you have 
actually reduced any potential risk from poultry litter by 
another 90 percent.
    And again, that is 90 percent of a very, very small risk to 
begin with. And so, the proposal really addresses a lot of the 
issues that remain around poultry litter.
    Senator Harkin. Is it possible, Mr. Sundlof, is it possible 
for the prions to come from a ruminant animal that actually 
might be fed to poultry or drop in the litter, and that litter 
could then possibly be fed back to a ruminant animal?
    Mr. Sundlof. It is possible, but the amount that would be--
first of all, if you take the brain and spinal cord out, you 
have eliminated 90 percent of whatever infectivity could go 
into that.
    Senator Harkin. I understand. I understand that.
    Mr. Sundlof. But the amount of animal protein that is in 
the litter is very, very small. Now, you know, we don't say, we 
never can say that the risk is absolutely zero. And so, to 
answer your question, yes, it is possible. But the probability 
of that occurring is very, very remote.
    Senator Harkin. Well, now, Canada has already banned 
poultry litter, right, from being fed?
    Mr. Sundlof. That is true.
    Senator Harkin. That is true in Europe, too?
    Mr. Sundlof. Yes.
    Senator Harkin. It is true around the rest of the world as 
far as I know. And my question, I guess you just raised this 
question in my mind, if poultry litter is so low in protein, 
why are they feeding it?
    Senator Bennett. Yes, that was the question I have. If it 
is so small, what does poultry litter bring to the table?
    Mr. Sundlof. Well, a little cattle physiology here. Cattle 
are able to convert non-protein materials like cellulose, in 
terms of grass, actually into protein. So a large part of 
cattle diet is made up of material that is very low in protein, 
but in the rumen of the cattle, the microorganisms actually 
make protein, which then the cattle digest.
    So in terms of why Canada and Europe and other countries 
don't feed poultry litter has to do more with the demographics. 
In the South, especially in the southeastern United States, 
cattle are raised on open land. They are raised in areas where 
there is a lot of poultry production in addition to cattle 
production.
    Poultry litter becomes an issue. The poultry industry has 
to get rid of this product somehow. They can either spread it 
onto the land and use it for fertilizer. But in general, there 
is more than can be disposed of by that method. It does have a 
fairly high nutritional value for cattle. It is something that, 
strangely enough, cattle seem to like to eat. And those 
conditions really don't occur in other parts of this country 
and especially in Canada and Europe.
    Senator Harkin. Well, again, since everyone else has banned 
it, it seems like we are always looking for ways to somehow get 
around banning the elements, all SRMs, not just the high risk, 
but all SRMS from getting back into ruminant feed. There are 
ways we can do that. Other countries have done it.

                 BSE RULE AND HARMONIZATION WITH CANADA

    Now I am told, Mr. Chairman, I am told that some FDA people 
told my staff they were working with Canada to make its rules 
similar to the United States. In other words, FDA is working, 
hoping to see that Canada weakens it rule to match that of the 
United States. Is that so? Are we working to try to get Canada 
to weaken its rule?
    Dr. von Eschenbach. We are exploring harmonization efforts 
with Canada.
    Senator Harkin. Now what does that mean?
    Dr. von Eschenbach. Well, that means that we are exploring 
whether or not, you know, this is a proposal----
    Senator Harkin. Are we exploring to get to their level or 
get them to our level?
    Dr. von Eschenbach. Well, we are holding discussions where 
we are looking at their assumptions behind their risk models 
compared to our risk models. And if we find that their risk 
models are a better reflection than what we have developed, 
then we would be willing to adjust our rule.
    But also we are just in the discussion phases now, where we 
are sitting down and examining the assumptions that went into 
each of our rules to determine whether or not those are valid 
in our particular countries, and there may be. And in the case 
with Canada, there may be some valid reasons why they should be 
different.
    Senator Harkin. Mr. Chairman, you have given me more than 
enough time. I do have some follow-up questions on the next 
round.
    Senator Bennett. Surely. We will have another round.
    Dr. von Eschenbach--and thank you, sir, for your expertise. 
You told me more about chicken litter than I probably wanted to 
know.

                        MEDICAL DEVICE USER FEES

    One of the things that I have been interested in since I 
have had this assignment in the Senate has been user fees and 
particularly medical device user fees. I found that FDA was 
delighted to have the extra money from the user fees, which 
were being paid somewhat reluctantly on the part of the users, 
but paid in an effort to increase the performance and lower the 
backlog of approvals.
    And there was a period when FDA simply took the money and 
then took the appropriated money that would have gone into 
improving performance and spent it someplace else. And I have 
been a bit of a nag on that issue and got an agreement out of 
OMB that that sort of thing would stop, that the user fees 
would, in fact, be matched with appropriated funds, and the two 
would be coupled rather than one becoming the replacement for 
the other. It is only fair that that be the case.
    Could you bring us up to date on where we are with 
performance out of MDUFMA? Now I have a copy of the answer that 
was given in the House with respect to this, and that is part 
of the transcript now of the House hearing. And I find that 
useful, but give you the opportunity to comment in general 
terms as to where we are with respect to greater performance in 
the medical device area and other areas where user fees are 
being paid in an effort to make sure that things move more 
rapidly.
    Dr. von Eschenbach. Well, Senator, as I have come to 
understand it and appreciate it, with regard to MDUFMA, or the 
medical devices user fees, that particular program has not had 
as long a history of experience and process improvement as has 
PDUFA with regard to the experience at FDA. And obviously, with 
medical devices, that introduces its own set of complexities 
with regard to the review process.
    Having said that, as MDUFMA has been implemented at the 
FDA, in most cases, there has been a full compliance with 
regard to the targets or the milestones that were put in place. 
But at the same time, it is also true that it has not been the 
case uniformly across the entire board and, in fact, in looking 
at even where we have met those milestones, the incremental 
improvement in terms of really being able to significantly 
reduce cycle time and streamline and accelerate the time to 
market is not to the degree that even we would be happy with 
and comfortable with.
    So we are looking at this from the point of view of process 
improvement. We are looking at it and working collaboratively 
and cooperatively with the industry in order to be able to 
continue to find ways to accelerate the process and make it 
more effective.
    We think there are opportunities to work with the industry, 
for example, with the preparation of their applications in a 
way that will help us proactively and prospectively be able to 
do that by greater consultations. We have noticed with regard 
to PDUFA that that opportunity for consultations before the 
application process has proven to be something highly 
attractive and very positive with regard to their experience.
    So we are looking at this. As you have pointed out, these 
dollars will be focused and targeted for a specific purpose, 
and that will remain so. And we will look to continue to 
improve the process.
    Senator Bennett. Thank you. I don't want user fees to 
become general taxes that just go into the general fund and 
then may or may not be producing the result for which people 
are paying extra.
    Senator Kohl.

                            FIELD INSPECTORS

    Senator Kohl. Thank you, Mr. Chairman.
    Dr. von Eschenbach, looking at your budget, it states that 
your field force of inspectors is going to decrease by some 48 
to 60 people. It also says in your budget in the very same 
section that the number of FDA-regulated imported products 
requiring inspection is increasing exponentially.
    Some of the other examples of activities that won't be 
performed as often by these inspectors, as I said, the analysis 
of imported and also domestic samples of food, inspections of 
veterinary feed manufacturers, inspections of human drug 
manufacturers, compliance and recall functions, including food, 
drugs, and animal drugs and feeds.
    How do you justify cutting field inspectors right now when 
the requirement for them seems to be going up and not down? Do 
you really believe that this is the best place for you to be 
trying to save money?
    Dr. von Eschenbach. What we are attempting to do, Senator, 
is to look at this again--as I have indicated in an answer to a 
previous question--as a process improvement issue. In looking 
at the total portfolio of activities and asking questions, 
where can we streamline? Where can we make this more efficient 
so that we are getting more outputs vis-a-vis the resources 
that we have to utilize to do that, including the human 
resources and the number of people that are involved?
    We think that there are opportunities to continue to 
improve the process. By, for example, focusing on preapproval 
inspections, working with manufacturers, working with regard to 
good manufacturing practice requirements, we can improve some 
of the processes and opportunities with regard to a proactive 
approach.
    We are targeting inspections to areas of high risk so that 
we are utilizing the workforce in a more efficient, more 
targeted way so that we are focusing on the areas where we see 
the highest concerns or the highest risks as opposed to simply 
disseminating those resources with less impact.
    So it is a process improvement problem. Looking at modern 
technologies that will enable us to enhance the ability to 
utilize the inspection process is another way we think we can 
continuously get more outputs, meet our responsibilities, but 
do that in a way that is efficient in the use of the human 
resources that we have so that we are deploying those where we 
see areas of higher public health need.

                      DRUG SAFETY OVERSIGHT BOARD

    Senator Kohl. All right. Dr. von Eschenbach, your budget 
talks about the creation last year of an independent Drug 
Safety Oversight Board to oversee the management of important 
drug safety issues.
    A quote from Secretary Leavitt regarding this board says, 
``The public has spoken. They want more oversight and more 
openness. We will address their concerns by cultivating 
openness and enhanced independence.'' That is his quote.
    And yet the FDA has received criticism because the board 
now has no public representatives, meets in private, and 
publishes only vague summaries regarding what is discussed in 
these meetings. So how do you respond to these criticisms?
    The board may be independent, but is it really transparent 
when the only members are from the FDA and other Government 
agencies and reports are so vague?
    Dr. von Eschenbach. Senator, this is an important area, 
obviously, with regard to our commitment to drug safety. And 
the Drug Safety Oversight Board, as you point out, does go 
beyond FDA, and it does include other Federal employees from 
the National Institutes of Health and from the Veterans 
Administration.
    That provides us a couple of opportunities. One, it does 
broaden the input. It does enhance the expertise that is 
involved in this oversight review, and it does take it outside 
the walls of the FDA so that it is subject to a larger and 
more, if you will, independent analysis and review by 
individuals who are not part of the agency and not part of the 
FDA internal process.
    The very fact that they are Government employees, however, 
provides a great deal of efficiency in the terms of which this 
board is able to function. First of all, it enables us to avoid 
some of the potential problems and barriers in timeliness that 
would come from having to have to resolve conflict of interest 
issues or problems should this be outside of the Government.
    It allows us to deal with confidential proprietary 
information within the confines and constraints of the 
committee so that we are looking at data and information that 
is much more sensitive and, therefore, has the potential to be 
much more important and insightful with regard to the safety 
issues.
    So we believe that it is a balance and a balance between a 
process that is framed within the rules and regulations of 
FOIA, the rules and regulations with regard to conflict of 
interest, while at the same time, it is broadening the input 
beyond the FDA and assuring that we have the right expertise of 
individuals who will be able to improve the oversight of these 
drug safety issues.

                OPENNESS OF DRUG SAFETY OVERSIGHT BOARD

    Senator Kohl. Well, Secretary Leavitt said that he wants to 
see more openness, more independence, and that he would take 
steps to improve that. Now if you meet in private, if the 
members are not public representatives, and if the reports that 
emanate from your meetings are not specific, what kind of 
openness is that?
    Dr. von Eschenbach. Well, I think there can be a great deal 
of attention paid to the openness and transparency of the 
process and the rules and regulations that frame how an 
oversight is being conducted. But the issues with regard to 
what is occurring in the internal discussions dealing with 
proprietary information, that in itself needs to continue to be 
protected or we won't be able to get the right information that 
we need to analyze and assess.
    So I think it is a balance, and it is an interplay between 
a process that is well defined, open, and, if you will, perhaps 
more precisely is transparent in terms of how it is being 
conducted with the rules that govern and frame how things are 
being done.
    But then the discussions occur within the context of the 
confidentiality that is required in order to protect 
proprietary interests and information that is not appropriate 
to disclose in a public venue. And the committee has been 
vigilant and active in its effort. There have been five 
meetings in 2005 looking at 17 different products.
    So it is active. It is engaged. It is an ongoing effort, 
and I think it is a process of balance between making sure that 
there is an additional layer of oversight, but one that is 
still being conducted within the constraints and confines of 
what the law and the regulatory process makes possible.
    Senator Kohl. Thank you, Mr. Chairman.
    Senator Bennett. Senator Harkin.

                    BOVINE SPONGIFORM ENCEPHALOPATHY

    Senator Harkin. Thank you, Mr. Chairman. Just one last 
follow-up on the BSE.
    I understand that FDA is going with the weaker rule because 
they are concerned about the costs of a stronger rule. Well, we 
can't ignore cost, but consider the cost that our country is 
bearing in lost export markets already because of that. Or 
consider the potential cost if consumers lose confidence in 
eating beef.
    I mean, you can argue about science and risk, but some 
things just make common sense. I mean, how many people know 
that cattle are fed chicken litter? Now that is not just the 
straw and the bedding, that is fecal matter. They are eating 
chicken feces, okay? And they are eating a lot of stuff that 
could fall into that litter that could be parts from SRMs that 
are fed a lot to poultry, a lot.
    And since other countries have banned it, I don't know why 
we are so reluctant to do that. Ask anybody even in this 
audience, how many, if you had a choice between hamburger from 
a cow that never ate fecal matter or one that did, what do you 
think you would get? It makes common sense.
    And my big concern is that with this recent case of BSE, 
obviously, I have an interest in this because I represent a lot 
of cattle feeders. I represent cattle people, and they are 
concerned about the loss of confidence that may happen if more 
of these problems start popping up.
    You may hear from the other side or some other side about 
this. But it seems to me that a big part of the problem that we 
have right now is that both FDA and USDA are telling the public 
that the feed rules are a firewall, a true safeguard. But now 
what I am hearing is you are saying that the feed rules are 
based on probabilities, 90 percent here, 90 percent there. You 
know, probabilities.
    Well, so what we are hearing, the rhetoric and the facts 
don't match. And I am just, again, concerned that we don't move 
ahead more aggressively to prohibit all SRMs, not just the high 
risk, all SRMs from all animal feed, including poultry, and to 
eliminate, finally get over that hurdle of plate waste.
    I can't believe we still permit plate waste in this country 
going into ruminant animals. Most other countries don't, but we 
still permit it. So, again, that is all I have to say on that.

                         FOOD AND NUTRITION FTE

    A couple of other things, Dr. von Eschenbach. Is it true 
that in this budget that there are somewhere between 50 and 80 
FTEs that will be taken away or transferred out of the food 
safety and nutrition area? Am I wrong in that?
    Are there any at all in this budget, are there FTEs being 
cut in food and nutrition?
    Dr. von Eschenbach. With regard to the area of food and 
nutrition, Senator, we are looking at redeploying activities 
within that area and synergizing and partnering in order to be 
able to meet the necessary commitments that we have within the 
budget. But do that in a way that is more efficient and more 
effective.
    We are looking at opportunities, for example, where 
mechanisms with regard to our management of personnel and 
opportunities for early buyout will enable us to reduce the 
cost of our workforce without necessarily reducing the number 
of FTEs. I would have to----
    Senator Harkin. Okay. Are there any in the budget? That is 
all I want to know. In this budget before us, is there a 
reduction in full-time equivalents in food and nutrition?
    Dr. von Eschenbach. I will have to give you for the record 
the specific----
    Senator Harkin. Okay. If you don't know, then if you could 
get back to us, I would sure appreciate it.
    Dr. von Eschenbach [continuing]. FTE reductions. But as I 
indicated to a prior question, I want to reassure the committee 
that whatever reductions and whatever redeployments are made in 
resources, we are doing that in a way that it has not 
compromised the commitment to public health and to safety.
    Senator Harkin. I appreciate that.
    [The information follows:]
                         Food and Nutrition FTE
    The strategic redeployment will be offsetting the requested 
increases in fiscal year 2007 for critical, high priority initiatives 
such as Pandemic Preparedness and Food Defense. This would be a change 
in FTE levels of -64 for Center for Food Safety and Applied Nutrition 
and -22 in Food related Field activities.
    The redeployment of the FTE in Center for Food Safety and Applied 
Nutrition will be made from programs such as food additives and food 
contact substances, research, cosmetics, dietary supplements, outreach 
and regulatory activities. The redeployment of the Food related Field 
FTE will be made in areas such as the collection and analysis of 
domestic and import food samples and in the management, supervision, 
and coordination of personnel at multiple locations.

                DIETARY HEALTH SUPPLEMENTS EDUCATION ACT

    Good manufacturing practices. Senator Hatch, the other 
Senator from Utah, and I 12 years ago joined forces. We got a 
bill passed called DSHEA, the Dietary Supplement Health and 
Education Act.
    At that time, we put a provision in the law that mandates 
that FDA is supposed to come with good manufacturing practices, 
GMPs we called them. About every 2 years since that, we have 
been told that FDA is going to come up with good manufacturing 
practices, going to come up with the regulations. This 
persisted in the 1990s. It has persisted since then.
    Twelve years later, we still don't have good manufacturing 
practices regulations. The industry is crying out for this. The 
public needs it. It will tend to get some of the bad actors and 
those that might be out there out of the business. It will set 
up good standards. And here I am told again, ``very soon.''
    Can you give us your personal assurance that you will work 
with OMB to get the GMPs published, and can you give us any 
definitive date?
    Dr. von Eschenbach. Thank you, Senator. And we are, along 
with you, committed to continuing to the full implementation of 
DSHEA and meeting the requirements that have been involved in 
that important law.
    With regard to the dietary supplement GMP, as you have 
indicated, it is at OMB. The staff of CFSAN have been working 
directly with them with regard to addressing any particular 
issues with regard to that GMP being finally issued.
    I will continue to commit to you and ensure you that FDA 
will do everything that is needed and required to work with OMB 
to bring that about as rapidly as possible. I understand that 
it is----
    Senator Harkin. It is frustrating.
    Dr. von Eschenbach [continuing]. Imminent. But----
    Senator Harkin. It is frustrating. Dr. Crawford, when he 
was before the help committee last year, said--he assured us 
that the GMPs for dietary supplements will be published in the 
Federal Register within months. Still hasn't happened.
    Senator Bennett. Depends on your definition of ``months.''
    Senator Harkin. Okay. Well, I suppose if you meant a lot of 
months, yes.
    Dr. von Eschenbach. I have looked into this, Senator, and I 
can tell you that it is in process and in progress. I am led to 
believe and understand that the issues are being and have been 
addressed.
    Senator Harkin. Can you give us any idea, can we see 
something happening here in the next 30, 60, 90 days? Anything 
at all that we can hold you accountable for?
    Dr. von Eschenbach. Please hold me accountable for working 
with the OMB in an effort to make this come forward as you have 
requested.
    Senator Harkin. I won't press the issue further.
    I just have one last question. I will wait until my next 
round. Thank you.
    Senator Bennett. Thank you.
    The experience of working with OMB is one that I have had, 
and it was an administration 30 years ago or longer, I guess. 
But I don't think OMB has changed that much, and it is very 
difficult many times.
    And I have been in the position of being a witness where I 
know what I want to say, but OMB has told me what I can say. So 
I think Dr. von Eschenbach's commitment is probably the only 
one he can make under these circumstances.

                  UNIFIED FINANCIAL MANAGEMENT SYSTEM

    Unified Financial Management System. This is a project 
initiated in 2001 to integrate several financial management 
systems across the department. I am assuming we are talking IT 
here, all right?
    Dr. von Eschenbach. Financial management, yes, sir.
    Senator Bennett. Everyone has experience with IT programs 
that start out with great hope and anticipation and then end up 
being over budget and behind time. Originally, FDA's share of 
the total project through fiscal 2007 was estimated at $36.5 
million. This subcommittee has provided more than $50 million 
over the last 5 years, and your budget requests an additional 
$1.2 million.
    These are not large sums, but it is my understanding that 
annual costs for the system were supposed to level off and go 
down after fiscal 2005. This has not been the case. Since 2004, 
annual costs have gone up roughly 37 percent.
    Can you give us any kind of light at the end of this tunnel 
as to where we are going and what kind of progress we have been 
making?
    Dr. von Eschenbach. I would be happy to, Senator, and I 
also, with your permission, will call Kathy Heuer, who is the 
head of our Office of Finance and Management, to provide 
additional details.
    As I have understood and appreciated the process, FDA is 
contributing its appropriate share to the larger HHS effort 
with regard to the UFMS initiative, and it has, in fact, 
undergone an activation period of time with activation costs 
for contractor support, training, vendor support for new tools 
and licenses, and a need to continue to stabilize the process 
with regard to its utilization.
    We are anticipating and expecting that those activation 
costs will come to an end through the year 2007 and into early 
2008, which will bring us then into a level of cost reductions 
and cost savings, in fact, with regard to once we have 
implemented the system fully.
    So that is my expectation and anticipation of the process 
and how it will unfold. Kathy, if you would add to that?
    Ms. Heuer. Thank you, Senator.
    UFMS will be the largest financial management system on the 
civilian side of the Federal Government when fully implemented. 
It is a way to consolidate financial management across Health 
and Human Services, allowing for better integration of 
information, comparability of information, and sounder 
management decisions based on easier access to data.
    The cost increase you reflected in terms of 2005, 2005 is 
the year that we implemented UFMS. We went live in April 2005. 
The original budget projections did not include operations and 
maintenance projections. Those are about $3 million per year.
    We have a consolidated operations and maintenance structure 
with the department. So that is something that we have to pay 
in addition. Those were not part of the original estimates in 
terms of the budget.
    The original estimate in terms of the budget was just the 
project development, and that is why there is that increase, as 
you mentioned, the 37 percent going up because that was not 
included. Originally, it was just development. But now the 
operations and maintenance is on top of that.
    As Dr. von Eschenbach said, when UFMS is fully developed 
into 2008, then the development costs will be eliminated, and 
our ongoing costs will just be the operations and maintenance 
costs.
    Senator Bennett. Thank you. I wish you well.
    Ms. Heuer. Thank you.
    Senator Bennett. Senator Kohl.
    Senator Kohl. Thank you, Mr. Chairman. I have finished my 
questioning. I will defer to Senator Harkin.
    Senator Bennett. Senator Harkin.

                         STRATEGIC REDEPLOYMENT

    Senator Harkin. Mr. Chairman, just one last thing. And 
again, Dr. von Eschenbach, you are going to get back to us on 
these FTEs?
    Dr. Von Eschenbach. Yes, sir.
    Senator Harkin. The question I asked, I had information 
that in the budget there is a cut in FTEs in food and 
nutrition?
    Dr. Von Eschenbach. Senator, I am looking forward to 
presenting to the entire committee for the record a detailed 
explanation----
    Senator Harkin. Okay.
    Dr. von Eschenbach [contining]. Of the redeployment 
strategy across all of the centers and offices within FDA. So 
that it will define what the programmatic shifts are in those 
programs, along with what the FTE changes will be. And we will 
give that to you not only with regard to CFSAN, but with regard 
to the entire portfolio so that you will have that with regard 
to answering your question.

                GELATIN CAPSULES FOR DIETARY SUPPLEMENTS

    Senator Harkin. Okay. My last question has to do with U.S. 
companies that want to export dietary supplements with gelatin 
capsules to Europe are first required to obtain a health 
certificate from the Food and Drug Administration, required to 
do so by the European Union.
    Now I wrote you a letter about this on February 28. I don't 
expect you to have replied. That is a short time ago. But I 
wrote you a letter about this on February 28.
    Now as I understand it, the EU requires U.S. companies to 
get a health certificate from FDA's Center for Food Safety and 
Nutrition. But according to the exporters that have talked to 
me, the EU does not require these certificates for 
pharmaceutical companies that are using the same gelatin 
capsules to export pharmaceuticals. But if you have a dietary 
supplement, same gelatin capsule, they require the FDA to give 
a health certificate.
    Well, I am told that the FDA does not issue such 
certificates. I don't know if that is so or not, but do you 
have any--I don't want to catch you flat-footed on this, but I 
am told that FDA does not issue them. So they are kind of 
caught.
    The EU says they have got to have a health certificate, and 
yet FDA says they don't issue those. So----
    Dr. von Eschenbach. Senator, I cannot give you the specific 
details in answer to that question. I would be happy to do that 
for the record or have one of the FDA staff that would be 
responsible for that respond.
    Senator Harkin. Well, please have your staff, and you 
personally, take a look at the letter I wrote you on February 
28. My staff will give you a copy here. I understand how those 
things go. But take a look at that because it is a big issue.
    Because it is the same gelatin capsule that pharmaceutical 
companies use. They order them from the same place, but the EU 
has rules that say you can't without a health certificate.
    So, they are sort of caught in a bind here. I need to find 
out about that and what we can do to help them overcome this 
trade barrier.
    Dr. von Eschenbach. I will look into that for you, Senator.
    Senator Harkin. I appreciate that very much.
    Thank you, Mr. Chairman.
    [The information follows:]
                Health Certificates for Gelatin Capsules
    FDA issues a certificate, sometimes called a health certificate, 
for bulk gelatin for human consumption exported to the European Union, 
also known as EU. In the certificate, FDA certifies compliance with 
relevant U.S. standards, which have been recognized for this purpose as 
equivalent to EU requirements for foods including dietary supplements. 
The EU requires the certificate include affirmations from the 
manufacturer and periodic state inspections confirming the gelatin is 
produced in accordance with U.S. standards, the gelatin meets certain 
criteria, and that raw materials are appropriately sourced.
    The EU legislation separates requirements for foods and 
requirements for pharmaceuticals. However, to date it is only the 
United Kingdom, in its implementation of EU legislation, has stopped 
shipment of gelatin capsules containing dietary supplements. It is our 
understanding that our EU counterparts are trying to resolve the 
situation since the gelatin used in human food is, in most cases, 
identical to the gelatin used for pharmaceuticals.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Bennett. Thank you.
    Dr. von Eschenbach, we appreciate your attention to all of 
these questions and you and your staff's response to what our 
concerns are.
    Dr. von Eschenbach. Thank you, Mr. Chairman. And may I 
express to you and to the committee our gratitude, as I 
indicated at the very beginning, for your support.
    I would also like to express personally, for however long I 
have the privilege to serve in this role, that both myself and 
the staff of the leadership of the FDA would look forward to an 
ongoing conversation and relationship about many of the 
important issues that you raise. Not simply at a time, for 
example, when we are requesting a budget appropriation, but in 
an ongoing basis.
    We intend to be responsive and timely to requests that are 
provided to us by mail, but I look forward to that opportunity 
in person as well. And I know that that is reflected by the 
talented and wonderful people who are sitting behind me, who 
are the content experts that are at your disposal.
    Thank you, sir.
    [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 Robert F. Bennett

         MEDICAL DEVICE USER FEE AND MODERNIZATION ACT (MDUFMA)

    Question. Please provide, for the record, specific information 
regarding FDA performance in each of the medical device user fee goal 
areas.
    Answer. Secretary Thompson's November 2002 letter to Congress, also 
known as the FDA commitment letter, defines the performance objectives 
FDA is pursuing under the Medical Device User Fee Act, or MDUFMA. The 
commitment letter defines a comprehensive set of challenging goals and 
a schedule for meeting the goals.
    To allow FDA time to build its capacity to meet the ultimate goals 
set by MDUFMA for fiscal year 2007, the commitment letter provides for 
a phased implementation of goals, with the addition of more goals and 
higher performance expectations each year. In fiscal year 2005, 18 
additional goals went into effect, with two exclusively for the Center 
for Biologics, Evaluation and Research, also known as CBER. Six 
additional goals go into effect in fiscal year 2006. In fiscal year 
2007, FDA will be responsible for a total of 77 quantitative goals 
covering five receipt cohorts. FDA is expected to pursue eight 
additional nonquantifiable commitments, such as developing an 
appropriate bundling policy, continuing our efforts to develop 
mechanisms for the electronic receipt and review of applications, and 
improving the scheduling and timeliness of preapproval inspections.
    Although we do not expect to meet every goal specified by MDUFMA, 
the trends are promising. Since some goals involve so few applications 
that missing the review time frame for a single application by a single 
day can result in ``failure'' to meet a MDUFMA goal. We are, in 
general, showing better performance as we implement new policies and 
procedures designed to improve the timeliness of our review processes. 
Although it is too soon to know what our final performance statistics 
will show, since many goals still have applications that remain open, 
our performance on applications within more recent receipt cohorts is 
better than our performance within older cohorts. If you had taken a 
snapshot of performance for the fiscal year 2003, fiscal year 2004, and 
fiscal year 2005 receipt cohorts on December 31, 2005, you would see 
that FDA is meeting or exceeding 19 of the 24 goals in effect, and is 
not meeting only two goals. No applications have qualified for the 
remaining three goals.
    We are confident that MDUFMA is producing positive results for FDA, 
for industry, and--of critical and highest importance--for patients and 
health care professionals.
    I would be happy to provide FDA's performance report for fiscal 
year 2004 for the record. We will forward our fiscal year 2005 report 
when it is complete.
    [The information follows:]

    
    
                        MEDICAL DEVICE USER FEES

    Question. During operation of the medical device user fee program, 
has the agency been able to determine specific direct and indirect 
costs of performing the various types of PMA and 510(k) device 
approvals? Will FDA be able to determine incremental direct and 
indirect costs that will be associated with improving review times 
under more aggressive performance goals in the future?
    Answer. FDA is engaging with industry and stakeholders as we work 
on the MDUFMA reauthorization. If the MDUFMA reauthorization results in 
changes to the performance goals, we will be able to estimate direct 
and indirect costs. During fiscal year 2005, FDA contracted with Dr. 
Dale R. Geiger, a recognized expert in the field of government cost 
accounting, to prepare a report of the costs of FDA medical device 
review processes. The statement of work for this report did not require 
Dr. Geiger to make findings and conclusions. Rather, Dr. Geiger 
prepared analysis for FDA to consider during the MDUFMA 
reauthorization. Dr. Geiger examined FDA medical device reviews 
conducted during fiscal year 2003 and fiscal year 2004, including 
investigational device exemption applications, investigational new drug 
applications, premarket approval applications, or PMAs, PMA 
supplements, biologics licensing applications, or BLAs, BLA 
supplements, and 510(k) premarket notifications.
    The methodology employed by Dr. Geiger follows generally accepted 
accounting principles for U.S. Government reporting entities, and 
parallels the methodology applied by an earlier Arthur Anderson study 
that measured PDUFA costs for 1992 and 1993. Dr. Geiger examined both 
direct and indirect costs, at CBER, CDRH, the Office of Regulatory 
Affairs, or field, and FDA general and administrative costs. This work 
will assist FDA with cost analysis in regards to the performance goals 
resulting from the MDUFMA reauthorization.
    Question. What criteria does the agency use to determine the 
allocation and priority for distribution of staff increases across FDA 
components, including offices, divisions, branches, regions, and 
districts resulting from medical device user fees and related 
Congressional appropriations?
    Answer. In the absence of a Congressional directive, FDA allocates 
medical device user fees and other medical device appropriations to 
best achieve FDA's public health objectives, the performance goals, and 
other expectations established under the Medical Device User Fee and 
Modernization Act of 2002 and its amendments. Resources have been 
allocated to reflect the workload balance between the Center for 
Devices and Radiological Health, or CDRH, and the Center for Biologics 
Evaluation and Research, or CBER. Soon after MDUFMA was enacted, FDA 
estimated that 83 percent of the device review work was performed in 
CDRH and 17 percent was performed in CBER. The Field resources 
associated with each Center are included in these percentages. FDA's 
fiscal year 2003 to fiscal year 2005 allocations were based on these 
percentages. FDA is presently reexamining this allocation and expects 
this examination will result in a higher percentage of MDUFMA being 
allocated to CDRH.
    Field resources are allocated among districts by the Office of 
Regulatory Affairs, or ORA, according to each district's projected 
medical device workload. To illustrate the use of workload to determine 
distribution of resources, CDRH's MDUFMA hiring priorities were 
established by product group experts who made recommendations about the 
type and order of new hires that would best contribute to improving the 
device review process. For example, the CDRH cardiovascular group, 
which included experts on those types of devices from across the 
Center, concluded that their highest priority for improving and 
speeding the review of cardiovascular devices were additional 
statisticians. Other product review teams--for example, those for in 
vitro diagnostic devices, ophthalmic and ENT devices, ob-gyn, gastro-
renal, and urological devices--identified the priority needs they 
believed were essential to improving the quality and timeliness of the 
review process.

                        POSTMARKET SAFETY ISSUES

    Question. At the industry-agency workshop on ongoing efforts to 
improve post-market safety activities in February of this year, several 
issues came up that are of potential concern.
    With regard to the notion of requiring ``unique product 
identifiers,'' how would this requirement differ from and improve on 
the existing device tracking requirements for high risk devices? What 
technical and labeling issues arise with regard to such a requirement 
for all devices?
    Answer. The device tracking requirement applies to manufacturers of 
a small set of mostly implantable devices, and intends to ensure that 
manufacturers can quickly locate defective devices and notify patients. 
Conversely, the idea underlying unique device identification, or UDI, 
is to require manufacturers to apply a unique code to the label of a 
variety of medical devices, in both human and machine readable formats, 
like barcodes. When combined with other health information technology 
efforts, UDI has the potential to provide a number of benefits to 
improve patient safety. Important potential benefits include the 
reduction of device-related medical errors through the recognition of 
compatibility and interoperability issues; facilitating the population 
of device information in patients' electronic health records; and 
improving the accuracy of information about marketed devices through 
the standardized identification of specific devices in adverse event 
reports. Additionally, an effective system of device identification 
should allow more efficient recall of defective devices and also assist 
in fighting counterfeit devices.
    The type of information included in the UDI will determine what 
technical and labeling issues arise. FDA is currently considering the 
appropriate scope of such information and intends to address these 
issues in a rulemaking.
    Question. With regard to the draft guidance document on 
requirements for additional information to be to be included in annual 
reports, does FDA already have this information in various formats and 
disparate offices throughout the device center? Would it make more 
sense for the agency to break down its internal barriers that prevent 
effective utilization of information already collected by the Center 
for Devices and Radiological Health?
    Answer. The Center for Devices and Radiological Health, also known 
as CDRH, believes that data and information gathered in the postmarket 
setting is critical to our continued confidence in the safety and 
effectiveness of marketed devices. Premarket Approval, or PMA, annual 
reports are one of the important tools that FDA relies upon to gather 
information about the device once it is marketed. For this reason, CDRH 
is assessing the information provided in annual reports to ensure that 
these submissions provide meaningful information for the agency and 
industry to assure postmarket safety. At this time, CDRH has not made a 
final decision as to the type of information that should be included in 
a PMA annual report. Once the decision is made, CDRH will take the 
necessary steps to ensure that the information required in the annual 
report is not duplicative of other regulatory reporting requirements.
    CDRH is also reviewing our internal processes and systems for 
communicating post-market information across the center. As part of its 
on-going effort to improve all aspects of post-market safety, CDRH 
initiated the Postmarket Transformation Leadership Team that consists 
of CDRH managers and external experts to guide the Center in this 
effort.

                        CRITICAL PATH INITIATIVE

    Question. FDA is requesting an increase of $5.9 million for the 
Critical Path Initiative. This funding is specified for the Center for 
Drug Evaluation and Research. However, I understand that the Critical 
Path Initiative is intended to speed the development of all medical 
products regulated by FDA.
    Will the requested funding be made available to other FDA Centers? 
If so, how much will be made available to each FDA center?
    Answer. All FDA centers will participate in Critical Path 
activities in order to achieve the public health benefits envisioned by 
FDA in its Critical Path report of March 16, 2004, and the Critical 
Path Opportunities List announced on March 16, 2006. In fact, several 
of the projects described in our budget request are cross-center 
projects, such as work to create a library of digital 
electrocardiograms, also known as ECGs, that involves both the Center 
for Drug Evaluation Research and the Center for Devices and 
Radiological Health.
    The Agency is still working with our partners in government, 
academia, and industry to determine which Critical Path activities, in 
addition to those identified in our fiscal year 2007 budget request, 
are the most appropriate activities to fund in fiscal year 2007.
    I would be happy to provide for the record the Critical Path 
Opportunities List that was announced on March 16, 2006.
    [The information follows:]

    
    
                      REUSE OF SINGLE-USE DEVICES

    Question. Last summer, Congress passed the Medical Device User Fee 
Stabilization Act to continue the medical device user fee program, 
adjust user fees, and tighten up branding provisions related to 
reprocessed devices.
    How soon will FDA issue the final guidance related to reprocessed 
devices?
    Answer. We hope to issue the final guidance shortly.
    Question. Will the final guidance differ significantly from the 
current draft?
    Answer. Because the guidance has not yet been finalized and 
cleared, we cannot say whether or not it will differ significantly from 
the current draft.
    Question. Will the final guidance assure that reprocessed single-
use devices are adequately marketed so reports of malfunctions and 
serious injuries are reported correctly during the entire time a 
particular device is being reprocessed or reused?
    Answer. Yes. FDA believes that the final guidance will be adequate 
to ensure that reprocessed single-use devices are adequately marked to 
ensure that reports of malfunctions and serious injuries are reported 
correctly during the time a reprocessed device is used.
    Question. Will the FDA ensure that the labels that meet the 
branding requirements actually make it in to the patient chart when 
used by a hospital?
    Answer. FDA's primary task will be to ensure and monitor that 
reprocessed single use devices include the appropriate identification 
and labeling. The hospitals and other facilities that use these devices 
will have responsibility for ensuring that health care personnel attach 
labels to patient charts as appropriate. FDA intends to work with 
manufacturers, hospitals, and the Joint Commission for the 
Accreditation of Health Organizations to do outreach and encourage 
health care facilities to establish procedures to ensure that these 
labels are properly attached to patient charts.
    Question. Recent media attention to the reprocessing of single use 
devices has raised many concerns about the practice. The original 
Medical Device User Fee and Modernization Act required the FDA to 
review the most commonly reprocessed devices. The FDA reviewed a small 
subset of reprocessed single use devices and nearly 50 percent of the 
reviewed devices were either withdrawn or were declared not-
substantially-equivalent.
    What is FDA doing to ensure patient safety is not compromised by 
the use of reprocessed single use devices? Can FDA do more to ensure 
patient safety is not compromised by the use of these reprocessed 
single use devices?
    Answer. FDA implemented the new premarket requirements put into 
place by the Medical Device User Fee Act, or MDUFMA, for reprocessed 
single-use devices, also known as SUDs. Manufacturers who intend to 
reprocess certain types of SUDs must now submit premarket 510(k) 
notifications for these devices which contain validation data on 
cleaning, sterilization and functionality. The additional premarket 
requirements apply to reprocessed SUDs determined to be high risk for 
transmission of infection or inadequate function following 
reprocessing, involving those reprocessed SUDs intended to come into 
contact with tissue at high risk of being infected with the causative 
agents of brain-wasting Creutzfeldt-Jakob disease. The reprocessed SUDs 
that are subject to the additional premarket requirements noted include 
21 device types that were previously exempt from premarket notification 
requirements, and 52 device types that were already subject to 510(k) 
premarket notification requirements, but were not previously required 
to submit validation data.
    FDA's postmarket oversight of reprocessors of SUDs includes 
inspections of manufacturing operations and review of adverse event 
reports. Since August 2000, FDA has inspected 29 reprocessing companies 
and over 200 hospitals to ensure that the third party reprocessors are 
following quality system regulations and that any hospitals engaged in 
reprocessing are also in compliance with these manufacturing 
requirements. During that time period, FDA issued eight warning letters 
to third party reprocessors and obtained two injunctions against firms. 
FDA issued regulatory correspondence outlining violations to four 
hospitals but has found that most hospitals are no longer reprocessing 
SUDs. In fiscal year 2005, FDA inspected seven reprocessing companies 
and found all of them in substantial compliance with applicable 
regulations.
    FDA continues to review adverse events submitted by manufactures, 
user facilities and the general public for problems associated with 
reprocessing of single use medical devices. FDA changed its MedWatch 
reporting forms to make it easier for device users to inform the agency 
when a reprocessed SUD is associated with an adverse event. In 
addition, FDA recently issued draft guidance to implement the provision 
of the Medical Device User Fee Stabilization Act, or MDUFSA, that 
requires reprocessors to ensure that each SUD clearly identifies the 
reprocessor. The new provision, which will go into effect in August 
2006, is intended to facilitate accurate reporting of adverse events 
involving reprocessed SUDs.
    FDA believes the measures Congress put into place for reprocessed 
single use devices under MDUFMA establish appropriate controls to 
provide reasonable assurance of safety and effectiveness for these 
devices. The controls, which include additional data requirements, 
premarket review, and labeling provisions, have supplemented the 
inspection and enforcement authorities FDA already had in place.

                             FDA DETAILEES

    Question. Please provide information on the FDA detailees sent to 
work in the Congress over the past 10 years, including the office they 
work in at FDA, the office they were or are detailed to in the 
Congress, the length of service, and FDA's policy on providing 
detailees to the Congress.
    Answer. I would be happy to provide that and the HHS Instruction 
300-3, Detail of Employees for the record.
    [The information follows:]

                                                  FDA DETAILEES
----------------------------------------------------------------------------------------------------------------
                 Name                        FDA offices            Detail location          Length of detail
----------------------------------------------------------------------------------------------------------------
David Dorsey, J.D....................  Office of the            Senate Health,           Jan. 2001-Present
                                        Commissioner; Office     Education, Labor, and
                                        of the Chief Counsel.    Pensions Committee.
Dr. Brian Harvey.....................  Center for Drug          White House, American    Oct. 2000-Oct. 2001
                                        Evaluation and           Political Science
                                        Research Office of New   Association
                                        Drugs.                   Congressional
                                                                 Fellowship.
Stacy M. McBride.....................  Office of the            Senate Appropriations    April 2005-Nov. 2005
                                        Commissioner; Office     Subcommittee.
                                        of Management.
Dr. Kevin Mulry......................  Center for Devices and   Office of Senator        Jan. 1998-Aug. 1998
                                        Radiological Health;     Richard Durbin Office
                                        Office of Device         of Legislative Affairs.
                                        Evaluation.
Thomas B. O'Brien....................  Office of the            House Appropriations     Feb. 2004-Nov. 2004
                                        Commissioner; Office     Committee.              Jan. 2005-Feb. 2006
                                        of Management; Office
                                        of Financial
                                        Management.
Dr. Donna-Bea Tillman................  Center for Devices and   Congresswoman Louise     Jan. 2000-July 2000
                                        Radiological Health;     Slaughter-New York.
                                        Office of Device
                                        Evaluation.
Lisa Siegel..........................  Office of the            House Agriculture        Feb. 1999-Oct. 1999
                                        Commissioner; Division   Appropriations
                                        of Budget Formulation    Subcommittee.
                                        and Presentation.
Maureen Holohan......................  Office of the            House Agriculture        Feb. 2000-Oct. 2000
                                        Commissioner; Office     Appropriations
                                        of Planning.             Subcommittee.
Margaret Carlson.....................  Center for Food Safety   Senate Health,           Mar. 2002-Jan. 2004
                                        and Applied Nutrition.   Education, Labor, and
                                                                 Pensions Committee.
Dennis Strickland....................  Center for Biologics     Office of Senator        Jan. 1996-Dec. 1996
                                        Evaluation and           William Frist
                                        Research; Office of      (Brookings Legislative
                                        Communication,           Fellows Program).
                                        Training and
                                        Manufacturers
                                        Assistance.
Tracy Summers........................  Center for Food Safety   Office of Senator        Aug. 1999-Nov. 1999
                                        and Applied Nutrition;   Edward Kennedy FDA
                                        Office of the Director.  Desk.
Diane Prince.........................  Office of the            House Energy and         May 1998-Jul. 1998
                                        Commissioner; Office     Commerce Subcommittee.
                                        of Legislative Affairs.
Jeff Shuren..........................  Office of the            Senate HELP Committee    Nov. 1999-Nov. 2000
                                        Commissioner; Office     Office of Senator
                                        of Policy.               Edward Kennedy's
                                                                 Office.
Theresa Mullin.......................  Office of the            Office of Senator Byron  Mar. 2000-Aug. 2000
                                        Commissioner; Office     Dorgan.
                                        of Planning.

Dave Doleski.........................  Center for Biologics     Office of Senator Paul   Jun. 1999-Dec. 1999
                                        Evaluation and           Wellstone (Brookings
                                        Research;                Legislative Fellows
                                        Manufacturers Branch     Program).
                                        II.
Serina Vandegrift....................  Office of the            Senate Agriculture       Jan. 2004-Jan. 2005
                                        Commissioner; Office     Committee (Chairman
                                        of Policy.               Cochran).
Tim Lynagh...........................  Office of the            Office of Congressman    2003
                                        Commissioner; Office     Chris Smith.
                                        of Legislation.
Mike Skonieczny......................  Office of the            Office of Congresswoman  2001
                                        Commissioner; Office     Rosa DeLauro.
                                        of Legislation.
----------------------------------------------------------------------------------------------------------------

                          HHS TRANSMITTAL 96.2
                            PERSONNEL MANUAL

Issue Date: 2/22/96
    Material Transmitted.--HHS Instruction 300-3, Detail of Employees 
(pages 1-3)
    Material Superseded.--HHS Instruction 300-3 (all).
    Background.--This Instruction has been substantially streamlined in 
accordance with National Performance Review recommendations, and in 
support of HHS administrative initiatives calling for more streamlined 
rules and greater delegations of authority.
    Any reference to ``OPDIV'' in this Instruction now includes the PHS 
agencies, the Office of the Secretary, the Program Support Center, 
HCFA, ACF, and AOA.
    This issuance is effective immediately. Implementation under this 
issuance must be carried out in accordance with applicable laws, 
regulations, and bargaining agreements.
    Filing Instructions.--Remove superseded material and file new 
material. Post receipt of this transmittal to the HHS Check List of 
Transmittals and file this transmittal in sequential order after the 
check list.
                                          John J. Callahan,
                     Assistant Secretary for Management and Budget.

                           INSTRUCTION 300-3
                   DISTRIBUTION: MS (PERS): HRFC-001
                    HHS PERSONNEL INSTRUCTION 300-3
              DELEGATION OF AUTHORITY TO DETAIL EMPLOYEES

A. Authority Delegated
    1. Heads of Operating Divisions (including PHS agencies and the 
Program Support Center), the Assistant Secretary for Management and 
Budget for the Office of the Secretary (OS), and the Inspector General 
(for OIG) are delegated the authority to:
    a. detail and extend details of civil service personnel within the 
    Department in increments not to exceed 120 days, pursuant to 5 
    U.S.C. 3341; and
    b. detail and extend details of civil service personnel to or from 
    other Federal organizations on either a reimbursable or a non-
    reimbursable basis pursuant to 31 U.S.C. 1535.
    2. These authorities may be redelegate with further redelegation 
authorized.
B. Restrictions
    1. The term ``Federal organizations'' in paragraph A.1.b. above 
does not include the Executive Office of the President and the 
Legislative and Judicial Branches of Government.
    2. The Assistant Secretary for Management and Budget retains the 
authority to approve all details to or from the Executive Office of the 
President and to or from the Legislative and Judicial Branches of 
Government (including the General Accounting Office, the Library of 
Congress, and the Government Printing Office).
C. Exclusions
    1. This delegation does not cover:
    a. Assignments of excepted employees other than those with Schedule 
    A and B or VRA appointments to competitive service position (5 CFR 
    6.5);
    b. Details of Administrative Law Judges (5 U.S.C. 3344);
    c. Details to certain Executive positions (5 U.S.C. 3344-3349) ;
    d. Details of members of the Senior Executive Service (5 CFR 
    317.903) ;
    e. Details of PHS Commissioned Officers (42 U.S.C. 215):
    f. Details between HHS and a non-Federal organization under Section 
    214 of the PHS Act, as amended;
    g. Details under the Intergovernmental Personnel Act of 1970 (5 
    U.S.C. 3372-3374; and 5 CFR Part 334); and
    h. Details to an International organization (5 U.S.C. 3343; and 5 
    CFR 352.304).
D. Information and Guidance
    1. The authorities delegated in paragraphs A.1.a and b. above must 
be exercised in accordance with the requirements and/or provisions in 
the following references:
    a. U.S.C. 112 (Details to the Executive Office of the President)
    b. U.S.C. 3341 (Details within Executive or Military Departments)
    c. Civil Service Rule 5 CFR 6.5 (Assignment of Excepted Employees)
    d. 31 U.S.C. 1301 (Appropriation Restrictions on Assignment of 
    Employees)
    e. 31 U.S.C. 1535 (Assignment of Employees Between Executive Branch 
    Departments and Agencies and Written Agreements Between Agencies 
    Detailing Employees)
    f. 4 CG 848-849, April 13, 1925 (Appropriations and Transfer)
    g. 21 CG 954, April 27, 1942 (Details to the Legislative Branch)
    h. 21 CG 1055, May 26, 1942 (Details to the Legislative Branch)
    i. 64 CG 370, B-211373, March 20, 1985 (Nonreimbursable Details)
E. Prior Delegations
    This delegation supersedes the February 19, 1991, Delegation of 
Authority to Detail Personnel, as amended September 29, 1993, from the 
Assistant Secretary for Personnel Administration to the Heads of 
Operating Divisions and Regional Directors. To the extent that previous 
redelegations of the authority to detail personnel made to other 
officials within HHS are consistent with the provisions of this 
delegation, they may remain in effect until new redelegations are made 
under the authority of this delegation.
F. Effective Date
    This delegation is effective on the date of this transmittal.
                             bse--feed ban
    Question. Yesterday afternoon, USDA announced that the third cow in 
United States history tested positive for BSE, commonly known as mad 
cow disease.
    The FDA feed-ban rule, issued in 1997, is the first line of defense 
in preventing BSE infection in U.S. cattle.
    What is FDA doing to ensure that it is inspecting all entities that 
are subject to the feed ban?
    Answer. FDA inspects a wide variety of firms in the animal feed 
industry to confirm compliance with the ruminant feed ban regulation. 
Every firm that manufactures, processes, blends, transports, or 
distributes animal feed or feed ingredients for any animal species is 
subject to inspection under the FDA ruminant feed ban compliance 
program. Firms are subject to inspection under the FDA ruminant feed 
ban regardless of whether prohibited material is used or the relative 
risk the firms practices may pose to the U.S. BSE feed control program. 
In addition to feed manufacturers and distributors, over one million 
farm operations feeding ruminants such as dairy and beef cattle are 
subject to the rule.
    The BSE Ruminant Feed Inspection Compliance Program guidance 
document constitutes the FDA risk-based inspection priority approach 
used by FDA and state investigators. FDA gives highest priority to 
inspecting firms that manufacture or process animal feeds or feed 
ingredients that contain prohibited material. This industry segment of 
renderers, protein blenders, and feed mills are inspected annually to 
ensure that ruminant feeds do not contain prohibited materials.
    FDA also conducts inspections on firms considered to have a reduced 
risk producing or causing contamination of ruminant feed. The agency 
conducts inspections of these lower risk firms to detect overall 
compliance trends. If FDA detects compliance trends, agency staff 
implements more targeted inspectional initiatives to increase our 
presence in some of these lower risk industry segments.

                           PANDEMIC INFLUENZA

    Question. How is FDA using the $20 million for pandemic influenza 
provided in the fiscal year 2006 supplemental?
    Answer. The $20 million supplemental was received at the end of the 
first quarter and the funds were available on January 26, 2006. I would 
be happy to provide the spending plan for the record.
    [The information follows:]

    
    

    Question. How does FDA plan to use the $30.5 million requested in 
fiscal year 2007?
    Answer. I would be happy to provide that information for the 
record.
    [The information follows:]

    
    
                           IMPORT INSPECTION

    Question. FDA plays a significant role in import inspection at 
ports. For example, FDA inspects food, human drugs, animal feeds, and 
medical devices at ports of entry across the country.
    For FDA-regulated food products, FDA estimates that by 2007 the 
amount that comes across the border will have nearly quadrupled since 
1999. In a typical year, FDA physically examines less than 1 percent of 
these food imports. How does FDA keep up with the ever increasing 
amount of imported products?
    Answer. FDA attempts to keep up with the increasing volume of 
imported products by using a risk based approach when selecting 
shipments to inspect and sample. All products are screened 
electronically by FDA's Operational and Administrative System for 
Import Support, also known as OASIS, against a set of criteria 
established as a result of previous laboratory findings, foreign 
inspections, information received from other regulatory agencies, and 
the relative risks posed by the products in question.
    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 requires anyone intending to import or offer for 
import a food product must provide prior notice to the FDA before the 
shipment arrives at the border. Every Prior Notice submission is 
screened electronically. If specific criteria are met, FDA's Prior 
Notice Center will review those submissions using various intelligence 
targeting parameters to protect the Nation's food supply against 
terrorist acts and other public health emergencies. For example, 
currently, working with information submitted through Customs and 
Border Protection's electronic systems used for import entries or 
through FDA's internet-based Prior Notice System Interface, FDA screens 
shipments electronically before they arrive in the United States to 
determine if the shipments meets identified criteria for physical 
examination or sampling and analysis or warrants other review by FDA 
personnel. This electronic screening allows FDA to better determine how 
to deploy our limited physical inspection resources at the border on 
what appear to be higher-risk food shipments while allowing lower-risk 
shipments to be processed in accordance with traditional import 
procedures after the electronic screening.
    Question. Does FDA have adequate resources to properly inspect 
imports?
    Answer. The rapid growth of imports combined with ever present 
security concerns has increased the need to assess the status of 
imported products. FDA estimates it will review more than 19 million 
import lines for admissibility into domestic commerce in fiscal year 
2007. To help ensure the safety of imported products entering the 
United States, FDA electronically screens imports through the 
Operational and Administrative System for Import Support, also known as 
OASIS. OASIS is an automated system for processing and making 
admissibility determinations for FDA regulated products that are 
offered for import. FDA also performs laboratory analysis on products 
offered for import into the United States; conducts foreign inspections 
to evaluate manufacturing conditions of products before they are 
offered for import; and performs periodic filer evaluations to ensure 
that the import data being provided to FDA is accurate.
    The Prior Notice Center, also known as PNC, is another important 
part of FDA's import strategy. The mission of FDA's PNC is to identify 
imported food and feed products that may be intentionally contaminated 
with biological, chemical or radiological agents, or which may pose 
significant health risks to the American public, and intercept them 
before they enter the United States. FDA will continue to focus 
resources on Intensive Prior Notice Import Security Reviews of products 
that pose the highest potential bioterrorism risks. The PNC uses a 
combination of adaptable targeting strategies and weighted risk 
indicators in the threat assessment process including contemporary 
intelligence involving terrorist activities, a history of prior notice 
violations, and compliance with admissibility standards as indicated by 
the results of import field exams, filer evaluations, firm inspections, 
repeated prior notice violations, and feedback from Field 
Investigators. By using a risk based approach, the PNC can intercept 
potentially hazardous products before they enter the United States.
    The benefit of these reviews comes from the quality and targeting 
of review activities; not from the volume of imports inspected. Thus 
the quality of import screening is a better measure of FDA's import 
strategy rather than simply focusing on the items physically examined.

                              DRUG SAFETY

    Question. Drug safety is a topic that has been very much in the 
news over the past year, and in your written testimony, you discuss the 
challenges the agency faces in balancing the need for proper risk 
analysis while trying to speed the review process.
    This subcommittee has closely followed FDA's drug safety 
activities. Last year, we provided an increase of $10 million for drug 
safety. This amount was $5 million more than the budget request. In 
fiscal year 2007, FDA is requesting an additional $3.9 million for drug 
safety.
    How is FDA using the $10 million increase we provided last year?
    Answer. In its fiscal year 2006 budget submission to Congress, FDA 
requested a base increase of $5 million to bolster the drug safety 
functions performed within the Center for Drug Evaluation and 
Research's Office of Drug Safety, also known as ODS. These included 
three important increases. First, ODS will increase the professional 
staff in ODS who manage and lead safety reviews. Second, ODS will 
increase the number of staff with expertise in critical areas, such as 
risk management, risk communication, and epidemiology. Third, ODS will 
expand our information technology infrastructure for monitoring post-
marketing data by increasing access to a wide range of clinical, 
pharmacy, and administrative databases. Valuable information regarding 
the safety of drug products is available in these types of databases 
for use by our scientists in ODS.
    The approval by Congress of the Administration's fiscal year 2006 
request for a $5 million increase significantly strengthens the ability 
to conduct drug safety activities within ODS.
    Congress increased our $5 million request to $10 million, adding to 
our original request an additional $5 million for general drug safety 
program activities. The Center for Drug Evaluation and Research will 
use these funds to increase its emphasis on effective risk 
communication. The additional funds will further enable FDA to 
modernize its drug safety program and expand the understanding of, 
involvement in, and access to, external population-based and ``linked'' 
databases, such as the CMS Medicare and Medicaid databases. Accessing 
these databases represent the future of more thorough and continued 
monitoring of drug products after they are marketed. Information 
obtained from these databases, combined with voluntarily reported 
adverse event information, will substantially increase the agency's 
ability to efficiently and effectively identify, investigate, and 
notify consumers of possible drug safety concerns and take appropriate 
regulatory actions. FDA will also continue its efforts to improve the 
Adverse Event Reporting System, also knows as AERS, so the agency can 
more efficiently review medication error reports and more quickly take 
appropriate action to avert further medication errors.
    These funds will also allow FDA to hire additional expert staff 
across the Center to enhance the ability to use multidisciplinary, 
multi-office teams to analyze and interpret drug safety data before and 
after product approval. FDA plans to hire additional scientists to 
address its highest priority safety needs, such as responding to 
emerging drug safety issues, supporting FDA's Drug Safety Oversight 
Board, and increasing resources devoted to risk assessment and 
communication activities. These funds will also assist Center efforts 
to ensure that drug safety information is available to healthcare 
professionals, patients, and other consumers.
    Question. What will the additional $3.9 million allow FDA to 
accomplish in fiscal year 2007?
    Answer. FDA requested additional funds in fiscal year 2007 to 
continue to modernize its AERS system and create ``AERS II''--a 
replacement web-accessible computer system that will enable FDA to 
maintain the current level of AERS functionality, while providing 
enhancements in several areas. With more than 5 years of experience 
with the database, we have identified areas of critical new 
functionality, including generating web-accessible adverse event 
information. The current AERS system is FDA's principal post-marketing 
monitoring tool. It allows FDA to identify events that were not 
observed or recognized before approval. It allows FDA to identify 
adverse events that might be happening because patients and prescribers 
are not using the drug as anticipated.
    Beyond the modernization of the AERS system, however, we requested 
these funds because the AERS system alone is not adequate for a 
successful, state-of-the-art drug safety program. To appropriately 
monitor drug safety after marketing, it is essential that FDA have 
access to a wide range of clinical, pharmacy, and administrative 
databases. These include databases maintained by organizations such as 
the Center for Medicare and Medicaid Services, the Department of 
Veterans Affairs, the Department of Defense, and the Indian Health 
Service. We will also access clinical and hospital and pharmacy 
networks and insurers, such as health maintenance organizations, 
preferred provider organizations, and pharmacy benefit management 
organizations.
    FDA is actively evaluating the utility and feasibility of 
conducting specific studies of high priority safety issues using such 
linked databases. Studies conducted on these types of databases will 
provide more evidence about drug use in a broader range of conditions, 
including more detailed evidence about drug safety in subgroups of 
patients. The planned modernizations for AERS are expected to optimize 
internal access and review of adverse event.

                          HUMAN TISSUE SAFETY

    Question. In February of this year, FDA ordered a New Jersey human 
tissue recovery firm to cease operation because it found that the 
company had seriously violated FDA regulations governing donor 
screening and record keeping practices. FDA inspection and action 
followed a news article that uncovered the fact that this company was 
regularly and illegally harvesting human tissues from funeral homes. 
These tissues were subsequently transplanted into dozens of patients.
    What is FDA doing to make sure situations like this do not happen 
again?
    Answer. FDA wishes to clarify information regarding this matter. As 
part of an audit consistent with FDA regulations, a tissue processor in 
Florida noticed discrepancies in records supplied to it by the New 
Jersey tissue recovery firm. The Florida firm then took the following 
steps: initiated a recall of tissue it had processed and distributed, 
quarantined tissue it still had in its possession, and notified FDA. 
FDA began an inspection of the New Jersey firm in October, 2005, and 
found that the firm had failed to comply with regulations designed to 
prevent the spread of communicable diseases. Tissues harvested by the 
New Jersey firm had been sold to several processors and subsequently 
transplanted.
    FDA is committed to establishing and maintaining high standards for 
tissue safety and to detecting, investigating and taking enforcement 
action against violations of its regulatory requirements. FDA continues 
to evaluate its tissue regulations and policies on an ongoing basis.
    Question. Is there a certification or licensing procedure that 
tissue processing firms must go through before they can begin 
operating?
    Answer. FDA regulations require that tissue processing 
establishments register with FDA and list their products within 5 days 
after beginning operations. FDA's District Offices use these 
registrations to schedule inspections to assure compliance with the 
regulations designed to promote patient safety and to prevent the 
spread of communicable diseases.
    Question. Does FDA regularly inspect human tissue firms?
    Answer. FDA performed 270 inspections of human tissue 
establishments in fiscal year 2005. The Agency anticipates it will 
perform 250 inspections in fiscal year 2006 and 325 inspections in 
fiscal year 2007. FDA is in the process of implementing its new risk-
based approach to assure the safety of human cells, tissues, and 
cellular and tissue-based products, or HCT/Ps. The Agency is using a 
comprehensive approach for regulating existing and new cell and tissue 
products. FDA is in the process of addressing issues related to safety 
and effectiveness of a rapidly growing industry.
    A rule expanding the types of tissue facilities required to 
register with the FDA and list their HCT/Ps became effective January 
21, 2004. The donor eligibility rule became effective May 25, 2005, and 
focuses on donor screening and testing measures to prevent the 
transmission of communicable diseases from the donor through HCT/Ps. 
The current good tissue practice rule also became effective May 25, 
2005. This rule requires manufacturers to recover, process, store, 
label, package and distribute HCT/Ps in a way that prevents the 
introduction, transmission, or spread of communicable diseases. These 
rules are critical new tools that give FDA the ability to monitor human 
tissue adverse reactions to target more effectively the products with 
the highest risks.

                           PROPOSED USER FEES

    Question. FDA is proposing two new user fees in the budget request. 
One will require manufacturers to pay for the full cost of follow-up 
inspections when FDA must revisit facilities because of initial bad 
inspection reports. The second fee would reimburse FDA for the cost of 
issuing export certificates for food and animal feeds.
    Can you explain why you believe these fees are necessary?
    Answer. Although FDA issues export certifications for all products 
it regulates, the agency only has authority to charge a fee to issue 
export certifications for human and animal drugs, and medical devices. 
Timely issuance of food and feed export certificates funded through 
user fees would improve the ability of food and animal feed producers 
to export their products and would eliminate the current preferential 
treatment of the food and feed industry differences in authority to 
collect fees for the food and feed industries.
    FDA conducts post-market inspections of food, human drug, biologic, 
animal drug and feed, and medical device manufacturers--both domestic 
and foreign--to assess their compliance with Current Good Manufacturing 
Practice, or CGMP, and other FDA requirements. In 2004, approximately 
1,500 out of 21,000 firms inspected were found non-compliant with CGMPs 
and other important FDA requirements. Under current law, FDA does not 
have the authority to assess fees for any follow-up inspections 
conducted by FDA to ensure that manufacturers have addressed violations 
that were found during the previous inspection. A fee for repeat 
inspections will serve as an incentive to industry to conform to CGMPs 
and other FDA requirements and will ensure that the financial burden of 
re-inspections is more equitably shared between industry and the 
public.
    Both fees are designed to improve the overall management of these 
activities.
    Question. Has FDA sought input from impacted organizations?
    Answer. Discussions with industry have not yet been held.
    Question. Have you submitted the text of your legislative proposal 
to the authorizing committee?
    Answer. The legislative proposals are in the final stages of 
review. We expect the proposals will be submitted to the Congress 
within the next several weeks.
    Question. Please explain the services FDA will be reimbursed for by 
the re-inspection user fee.
    Answer. If a firm undertakes corrective action to achieve 
compliance, FDA will verify the appropriateness and completeness of the 
corrective action. For the firm to satisfy FDA's concerns and, if 
regulatory action was taken, to resume its full ability to market 
products, the firm must be reinspected by FDA and found in compliance.
    These user fees will provide funding to FDA to act in a timely 
manner to ensure that noncompliant firms have taken appropriate 
corrective action and to facilitate the return of compliant firms to 
full marketing of violative products. Some of the activities that FDA 
performs in conducting reinspections include the scheduling and 
preparatory reinspection work by the FDA investigator, the reinspection 
itself, sample analyses, report writing, compliance officer review and 
analysis, conferring with experts, and travel and administrative time.
    Question. Please explain the services FDA will be reimbursed for by 
the food and animal feed certification fee.
    Answer. The services FDA will be reimbursed for by the food and 
animal feed certification fee include: reviewing applications and 
attestations; checking of field and headquarters administrative 
records, and with personnel for the compliance status of the firm; 
review of the product label for compliance with the law; preparing, 
processing, and issuing of the certifications, including notarization; 
maintenance of applications and copies for tracking of services 
rendered and for provision of certificate copies when requested; all 
other clerical procedures necessary to issue the certifications within 
20 days including processing of billing and receipts, and other costs 
attributable to the issuance of certifications. Currently 
certifications are processed on an ``as resources permits'' basis.

                              FOOD DEFENSE

    Question. Over the past 5 years, this subcommittee has provided 
more than $600 million for food defense activities at FDA. The fiscal 
year 2007 budget requests an increase of $19.8 million for food defense 
activities. This is a significant investment.
    How has FDA used the funding we have provided to make the food 
supply safer?
    Answer. FDA uses the food defense funding to build upon the 
Nation's core food safety and public health systems and to strengthen 
our capabilities to address terrorist threats. FDA's efforts to protect 
the food supply focus primarily on six major crosscutting initiatives 
under Homeland Security Presidential Directive-9, also known as HSPD-9, 
for food defense.
    One example of FDA's HSPD-9 activities is the establishment of the 
Food Emergency Response Network, a national network also known as FERN, 
to increase analytic surge capacity in the event of terrorist attack by 
developing adequate laboratory testing capacity for biological, 
chemical and radiological agents in food. The Agency continues to 
develop FERN by providing laboratory infrastructure, training, and 
proficiency testing to member laboratories. FDA is conducting targeted 
food defense research efforts, including prevention technologies, 
methods development, determination of infectious dose for certain 
agents when ingested with food, and agent characteristics within 
specified foods. Also, FDA is performing more effective targeted risk-
based inspections using data from FDA's Prior-Notice system and Prior 
Notice Import Security Reviews based on intelligence, FDA inspection 
reports, discrepancies in prior notice reporting, and sample collection 
and analysis. As part of the government-wide Biosurveillance 
Initiative, FDA is improving coordination and integration of existing 
food surveillance capabilities with the Department of Homeland 
Security's integration and analysis function. FDA is upgrading and 
expanding its Emergency Operations Network Incident Management System 
to assist in the management and coordination of the Agency's response 
to incidents affecting the U.S. food supply. Along with the U.S. 
Department of Agriculture, the Federal Bureau of Investigation, and 
Department of Homeland Security, FDA began a new collaborative effort 
with States and private industry to protect the Nation's food supply 
from terrorist threats through the Strategic Partnership Program 
Agroterrorism Initiative. FDA has spearheaded this effort to identify 
sector-wide vulnerabilities, mitigation strategies, and research needs 
to protect our Nation's food supply.
    Question. Does FDA have an overall plan for food defense, including 
out-year costs? Can you provide this information for the record?
    Answer. FDA's overall plan for food defense aligns with the 
activities outlined in Homeland Security Presidential Directive-9 also 
known as HSPD-9, which establishes a national policy to defend the food 
and agriculture system. The directive lays out a framework for 
augmenting the Nation's food safety protections by identifying and 
prioritizing sector-critical infrastructure and key resources for 
establishing protection requirements, developing awareness and early 
warning capabilities to recognize threats, mitigating vulnerabilities 
at critical production and processing nodes, enhancing screening 
procedures for domestic and imported products, and enhancing response 
and recovery procedures.
    With regard to future activities, the fiscal year 2007 requested 
funds will be used expand the Food Emergency Response Network, also 
known as FERN, to include 16 State laboratories, provide grants and 
technical support to these laboratories, and build analytic surge 
capacity to respond to a terrorist attack. We will also use these funds 
to manage, through the National Program Office, the network and to 
provide training and proficiency testing for FERN laboratories. We will 
continue Field support for food defense operations, including targeting 
potentially high-risk imported foods through Prior Notice Import 
Security Reviews based on intelligence, FDA inspection reports, 
discrepancies in prior notice reporting, and sample collection and 
analysis.
    FDA also will continue laboratory preparedness efforts and valuable 
short-term food defense research projects. Many of the projects 
undertaken are derived from direct interaction with industry following 
vulnerability assessments. The results of these projects can be 
communicated directly to industry. These efforts will result in a 
better understanding of which interventions work, and which do not, for 
certain agents in specific foods.
    In addition, the fiscal year 2007 requested funds will further 
joint food defense and food safety assignments that will enhance and 
facilitate the integration of food defense with food safety. In these 
assignments, samples obtained as part of routine food safety programs 
will also be tested in a variety of laboratories for a range of select 
agents that are of most concern. The foods chosen for these assignments 
are generally foods that we have most concern about based on 
vulnerability assessments.
    Out-year activities will further strengthen our food defense system 
and advance the objectives identified in HSPD-9.
       drug efficacy study implementation (desi) monograph system
    Question. In response to Senate Committee Report language 
accompanying the fiscal year 2005 agriculture appropriations bill, FDA 
prepared a report on the feasibility of developing a drug monograph 
system for older prescription drugs that have been marketed for a 
material extent and material amount of time without documented safety 
problems. In this report, FDA stated that a monograph system would be 
scientifically infeasible and cost prohibitive. However, FDA did not 
propose an alternate solution to this monograph system.
    The Senate Committee Report to accompany the fiscal year 2006 
Agriculture appropriations bill requested a second report asking FDA to 
propose an alternate approach that provides for the uniform and 
transparent regulation of these products.
    What is the status of this report?
    Answer. FDA is working on this report and hopes to submit it to 
Congress this summer.
    Question. Has FDA developed an alternate method as requested in the 
report language?
    Answer. The agency is working on its approach to the regulation of 
these products and plans to discuss alternatives in our report to the 
subcommittee.

                         MEDICAL IMAGING DRUGS

    Question. Since FDA terminated the Medical Imaging Drugs Advisory 
Committee in 2002, FDA has tried to fill the gap in medical imaging 
expertise by retaining experts as special government employees and 
appointing them on an ad hoc basis to meetings of a standing advisory 
committee when a medical imaging product or issue needs advisory 
committee review. I understand that at the last advisory committee 
meeting to consider a medical imaging product, which was held in March 
2005, FDA appointed three medical imaging drug experts to a standing 
panel of 17 experts. In light of the increasingly important role of 
medical imaging drugs and medical imaging biomarkers under FDA's 
Critical Path initiative, I am interested in FDA's ability to get the 
necessary medical imaging expertise on these panels. How many medical 
imaging experts has FDA retained as special government employees?
    Answer. Currently, FDA has a list of 89 special government 
employees, or SGEs, with medical imaging expertise who may be requested 
to participate in regulatory activities, including FDA drug advisory 
committee and device panel discussions. The 89 SGEs includes 72 members 
of various Medical Devices Advisory Committees and consultants. These 
SGEs are also accessible for drug review consultation.
    Question. What is FDA doing to improve the recruitment of medical 
imaging experts as special government employees? Are there any barriers 
to such recruitment?
    Answer. The ability of a special governmental employee, or SGE, to 
assist in FDA activities varies considerably, based predominantly upon 
competing SGE commitments and timelines. Hence, FDA is actively 
recruiting additional SGEs via interactions with professional societies 
and visiting professor lecture activities. Barriers to SGE recruitment 
relate to conflict of interest considerations and the limited 
reimbursements to SGEs.
    Question. How many medical imaging expert special government 
employees does FDA intend to hire in the future?
    Answer. FDA is currently processing materials for 12 medical 
imaging experts as potential special government employees. When 
vacancies are imminent on Medical Devices Advisory Committees, FDA 
requests professional society assistance in obtaining voluntary 
applicants.

                          COLOR CERTIFICATION

    Question. The fiscal year 2007 budget request includes an increase 
in current law user fees of $180,000 for the Color Certification 
Program. Please explain this increase.
    Answer. As in previous years, FDA estimates that an increase of 3 
percent in poundage will be submitted for color certification in fiscal 
year 2007 over fiscal year 2006. This will generate an estimated 
$180,000 in additional color certification revenue and is not related 
to any rate increase for the Color Certification Program.
    Question. In April 2005, FDA increased the color certification fee 
through an interim final rule, with no opportunity for comment from 
industry. FDA has stated this was necessary in order to ensure that the 
fund was not depleted. At the same time, FDA stressed the need to keep 
adequate reserves in order to ensure adequate levels of funding. Given 
that FDA has worked to ensure an adequate reserve fund, would it be 
possible for FDA to seek public comment in advance of any future color 
certification fee increase?
    Answer. Historically, solicitation of public comment has not been 
deemed a prerequisite for increasing color certification fees. As 
required under the Federal Food, Drug, and Cosmetic Act, also known as 
the FD&C Act, Section 721(e), the fees assessed for color certification 
reflect those costs necessary to provide, maintain, and equip an 
adequate service for such purposes. Section 721(e) does not provide for 
notice-and-comment rulemaking for assessing or increasing fees. Since 
passage of the 1938 FD&C Act, FDA increased the color certification 
fees several times, most recently in 1963, 1982, 1994 and 2005. FDA 
stated, in the March 29, 2005 interim final rule, that the fee 
modification is necessary because of a general increase in all costs of 
operating the certification program. In the interim final rule, FDA 
found under 5 U.S.C. 553(b)(B) and 21 CFR 10.40(e) that providing for 
public comment before establishing the fees, and for revising the basis 
for calculating the fees, is contrary to the public interest. Despite 
this finding, the agency stated in the interim final rule that it 
invited and would consider public comments on the requirements in the 
rule. The interim final rule became effective on April 28, 2005, and 
FDA requested comments by May 31, 2005. Comments, as well as a request 
for a stay of the effective date and a citizen petition, were submitted 
to the docket and are under consideration.
    Question. Has FDA taken any steps to make the color certification 
fees and program expenses more transparent?
    Answer. FDA's Office of Financial Management, also known as OFM, 
occasionally submits certification fund updates to industry 
representatives; this information is always provided to industry 
representatives upon request. OFM maintains detailed accounting records 
of color certification expenditures and other related non-proprietary 
information. These statements include expenditure reports, status of 
funds reports, and projected yearly estimates for the various 
allowances within the Color Certification program.
    Question. Please provide a list of anticipated equipment needs, 
including estimated costs, necessary to maintain adequate service for 
certification of batches of color additives.
    Answer. I would be happy to provide that information for the 
record.
    [The information follows:]

  COLOR CERTIFICATION PROGRAM--ANTICIPATED EQUIPMENT NEEDS AND RELATED
                COSTS--FISCAL YEAR 2007-FISCAL YEAR 2009
------------------------------------------------------------------------
                                                          Estimated Cost
               Item                      Description        (per three
                                                              years)
------------------------------------------------------------------------
Maintenance contract for computer   Certification               $300,000
 database.                           operating system
                                     and web-based
                                     industry interface.
Maintenance contracts for large     High-performance             250,000
 equipment.                          liquid
                                     chromatographs
                                     (approximately 21
                                     systems).
                                    Liquid chromatograph/         25,000
                                     mass selective
                                     detector.
                                    X-ray fluorescence            60,000
                                     spectrometer.
                                    Atomic absorption             30,000
                                     spectrometer.
                                    Ion chromatograph...          16,500
                                    Microwave digestion           15,000
                                     and ashing systems.
Replacement parts for equipment...  X-ray fluorescence            75,000
                                     spectrometer (x-ray
                                     tubes, sample
                                     changer parts,
                                     helium/vacuum
                                     switch).
                                    Atomic absorption             30,000
                                     spectrometer
                                     (furnace tubes,
                                     lamps).
                                    Microwave digestion            7,500
                                     and ashing systems
                                     (parts, crucibles).
                                    Shatterbox (grinding           5,000
                                     tools).
                                    Pellet press (press            2,500
                                     tools).
Anticipated new large equipment...  High-performance             460,000
                                     liquid
                                     chromatographs
                                     (expect to purchase
                                     two annually).
                                    X-ray fluorescence           350,000
                                     spectrometer.
                                    Liquid chromatograph/        120,000
                                     mass selective
                                     detector.
                                    Ion chromatograph...          10,000
                                    Preparative high-             45,000
                                     performance liquid
                                     chromatograph.
                                    Flash preparative             25,000
                                     chromatograph.
                                    Automatic titrator..          17,000
                                    Microwave ashing              20,000
                                     system.
                                    Fusion machine and            50,000
                                     platinum ware.
                                    Freeze drier........          15,000
                                    Microwave                     20,000
                                     synthesizer.
                                    Uninterruptible               30,000
                                     power supply.
                                    Reaction system.....          20,000
Anticipated new small equipment...  Analytical balances          250,000
                                     (5), top-loading
                                     balances, lab
                                     computers,
                                     spectrophotometers,
                                     fluorescence
                                     detector, moisture
                                     analyzer,
                                     centrifuge rotor,
                                     digital camera.
Hazardous waste disposal..........  Disposal of chemical         300,000
                                     waste.
Stockroom contract................  Reagents, glassware,         330,000
                                     misc. lab supplies.
Misc. purchases...................  Computer software,           400,000
                                     reagents, misc. lab
                                     supplies.
                                                         ---------------
      Total.......................  ....................       3,278,500
------------------------------------------------------------------------

    Question. What is the anticipated timeframe for these equipment 
needs?
    Answer. Certification requirements are assessed in 3 year cycles. 
FDA's anticipated timeframe for these equipment needs is 3 years.

                        FOOD CONTACT SUBSTANCES

    Question. Since its implementation 6 years ago, the Food Contact 
Notification program has been successful. I understand that the Food 
Contact Notification program requires less FDA resources than the 
previously used Food Additive Petition process because the FCN program 
does not require the Agency to follow Notice and Comment Procedures and 
promulgate a new regulation. In addition, the clearance of a new 
material under the Food Additive Petition program typically took 2 to 4 
years, but the Notification program only takes 4 months. The success of 
the program has led to the clearance of over 500 new types of packaging 
materials.
    If the FCN program is more efficient, why would FDA seek to 
eliminate the program and return to promulgating regulations, and how 
does FDA plan to accomplish its statutory mandate under the food 
additive petition process when it does not seek to add additional 
resources to handle these submissions?
    Answer. The Food Contact Notification, also known as FCN, program 
has been very successful. Under the FCN program, if FDA does not object 
within the 120-day review period, a company can legally market its 
product. To date, FDA has always met the 120-day deadline. In contrast, 
under the Food Additive Petition, also known as FAP, program, the 
petitioned food contact substance cannot lawfully be marketed until a 
regulation is published by FDA. Reverting to the FAP process for food 
contact substances will not have an adverse impact on the public health 
because these substances cannot be marketed until FDA completes a full 
safety review of each substance. Prior to the implementation of the FCN 
program, FDA had implemented many changes to the FAP process and had 
made significant progress in streamlining the review of food additive 
petitions. Although FDA does not expect to be able to meet its 
statutory mandate of publishing a decision on a petition within 180 
days of filing, we will continue our efforts to streamline the petition 
review process and to reach decisions in a timely manner.
    Question. What is FDA's assessment of the impact that the 
elimination of the FCN program will have on packaging innovation and on 
public health?
    Answer. Elimination of the FCN program will not have a significant 
adverse impact on the public health because pre-market approval of food 
contact substances will still be required and food contact substances 
will still have to meet the same safety standard so that unsafe food 
contact substances do not reach the market. As in the past, petitions 
in which the subject additive is intended to have an impact on the 
public health, for example reducing pathogens on food, will be 
prioritized and expedited through the review and administrative 
process. Thus any impact on public health will be minimal.

                         NEW DRUG APPLICATIONS

    Question. On February 13, 2006, the Justice Department, on behalf 
of FDA, represented to the U.S. District Court for the District of 
Columbia that the Omnitrope New Drug Application, which was submitted 
in fiscal year 2003, is still undergoing active review by the Agency. 
However, in the FDA's fiscal year 2007 budget submission the Agency 
reported that, for NDA submissions during fiscal year 2003, which would 
include this application, FDA reviewed and acted on ``100 percent of 
82'' fiscal year 2003 NDA submissions by the end of fiscal year 2004. 
Please explain this apparent discrepancy. Was action completed on all 
NDAs or are there submissions from fiscal year 2003 still under review?
    Answer. As FDA described in an August 2004 letter to the sponsor of 
the Omnitrope NDA, the reviewing division had completed its review of 
the information in the NDA. However, because the agency was considering 
related scientific and legal issues in its review of pending citizen 
petitions, and scientific considerations related to the approval of 
products like Omnitrope were to be the subject of a series of public 
meetings, FDA was not ready to make an approval decision on the 
application. The agency deferred a decision on the Omnitrope NDA until 
the agency knew whether the data in the NDA was sufficient for approval 
and, if not, what additional substantive information and data might be 
necessary to support approval. The letter identified what additional 
steps had to be completed before the agency could inform the sponsor of 
the actions necessary to place the Omnitrope NDA in condition for 
approval. Therefore, it was considered an action in accordance with the 
PDUFA performance goals. All fiscal year 2003 NDA submissions have been 
completed and final performance has been reported.

                          SUNSCREEN MONOGRAPHS

    Question. The statement of managers accompanying the fiscal year 
2006 conference report directed FDA to issue a comprehensive final 
monograph for labeling over-the-counter sunscreen products, including 
UVA and UVB labeling requirements, by May 10, 2006. Please describe the 
status of FDA's efforts or plans to finalize the sunscreen labeling 
guidelines by this deadline.
    Answer. We are currently working on a rulemaking for OTC sunscreen 
drug products to address both UVA and UVB labeling requirements. We are 
currently working to publish the document for this rulemaking in the 
Federal Register.
                                 ______
                                 

             Questions Submitted by Senator Mitch McConnell

     NATIONAL INSTITUTE FOR PHARMACEUTICAL TECHNOLOGY AND EDUCATION

    Question. In June 2005 the Center for Drug Evaluation and 
Research's Office of Pharmaceutical Science within the Food and Drug 
Administration (FDA) signed a Memorandum of Agreement with the National 
Institute for Pharmaceutical Technology and Education (NIPTE). The 
University of Kentucky (UK) is a member of NIPTE.
    As the FDA considers funding priorities for fiscal year 2007, I am 
interested in answers to the following questions raised by NIPTE and 
UK.
    The Memorandum of Agreement expresses the FDA's desire to 
collaborate with NIPTE on issues related to pharmaceutical development, 
manufacturing practices and technologies.
    To date, what interaction has the FDA had with NIPTE?
    Answer. FDA has had some preliminary discussions with NIPTE about 
issues of mutual interest. NIPTE has expressed concerns about the level 
of products failing during development.
    Question. NIPTE has concerns that product failure during 
development is often related to the transition from a laboratory 
prototype to final product. They have expressed concerns that the 
limited amount of research into these failures causes production 
technology to lag behind efforts to discover new compounds.
    Do you anticipate that the relationship between FDA and NIPTE will 
promote a more efficient therapy development and production process and 
if so, how?
    Answer. It is not possible to determine, at this time, the outcome 
of any interactions with NIPTE. FDA works with many academic 
institutions and other interested parties on pharmaceutical development 
and manufacturing research to support FDA policy relating to Process 
Analytical Technologies product applications.
    Question. The FDA's stated goal of the Critical Path to New Medical 
Products initiative is to modernize the scientific process through 
which drugs and other treatments are transformed from ``proof of 
concept'' into medical products.
    How can the FDA take advantage of the infrastructure and resources 
of NIPTE's member institutions to promote the goals of the Critical 
Path initiative?
    Answer. We expect the new manufacturing science created through 
CDER's contract with NIPTE to promote manufacturing process 
improvements as part of the Critical Path Initiative. It is not 
possible to determine, at this time, whether FDA can take further 
advantage of infrastructure and resources at NIPTE. FDA believes that 
the best way to advance the goals of Critical Path is to stimulate 
broad-based efforts that advance the goals of this initiative.
                                 ______
                                 

              Questions Submitted by Senator Sam Brownback

                            CLINICAL TRIALS

    Question. I understand the FDA has regulatory authority to utilize 
a number of various controls to determine efficacy in the clinical 
trials process, which include the use of historical controls and 
placebo controls.
    Is the FDA considering increasing the frequency of approval for 
study designs involving historical controls or even Bayesian 
statistics?
    Answer. FDA is actively considering, under its critical path 
initiative, a variety of study designs, methods of analysis, and uses 
of data from other studies to improve decision making and the rate of 
success of studies. Although FDA does not approve study designs, we do 
discuss with sponsors whether we are likely to consider a particular 
design as representing an adequate and well-controlled study that could 
support approval under the Federal Food, Drug, and Cosmetic Act. The 
appropriate use and applicability of historical controls in which 
treatment of a group of patients is compared to well-documented 
experience from other studies is considered in detail in the ICH 
guidance E-10 known as the Choice of Control Group and Related Issues 
in Clinical Trials. FDA's regulations at 21 CFR 314.126, state that 
historical controls can be an acceptable kind of ``adequate and well-
controlled study,'' but only in special circumstances, such as studies 
of diseases with high and predictable mortality. Such controls are 
regularly used now, for example, in accelerated approvals of anti-
cancer drugs based on tumor response rates. See 21 CFR 314.500. It is 
possible, and is worth studying, particularly for rare diseases, that 
better documentation of the natural history of diseases will provide a 
basis for wider use of historically controlled trials. With regard to 
medical devices, FDA's regulations at 21 CFR 860.7, allow for a wide 
variety of valid scientific evidence for premarket approval 
applications, including historical controls, where appropriate.
    FDA has viewed Bayesian approaches as an alternative method in the 
design and evaluation of clinical studies. The frequency of use of such 
an approach is related to the medical product itself, the sponsor, the 
target population, and many other factors. Although FDA would consider 
the use of Bayesian statistics, few drug sponsors propose such designs. 
In May 2004, in an effort to emphasize our willingness to examine such 
designs, FDA and Johns Hopkins University jointly sponsored a very 
well-attended workshop for industry, academia, and government entitled, 
``Can Bayesian Approaches to Studying New Treatments Improve Regulatory 
Decision-Making?'' The Center for Devices and Radiological Health has 
accepted designs involving Bayesian statistics since 1998, and there 
has been an increase in the frequency of investigational device 
exemptions that use Bayesian design and plan appropriate analyses.
    Question. Please list the number of cancer drugs for which the FDA 
approved a study design that included a placebo-controlled trial, over 
the past 4 year period.
    Answer. FDA does not ``approve'' study designs or protocols. 
Companies generally develop an overall drug development strategy, 
including specific protocols, to seek registration or approval in 
multiple countries such as the European Union, Japan, Switzerland, 
Canada, and Australia. FDA reviews, but does not approve these 
protocols.
    In cancer settings, the term placebo-controlled is a misnomer. It 
is very rare for a cancer patient to only receive a placebo. Whenever 
possible, FDA encourages use of another available therapy as an active-
control rather than a placebo. In situations where an active-control 
study cannot be conducted, FDA seeks to ensure that all patients 
receive best supportive care in addition to the test-article or placebo 
to which they are randomized.
    Question. Please describe the process by which a cancer patient who 
has exhausted all other treatment options can gain access to a drug 
that has shown efficacy in an earlier stage of the clinical trials 
process.
    Answer. The FDA has a long-standing commitment to desperately ill 
patients, including patients with cancer, to facilitate the 
availability of promising new drugs during the drug development 
process, when promising drugs are being studied, but are not yet 
approved for marketing. FDA's statute and regulations enable a patient 
suffering from a serious or immediately life threatening disease for 
whom no comparable or satisfactory alternative drug or other therapy is 
available to get access to a promising investigational drug. FDA is 
developing regulations to further clarify and publicize the expanded 
access mechanisms for such treatment use of investigational new drugs, 
in the belief that such new regulations will increase the awareness of 
and participation in expanded access programs. However, it should be 
noted that FDA does not have authority to compel a sponsor to make an 
investigational new drug available for treatment use.
    In December 2003, FDA submitted to Congress its report on Patient 
Access to New Therapeutic Agents for Pediatric Cancer. This report 
includes how patients can access investigational drugs under current 
rules. I would be happy to provide for the record, the section of the 
report that describes our current system.
    [The information follows:]

                           EXISTING PROGRAMS

Access Outside of Clinical Trials
    It is not always possible for all patients who want access to 
investigational drugs to enroll in clinical trials. Patients may not 
meet eligibility criteria or may be geographically isolated from a 
study site. It may be difficult to find an ongoing trial for a 
particular type and stage of cancer. In these situations, FDA and NCI 
believe that it is appropriate to help make certain promising, but as 
yet unproven, products available outside of a clinical trial (non-
protocol) to patients with cancer as well as other serious and life-
threatening illnesses. Non-protocol investigational therapy should be 
offered in a way that does not pose an unreasonable risk to the patient 
or an unreasonable risk of losing valuable information about the effect 
of the drug. For these reasons, although treatment is focused on the 
individual patient, a study plan (protocol) may be written to ensure 
that the treatment is administered appropriately and that patients are 
monitored for toxicity. The programs available through both agencies 
are discussed below. It is important to note that a pharmaceutical 
manufacturer must first agree to provide the requested product for a 
non-protocol investigational therapy to begin. NCI and FDA cannot 
mandate that the requested products be supplied to these programs; the 
agencies can only review and approve proposals to use them.
FDA Programs for Non-protocol Access
    FDA programs that permit non-protocol access to investigational 
agents for patients with serious or life-threatening disease include 
the single patient IND, the emergency IND, and the Treatment IND 
(sometimes informally referred to as an expanded access protocol). The 
lay public frequently refers to these programs as compassionate use, 
although the term compassionate use does not appear in FDA regulations. 
Single patient or emergency INDs refer to a treatment program for a 
single individual. Treatment IND refers to a single study plan used to 
treat multiple patients.
            Single Patient IND Submissions
    Single-patient IND submissions can represent entirely new uses for 
a drug or exceptions to an ongoing clinical trial protocol for a 
patient who does not meet protocol entry criteria. Single patient IND 
requests can be submitted as amendments to an existing IND or as an 
entirely new IND. They can be submitted by a drug manufacturer (usually 
amending an existing IND) or by an individual physician, following 
usual procedures for IND filing, including IRB review and informed 
consent. If the need for treatment is urgent and does not allow time 
for submission of an IND, an emergency IND can be obtained allowing FDA 
to authorize shipment of a drug for the specified use before the IND is 
submitted (21 CFR 312.36). The IND should then be submitted as soon as 
possible after receiving authorization. As with all INDs, both 
mechanisms require adverse event reporting and an annual summary to be 
submitted to FDA.
            Treatment IND
    Treatment IND study plans ``facilitate the availability of 
promising new drugs to desperately ill patients as early in the drug 
development process as possible, before general marketing begins, and 
obtain additional data on the drug's safety and effectiveness'' (21 CFR 
312.34). Certain criteria must be met for a drug to be considered for 
approval in a Treatment IND,1 including:
  --The patients' disease must be serious or life-threatening.
  --No comparable or satisfactory treatment is available to the target 
        population of patients.
  --The drug is in clinical trials (generally Phase 3 and not 
        ordinarily prior to Phase 2).
  --The sponsor of the clinical trials is actively pursuing marketing 
        of the drug.
    FDA may refuse the request if:
  --For a serious disease, sufficient evidence of safety and potential 
        efficacy is not provided to support use of the drug to treat 
        it.
  --For a life-threatening disease, available scientific evidence does 
        not provide a reasonable basis for concluding that the drug may 
        be effective and would not expose patients to serious 
        additional risk of illness or injury.
    The same safeguards and reporting requirements that apply to any 
IND study apply to a Treatment IND, including IRB approval. The study 
plan must contain a rationale for the use of the investigational drug, 
as well as a list of what available regimens should be tried prior to 
its use, or an explanation of why the use of the investigational drug 
is preferable to the use of available marketed treatments.
NCI Programs for Non-protocol Access
    At NCI, Special Exception and Group C protocols provide access to 
investigational agents for those patients unable to participate in a 
clinical trial.
            Special Exception
    The Special Exception is comparable to the single patient IND, but 
investigators may obtain investigational agents directly from NCI using 
NCI's Special Exception mechanism instead of filing a new IND with FDA. 
NCI does not grant these requests for drugs in Phase 1 development, 
because NCI requires some demonstration of efficacy before permitting 
individual treatment. The written policy for this program requires 
objective evidence that the investigational agent is active in the 
disease for which the request is being made.
    Anecdotal reports or reports that show low response rates or 
responses of brief duration are not sufficient to justify approval of 
the request. Patients must be ineligible for ongoing research protocols 
and must have received standard therapies.
            Group C
    Group C designation is an expanded access program similar to a 
Treatment IND that allows broadened access to investigational agents 
with reproducible activity in one or more specific tumor types. An 
agent must alter or be likely to alter the pattern of treatment of the 
disease, and properly trained physicians without specialized supportive 
care facilities must be able to administer the agent safely. For an 
agent that meets this definition, CTEP may submit a formal application 
to FDA to authorize distribution of the agent (Group C distribution) by 
NCI for the specific indication described in the application. This 
application is not a marketing application, and FDA approval of a Group 
C protocol does not replace an FDA conclusion that the drug is safe and 
effective. The study plan must contain the indication, dosage, 
precautions, warnings, known adverse events of the product, and an 
informed consent form. Approval of the Group C protocol carries the 
obligation of the usual safety reporting requirements. This mechanism 
is used only with agents for which activity is sufficiently established 
and for which a New Drug Application (NDA) or Biological Licensing 
Application (BLA) approval is considered likely in the relatively near 
future.
                                 ______
                                 

                Questions Submitted by Senator Herb Kohl

                              FIELD STAFF

    Question. We discussed earlier the decrease in FDA field force, and 
I was told that this was a result of the streamlining of the FDA 
inspection process, and would not result in fewer, or less effective, 
inspections.
    Please provide specific numbers of inspections that are scheduled 
to take place by all FDA field staff members in fiscal year 2007. 
Please organize these into the types of inspections FDA performs--for 
example, inspections of feed manufacturers, ports, food manufacturers, 
drug companies, overseas companies, etc. How do each of these numbers 
compare to fiscal year 2006 and 2005 levels?
    Answer. I will be happy to provide a table that lists activities, 
by type of inspections, for fiscal years 2005, 2006, and 2007 for the 
record. Traditionally, that information is captured in a table 
entitled, ``Combined Field Activities--ORA Program Activity Data'' that 
appears in the published fiscal year 2007 FDA Congressional 
Justification, pages 272-277.
    [That information follows:]

                              COMBINED FIELD ACTIVITIES--ORA PROGRAM ACTIVITY DATA
----------------------------------------------------------------------------------------------------------------
                                                                    Fiscal year     Fiscal year     Fiscal year
                                                                    2005 actual    2006 estimate   2007 estimate
----------------------------------------------------------------------------------------------------------------
                           FOODS FIELD

Program Outputs--Domestic Inspections:
    Domestic Food Safety Program Inspections....................           4,573           3,400           3,400
    Imported and Domestic Cheese Program Inspections............             477             400             400
    Domestic Low Acid Canned Foods/Acidified Foods Inspections..             481             400             400
    Domestic Fish & Fishery Products (HACCP) Inspections........           2,467           2,480           2,480
    Import (Seafood Program Including HACCP) Inspections........             500             500             500
    Juice HACCP Inspection Program (HACCP)......................             490             375             375
    Interstate Travel Sanitation (ITS) Inspections..............           1,510           1,700           1,700
    State Contract Food Safety (Non HACCP) Inspections..........           6,992           8,130           8,130
    State Contract Domestic Seafood HACCP Inspections...........             953           1,135           1,135
    State Contract Juice HAACP..................................              35              35
    State Partnership Inspections...............................           1,284           1,300           1,300
                                                                 -----------------------------------------------
      Total Above FDA and State Contract Inspections............          19,774          19,855          19,855
                                                                 -----------------------------------------------
      Total Domestic Reinspections (Non-add)....................             523             523             523
                                                                 ===============================================
    State Contract and Grant Foods Funding......................      $6,825,000      $7,100,000      $6,940,000
    Number of FERN State Laboratories...........................               8              10              16
    Annual FERN State Cooperative Agreements/Operations.........     $12,270,000      $7,037,000     $12,236,000
                                                                 -----------------------------------------------
      Total State & Annual FERN Funding.........................     $19,095,000     $14,137,000     $19,176,000
                                                                 ===============================================
    Domestic Field Exams/Tests..................................           3,528           5,000           5,000
    Domestic Laboratory Samples Analyzed........................          15,390          11,425           9,425
    All Foreign Inspections.....................................             129             200             100
                                                                 -----------------------------------------------
      Total Foreign Reinspections (Non-add).....................              15              15              15
                                                                 ===============================================
    Import Field Exams/Tests....................................          84,997          75,000          71,000
    Import Laboratory Samples Analyzed..........................          25,549          31,600          29,600
                                                                 -----------------------------------------------
    Import Physical Exam Subtotal...............................         110,546         106,600         100,600
                                                                 ===============================================
    Import Line Decisions.......................................       8,672,168      10,059,715      11,669,269
    Percent of Import Lines Physically Examined.................            1.27            1.06            0.86
    Prior Notice Security Import Reviews (Bioterrorism Act                86,187          45,000          60,000
     mandate)...................................................

                         COSMETICS FIELD

Program Outputs--Domestic Inspections:
    All Inspections.............................................             138             100             100
                                                                 -----------------------------------------------
      Total Domestic Reinspections (Non-add)....................               7               7               7
                                                                 ===============================================
Program Outputs--Import/Foreign Inspections:
    Import Field Exams/Tests....................................           1,983           2,000           2,000
    Import Laboratory Samples Analyzed..........................             241             200             200
                                                                 -----------------------------------------------
      Import Physical Exam Subtotal.............................           2,224           2,200           2,200
                                                                 ===============================================
    Import Line Decisions.......................................       1,146,049       1,398,180       1,705,779
      Percent of Import Lines Physically Examined...............            0.19            0.16            0.13

                           DRUGS FIELD

Program Outputs--Domestic Inspections:
    Pre-Approval Inspections (NDA)..............................             149             130             130
    Pre-Approval Inspections (ANDA).............................              81             135             135
    Bioresearch Monitoring Program Inspections..................             562             520             520
    Drug Processing (GMP) Program Inspections...................           1,365           1,500           1,440
    Compressed Medical Gas Manufacturers Inspections............             125             155             150
    Adverse Drug Events Project Inspections.....................             106             135             135
    OTC Monograph Project Inspections and Health Fraud Project                53              11              45
     Inspections \1\............................................
    State Partnership Inspections: Compressed Medical Gas                     85             110             110
     Manufacturers Inspections..................................
    State Partnership Inspections: GMP Inspections..............              57              50              50
                                                                 -----------------------------------------------
      Total Above FDA and State Partnership Inspections.........           2,594           2,780           2,715
                                                                 -----------------------------------------------
      Total Domestic Reinspections (Non-add)....................             220             220             220
                                                                 ===============================================
    Domestic Laboratory Samples Analyzed........................           1,446           1,735           1,600
                                                                 ===============================================
Programs Outputs--Import/Foreign Inspections:
    Foreign Pre-Approval Inspections (NDA)......................             163             180             180
    Foreign Pre-Approval Inspections (ANDA).....................              77              60              60
    Foreign Bioresearch Monitoring Program Inspections..........              85              65              65
    Foreign Drug Processing (GMP) Program Inspections...........             217             195             195
    Foreign Adverse Drug Events Project Inspections.............              10              25              25
                                                                 -----------------------------------------------
      Total Above Foreign FDA Inspections.......................              52             525             525
                                                                 -----------------------------------------------
      Total Foreign Reinspections (Non-add).....................              17              17              17
                                                                 ===============================================
    Import Field Exams/Tests....................................           4,288           4,400           4,400
    Import Laboratory Samples Analyzed..........................           1,045             355             300
                                                                 -----------------------------------------------
    Import Physical Exam Subtotal...............................           5,333           4,755           4,700
                                                                 ===============================================
    Import Line Decisions.......................................         264,559         317,471         380,965
    Percent of Import Lines Physically Examined.................            2.01            1.50            1.23
                                                                 ===============================================

                         BIOLOGICS FIELD

Program Outputs--Domestic Inspections:
    Bioresearch Monitoring Program Inspections..................             121             156             156
    Blood Bank Inspections......................................           1,439           1,130           1,070
    Source Plasma Inspections...................................             188             165             160
    Pre-License, Pre-Approval (Pre-Market) Inspections..........               3              10              10
    GMP Inspections.............................................              42              36              36
    GMP (Device) Inspections....................................              14              35              35
    Human Tissue Inspections....................................             270             250             325
                                                                 -----------------------------------------------
      Total Above Domestic Inspections..........................           2,077           1,782           1,792
                                                                 -----------------------------------------------
      Total Domestic Reinspections (Non-add)....................              50              50              50
                                                                 ===============================================
Program Outputs--Import/Foreign Inspections:
    Blood Bank Inspections......................................              16              24              24
    Pre-License Inspections.....................................               6  ..............  ..............
    GMP Inspections.............................................              15              24              17
                                                                 -----------------------------------------------
      Total Above Foreign FDA Inspections.......................              37              48              41
                                                                 -----------------------------------------------
      Total Foreign Reinspections (Non-add).....................               4               4               4
                                                                 ===============================================
    Import Field Exams/Tests 1..................................             143             100             100
    Import Line Decisions.......................................          39,979          44,377          49,258
    Percent of Import Lines Physically Examined.................            0.36            0.23            0.20

                   ANIMAL DRUGS & FEEDS FIELD

Program Outputs--Domestic Inspections
    Pre-Approval/BIMO Inspections...............................              72             140             110
    Drug Process and New ADF Program Inspections................             230             210             210
    BSE Inspections.............................................           3,025           3,760           3,760
    Feed Contaminant Inspections................................               3              15              15
    Illegal Tissue Residue Program Inspections..................             203             245             245
    Feed Manufacturing Program Inspections......................             369             240              40
    State Contract Inspections: BSE.............................           3,309           4,562           4,562
    State Contract Inspections: Feed Manufacturers..............             457             347             347
    State Contract Inspections: Illegal Tissue Residue..........             370             750             600
    State Partnership Inspections: BSE and Other................             988             900             900
                                                                 -----------------------------------------------
      Total Above FDA and State Contract Inspections............           9,036          11,169          10,789
                                                                 -----------------------------------------------
      Total Domestic Reinspections (Non-add)....................             173             173             173
                                                                 ===============================================
    State Animal Drugs/Feeds Funding............................      $1,300,000      $1,700,600      $1,800,000
    BSE Grant Increase..........................................      $3,000,000      $3,000,000      $3,000,000
    State Contract for Tissue Residue...........................        $220,000        $220,000        $210,000
                                                                 -----------------------------------------------
      Total State Funding.......................................      $4,520,000      $4,920,600      $5,010,000
                                                                 ===============================================
    Domestic Laboratory Samples Analyzed........................           1,841           1,770           1,730
                                                                 ===============================================
Programs Outputs--Import/Foreign Inspections:
    Foreign Pre-Approval/Bioresearch Monitoring Program Inspec                26              45              45
     tions......................................................
    Foreign Drug Processing and New ADF Program Inspections.....              12              10              10
                                                                 -----------------------------------------------
      Total Above Foreign FDA Inspections.......................              38              55              55
                                                                 -----------------------------------------------
      Total Foreign Reinspections (Non-add).....................               3               3               3
                                                                 ===============================================
    Import Field Exams/Tests....................................           4,298           4,500           4,500
    Import Laboratory Samples Analyzed..........................             753           1,120             900
                                                                 -----------------------------------------------
    Import Physical Exam Subtotal...............................           5,051           5,620           5,400
                                                                 ===============================================
    Import Line Decisions.......................................         212,254         235,602         261,518
    Percent of Import Lines Physically Examined.................            2.38            2.39            2.06
                                                                 ===============================================

                          DEVICES FIELD

Programs Outputs--Domestic Inspections:
    Bioresearch Monitoring Program Inspections..................             329             300             300
    Pre-Approval Inspections....................................              64             130             130
    Post-Market Audit Inspections...............................              63              65              65
    GMP Inspections (Levels I, II, III and Accredited Persons)..           1,430           1,530           1,530
                                                                 -----------------------------------------------
      Total Above Domestic Inspections: Non MQSA................           1,886           2,025           2,025
                                                                 ===============================================
    Inspections (MQSA) FDA Domestic (non-VHA)...................             366             335             371
    Inspections (MQSA) FDA Domestic (VHA).......................              32              32              32
    Inspections (MQSA) by State Contract........................           8,340           7,924           7,700
    Inspections (MQSA) by State non-Contract....................             545             530             530
                                                                 -----------------------------------------------
      Total Above Domestic Inspections: MQSA....................           9,283           8,821           8,633
                                                                 -----------------------------------------------
      Total Domestic Reinspections (Non-add)....................             237             237             237
                                                                 ===============================================
    State Contract Devices Funding..............................      $1,350,000        $250,000        $275,000
    State Contract Mammography Funding..........................      $9,800,000      $9,200,000      $9,940,000
                                                                 -----------------------------------------------
      Total State Funding.......................................     $11,150,000      $9,450,000     $10,215,000
                                                                 ===============================================
    Domestic Radiological Health Inspections....................             107             130             130
    Domestic Field Exams/Tests..................................             944           1,215           1,215
    Domestic Laboratory Samples Analyzed........................             200             217             217
                                                                 ===============================================
Programs Outputs--Import/Foreign Inspections:
    Foreign Bioresearch Monitoring Inspections..................               6              10              10
    Foreign Pre-Approval Inspections............................              17              34              34
    Foreign Post-Market Audit Inspections.......................              26              27              27
    Foreign GMP Inspections.....................................             225             207             189
    Foreign MQSA Inspections....................................              16              15              15
    Foreign Radiological Health Inspections.....................               9              19              19
                                                                 -----------------------------------------------
      Total Above Foreign FDA Inspections.......................             299             312             294
                                                                 -----------------------------------------------
      Total Foreign Reinspections (Non-add).....................              24              24              24
                                                                 ===============================================
    Import Field Exams/Tests....................................           6,901           5,000           5,000
    Import Laboratory Samples Analyzed..........................           1,333           1,440           1,440
                                                                 -----------------------------------------------
    Import Physical Exam Subtotal...............................           8,234           6,440           6,440
                                                                 ===============================================
    Import Line Decisions.......................................       3,484,393       4,460,023       5,708,829
    Percent of Import Lines Physically Examined.................            0.24            0.14           0.11
----------------------------------------------------------------------------------------------------------------
\1\ The OTC Monograph and Health Fraud Inspections will no longer be planned separately in fiscal year 2006.

                               AVIAN FLU

    Question. Is there any vaccine currently available that would 
protect humans from the H5N1 flu virus? How much? Please include 
experimental and approved, and explain the difference, and how the 
distribution would occur.
    Answer. There is currently no FDA-approved vaccine available to 
protect humans from the H5N1 influenza virus that currently is 
circulating in Asia and parts of Europe. However, candidate H5N1 
vaccines are in development.
    In 2004, the National Institute of Allergy and Infectious Diseases, 
or NIAID, awarded two contracts for the production and clinical testing 
of H5N1 vaccines based on an H5N1 reference strain produced through 
reverse genetics. These vaccines are currently under evaluation in 
clinical trials, under protocols developed with FDA input. We have 
stated that, if provided adequate data, we would be able to approve a 
pandemic influenza strain that is used in an existing licensed vaccine 
process, in an expedited manner and without requiring a new license. 
Therefore, as the results of these studies are submitted to us by 
licensed manufacturers, we will be able to consider them rapidly for 
approval as supplements to existing vaccine licenses. Currently, 
unlicensed vaccines made with new technologies or with the addition of 
adjuvants to stimulate the immune response would require more extensive 
evaluation by FDA as new products. However, we are providing 
accelerated development and evaluation pathways to help assure the 
safety and immunogencity of new influenza vaccines as efficiently and 
rapidly as possible.
    To help manufacturers develop pandemic and seasonal influenza 
vaccines, we recently issued two draft guidances. These guidances 
provide recommendations on developing the information needed to show 
safety and effectiveness for new vaccines and outline expedited 
pathways to licensure. Among the issues discussed in the guidances are 
the use of new technologies, such as cell culture, recombinant 
technologies, and the use of adjuvants, in vaccine development and 
production.
    To facilitate the availability of pandemic influenza vaccines prior 
to their licensure, if needed in an emergency, FDA could evaluate the 
benefit/risk ratio of pandemic influenza vaccines and, where 
appropriate, make such vaccines available under other regulatory 
mechanisms, including investigational new drug or Emergency Use 
Authorizations. With regard to vaccine distribution, the Department of 
Health and Human Services, or HHS, has announced procurement for the 
Strategic National Stockpile, also known as SNS, which includes 
vaccines that could be distributed for use in the event of a potential 
influenza pandemic. HHS provides oversight of the SNS, including 
responsibility for procurement and maintenance of vaccines and other 
medical products to be used in the event of an influenza pandemic or 
other public health emergency. FDA's role is to provide technical 
assistance and support for HHS efforts regarding the development, 
procurement, maintenance, and deployment of pandemic influenza 
countermeasures and other medical products held in the SNS.
    After consultation with HHS, FDA offers the following information 
on the status of HHS efforts to support the stockpiling and 
distribution of candidate pandemic vaccines. Based on the latest 
scientific research, which indicates that two 90 microgram doses of the 
pre-pandemic H5N1 vaccine will be effective as a course of vaccination, 
HHS has ordered approximately 4 million courses of the vaccine. Of the 
4 million courses, approximately 3.75 million courses have been 
manufactured, with the remaining courses on order. These courses are 
not being held in the Strategic National Stockpile; rather, they are 
being stored in bulk at cGMP-compliant storage facilities of the 
vaccine manufacturers awaiting instructions for formulation and fill 
finish into final containers. HHS will review clinical results from 
studies this summer which may indicate that adding adjuvant to the H5N1 
vaccine may boost immune response to those who receive the vaccination. 
Once these results have been obtained and all doses are formulated and 
filled accordingly, they may be distributed to critical workforce 
groups as needed. Currently plans are for the H5N1 vaccine to reside 
with the vendor or vaccine manufacturer until deployment.
    Question. Please summarize the FDA's ability, and timeframe 
necessary, in order to mass-produce vaccines for a human strain of 
H5N1?
    Answer. FDA is actively engaged in facilitating the efforts of 
DHHS, manufacturers and other partners to develop and make available 
influenza vaccines, including those for the currently circulating H5N1 
strain. While FDA can rapidly evaluate and approve the use of a new 
vaccine strain by a licensed manufacturer, and a new vaccine could 
start to become available within 4 months of its identification, 
current U.S. influenza vaccine manufacturing and the available 
technologies that support it are not adequate to quickly produce enough 
pandemic vaccine for the U.S. population. Therefore, we are 
aggressively supporting multiple efforts to increase manufacturing 
capacity using both new and existing technologies, including antigen 
sparing vaccines using both aluminum and novel adjuvants, which is a 
nonspecific simulators of immune response, as well as live attenuated 
vaccines, and cell-culture based and recombinant vaccines, which 
involves combining DNA from two or more sources. FDA scientists work 
with manufacturers throughout the year to collect information on the 
capability of new influenza viruses to be used for large-scale 
production of influenza virus vaccines and to provide needed reagents 
and technical assistance. FDA has initiated annual inspections of 
licensed influenza vaccine manufacturers to help ensure that 
manufacturers are in compliance with good manufacturing practices, and 
to identify and, where possible, prevent problems ahead of time, and 
thus are able to manufacture safe and effective pandemic influenza 
vaccines in emergent circumstances.
    Increasing the Agency's capacity to facilitate rapid evaluation, 
product testing, licensure, and production of vaccines is critical to 
expanding product availability, assuring timely and expert evaluation 
of product quality, supporting national preparedness and response 
capacities for pandemic influenza, and achieving public confidence in 
vaccine products. The funds requested for fiscal year 2007 are critical 
to achieving our goal of supporting a process whereby manufacturers can 
produce pandemic influenza vaccine in the shortest possible time to 
protect the greatest number of people, using a vaccine that is safe, 
effective, and easy to deliver.
    With regard to vaccine production issues, we will use fiscal year 
2007 requested funds to facilitate HHS and manufacturers' efforts to 
increase domestic manufacturing capacity to meet HHS goals, including a 
stockpile with enough vaccine to vaccinate 20 million people. FDA is 
supporting the longer term goals of HHS, manufacturers, and other 
partners to achieve pandemic surge production capacity that would make 
it possible to provide licensed vaccine for the entire U.S. population 
within 6 months of a strain being isolated, using a combination of 
current egg-based and, potentially, new high-volume, rapid response 
cell-based production. How quickly these goals can be met will in part 
be dependent on the results of current industry vaccine development 
programs, mostly assisted by HHS, including ongoing studies of 
adjuvanted and cell culture vaccines. In 2005, we were able to very 
rapidly facilitate the evaluation and U.S. licensure of an additional 
annual influenza vaccine, using our accelerated approval process, 
helping avoid major shortages. We will continue to do everything 
possible to facilitate both the process of vaccine development and the 
enhancement of manufacturing capacity, and Congress' support is 
critical in assuring FDA's capacity to both prepare for and respond to 
a pandemic.
    Question. The budget proposes over $55 million for pandemic flu 
preparedness. The very earliest this funding would be available is 
October 1, but we are hearing reports that the virus could arrive here 
in the United States, at least in birds, and potentially in humans, 
prior to that.
    Do you believe we can afford to wait until the fiscal year 2007 
bill to make this money available to FDA? If so, why? Would you support 
adding the additional funding to the pending supplemental in order to 
make it available more quickly?
    Answer. Thank you for the opportunity to discuss the funding of 
FDA's Pandemic Preparedness activities. We appreciate your interest in 
supporting the FDA efforts in this initiative. The President's budget 
requests in fiscal year 2006 and fiscal year 2007 were carefully 
considered with respect to identifying the immediate needs and the 
urgent nature of the overall initiative. The most immediate needs are 
identified in the fiscal year 2006 supplemental request and the fiscal 
year 2007 request builds upon the activities identified in fiscal year 
2006. In fiscal year 2006, total enacted funding for Pandemic 
activities is approximately $24.8 million. Included in this number is 
the fiscal year 2006 $20 million supplemental increase and 
approximately $4.8 million in base spending. The $20 million 
supplemental was received at the end of the first quarter of fiscal 
year 2006 and the funds were available on January 26, 2006.
    The fiscal year 2007 total funding request for Pandemic 
Preparedness request is approximately $55.3 million and includes the 
$24.8 million from the fiscal year 2006 that includes the emergency 
supplemental appropriation and a requested increase of $30.5 million 
over the fiscal year 2006 enacted level for pandemic influenza. We 
would be happy to provide the activities covered under the fiscal year 
2006 supplemental request.
    [The information follows:]

    
    
               GENERIC DRUGS USER FEES/CITIZEN PETITIONS

    Question. I understand that FDA believes it is time to implement a 
user fee program for generics. The generic drug industry has several 
criticisms of this idea. One is that they will still face many 
regulatory issues after their drug is approved. Another is that their 
budget has been chronically under funded--especially in relation to 
dollars spent approving new drugs, even without including user fee 
money.
    How would you respond to these criticisms?
    Answer. First, FDA has made significant investments to improve the 
generic drug review process with the funds appropriated by Congress. 
These investments have helped lower the median review time by 2 months. 
FDA has not made any decisions concerning a user fee program for 
generics. Given the existence of user fee programs for other product 
reviews, there have been suggestions that the idea may need to be 
explored, but these suggestions are general comments. There is no 
commitment to propose generic user fees and no formal Administration 
proposal for a generic user fee program. If a proposal is considered, 
we will certainly consider the concerns and criticisms about the 
proposal from the generic industry. We continue to work with the 
generic industry to address their current concerns with the Office of 
Generic Drugs.
    Question. Have you begun working on legislation?
    Answer. FDA has not made any decisions concerning a user fee 
program for generics, nor has the Agency begun work on legislation to 
enact such a program. Given the existence of user fee programs for 
other product reviews, there have been suggestions that the idea may 
need to be explored, but these suggestions are general comments. There 
is no commitment to propose generic user fees and no formal 
Administration proposal for a generic user fee program. If a proposal 
is considered, we will certainly consider the concerns and criticisms 
about the proposal from the generic industry. We continue to work with 
the generic industry to address their current concerns with the Office 
of Generic Drugs.
    Question. It has been reported that one cause of unnecessary delays 
in getting generic drugs on the market are certain citizen petitions. I 
am aware that FDA is working on a study to figure out what the actual 
effects of these citizen petitions are. In last year's Senate report, 
we asked for an update on this study--including any changes FDA plans 
to make in the process. I understand that this report is still in your 
clearance process, but can you give us a preview of what we might be 
provided?
    Answer. The Senate report is currently undergoing final clearance, 
but I would be happy to provide you with an overview of how FDA is 
addressing potential improvements to the citizen petition process. In 
response to the significant increase in the number of citizen petitions 
submitted to FDA's Center for Drug Evaluation and Research, CDER, and 
an increasing backlog of pending petitions, the Center's Office of 
Regulatory Programs or ORP, initiated an extensive review of CDER's 
processes for responding to citizen petitions.
    The Office of Generic Drugs has made organizational changes 
designed to improve the citizen petition response process. The office 
has dedicated a specific group of scientists who will be responsible 
for addressing citizen petition responses. This organizational change 
is expected to increase the consistency, quality, and speed of the 
Office of Generic Drug's input on citizen petition responses.
    ORP is currently undertaking an initial review of its citizen 
petition process improvement efforts. Although FDA has been 
implementing changes to its process for less than a year, the agency is 
trying to gather some early data to evaluate whether these new 
processes have been helpful and to examine whether additional 
improvements might be beneficial. The review and response to citizen 
petitions, however, requires careful and painstaking research, precise 
writing and editing, and thorough legal review to produce a document 
that is a clear representation of FDA's scientific and legal opinion of 
what are often very complex issues. This process requires input from 
many agency components.
    In addition, ORP, the Office of Generic Drugs, and the Office of 
Chief Counsel plan to review blocking petitions that have been denied 
to consider such factors as the timing of the petition and the nature 
and age of the data upon which the petition was based. In some cases, 
individuals submitted petitions that were very close to the date of 
patent or exclusivity expiration were based on information that was 
readily available well before the petitions were submitted. Where we 
believe that further investigations may be warranted, the agency is 
considering the option to refer the cases to the Federal Trade 
Commission.
    I would be happy to provide for the record a timeline for our 
recent activities related to improvements to the citizen petition 
process.
    [The information follows:]

Timeline for Improvements to Citizen Petition Process
    Fall of 2004.--ORP convened a process improvement team comprising 
representatives from ORP, the Office of New Drugs, and the Office of 
Generic Drugs and consulted with other offices involved in the petition 
process, such as the Office of Chief Counsel, to discuss improvements 
to the petition process.
    October 2004 to May 2005.--The process improvement group generally 
met on a biweekly basis; sometimes more frequently. The group began by 
describing the existing process in detail and then looked for areas 
where FDA could make improvements and achieve efficiency.
    June 2005.--ORP finalized new procedures to improve the citizen 
petition process and began full implementation of process improvements. 
ORP instituted some of these improvements while the meetings to 
identify improvements were ongoing.
    May and June 2005.--ORP presented process improvement efforts to 
senior management within CDER and various groups involved in working on 
citizen petition responses.
    Currently.--ORP is documenting its new procedures in a Manual of 
Policies and Procedures, also known as MAPP.

                         GENERIC DRUG APPROVAL

    Question. I appreciate your response to my letter of February 6th, 
regarding generic drugs and the FDA strategic redeployment. However, 
there were some questions that were not answered.
    What additional staffing and funding would be required to decrease 
the backlog of generic drug applications by 1/3 over the next fiscal 
year?
    Answer. FDA understands that Congress and the public are concerned 
about the high cost of prescription drug products. Generic drugs play 
an important role in granting access to products that will benefit the 
health of consumers and the government. Prompt approval of generic drug 
product applications, also known as abbreviated new drug applications, 
or ANDAs, is imperative to making generic products available to 
American consumers at the earliest possible date. This has been a high 
priority for FDA.
    FDA believes that making improvements in the process for the review 
of generic drug applications offers the best promise for reducing ANDA 
review time. Total spending on the Generic Drug Program is $64.6 
million, which is more than a 66 percent increase from the comparable 
fiscal year 2001 amount, and has helped lower the median review time. 
In addition, FDA believes that making improvements in the process for 
the review of generic drug applications offers the best promise for 
reducing ANDA review time. With this goal in mind, in fiscal year 2005, 
FDA's Office of Generic Drugs, or OGD, focused on streamlining efforts 
to improve the efficiency of the ANDA review process. OGD added 
chemistry and bioequivalence review teams and has taken steps to 
decrease the likelihood that applications will face multiple review 
cycles. OGD also instituted revisions to the review process such as 
early review of the drug master file as innovator patent and 
exclusivity periods come to an end, cluster reviews of multiple 
applications, and the early review of drug dissolution data.
    In fiscal year 2006, we will build on these process improvements. 
We have begun a major initiative to implement Question-based Review for 
assessment of chemistry, manufacturing, and controls data in ANDAs. 
This improvement builds on the Quality-by design and risk-based review 
initiatives of FDA's Center for Drug Evaluation and Research. This 
mechanism of assessment is consistent with the International Conference 
on Harmonization Common Technical Document and will enhance the quality 
of evaluation, accelerate the approval of generic drug applications, 
and reduce the need for supplemental applications for manufacturing 
changes.
    FDA's OGD will continue institute efficiencies in the review 
process to accelerate the review and approval of ANDAs. FDA will also 
continue to work very closely with the generic manufacturers and the 
generic drug trade association to educate the industry on how to submit 
applications that can be reviewed more efficiently and that take 
advantage of electronic efficiencies that speed application review. We 
will also work with new foreign firms entering the generic drug 
industry. The agency recognizes that it will take time for these new 
firms to understand the requirements for generic drug products. In the 
long term, however, these efforts should shorten overall approval time 
and increase the number of ANDAs approved during the first cycle of 
review. In fiscal year 2006, FDA plans to spend $62.8 million relating 
to generic drugs and, specifically, $28.3 million in OGD. In fiscal 
year 2007, FDA plans to spend $64.6 million relating to generic drugs 
and $29 million in OGD.
    Question. What additional staffing and funding is required to 
decrease the length of time it takes to approve a generic drug 
application by 25 percent?
    Answer. FDA recognizes that generic drugs play an important role in 
granting access to products that will benefit the health of consumers 
and the government. The total spending on the Generic Drugs Program is 
$64.6 million, which is more than a 66 percent increase from the 
comparable fiscal year 2001 amount. This has helped lower median drug 
review time by 2 months. FDA believes that making improvements in the 
process for the review of generic drug applications offers the best 
promise for reducing Abbreviated New Drug Application, also known as 
ANDA, review time. With this goal in mind, in fiscal year 2005, FDA's 
Office of Generic Drugs, or OGD, focused on streamlining efforts to 
improve the efficiency of the ANDA review process. In fiscal year 2006, 
we will build on these process improvements, including efforts to 
implement Question-based Review. FDA's OGD will continue institute 
efficiencies in the review process to accelerate the review and 
approval of ANDAs. FDA will also continue to work to educate the 
industry on how to submit applications that can be reviewed more 
efficiently. We will also work with new foreign firms entering the 
generic drug industry. The agency recognizes that it will take time for 
these new firms to understand the requirements for generic drug 
products. In the long term, however, these efforts should shorten 
overall approval time and increase the number of ANDAs approved during 
the first cycle of review.
    Question. Please provide the number of new drug applications that 
have been submitted and approved in each of the last 5 years, including 
the average timeframe for approval. How does this number compare with 
the number of generic drugs that have been submitted and approved?
    Answer. I would be happy to provide that information for the 
record.
    [The information follows:]

    The following two tables provide a 5-year summary of approval 
statistics for new drugs. Please note: The submissions approved in a 
particular fiscal year are not necessarily filed in that fiscal year.

                             APPROVAL TIMES FOR PRIORITY AND STANDARD NEW DRUG AND BIOLOGIC APPROVALS, NDAS/BLAS FISCAL YEARS 2001 TO 2005--APPROVAL TIMES IN MONTHS
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Priority                                                        Standard
                                                                 -------------------------------------------------------------------------------------------------------------------------------
                           Fiscal year                              Submissions       Number       Mean Approval      Median        Submissions       Number       Mean Approval      Median
                                                                       Filed         Approved          Time        Approval Time       Filed         Approved          Time        Approval Time
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2001............................................................              10              10             7.9             6.0              86              61            17.8            15.0
2002............................................................              12              10            14.3            13.0              84              54            19.4            14.8
2003............................................................              19              14            18.2             6.0              82              72            21.9            13.3
2004 \1\........................................................              28              19            13.8             9.0              94              74            19.7            12.7
2005 \1\........................................................              32              27            10.1             6.0              71              82            20.6            12.9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Beginning in fiscal year 2004, CDER figures include BLAs for therapeutic biologic products which were transferred from CBER to CDER.


                           APPROVAL TIMES FOR PRIORITY AND STANDARD NEW MOLECULAR ENTITIES, NMES AND NEW BIOLOGICS FISCAL YEARS 2001 TO 2005--APPROVAL TIMES IN MONTHS
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Priority NMEs/New Biologics \1\                                 Standard NMEs/New Biologics \1\
                                                                 -------------------------------------------------------------------------------------------------------------------------------
                           Fiscal Year                                                Number       Mean Approval      Median                          Number       Mean Approval      Median
                                                                   Number Filed      Approved          Time        Approval Time   Number Filed      Approved          Time        Approval Time
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2001............................................................               8               5             8.5             6.0              24              10            24.7            21.9
2002............................................................               8               8            13.7            13.0              14              14            16.4            12.5
2003............................................................              12               8             9.0             6.0              17              13            21.6            22.8
\1\ 2004........................................................              18              13            12.7             6.0              15              14            22.8            19.3
\1\ 2005........................................................              18              17            12.4             6.0              14              10            25.5           23.9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Beginning in fiscal year 2004, CDER figures include BLAs for therapeutic biologic products which were transferred from CBER to CDER.

    The following table provides information regarding generic drug 
approvals

               APPROVAL TIMES FOR GENERIC DRUG FISCAL YEARS 2001 TO 2005--APPROVAL TIMES IN MONTHS
----------------------------------------------------------------------------------------------------------------
                                                    Receipts of      Number of     Mean Approval      Median
                   Fiscal Year                    Original ANDAs     Approvals         Time        Approval Time
----------------------------------------------------------------------------------------------------------------
2001............................................             307             241            20.9            18.4
2002............................................             361             296            21.4            18.3
2003............................................             449             284            20.7            17.3
2004............................................             563             320            20.5            16.3
2005............................................             766             361            19.5            16.3
----------------------------------------------------------------------------------------------------------------

    Question. What total funding has been spent annually on approval of 
new drugs for the past 5 years? Please list appropriated funding and 
user fees separately.
    Answer. I would be happy to provide the amount spent annually on 
the approval of new drugs in the past 5 years for the record.
    [The information follows:]

                      FUNDING TOTALS FOR NEW DRUGS
------------------------------------------------------------------------
                                                              Amount
------------------------------------------------------------------------
Fiscal year 2001:
    Appropriated Funding................................     $76,000,000
    User Fees...........................................      47,500,000
                                                         ---------------
      Total.............................................     123,500,000
                                                         ===============
Fiscal year 2002:
    Appropriated Funding................................      70,000,000
    User Fees...........................................      49,300,000
                                                         ---------------
      Total.............................................     119,300,000
                                                         ===============
Fiscal year 2003:
    Appropriated Funding................................      75,000,000
    User Fees...........................................      56,500,000
                                                         ---------------
      Total.............................................     131,500,000
                                                         ===============
Fiscal year 2004:
    Appropriated Funding................................      72,000,000
    User Fees...........................................      76,900,000
                                                         ---------------
      Total.............................................     148,900,000
                                                         ===============
Fiscal year 2005:
    Appropriated Funding................................      75,200,000
    User Fees...........................................      83,400,000
                                                         ---------------
      Total.............................................     158,600,000
------------------------------------------------------------------------

                            DRUG ADVERTISING

    Question. I understand that FDA issued approximately 15 warning 
letters to drug companies regarding advertisements in 2005, an increase 
from the past several years. As we all know, though, the number of 
drugs ads has also increased. I am pleased that drug companies have 
published guidelines for their ads, and appear to be working with the 
FDA to try to ensure that ads are more responsible and presented 
fairly. I believe FDA is working on guidance to be published this year 
to assist drug companies in that effort.
    Can you give us an update on FDA's activities relating to drug ads? 
Is it still FDA's position that companies should not be required to 
submit ads to FDA prior to their publication?
    Answer. On November 1 and 2, 2005, the FDA held a two-day public 
hearing to provide an opportunity for broad public participation and 
comment on direct-to-consumer, also known as DTC, promotion of 
regulated medical products, including prescription drugs for humans and 
animals, vaccines, blood products, and medical devices. FDA is in the 
process of developing additional guidance for industry. Our major 
effort is a draft guidance to address the presentation of risk 
information in prescription drug and medical device promotion. Another 
effort is to finalize the draft guidance on the brief summary of risk 
information for the page adjacent to direct-to-consumer print 
advertisements for prescription drugs. FDA will conduct a series of 
three studies to examine the format and content of brief summaries in 
direct-to-consumer print advertisements to assist the agency in 
finalizing this draft guidance. FDA is also working to finalize the 
draft guidance on criteria FDA uses to distinguish between disease 
awareness communications and promotional materials, to encourage 
manufacturers to disseminate educational messages to the public, and 
the guidance on the manner in which restricted device firms can comply 
with the rules for disclosure of risk information in consumer-directed 
broadcast advertising for their products. FDA has created a Promotion 
Steering Committee to leverage policy development for prescription drug 
promotion, including DTC promotion. The committee consists of 
representatives from the Office of the Commissioner, Office of Chief 
Counsel, and each center responsible for medical products. The 
committee meets to determine how to best allocate our limited resources 
for policy development.
    Under current law and regulations, FDA cannot require companies to 
submit promotion materials prior to use. In addition, there are tens of 
thousands of promotional pieces per year, prior review, even if 
authorized, would be a major challenge.
    Question. If legislation were enacted calling for prior approval of 
prescription drug ads before airing, would your agency have adequate 
personnel and resources to meet this mandate? Could you provide us more 
information on this?
    Answer. The Administration has not established a position on the 
legislative proposal you describe. The Center for Drug Evaluation and 
Research receives over 54,000 pieces per year, of which 9,000 are 
direct-to-consumer, or DTC. Of the 9,000 pieces of DTC final materials, 
only 467 are sent in as proposals. Providing timely review of these 
promotional material would represent a tremendous increase in workload 
and FDA could not conduct timely reviews of these promotional material 
with the resources available.
    FDA feels that it is highly valuable to the public for us to review 
and provide advice to manufacturers about broadcast advertisements 
while they are being produced. Therefore, we have made that one of our 
highest priorities. This helps ensure DTC compliance and reduces the 
number of advertisements that might otherwise violate the Food, Drug & 
Cosmetic Act from appearing in public.

                              FOOD DEFENSE

    Question. Dr. Von Eschenbach, the past several years have seen huge 
increases for ``food defense'': $20.5 million in fiscal year 2004, 
$35.5 million in fiscal year 2005, $10 million in fiscal year 2006, and 
the budget this year proposes an increase of nearly $20 million.
    In your written statement, you spend just under two pages 
discussing what this money will buy. FERN Labs, eLexnet systems, and 
Emergency Operations Networks all sound, and I'm sure in fact are, very 
important, but this is a lot of money, and I think we should spend a 
little more time focusing on it--especially if these increases are 
coming at the expense of other activities.
    Can you walk us through a scenario that illustrates how this money 
will be used, in a practical way, to prevent or contain an outbreak 
involving contaminated food of drugs? How are we safer now that all of 
this money has been spent?
    Answer. In one such scenario, a truck driver for a food 
manufacturing plant introduces a biological, chemical, or radiological 
agent into truck loads of a byproduct en route between the food 
manufacturing plant and one of several plants that converts the 
byproduct into a usable food ingredient. The food ingredient is 
distributed nationwide as well as overseas. The ingredient is used in 
the manufacture of a variety of seemingly unrelated food items. Many of 
these food items are themselves used as ingredients in other foods. 
Consequently, contaminated ingredients from several plants would end up 
in a large number of foods, under a variety of brand names, with 
national distribution.
    Food Emergency Response Network, or FERN, laboratory testing in the 
scenario listed above would likely include finished product testing of 
foods implicated in human illness; and, food of the same lots as those 
implicated in human illness at various points in the production and 
distribution systems totaling approximately 100,000 samples for 
analysis. To fully recover from this scenario or from a terrorist 
attack or national emergency, FDA would need to conduct recalls, 
seizures, and/or disposal of contaminated food which would then restore 
confidence in the Nations food supply.
    Food Defense funding supports FDA's five key areas of awareness, 
prevention, preparedness, response, and recovery. FDA strives to 
increase awareness of the role of food as a vehicle for terrorism, 
various illnesses, and symptoms that are caused by foodborne threat 
agents; and, by educating and coordinating the dissemination of 
information to State and local partners, relevant associations, and 
industry. With Food Defense funding, FDA is able to conduct 
surveillance, inspectional and sampling programs to monitor 
manufacturers and their products for the presence of threat agents 
where such an intentional tampering may be found prior to full human 
consumption. FDA studies food prevention technologies to improve the 
safety of food and establish guidelines and or performance standards 
for industry which might prevent the contamination altogether. FDA has 
worked on method validation and matrix extension to strengthen the 
Nation's food testing laboratory capability in order to be prepared to 
quickly detect threat agents in the food supply. In addition, the FERN 
provide response capabilities by rapidly testing large numbers of 
samples of food. The Emergency Operations Network, or EON, is an 
enhanced communication system that provides seamless information access 
to all FDA offices, enabling them to respond quickly to the full range 
of FDA emergencies.
    Question. With regard to the technology we are buying and labs we 
are outfitting- are they flexible? Can they be used for other 
activities when there are no emergencies? How do they complement or 
duplicate similar USDA labs?
    Answer. Many of the agents we are concerned about in food defense 
are also of food safety concern. Therefore, the equipment is useful for 
our routine food safety surveillance programs as well as food defense 
activities. The state Food Emergency Response Network, or FERN, 
Chemistry laboratories that were awarded FDA FERN chemistry Cooperative 
Agreements in fiscal year 2005 are utilizing the equipment and 
resources provided by FDA to increase capability of FERN analytical 
methods and for surveillance of the food supply. Currently, these 
laboratories are actively engaged in increasing the number of analytes 
and food commodities that the current FERN Chemistry methods can 
detect. This method validation work not only increases the capabilities 
of the Cooperative Agreement laboratories but also increases the 
capabilities of the entire FERN Network when the expanded methods are 
shared with all FERN Chemistry laboratories.
    In addition, the Cooperative Agreement laboratories are involved in 
the surveillance of the food supply through ad hoc analysis of food 
commodities for Food Defense analytes. These surveillance analyses are 
based on vulnerability and risk assessments. This surveillance sampling 
provides a wider food shield and an opportunity to demonstrate and 
assess the capabilities, capacity, and communication within the FERN. 
Cooperative Agreement laboratories also analyze proficiency test 
samples throughout the year to demonstrate their continuing capability 
to analyze particular food commodities for identified analytes. These 
proficiency test samples build confidence in each laboratory's ability 
to find threat agents in a variety of food commodities, were there to 
be terrorist attack or a national emergency.
    To avoid duplication, FDA has taken the lead in funding both 
Chemistry and Radiological FERN laboratories to build capability and 
capacity for these disciplines across the Nation, whereas United States 
Department of Agriculture, or USDA, is responsible for funding the 
Microbiological laboratories. Therefore, our coordinated efforts are 
complementary to FDA's overall FERN program.
    Question. Do you anticipate a time we won't have to provide huge 
increases every year for these activities--when will we simply be able 
to maintain our safeguards?
    Answer. Thank you for the opportunity to address FDA's efforts to 
safeguard the food supply from attack. FDA regulates $240 billion worth 
of domestic food and $15 billion of imported food. The American food 
industry contributes approximately 20 percent of the U.S. Gross 
National Product, employs about 14 million individuals, and provides an 
additional 4 million jobs in related industries. FDA's capacity to 
defend the food supply from attack and to maintain consumer confidence 
in our ability to do so has significant impacts on the public health 
and the Nation's economy.
    Our plan for food defense aligns with the mandate of Homeland 
Security Presidential Directive-9, which establishes a national policy 
to defend the food and agriculture system. Among the key food defense 
projects funded to date is the Food Emergency Response Network, or 
FERN. FERN establishes and expands a national laboratory network to 
increase analytic surge capacity for biological, chemical and 
radiological agents in food. Other key food defense projects include 
targeted food defense research; targeted, risk-based inspections; 
Biosurveillance, to improve coordination and integration of existing 
food surveillance capabilities under the government-wide 
Biosurveillance Initiative; and emergency Operations Network Incident 
Management System, to upgrade and expand FDA's management and 
coordination capabilities for responding to incidents affecting the 
U.S. food supply.
    FDA conducts these activities in the context of an ever-increasing 
volume of imported foods and the growing complexity of the food 
industry and of the technologies used in food production and packaging. 
This transformation will continue to present fresh challenges for FDA 
and for the plans and strategies we use to defend the food supply from 
attack. We will direct any food defense funding provided in fiscal year 
2007 to address these new challenges, to build upon past successes, and 
to strengthen our capabilities to address terrorist threats to the food 
supply.
    Although the Administration has not formulated a budget for fiscal 
year 2008 and later years, the long-term recommendation for the FERN 
program is for FDA to achieve a total of 50 state laboratories. With 
the funding in our fiscal year 2007 budget, we estimate that we will 
increase the number of operational facilities to 16 laboratories. You 
are correct in pointing out that we will not need budget increases to 
expand the number of FERN laboratories once we establish all of these 
labs. However, there may still be an annual need for resources to 
maintain and support FERN labs.

                          UNIFORM FOOD SAFETY

    Question. Does FDA support the National Uniformity for Food Act as 
passed recently in the House of Representatives? Please explain why or 
why not.
    Answer. The Administration has not taken a position on this 
legislation.

                         POST-MARKETING STUDIES

    Question. What activities, if any, is FDA undertaking in order to 
decrease the number of post-marketing studies that have been pledged to 
FDA but not yet undertaken? Does FDA see this as a problem? Why or why 
not?
    Answer. Postmarketing Study Commitments, also known as PMCs, for 
approved drug products, including biological drugs, are studies that a 
product sponsor either is required or agrees to conduct after FDA 
approves a product for marketing to further define the safety, 
efficacy, or optimal use of a product. FDA closely monitors the status 
of PMCs to ensure that product sponsors initiate and complete the 
studies in a timely manner. In some cases, the studies can take years 
to complete, even if everything is on schedule. In other cases, there 
are considerable obstacles, such as difficulty in recruiting patients 
and investigators to participate in a clinical trial when an approved 
therapy is available. Sponsors must resolve these issues before they 
can complete the studies. When obstacles arise, FDA works closely with 
sponsors to address these obstacles. Approximately 38 percent of the 
currently pending PMCs for new drug applications were established in 
applications approved between October 1, 2003 and September 30, 2005. 
Depending on the complexity of the study, FDA would expect that many of 
these studies would not have been initiated yet.
    As of the Senate Hearing date, FDA had planned to undertake a 
review of the decision-making process behind requests for PMCs but had 
not formally issued a contract. On April 5, 2006, FDA awarded a 
contract to an outside organization to conduct a thorough evaluation of 
the postmarketing study commitment process for collecting medical 
information. The contractor will examine in-depth the agency's internal 
processes regarding PMCs and make recommendations regarding ways to 
improve FDA's PMC processes and practices. The outside contractor will 
evaluate how review divisions decide whether to request PMCs, how 
divisions make decisions surrounding what kinds of PMCs to request, and 
how divisions establish reasonable timeframes for completing PMCs. The 
study will serve to assist FDA in determining whether industry needs 
better guidance regarding PMCs and to ensure there is a standardization 
of the procedures. In addition, the Centers within FDA also have 
undertaken activities to improve the response on postmarketing and 
post-approval studies.
    FDA takes its statutory obligations under the Food and Drug 
Administration Modernization Act of 1997 to track and monitor the 
progress of PMCs very seriously. FDA recently published a final 
guidance for industry to describe in greater detail the content, 
format, and timing of PMC annual status reports submitted by the drug 
industry. Furthermore, FDA reports annually in the Federal Register on 
the performance of applicants in conducting their PMCs and maintains a 
public Web site that contains the basic information that FDA committed 
to make available to the public. These initiatives, along with other 
FDA internal procedures, are all intended to ensure that industry 
undertakes their commitments and completes them in a timely manner.
    On January 1, 2005, the Center for Devices and Radiological Health, 
also known as CDRH, initiated the use of the new Condition of Approval 
Tracking System. As of that date, all postapproval studies are entered 
into the system, along with the due dates of any agreed upon report 
deliverables. CDRH monitors the system daily to see that sponsors are 
honoring their commitments. Procedures are in place to notify the 
sponsor immediately if deadlines are not met, and also to acknowledge 
the receipt of reports that are on time and are reviewed. Under the new 
system, all reports have been delivered on time.
    CDRH is also developing the Postapproval Study Web site that will 
be available to the public. This Web site will list the postapproval 
studies being done, briefly describe the study, and document the status 
of studies, as reported by industry.
    FDA believes that changes to the Condition of Approval study 
program will improve communication with industry about these studies 
and increase collaboration in designing high quality studies with 
targeted end points. The results of these studies will be important to 
FDA, industry and the health care community. Acknowledgement of receipt 
of study reports and follow-up on overdue reports will encourage 
compliance. Finally, we believe the public Web site will prompt 
industry to conduct the studies and report to FDA on time.

                      MICROBIOLOGICAL DATA PROGRAM

    Question. The USDA is proposing to eliminate that Microbiological 
Data Program, currently carried out by the Agricultural Marketing 
Service. One reason offered for this proposal is that FDA currently 
undertakes, or will continue, the work of this program. Reports of 
increased food illnesses from fruits and vegetables appear to highlight 
the importance of the Microbiological Data Program.
    Has FDA worked with AMS in order to ensure that none of the 
sampling currently carried out through the Microbiological Data Program 
will be eliminated?
    Answer. As a science-based agency, FDA collects data that can be 
used to direct policy decisions, risk assessments, regulatory actions, 
and other actions. In comparison, the Microbiological Data Program, or 
MDP, program of the USDA Agricultural Marketing Service, also called 
AMS, is a non-regulatory sampling survey. Because the MDP program is 
not bound by the same regulatory requirements as FDA, it provides an 
opportunity for collection of a much larger data set. However, the MDP 
is not designed to provide the same source information, traceback, or 
support for regulatory follow-up that are built into the FDA sampling 
assignments. If a positive sample is found in an FDA produce sampling 
assignment, follow-up action can be taken, while the design of the MDP 
program does not allow for follow-up. Therefore, if AMS does eliminate 
the MDP program, it would not produce a surveillance gap as FDA defines 
this term.
    Question. Is FDA already working on similar activities?
    Answer. Since 1999, FDA has routinely issued sampling assignments 
for selected commodities produced both domestically and abroad. The 
purpose of FDA's produce sampling assignments is to gather information 
on both the incidence of contamination and the practices and conditions 
associated with contaminated produce and to take regulatory action, as 
appropriate, when contaminated produce is found. The FDA sampling 
assignments differ from the Agricultural Marketing Service's 
Microbiological Data Program, also known as MDP, in important ways. FDA 
samples are routinely collected at the farm gate or packinghouse for 
domestic produce or at the border for imported produce. With domestic 
samples, if contamination is present, it must have occurred at the farm 
or packing facility. MDP samples are routinely collected at a later 
stage of the supply chain, such as a distribution center, making it 
more difficult to narrow down where contamination might have occurred. 
The MDP program is a blind study. It does not collect information about 
the samples that would allow traceback to the source; therefore, it 
does not provide an opportunity to visit farms or packinghouses 
associated with positive sample to gather information about practices 
or conditions at those firms that may have led to contamination. FDA 
samples are tested in FDA laboratories, while MDP samples are tested at 
state laboratories. FDA data have a relatively well known performance 
standard across the United States.
                                 ______
                                 

               Questions Submitted by Senator Tom Harkin

                               AFLATOXIN

    Question. Late last year, a pet food company based in South 
Carolina initiated a recall of dog food that had been made with corn 
contaminated with aflatoxin, produced by mold that sometimes develops 
in crops under drought or other weather stress conditions. The death of 
dozens of dogs has been attributed to consumption of this product both 
before and after the recall was announced.
    What steps has FDA taken to address this situation to ensure the 
recall is fully and effective and completed?
    Answer. FDA determined that this situation represented a serious 
life-threatening health hazard to pet dogs and pet cats and classified 
this recall as Class I. In a Class I Recall, FDA requests that the firm 
conduct 100 percent effectiveness checks of their consignees to confirm 
that they received notification about the recall and have taken 
appropriate action. Additionally, our Atlanta district office issued 
audit check assignments in coordination with the Center for Veterinary 
Medicine to determine the effectiveness of the company's recall. The 
vast majority of FDA audit checks are completed and show the recall of 
dog food to be effective. FDA will monitor the disposal of all 
recovered products. FDA will terminate this recall when disposition of 
the recalled products is finalized.
    Question. How can we assure the pet owners of this country that 
this kind of event won't happen again?
    Answer. As part of the investigation, FDA evaluated the company's 
descriptions of the actions it has implemented at all of its plants to 
ensure that an aflatoxin event does not happen again and found the 
corrective actions acceptable. This situation generated much attention 
and has served as a reminder to the pet food industry of the importance 
of using appropriate manufacturing and quality control procedures.

                              BIOTERRORISM

    Question. In December of 2004, the outgoing Secretary of Health and 
Human Services Tommy Thompson stated ``I, for the life of me, cannot 
understand why the terrorists have not attacked our food supply, 
because it is so easy to do.'' The President's 2007 budget increases 
funding for food defense to continue lab preparedness efforts and 
expand State laboratories. However, it cuts funding for food import 
inspections at ports of entry which a terrorist might use to smuggle 
contaminated food products into the country. Since 1994, food imports 
have grown five-fold to 6 million food import shipments annually, but 
the FDA inspects less than 2 percent of these shipments.
    Won't these proposed budget cuts for import inspection and testing 
actually weaken FDA's ability to prevent an attack on the food supply 
and make more likely the event that Secretary Thompson predicted?
    Answer. For fiscal year 2007, FDA is requesting an increase of 
$19.9 million in food defense to a total request of $178.2 million. 
This is a 21,500 percent increase in funds from fiscal year 2001. The 
funds requested would continue to improve laboratory preparedness and 
food defense field operation, food defense research, surveillance, and 
incident management capabilities. FDA uses a risk-based approach to 
allocate resources. By focusing on risk through the cooperative work of 
Customs and Border Protection, or CBP, FDA's Prior Notice Center, and 
FDA field examinations, we will work smarter to target higher risk 
products, manufacturers, and importers to ensure the safety of the 
public health, protect the Nation's food supply and prevent an attack 
on the Nation's food supply.
    For example, currently, working with information submitted through 
CBP's electronic systems used for import entries or through FDA's 
internet-based Prior Notice System Interface, FDA screens shipments 
electronically before they arrive in the United States to determine if 
the shipments meets identified criteria for physical examination or 
sampling and analysis or warrants other review by FDA personnel. This 
electronic screening allows FDA to better determine how to deploy our 
limited physical inspection resources at the border on what appear to 
be higher-risk food shipments while allowing lower-risk shipments to be 
processed in accordance with traditional import procedures after the 
electronic screening.
    Question. Instead of cutting border inspection, shouldn't the Bush 
administration apply more resources to food import inspections to 
bolster our defenses against bioterrorism?
    Answer. Through smart allocation of FDA resources, fine tuning 
FDA's risk based approach, and smarter screening criteria, the FDA will 
be able to continue ensuring a safe food supply and protecting the 
pubic health despite cuts in border inspections, which will allow 
funding to other higher risk food defense and lab preparedness areas.

                               SUNSCREEN

    Question. Skin cancer is on the rise in the United States. A 
significant contributor is exposure to UVA rays. FDA has been 
developing a monograph for sunscreens since 1978 to address the 
critical issue of UVA rays but has not, thus far, issued it. As part of 
the Fiscal year 2006 Agriculture Appropriations Act, FDA was asked to 
issue a ``comprehensive final monograph for over-the-counter sunscreen 
products, including UVA and UVB labeling requirements within 6 months 
of enactment.''
    What is the status of the monograph?
    Answer. We are currently working on a rulemaking for OTC sunscreen 
drug products to address both UVA and UVB labeling requirements.
    Question. Will the monograph be issued by May 10th, the date the 
fiscal year 2006 Act requires?
    Answer. We are working to publish the document for this rulemaking 
in the Federal Register.

                             GENERIC DRUGS

    Question. Generic drugs help to make health care more affordable. 
Currently, FDA has a backlog of 850 applications for generic drugs--
there are expected to be more over the next several years. Yet, the 
President's budget flat funds the Office of Generic Drugs. In your 
testimony before the Committee, you stated that generics were reviewed 
in priority order, meaning that new generics for branded drugs without 
a generic counterpart would be bumped to the front of the line. 
However, more price competition between generics is also a valuable way 
to decrease the price consumers pay for drugs. Therefore, I believe 
prioritization is not, in and of itself, a sufficient solution to the 
problem. In addition, approval delays effectively extend the patent 
life of branded drugs despite Congress' clear intention otherwise. FDA 
has increased its generic drugs Full Time Evaluators (FTEs) from 134 in 
2001 to 201 in 206. Despite the increase, I am concerned FDA is not 
devoting enough personal and resources to generic drugs given the 
current workload and the future increase.
    How many FTEs would be required to eliminate the current backlog 
within the next year?
    Answer. FDA understands that Congress and the public are concerned 
about the high cost of prescription drug products. Generic drugs play 
an important role in granting access to products that will benefit the 
health of consumers and the government. Prompt approval of generic drug 
product applications, also known as abbreviated new drug applications, 
or ANDAs, is imperative to making generic products available to 
American consumers at the earliest possible date. This is a key 
priority for FDA. Since 2001, FDA has increased spending on the Generic 
Drugs Program to $64.6 million for fiscal year 2007, which is more than 
a 66 percent increase from the comparable fiscal year 2001 amount. This 
has allowed FDA to reduce median review time by 2 months.
    FDA believes that making improvements in the process for the review 
of generic drug applications offers the best promise for reducing ANDA 
review time. With this goal in mind, in fiscal year 2005, FDA's Office 
of Generic Drugs, or OGD, focused on streamlining efforts to improve 
the efficiency of the ANDA review process. OGD added chemistry and 
bioequivalence review teams and has taken steps to decrease the 
likelihood that applications will face multiple review cycles. OGD also 
instituted revisions to the review process such as early review of the 
drug master file as innovator patent and exclusivity periods come to an 
end, cluster reviews of multiple applications, and the early review of 
drug dissolution data.
    In fiscal year 2006, we will build on these process improvements. 
We have begun a major initiative to implement Question-based Review for 
assessment of chemistry, manufacturing, and controls data in ANDAs. 
This improvement builds on the Quality-by design and risk-based review 
initiatives of FDA's Center for Drug Evaluation and Research. This 
mechanism of assessment is consistent with the International Conference 
on Harmonization Common Technical Document and will enhance the quality 
of evaluation, accelerate the approval of generic drug applications, 
and reduce the need for supplemental applications for manufacturing 
changes. FDA believes that these process improvements will work to make 
more generic drugs available to the public.
    FDA's OGD will continue institute efficiencies in the review 
process to accelerate the review and approval of ANDAs. FDA will also 
continue to work very closely with the generic manufacturers and the 
generic drug trade association to educate the industry on how to submit 
applications that can be reviewed more efficiently and that take 
advantage of electronic efficiencies that speed application review. We 
will also work with new foreign firms entering the generic drug 
industry. The agency recognizes that it will take time for these new 
firms to understand the requirements for generic drug products. In the 
long term, however, these efforts should shorten overall approval time 
and increase the number of ANDAs approved during the first cycle of 
review. In fiscal year 2006, FDA plans to spend $62.8 million relating 
to generic drugs and, specifically, $28.3 million in OGD. In fiscal 
year 2007, FDA plans to spend $64.6 million relating to generic drugs 
and $29 million in OGD.
    Question. How much would that cost?
    Answer. FDA recognizes that generic drugs play an important role in 
granting access to products that will benefit the health of consumers 
and the government. FDA believes that making improvements in the 
process for the review of generic drug applications offers the best 
promise for reducing ANDA review time. With this goal in mind, in 
fiscal year 2005, FDA's Office of Generic Drugs, or OGD, focused on 
streamlining efforts to improve the efficiency of the ANDA review 
process. In fiscal year 2006, we will build on these process 
improvements, including efforts to implement Question-based Review. 
FDA's OGD will continue institute efficiencies in the review process to 
accelerate the review and approval of ANDAs. FDA will also continue to 
work to educate the industry on how to submit applications that can be 
reviewed more efficiently. We will also work with new foreign firms 
entering the generic drug industry. The agency recognizes that it will 
take time for these new firms to understand the requirements for 
generic drug products. In the long term, however, these efforts should 
shorten overall approval time and increase the number of ANDAs approved 
during the first cycle of review.
    Question. Does FDA estimate the number of future Abbreviated New 
Drug Applications when making decisions to allocate resources to hiring 
and training FTEs?
    Answer. FDA attempts to project application numbers by ongoing 
tracking of receipts and by looking at the products that will be going 
off patent as well as other industry forecasts of trends. FDA also 
ensures that it can meet the specified budget earmark for the generic 
drug review program.

                      EARLY FOOD SAFETY EVALUATION

    Question. I understand your agency is nearing publication of its 
final Early Food Safety Evaluation, (EFSE) guidelines. I'm happy to 
hear that as it is an important issue for American agriculture and I 
look forward to its release.
    Can you offer us more specifics on when we can expect to see final 
publication?
    Answer. We are moving to complete the last steps necessary to 
finalize the guidance. For example, we are currently nearing completion 
of the requirements of the Paperwork Reduction Act of 1995. The comment 
period for the Notice for the agency information collection activities 
recently closed on March 13, 2006. We expect publication soon after 
completion of these final steps.

                              FOOD IMPORTS

    Question. More than 80 percent of the seafood and an estimated 20 
percent of fresh produce that Americans consume is imported. 
Increasingly, imported foods are the source of food-borne illness. For 
example, in 2003, a hepatitis A outbreak associated with green onions 
imported from Mexico sickened over 550 people, killing at least 3. 
There are many other examples of contaminated food that caused large 
scale outbreaks and fatalities in the last 10 years.
    How do you intend to improve FDA's oversight of imported food?
    Answer. FDA will continue to implement the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002, which provides 
FDA with authorities aimed at enhancing the security of imported foods. 
For example, the requirement for domestic and foreign facilities to 
register with FDA will help FDA quickly identify, locate, and notify 
the facilities that may be affected in the event of a potential or 
actual terrorist incident or outbreak of foodborne illness. The advance 
information about imported food shipments, provided under the prior 
notice requirement, enables FDA, working closely with Customs and 
Border Protection, or CBP, to more effectively target inspections of 
food at the border at the time of arrival to ensure the safety and 
security of imported food. This advance notice not only allows FDA's 
and CBP's electronic screening systems to review and screen the 
shipments for potential serious threats to health, intentional or 
otherwise, before food arrives in the United States, but it also allows 
FDA staff to review prior notice submissions for those products flagged 
by the systems as presenting the most significant risk and determine 
whether the shipment should be held for further investigation.
    For fiscal year 2007, FDA is requesting an increase of $19.9 
million in food defense to a total of $178.2 million. This is a 21,500 
percent increase in funds from fiscal year 2001. The funds requested 
would continue to improve laboratory preparedness and food defense 
field operation, food defense research, surveillance, and incident 
management capabilities.
    FDA has worked to develop an automated risk-based import entry 
examination system. This system is designed to assess risk in 
individual import shipments. The system will combine expert knowledge, 
open source intelligence and advanced self-learning algorithms to 
dynamically assess entry-line level risk. In 2005, the first of a 
series of research and analysis papers on this system provided timely 
and relevant information to serve as the basis for exogenous-source 
rules development for risk-based import examination. The goal in the 
project is to provide early identification and assessment of events, 
conditions, and situations in the world that could have an impact on 
the safety or security of FDA-regulated imports. The project is 
currently focused on imported seafood.
    Question. How much would it cost to increase food import 
inspections from 2 percent to 5 percent or 10 percent?
    Answer. During fiscal year 2005, the Field conducted approximately 
85,000 Import Food Field Exams/Tests; analyzed approximately 25,550 
food import lab samples; and, made 8,672,168 Import Line Decisions. 
Over 1.27 percent of food import lines were physically examined during 
fiscal year 2005. In addition, critical steps in our counter terrorism 
efforts are the Prior Notice Security Import Reviews. During fiscal 
year 2005, the Field conducted 86,187 Prior Notice Security Import 
Reviews in the foods area.
    The mission of FDA's Prior Notice Center, or PNC, is to identify 
imported food and feed products that may be intentionally contaminated 
with biological, chemical or radiological agents, or which may pose 
significant health risks to the American public, and intercept them 
before they enter the United States. FDA will continue to focus 
resources on Prior Notice Import Security Reviews of products that pose 
the highest potential bioterrorism risks. The PNC uses a combination of 
adaptable targeting strategies and weighted risk indicators in the 
threat assessment process including contemporary intelligence involving 
terrorist activities, a history of prior notice violations, and 
compliance with admissibility standards as indicated by the results of 
import field exams, filer evaluations, firm inspections, repeated prior 
notice violations, and feedback from Field Investigators. By using a 
risk based approach, the Prior Notice Center can intercept potentially 
hazardous products before they enter the United States.
    The benefit of these reviews comes from the quality and targeting 
of review activities; not from the volume of imports inspected. Thus, 
the quality of import screening is a better measure of FDA's import 
strategy rather than simply focusing on the items physically examined.
    Question. Could FDA improve its oversight of imports if it had 
inspectors checking farms and factories in the country where our food 
originates?
    Answer. FDA continues to enhance our risk based approach to target 
higher risk products, manufacturers, and importers with available 
resources. FDA-conducted foreign inspections are an important aspect of 
this multifold approach. It is important to understand, however, that 
this is only one component of our approach. We also use previous 
examination and laboratory sampling results, compliance information 
received from other domestic and foreign regulatory agencies, 
examination at the ports of entry, and general risk factors posed by 
the products in question to provide controls of the safety of import 
food commodities. FDA also focuses on risk by working cooperatively 
with Customs and Border Protection and through the FDA's 24/7 Prior 
Notice Center in counter- and bioterrorism targeting and evaluation of 
supply chain integrity.
    Although foreign inspections and border operations provide some 
assurance that imported foods are safe, the agency continues to work to 
foster international agreements and harmonize regulatory systems. For 
example, we actively participate in the Canada/United States/Mexico 
Compliance Information Group, which shares information on regulatory 
systems and the regulatory compliance status of international firms to 
protect and promote human health. In addition, FDA is heavily involved 
in the Codex Alimentarius Commission Committees, which develop Codes of 
Practice and standards to harmonize international food safety 
practices.

                              FOOD RECALL

    Question. The Food and Drug Administration (FDA) does not have 
mandatory authority to recall contaminated food products and instead 
relies on voluntary cooperation by food companies to get contaminated 
food out of supermarkets, restaurants, and consumers' homes. In a 
recent GAO study, FDA identified over 3,000 recalls of non-meat and 
poultry foods from 1986 to 1999 and GAO identified nine instances 
during that time where companies delayed or refused compliance with an 
FDA recall request.
    Should FDA have mandatory recall authority in order to protect 
American consumers from contaminated food? Why or Why not?
    Answer. The vast majority of food recalls are initiated voluntarily 
by firms when a problem is discovered, often after the product has 
entered the marketplace. It is the responsibility of the recalling firm 
to account for product remaining under its direct control, to quickly 
notify direct consignees of the identity of the product and any 
potential hazard that it presents, and to request subrecalls where 
indicated. FDA monitors recalls and either discusses follow-up actions 
with the firm if it appears that the recall is not effective, or if 
necessary, takes direct action to complement actions taken by the firm. 
FDA encourages firms to conduct recalls that are effective and may take 
enforcement action to remove products from the market if a firm is 
unable or unwilling to do so.
    When the hazard is significant, FDA expects that firms will 
initiate a public notification process to make the public aware of the 
problem and to recommend steps to be taken in order to prevent injury 
or illness. Recall notifications provide the corrective action 
necessary and a means for returning and/or reporting the status of the 
recalled product.
    In the event that public notice is not provided or is not 
sufficient, FDA has and will continue to notify the public of the 
hazard.
    Question. If a terrorist attack against the food supply occurred, 
how would FDA ensure the food was removed from the distribution chain, 
supermarket shelves, and people's homes?
    Answer. The Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 includes a number of provisions that give new 
authority to FDA to take action to protect the food supply against the 
threat of intentional or accidental contamination of the food supply. 
If a terrorist attack on the food supply occurs, FDA would work with 
State and local food safety officials to remove products from store 
shelves and distribution channels. FDA would also work with the press 
to alert the trade industry and consumers about the potential hazard 
and would provide consumers with information on how and where to 
dispose of contaminated foods. We would include information to 
consumers on what they should do if they had been exposed to the 
contaminated food.
    To ensure efficiency if an emergency occurred, FDA continues to 
take additional measures to improve the success of recalls. On November 
3, 2003, FDA posted guidance to the industry on our website intended to 
assist industry in handling all aspects of a product recall, including 
all corrections and removals. We also continue to develop the Recall 
Enterprise System, which, when completed, will post recalls on our 
website in real time.

                             METHYLMERCURY

    Question. FDA and EPA have issued a joint advisory warning pregnant 
women and women planning a pregnancy to avoid swordfish, shark, some 
types of tuna and king mackerel, since those fish accumulate large 
quantities of methylmercury which can harm their unborn children. 
Eating seafood is the leading cause of exposure to methylmercury, a 
toxin that can cause neurological damage to the developing fetus and 
young children.
    Although the advisory is useful, some groups have complained that 
it is complicated and hard-to-remember. The Center for Science in the 
Public Interest recently recommended that all grocery stores and fish 
retailers should post the warning at the counter where consumers 
actually purchase the seafood.
    Why doesn't FDA enforce the limit for methylmercury in seafood, 
e.g. test and remove seafood from the market that exceeds the limit of 
1 ppm?
    Answer. Risk from methylmercury is generally understood to derive 
from substantial exposure over time of many meals that include fish. 
That is why we issued a consumer advisory on methylmercury directed 
toward women of childbearing age and young children. We are conducting 
surveys to determine how the public, including pregnant women and 
health care providers, are reacting to the consumer advisory on 
methylmercury and to other information they may be receiving from all 
sources about seafood risks and benefits.
    It is useful to note that data from the National Health and 
Nutrition Examination Survey, operated by the Centers for Disease 
Control and Prevention, that measures levels of methylmercury in U.S. 
women of childbearing age and young children through 5 years of age 
reveal that the overwhelming majority of both women of childbearing age 
and young children are exposed to methylmercury at very low levels. The 
next phase of our risk management process for methylmercury involves a 
risk analysis that is examining the likelihood of adverse effects 
through the range of exposures being experienced by U.S. consumers. 
This project is also examining the likelihood of health and nutritional 
benefits from eating fish at various levels of consumption.
    Question. To make the advisory truly effective, why doesn't FDA 
require point-of-purchase notices giving consumers detailed information 
on which types of fish contain high levels of methylmercury at the fish 
counter?
    Answer. FDA, in conjunction with the Environmental Protection 
Agency, or EPA, has implemented a cost-effective public education 
campaign. This campaign is designed to inform high-risk consumers about 
reducing their exposure to high levels of mercury, while emphasizing 
the health benefits of consuming fish and shellfish. This has resulted 
in raising awareness about methylmercury in seafood. We believe the 
steps that have been taken are more appropriate and more effective than 
using point-of-purchase signage to convey a complex consumer message. 
The program uses health professionals and the media to inform high-risk 
populations, including women who may become pregnant, pregnant women, 
nursing mothers and the parents of young children, about mercury in 
seafood. The goal is to inform these high-risk consumers that they 
should avoid or restrict their consumption of certain kinds of fish, 
while emphasizing the importance of fish and shellfish as part of a 
healthy diet.
    The public education campaign includes an extensive outreach effort 
to over 9,000 print and electronic media outlets. FDA and EPA have also 
distributed over four million brochures about the advisory on 
methylmercury in fish and shellfish to members of over 50 organizations 
of healthcare providers to women and children. The brochures have also 
been given to all practicing pediatricians, obstetricians, 
gynecologists, nurse practitioners, and nurse midwives throughout the 
country for office distribution. And, finally, we distribute it through 
exhibits at medical and public health professional organization 
meetings. This information is also available on our Web site for use by 
States, food facilities, health care professionals, and consumer 
groups.
    In August 2005, FDA launched an educational program entitled ``Food 
Safety Moms-To-Be'' that builds upon several food safety messages and 
includes information for use by health educators about the advisory on 
methylmercury in fish and shellfish. More than 45,000 Educator 
Toolkits, including an Educators Resource Guide, video, and DVD were 
sent to health professionals who have direct contact with pregnant 
women via pregnancy planning, prenatal and post-natal care, and 
childbirth education classes.
    FDA also established a Web site for pregnant women to obtain 
information about foodborne safety. The Web site received more than 
35,000 visitors in its first full month of September 2005, is available 
in both English and Spanish, and has an ``email a friend'' feature that 
allows users to share this information with others.

                                FOODNET

    Question. The Foodborne Diseases Active Surveillance Network 
(FoodNet) is the principle foodborne disease component of CDC's 
Emerging Infections Program (EIP). It is a collaborative project of the 
CDC, FDA, and USDA. Unlike the direct funding that comes from USDA 
which has remained consistent, the funds from CDC and FDA are derived 
from the larger Food Safety Initiative and are thus subject to being 
reallocated. Over the last 5 years the program has experienced a 10 
percent decrease in funding. Cuts to the FoodNet Program will have a 
direct effect on our Nation's ability to identify and track foodborne 
illness.
    How have these cuts impacted our ability to identify and track 
foodborne illness?
    Answer. FDA has provided a consistent level of funding in support 
of FoodNet over the years and has experienced no change in the 
availability of information we need to direct and evaluate the 
effectiveness of our regulatory programs. FDA will work with the 
Committee if specific funding information is needed from CDC.
    Question. Do you support giving direct line item funding to the 
FoodNet Program?
    Answer. While FDA believes that FoodNet is a valuable tool for 
identifying and tracking foodborne illness, which allows the agency to 
evaluate the effectiveness of its regulatory programs, FDA does not 
support giving direct line item funding to the FoodNet program in the 
FDA appropriation.
                                 ______
                                 

             Questions Submitted by Senator Byron L. Dorgan

                      IMPORTED PRESCRIPTION DRUGS

    Question. Given the substantial price differences between products 
sold in the United States and abroad, it should come as no surprise 
that millions of Americans already import prescription drugs.
    How much did the FDA spend in fiscal year 2005 to prevent Americans 
from importing prescription drugs from Canada and other countries?
    Answer. FDA prevents unauthorized importation of drugs from other 
countries through post-market import inspections and post-market import 
laboratory analyses. In fiscal year 2005, the Office of Regulatory 
Affairs spent $6.4 million on post-market import inspections and $1.7 
million on post-market import laboratory analyses of human drug imports 
from all countries. Post-market import inspections are defined as 
physical inspections, product information, line entry & label review. 
They include all the activities relating to the decision to permit or 
refuse entry to regulated products. Examples include: import field 
exams, import sample collections, Operational and Administrative System 
for Import Support on-screen reviews, review of physical documents, 
detention without physical examination, private laboratory report 
review and audit activities, filer evaluation, and follow up to 
refusals. Post-market import laboratory analyses are defined as sample 
analysis, product testing, methods development for testing purposes, 
specific regulatory problems that FDA develops solutions for. They 
exclude applied research and premarket review analyses and include 
fingerprinting.
    Question. Much of the apparatus for assuring safe consumer access 
to imported drugs is already in place. Under current law, drug 
companies are free to manufacture prescription drugs in other countries 
and import them for sale in the United States. More than $40 billion of 
the prescription drugs consumed by Americans in 2002--one quarter of 
all drugs--was made in other countries and imported to the United 
States for sale by pharmaceutical manufacturers.
    If importation can be deemed safe for manufacturers, why can't it 
be made safe for consumers? Wouldn't a regulated system be safer than 
what is occurring today?
    Answer. 21 USC 381(d)(1) was included in the Federal Food, Drug, 
and Cosmetic Act with the understanding that the manufacturer of a drug 
product is in the best position to know if a drug product destined for 
import into the United States is their genuine product, and not a 
counterfeit, and whether it has been stored or handled in such a way as 
to affect the integrity of the product. Because counterfeiters are so 
sophisticated in their methods of copying drug products and packaging, 
consumers, distributors, and retailers, are not in a position to easily 
distinguish genuine from counterfeit drug product. Oftentimes, the 
manufacturer must perform costly and complicated analysis to determine 
if a product is genuine or not.
    The HHS Drug Importation Task Force Report issued in December 2004 
outlined the measures that would be needed to implement an importation 
program that provides adequate safeguards and resources to ensure that 
the imported drugs are safe and effective. A program that does not take 
these measures into consideration, regulated or not, would perpetuate 
the buyer beware situation that is currently occurring and consumers 
would continue to put themselves at risk for harm by importing 
unapproved drugs into the United States for personal use.
    Specifically, the Task Force made a number of significant finding 
about an importation program. The Task Force determined that first, 
integrity of the distribution system must be ensured by, among other 
measures, requiring drug pedigrees with adequate documentation, 
limiting ports of entry and distribution channels, and allowing 
commercial importation only from licensed foreign wholesalers to 
authorized sellers in the United States. The program must exclude 
personal shipments via the mail and courier services. Indeed, 
regulating personal importation could be extraordinarily costly, on the 
order of $3 billion a year based on estimates of the current volume.
    Second, any program must limit importation to those prescription 
drugs most likely to yield savings--namely high-volume products for 
which a United States--approved generic is not available--and allow 
importation only from countries for which we have a high degree of 
confidence in the comparability of their drug regulatory systems. In 
the Administration's view, Canada is the only country from which 
importation should be considered at this point. Congress should also 
exclude drugs or classes of drugs that pose increased safety risks in 
the context of importation, such as controlled substances and drugs 
that require refrigeration during shipping.
    Third, any program must require that imported prescription drugs be 
dispensed pursuant to a valid U.S. prescription pursuant to advice from 
a trusted medical professional.
    Fourth, measures must be included to ensure that any purchasers of 
imported drugs are given full and adequate information regarding, among 
other things, the source of the drugs, and that packaging and labels on 
imported drugs meet all FDA requirements.
    Fifth, any importation program must ensure effective oversight and 
adequate government resources to protect American consumers.
    Sixth, any program must include the ability to use streamlined 
inspection procedures, and ensure appropriate remedial steps can be 
taken in the event of adverse events from imported drugs.
    Seventh, any program must avoid anti-competitive provisions such as 
so-called ``forced sale'' provisions, and other types of price 
controls.
    The Task Force found that such a system would have minimal cost 
savings.
    Question. Congress has twice enacted legislation to allow for the 
importation of prescription drugs. Both times provisions were included 
that required the Secretary of Health and Human Services to certify 
that imported drugs would be safe and would result in significant 
savings for the American consumer. The Congressional Budget Office has 
already determined that legalizing importation will reduce prescription 
drug expenditures by $50 billion. CBO estimates Federal savings of $1.6 
billion over the 2006-2010 period and $6.1 billion over the 2006-2015 
period. That takes care of the savings argument.
    In terms of safety, how do you guarantee the safety of drugs that 
are sold in the United States? How did the FDA guarantee the safety of 
Vioxx? Why is the bar set higher for imported drugs?
    Answer. At FDA, the Center for Drug Evaluation and Research, or 
CDER, is responsible for ensuring that America's drug product supply is 
safe, effective, adequately available, and of the highest quality. 
CDER's responsibility for ensuring drug safety is two fold, consisting 
of premarket safety review and postmarket safety surveillance. We 
evaluate the safety of a drug before it can be marketed in the United 
States in a pre-market safety review. FDA grants approval to drugs 
after a sponsor demonstrates that they are safe and effective for their 
intended use. Since the full magnitude of some potential risks do not 
always emerge during the mandatory clinical trials conducted before 
approval to evaluate these products for safety and effectiveness, if 
CDER approves a drug, we continue to monitor the safety of that drug 
after it is on the market by collecting data about its use and watching 
for signs of troubling or dangerous side effects. We call this post-
market safety surveillance.
    No drug product is ``perfectly'' safe. Moreover, FDA approval of a 
drug is not a ``guarantee'' that the drug is ``perfectly'' safe. All 
approved drugs pose some level of risk since every drug that affects 
the body will have some side effects. FDA considers both the benefits 
and risks of all medications before approval and unless a new drug's 
demonstrated benefit outweighs its known risk for an intended 
population, FDA will not approve the drug. Medications needed to treat 
very severe or life-threatening illnesses such as cancer treatments may 
be approved with more serious side effects than other types of 
medications. FDA makes sure the label or package insert accurately 
describes the benefits and risks discovered in the clinical trials and 
after marketing. With the help of a health-care provider, a patient 
should decide if the benefits for the drug outweigh the risks.
    The pre-market process for approving drug products begins with the 
drug companies who must first test their products. CDER monitors their 
clinical research to ensure that people who volunteer for studies are 
protected and that the quality and integrity of scientific data are 
maintained. CDER assembles a team of physicians, statisticians, 
chemists, pharmacologists, and other scientists to review the company's 
data and their proposed use for the drug. If the drug is effective and 
we are convinced that it is safe for its intended use-- meaning that 
its health benefits outweigh its risks, we approve it for marketing in 
the United States CDER does not actually test the drug when we review 
the company's data. By setting clear standards for the evidence FDA 
needs to approve a drug, including evidence for demonstrating the 
safety of the drug for its intended use, the Agency helps medical 
researchers bring new drugs to American consumers more rapidly.
    Once a drug is approved for sale in the United States, FDA monitors 
the use of marketed drugs for unexpected health risks, either through 
post-marketing clinical trials or through spontaneous voluntary 
reporting of adverse events from patients, doctors, and nurses through 
MedWatch system that are entered into the Adverse Event Reporting 
System, or AERS. Our safety reviewers monitor the data in AERS looking 
for indications of potential serious, unrecognized drug-associated 
reactions. If new, unanticipated risks are detected after approval, we 
take steps to inform the public and change how a drug is used or even 
remove a drug from the market.
    Following the process and fundamental principles just described, 
FDA originally approved Vioxx in May 1999 for the reduction of signs 
and symptoms of osteoarthritis, as well as for acute pain in adults and 
for the treatment of primary dysmenorrhea. The original safety database 
included approximately 5,000 patients on Vioxx and did not show an 
increased risk of heart attack or stroke. A later study, VIGOR, which 
stands for VIOXX GI Outcomes Research, was primarily designed to look 
at the effects of Vioxx on GI effects such as stomach ulcers and 
bleeding and was submitted to the FDA in June 2000. The study showed 
that patients taking Vioxx had fewer stomach ulcers and bleeding than 
patients taking naproxen, another NSAID, however, the study also showed 
a greater number of heart attacks in patients taking Vioxx. The VIGOR 
study was discussed at a February 2001 Arthritis Advisory Committee and 
the new safety information regarding all that was known at the time 
about the potential risk of cardiovascular effects with Vioxx from this 
study was added to the labeling for Vioxx in April 2002. Merck then 
began to conduct longer-term trials to obtain more data on other 
potential indications of this product. All trials for chronic use were 
designed to monitor carefully for cardiovascular safety. The serious 
side effect risks for which Vioxx was ultimately withdrawn from the 
market voluntarily by Merck were identified when Merck collected new 
data from a trial called the APPROVe, which stands for Adenomatous 
Polyp Prevention on VIOXX trial where Vioxx was compared to placebo. 
The purpose of this new trial was to see if Vioxx 25 mg was effective 
for a new indication--for preventing the recurrence of colon polyps. 
This trial was stopped early because there was an increased risk for 
serious cardiovascular events, such as heart attacks and strokes, first 
observed after 18 months of continuous treatment with Vioxx compared 
with placebo.
    The bar is not set higher for imported drugs. In fact, the bar is 
identical to that for FDA-approved drugs. The problem with illegally 
imported prescription drugs is that we often have no assurance that 
they have been manufactured, processed and held according to the same 
requirements and standards as FDA-approved drugs. FDA drug approvals 
are manufacturer- and product-specific and include many requirements 
relating to the product, such as manufacturing location, formulation, 
source and specifications of active ingredients, processing methods, 
manufacturing controls, packaging location, container/closure system, 
and appearance (21 CFR 314.50). Frequently, drugs sold outside of the 
United States are not manufactured or packaged by a firm that has FDA 
approval for that drug. Moreover, even if the manufacturer has FDA 
approval for a drug, the version produced for foreign markets may not 
meet all of the specific requirements of the United States approval, 
and thus would be considered to be unapproved (section 505 of the Act 
(21 U.S.C. 355)).
    In December 2004, the HHS Drug Importation Task Force Report on 
Prescription Drug Importation concluded that any safe system of 
importation would likely produce only modest savings on the national 
level. The small quantity of available drugs to import would result in 
little aggregate cost savings. The Task Force included a report with 
the results from a Department of Commerce study. That study concluded 
the reduction of research and development of competitive markers for 
generic medicines, thereby denying consumers in those markets benefits, 
including lower prices that Americans obtain as result of competition 
between generic and brand-name drugs. In fact, U.S. consumers would 
pay, on average, 50 percent more for their generic medications if they 
bought them abroad.
    Question. Mark McClellan has said, ``If you're certain you're 
buying approved Canadian drugs from an approved Canadian pharmacy,'' he 
says, ``you can have a high level of confidence that that's a good 
product.''
    If we could figure out a system that makes importing drugs just 
like walking into a brick and mortar Canadian pharmacy, wouldn't it be 
safer than what is occurring today?
    Answer. The HHS Drug Importation Task Force Report on Prescription 
Drug Importation issued in December 2004 outlined measures that would 
be needed to implement an importation program that provides adequate 
safeguards and resources to ensure that the imported drugs are safe and 
effective within the meaning of the Federal Food, Drug, and Cosmetic 
Act. An importation program that does not take these measures into 
consideration would frustrate our ability to ensure that the 
prescription drugs imported for personal use were safe and effective 
for their labeled uses.
    Specifically, the Task Force made a number of significant finding 
about an importation program. The Task Force determined that first, 
integrity of the distribution system must be ensured by, among other 
measures, requiring drug pedigrees with adequate documentation, 
limiting ports of entry and distribution channels, and allowing 
commercial importation only from licensed foreign wholesalers to 
authorized sellers in the United States. The program must exclude 
personal shipments via the mail and courier services. Indeed, 
regulating personal importation could be extraordinarily costly, on the 
order of $3 billion a year based on estimates of the current volume.
    Second, any program must limit importation to those prescription 
drugs most likely to yield savings--namely high-volume products for 
which a United States--approved generic is not available--and allow 
importation only from countries for which we have a high degree of 
confidence in the comparability of their drug regulatory systems. In 
the Administration's view, Canada is the only country from which 
importation should be considered at this point. Congress should also 
exclude drugs or classes of drugs that pose increased safety risks in 
the context of importation, such as controlled substances and drugs 
that require refrigeration during shipping.
    Third, any program must require that imported prescription drugs be 
dispensed pursuant to a valid U.S. prescription pursuant to advice from 
a trusted medical professional.
    Fourth, measures must be included to ensure that any purchasers of 
imported drugs are given full and adequate information regarding, among 
other things, the source of the drugs, and that packaging and labels on 
imported drugs meet all FDA requirements.
    Fifth, any importation program must ensure effective oversight and 
adequate government resources to protect American consumers.
    Sixth, any program must include the ability to use streamlined 
inspection procedures, and ensure appropriate remedial steps can be 
taken in the event of adverse events from imported drugs.
    Seventh, any program must avoid anti-competitive provisions such as 
so-called ``forced sale'' provisions, and other types of price 
controls.
    The Task Force found that such a system would have minimal cost 
savings.
    Question. The FDA claims that more than 10 percent of drugs 
worldwide are counterfeit.
    What is this based on? What is the percentage in the European 
Union? Canada? Are drugs made in Canada that enter the United States 
considered counterfeit?
    Answer. FDA has not stated that 10 percent of the drugs worldwide 
are counterfeit. Many sources have attributed FDA with this figure; 
however, it did not come from FDA. In fact, FDA does not know what the 
prevalence of counterfeit drugs is globally, in the European Union, EU, 
or in Canada. Drugs that are made in Canada are not considered 
counterfeit unless they meet the definition of ``counterfeit drug'' 
under 21 U.S.C. 321(g)(2). Rather, virtually all prescription drugs 
imported into the United States from Canada for personal use violate 
the Federal Food, Drug, and Cosmetic Act, the Act, because they are 
unapproved new drugs (section 505 of the Act (21 U.S.C. 355)), labeled 
incorrectly (sections 502 and 503 of the Act (21 U.S.C. 352 and 353)), 
dispensed without a valid prescription (section 503(b)(1) of the Act 
(21 U.S.C. 353(b)), or imported in violation of the Act's ``American 
goods returned'' provision (21 U.S.C.  381(d)(1)). Under the American 
Goods Returned provision of 801(d)(1), it is illegal for anyone other 
than the original manufacturer of the drug to import into the United 
States a prescription drug that was originally manufactured in the 
United States and sent abroad. Because a consumer is not the 
manufacturer, they are not permitted to reimport prescription drugs 
into the United States, even if the drugs were made in the United 
States. Importing a drug into the United States that does not comply 
with the labeling and dispensing requirements in the Act and/or is an 
unapproved new drug is prohibited under section 301(a) and/or (d) of 
the Act (21 U.S.C. 331(a) and/or (d)).
    Question. There have been several recent reports that your agency, 
along with the Customs and Border Patrol, has increased enforcement 
efforts to stop prescription drugs from coming into the United States. 
Did the FDA change its policy?
    Answer. FDA's guidance on the personal importation of prescription 
medicine has not changed. However, we have accommodated CBP's new role 
in the initial screening of packages containing pharmaceuticals by 
adjusting the application of our procedures for handling pharmaceutical 
products shipped through international mail facilities. We anticipate 
that efficiencies gained as a result of the revised CBP procedures will 
allow CBP and FDA to screen and process a larger number of packages 
than in the past.
                                 ______
                                 

            Questions Submitted by Senator Richard J. Durbin

                          DIETARY SUPPLEMENTS

    Question. Most dietary supplements provide great health benefits 
for many Americans. As you know, I have worked for years to ensure that 
dietary supplements are safe for the public--I hope that the dietary 
supplement adverse reporting system is enacted in the near future. 
Clearly, such a system would increase the workload of the FDA, and 
Congress would need to do its part and provide extra funding for your 
agency.
    In the meantime, please advise the Subcommittee on the timeline to 
publish the final rule on Good Manufacturing Practices for dietary 
supplements, which were mandated by Congress 12 years ago and still 
have yet to be finalized.
    Answer. The proposed rule was published March 13, 2003, and 
included responses to numerous comments received after publication of 
the advanced notice of proposed rulemaking in 1997. The comment period 
for the proposed rule was extended until August 2003. We held public 
stakeholder meetings on April 29, 2003, in College Park, MD, and on May 
6, 2003, in Oakland, CA. We also held a public meeting, via satellite 
downlink, on May 9, 2003, with viewing sites at our district and 
regional offices throughout the country. After the comment period 
closed, we began the process of analyzing the comments submitted to the 
proposed rule. The issues raised by the comments are complex, legally 
and substantively, and in some cases, novel. We have expended 
significant internal resources on reviewing and preparing responses to 
the comments received. In addition, we have worked to ensure that the 
goals of Dietary Supplement Health and Education Act are carried out 
with careful consideration of the impact on the dietary supplement 
industry. We are working to complete the rulemaking.

                             WOMEN'S HEALTH

    Question. In late August, Dr. Susan Wood, the Assistant FDA 
Commissioner for Women's Health and Director for the Office of Women's 
Health, resigned over the Administration's refusal to issue a final 
decision on the emergency-contraception (Plan B) application. She said, 
``I can no longer serve as staff when scientific and clinic evidence, 
fully evaluated and recommended for approval by professional staff 
here, has been overruled.'' This decision was contrary to the 
recommendations of the FDA's advisory commission and its review staff. 
I requested a GAO study, released in November, which found that the 
decision process to deny the application ``was unusual.'' It is my 
understanding that the FDA is currently considering a revised request 
to make emergency contraception available over the counter to women, 
but require a prescription for younger girls.
    What is the status of this request, and what is the FDA doing to 
further all aspects of women's health?
    Answer. On May 6, 2004, the FDA issued a ``Not Approvable'' letter 
to Barr Laboratories, sponsor of a supplemental New Drug Application 
proposing to make the currently approved Plan B emergency contraception 
prescription product available as an over-the-counter, or OTC product. 
After reviewing the supplemental application, FDA concluded that the 
application could not be approved at that time because adequate data 
were not provided to support the conclusion that young adolescent women 
can safely use Plan B for emergency contraception without the 
professional supervision of a licensed practitioner and a proposal from 
the sponsor to change the requested indication to allow for marketing 
of Plan B as a prescription-only product for women under 16 years of 
age and a nonprescription product for women 16 years and older was 
incomplete and inadequate for a full review.
    The applicant chose to revise its application, and in a July 2004 
resubmission, the applicant requested to market Plan B as prescription-
only for women under the age of 16 and OTC for women 16 years of age 
and older. In addition, they proposed an educational program for 
healthcare providers, pharmacists, and patients.
    On August 26, 2005, FDA issued a letter to Duramed Research, the 
successor to the Barr Laboratories application, in response to their 
July resubmission. The response concluded that the available scientific 
data are sufficient to support the safe and effective use of Plan B as 
an OTC product for women who are 17 years of age and older. However, 
the Agency stated that it was unable to reach a decision on the 
approvability of the application because of unresolved issues that 
relate to whether a drug may be both prescription and OTC, depending on 
the age of the patient, how an age based distinction could be enforced, 
and whether Rx and OTC versions of the same active ingredient may be 
marketed in a single package.
    On the same date that FDA issued this letter to Duramed Research, 
FDA issued an advance notice of proposed rulemaking. This rulemaking 
requested comment on whether to initiate a rulemaking to codify its 
interpretation of section 503(b) of the Food, Drug, and Cosmetic Act 
regarding when an active ingredient may be simultaneously marketed as 
both a prescription and OTC drug product. The comment period on this 
notice closed on November 1, 2005, and FDA is currently evaluating 
those comments.
    With regard to your question on what FDA is doing to further 
women's health, FDA's Office of Women's Health also known as OWH 
continues to expand patient protection and empower consumers for better 
health by providing consumer information and funding research. OWH 
continues its Take Time to Care Campaign, a multi-faceted campaign that 
focuses on the dissemination of health education materials for 
consumers through activities and collaborative partnerships. OWH 
continues its Menopause and Hormones Education Campaign providing clear 
and useful information to women about the use of hormones during 
menopause. OWH continues to develop and distribute numerous consumer 
information fact-sheets about FDA-regulated products for women and 
their families. OWH consumer information and publications are available 
in approximately 20 different languages.
    OWH funds research projects related to FDA products and relevant to 
women's health and sex differences. The office funds research projects 
at FDA and academic institutions that are of regulatory significance to 
FDA. OWH partners with other HHS organizations to identify gaps in 
women's health research and to leverage limited funding. The office 
participates in national medical, scientific, and health care 
conferences sharing information with consumers about FDA regulated 
products and participating in scientific discussions and presentations 
advancing the science related to sex and gender differences.
    OWH enhances patient protection and consumer health by maintaining 
an extensive and current electronic ``contact database'' used to inform 
patient advocacy groups, health professionals, national organizations, 
and large insurance carriers of innovative products approved by FDA and 
important safety information related to FDA regulated products.
    OWH is working to transform systems and infrastructure to support 
critical agency operations regarding electronic knowledge/information 
management for an integrative IT environment across FDA Centers. The 
office is developing a ``SMART'' document approach for FDA reviewers to 
enhance review quality and consistency. OWH has been working on a 
business case plan to better allow for electronically tracking the 
inclusion of women and sex-specific analyses in studies submitted to 
FDA.

                          ADVISORY COMMITTEES

    Question. As you know, Congress required FDA to publish a quarterly 
report on your efforts to find unconflicted scientists for FDA panels. 
Your first report, published January 2006, gave some raw numbers (over 
200 resumes review for a limited number of slots) but did nothing to 
document any specific efforts to find unconflicted scientists.
    What specific steps other than cursory resume reviews have you 
taken to find scientists to serve on advisory committees this year that 
don't have conflicts of interest?
    Answer. FDA has instituted a number of additional steps this year 
to find experts with limited or no conflicts of interest to serve on 
FDA advisory committees and panels. FDA scientific and technical staff 
and their managers generally identify and contact experts, inviting 
them to fill vacancies on advisory committees or panels. In the past 
year, FDA's Advisory Committee and Management Staff in the 
Commissioner's Office and committee management staff at the Center 
levels have briefed FDA scientific and technical staff and their 
managers on the importance of identifying potential committee nominees 
with limited or no conflicts of interest. In an effort to help identify 
potential conflicts at the earliest possible stage, staff and 
management were also advised to consider, to the extent possible, the 
types of products likely to be discussed at upcoming committee and 
panel meetings when interviewing candidates about financial holdings 
and industry relations.
    Panel and committee members themselves also identify possible 
candidates to serve on advisory committees and panels. Current 
committee and panel members are therefore advised to consider possible 
conflicts of interest when recommending candidates for participation.
    We anticipate that the efforts described above will result in the 
need for fewer waivers in the future. Because committee and panel 
vacancies are often filled well ahead of meetings, it can be difficult 
to identify the relevant sponsors or competing companies, and therefore 
potential conflicts of interest, during the nomination stage. 
Importantly, one of the most critical mechanisms for preventing and 
addressing conflict of interest issues continues to be the rigorous 
analysis FDA conducts to identify conflicts of interest once we know 
the context of a committee or panel meeting, as well as the process, 
guided by both Federal statutes and regulations, for determining 
whether conflict of interest waivers are appropriate. As we pursue 
FDA's mission to protect the public health, we strive to fill committee 
and panel vacancies with qualified experts who satisfy the committee 
composition requirements set forth by Federal law. Finding experts who 
have no or limited conflict of interest remains one of multiple 
considerations in identifying who will fill a committee or panel 
vacancy.
    Question. On January 23, a joint meeting of the FDA's 
Nonprescription Drug Advisory Committee and the Endocrinologic and 
Metabolic Drugs Committee met to discuss GlaxoSmithKline's weight loss 
drug, Orlistat, going over-the-counter. It was eventually approved 11-
3. Seven scientists were granted waivers for that meeting, including 
two who had direct ties to Glaxo.
    Do you think that public's faith in this committee's decision is 
undermined by the fact that so many scientist required waivers of 
conflicts of interest? Does your staff have enough resources to conduct 
adequate background research on potential advisory committee members to 
find people without such conflicts?
    Answer. We believe that several factors should serve to bolster the 
public's faith in the advisory committee recommendation described 
above.
    First, the conflict of interest waivers were granted in accordance 
with Federal law. The waivers approved for the meeting described above 
were granted in compliance with 18 U.S.C. 208(b)(3), 21 U.S.C. 
355(n)(4), and the applicable Office of Government Ethics regulations.
    Second, information regarding these waivers and the underlying 
conflicts of interest was made publicly available before the advisory 
committee meeting, as required by law. Waiver documents and information 
regarding the nature and magnitude of the underlying conflicts of 
interest were posted on FDA's Internet page prior to the meeting.
    Third, the voting results of this meeting do not suggest a bias 
resulting from conflicts of interest. Five of the seven waivers were 
granted for members with minimal interests in competing companies. If 
financial bias was present, one might expect that the final vote would 
have been directed against the product under discussion. Instead, a 
significant majority of the members voted in support of the product. 
Moreover, as stated in the waiver documents posted online, the two 
additional waivers were granted to scientists receiving minimal 
compensation that arguably did not constitute ``financial interests'' 
under 18 U.S.C. 208(a). FDA proceeded with waivers for these 
individuals, however, out of an abundance of caution.
    To identify potential conflicts at the earliest possible stage, 
staff and management are advised to consider, to the extent possible, 
the types of products likely to be discussed at upcoming committee and 
panel meetings when interviewing candidates about financial holdings 
and industry relations. Panel and committee members themselves also 
identify possible candidates to serve on advisory committees and 
panels. Current committee and panel members are therefore advised to 
consider possible conflicts of interest when recommending candidates 
for participation. We believe these steps are sufficient and adequately 
resourced.

                             METHYLMERCURY

    Question. It is well known that mercury occurs naturally in the 
environment and can also be released into the air through pollution. It 
is well established that exposure to elevated levels of mercury during 
fetal development can have adverse effects on the developing brain and 
nervous system that can lead to delayed speech and motor development. 
For these public health reasons, what else can be done to reduce the 
amount of mercury in seafood?
    Answer. There is no technical process that can remove methylmercury 
from fish. Therefore, FDA and the Environmental Protection Agency (EPA) 
have implemented a comprehensive public education campaign through 
health professionals and the media to inform high-risk populations, 
including women who may become pregnant, pregnant women, nursing 
mothers and the parents of young children, about mercury in seafood. 
The purpose of this campaign is to inform these high-risk consumers 
that they should avoid or restrict their consumption of certain kinds 
of fish, while emphasizing the importance of fish and shellfish as part 
of a healthy diet.
    The public education campaign includes an extensive outreach effort 
to over 9,000 print and electronic media outlets, including magazines 
about pregnancy and young children. Information has also been sent to 
members of over 50 organizations of healthcare providers to women and 
children, such as the American Academy of Pediatrics, the American 
Academy of Family Physicians, the American College of Obstetricians and 
Gynecologists, and the American College of Nurse Midwives, directors of 
the Women, Infants, and Children programs, as well as all local health 
departments.
    In addition, brochures about the methylmercury advisory have been 
sent to all practicing pediatricians, obstetricians, gynecologists, 
nurse practitioners, and nurse midwives throughout the country for 
distribution in their offices. The brochures are accompanied by a 
letter to the health professional that emphasizes the health benefits 
of fish. The advisory is also being distributed through exhibits at 
medical and public health professional organization meetings.
    To date, FDA and EPA have distributed over four million brochures. 
The brochures are currently available in English and Spanish, and will 
soon be available in Korean, Cambodian, Chinese, Vietnamese, Hmong, and 
Portuguese. This information is also available on our Web site for use 
by States, food facilities, health care professionals, and consumer 
groups.
    FDA and EPA will continue to review these recommendations and make 
adjustments, as needed, so that consumers have access to clear, sound 
dietary information. We recognize that the marketplace often has 
multiple, and at times confusing or contradictory, messages. FDA will 
continue to provide a clear channel for public health information 
concerning methylmercury and other foodborne contaminants.
    To reiterate FDA's position, consumers should continue to eat a 
diet that follows the advice given in the 2005 Dietary Guidelines, 
including eating a variety of seafood. It is useful to note that data 
from the National Health and Nutrition Examination Survey, operated by 
the Centers for Disease Control and Prevention, that measures levels of 
methylmercury in U.S. women of childbearing age and young children 
through 5 years of age reveal that the overwhelming majority of both 
women of childbearing age and young children are exposed to 
methylmercury at very low levels.
    The next phase of our risk management process for methylmercury 
involves a risk analysis that is examining the likelihood of adverse 
effects through the range of exposures being experienced by U.S. 
consumers. This project is also examining the likelihood of health and 
nutritional benefits from eating fish at various levels of consumption.
    Question. You recently met with Dr. David Acheson, Director of Food 
Safety, regarding the adequacy of the FDA's mercury advisory. Dr. 
Acheson said that the advisory is geared toward childbearing women and 
young children and the information is disseminated through healthcare 
providers. At present levels of mercury in canned light tuna, a child 
would exceed the recommended maximum level of mercury consumption by 
eating as few as two sandwiches a week that contain tuna.
    What steps can the FDA take to better educate consumers about 
avoiding excessive mercury intake?
    Answer. FDA and the Environmental Protection Agency, also know as 
the EPA, have implemented a comprehensive public education campaign 
through health professionals and the media. The campaign is intended to 
inform high-risk populations. These include women who may become 
pregnant, pregnant women, nursing mothers and the parents of young 
children, about mercury in seafood. The purpose of this campaign is to 
inform these high-risk consumers that they should avoid or restrict 
their consumption of certain kinds of fish, while emphasizing the 
importance of fish and shellfish as part of a healthy diet.
    The public education campaign includes an extensive outreach effort 
to over 9,000 print and electronic media outlets, including magazines 
about pregnancy and young children. Information has also been sent to 
members of over 50 organizations of healthcare providers to women and 
children, such as the American Academy of Pediatrics, the American 
Academy of Family Physicians, the American College of Obstetricians and 
Gynecologists, and the American College of Nurse Midwives, directors of 
the Women, Infants, and Children programs, as well as all local health 
departments.
    In addition, brochures about the methylmercury advisory have been 
sent to all practicing pediatricians, obstetricians, gynecologists, 
nurse practitioners, and nurse midwives throughout the country for 
distribution in their offices. The brochures are accompanied by a 
letter to the health professional that emphasizes the health benefits 
of fish. The advisory is also being distributed through exhibits at 
medical and public health professional organization meetings.
    To date, FDA and EPA have distributed over four million brochures. 
The brochures are currently available in English and Spanish, and will 
soon be available in Korean, Cambodian, Chinese, Vietnamese, Hmong, and 
Portuguese. This information is also available on our Web site for use 
by States, food facilities, health care professionals, and consumer 
groups.
    FDA and EPA will continue to review these recommendations and make 
necessary adjustments to ensure consumers have access to clear, sound 
dietary information. We recognize that the marketplace often has 
multiple, and at times confusing or contradictory, messages. FDA will 
continue to provide a clear channel for public health information 
concerning methylmercury and other foodborne contaminants.
    To reiterate FDA's position, consumers should continue to eat a 
diet that follows the advice given in the 2005 Dietary Guidelines, 
including eating a variety of seafood. It is useful to note that data 
from the National Health and Nutrition Examination Survey, operated by 
the Centers for Disease Control and Prevention, that measures levels of 
methylmercury in U.S. women of childbearing age and young children 
through 5 years of age reveal that the overwhelming majority of both 
women of childbearing age and young children are exposed to 
methylmercury at very low levels.

                             DRUG LABELING

    Question. The FDA recently issued a final rule on warning label 
requirements for prescription drugs. In the proposed rule, which was 
issued in December of 2000, the FDA stated that the rule would NOT 
preempt state law. Then, in the final rule, the agency asserts that the 
rule should be interpreted to preempt state law and state tort 
liability.
    Given that the FDA provided no notice of its intention to preempt 
state law, how did the FDA comply with the notification and 
consultation requirements mandated by both the Administrative 
Procedures Act and an existing Executive Order?
    Answer. The Administrative Procedure Act requires the Agency to 
address the comments it receives in response to proposed rules. The 
discussion you reference in the preamble to the final rule regarding 
Federal preemption was written in response to the comments received and 
merely restates the Agency's longstanding position as articulated in 
amicus briefs filed in court by the Department of Justice, or DOJ, in 
cases regarding Federal preemption and drug labeling. These product 
liability cases involved state law challenges to FDA approved labeling. 
DOJ argued on behalf of FDA that such law suits are preempted by the 
Federal Food, Drug, and Cosmetic Act when State requirements cause drug 
products to be misbranded under Federal law.
    Next, you correctly reference the preamble to the proposed rule's 
statement that it was not intended to preempt state actions. Because 
the rule itself is about the labeling of prescription drugs and is not 
a rule regarding preemption, and because the codified language did not 
expressly propose to preempt state law, FDA included the statement you 
reference in the proposed rule. However, FDA received comments about 
the product liability implications of the proposed rule and in 
responding to those comments, FDA mentioned its view of preemption law 
as it relates to the Physician Labeling Rule. In fact, the rule itself 
does not create new preemption law in any way; FDA was simply stating 
in the preamble what it believes the law already is with regard to 
implied conflict preemption. In addition, implied conflict preemption 
works to preempt state law when ever conflict with Federal law arises. 
The agency need not state in a proposed rule that implied preemption 
might arise for it to actually do so.
    With regard to the Executive Order relating to Federalism, although 
the preamble to the final rule merely stated the agency's view of 
current implied conflict preemption law and is not part of the codified 
portion of the rule, FDA consulted with a variety of State officials 
and representative organizations that represent State officials and 
governments on its proposed course of action before the final rule was 
published. FDA considered their input before proceeding.
    Question. The FDA had a long-standing policy of allowing States to 
implement additional safety requirements that would compliment FDA's 
rules and regulations. Why did the FDA recently stray from the long-
standing policy and assert that any differing state law or requirement 
should be extinguished in favor of the Federal standards, especially in 
light of new evidence showing some FDA-approved drugs and medical 
devices are dangerous?
    Answer. All drug products have risks and their FDA-approved 
labeling is designed to reflect the known risks at any given time. 
Companies are put in the impossible situation of complying with 
conflicting Federal and state law when Federal law demands they use 
approved drug labeling and state law requires different warnings. The 
preamble language represents FDA's view of preemption law and does not 
abrogate the State's ability to implement safety requirements. States 
can do so as long as they do not attempt to impose requirements that 
conflict with Federal law nor frustrate the purposes of Federal law. In 
addition, the preamble language reflects FDA's long standing views 
about Federal preemption law and does not reflect a change in FDA 
policy.
    Question. Unelected Federal agencies like the FDA cannot decide, on 
their own, to extinguish an entire area of state law without 
congressional authority. Given that Congress never gave the FDA the 
authority to wipe out numerous state safety laws and requirements, how 
does the agency find the authority to assert this position?
    Answer. FDA did not decide to extinguish an entire area of state 
law without congressional authority. The six examples in the preamble 
describe the types of instances where FDA believes that under the 
Supremacy Clause of the U.S. Constitution and relevant case law, 
Federal law trumps state law. For instance, state law can not require a 
warning that would misbrand the product under the Federal Food, Drug, 
and Cosmetic Act. Similarly, FDA is the expert agency charged by 
Congress in evaluating the safety and efficacy of drug products, and 
implied conflict preemption would arise if a State allowed a product 
liability suit for failing to warn about a specific risk that FDA 
excluded from the approved label. Companies could be held liable under 
state law where state requirements neither conflict with Federal 
requirements nor frustrate Federal purposes.
    Question. The final rule makes clear the agency's position that 
even if a drug company failed to warn doctors about a drug's known 
potential dangers--but the warning label was approved by the FDA--the 
company would be immune from liability no matter how many patients are 
injured or killed. In those situations, why shouldn't States be allowed 
to protect their own citizens and allow consumers to hold these drug 
companies accountable?
    Answer. All drug products carry risk. With regard to safety, FDA 
attempts to approve drugs that have favorable risk benefit balances, 
and to approve labeling that accurately reflects the known risks about 
the product. It is unfortunate that people are injured and killed by 
drug products, but FDA believes that Federal law mandates what warnings 
are appropriate in the form of approved drug labeling, and that state 
law requiring different warnings is trumped by Federal law under the 
doctrine of implied conflict preemption.

                     ADDITIONAL SUBMITTED STATEMENT

    Senator Bennett. The subcommittee has received a statement 
from the Advanced Medical Technology Association which will be 
inserted in the record at this point.
    [The statement follows:]

   Prepared Statement of the Advanced Medical Technology Association

    AdvaMed is pleased to provide this testimony on behalf of our 
member companies and the patients and health care systems we serve 
around the world. AdvaMed is the largest medical technology trade 
association in the world, representing more than 1,300 medical device, 
diagnostic products and health information systems manufacturers of all 
sizes. AdvaMed's members manufacture nearly 90 percent of the $86 
billion of health care technology products purchased annually in the 
United States, and more than 50 percent of the $220 billion purchased 
annually around the world. AdvaMed members range from the largest to 
the smallest medical technology innovators and companies and directly 
employ about 350,000 workers in the United States. More than 70 percent 
of our members have less than $30 million in domestic sales annually.
    AdvaMed supports the President's fiscal year 2007 budget request of 
$229,334,000 for the Food and Drug Administration's (FDA's) Center for 
Devices and Radiological Health (CDRH). This inflationary increase 
amount satisfies the fiscal year 2007 requirements of the Medical 
Device User Fee and Modernization Act (MDUFMA--Public Law 107-250) and 
the Medical Device User Fee and Stabilization Act (MDUFSA--Public Law 
109-43) and is crucial to ensure patients have timely access to 
lifesaving and life-enhancing products.
Medical Device User Fees
    The increasing number and complexity of medical device submissions 
have overwhelmed CDRH over the last decade. When MDUFMA was crafted, 
review times for breakthrough products often exceeded over 400 days, 
despite a statutory ceiling of 180 days. To address these chronic 
delays, Congress passed MDUFMA in October of 2002 to supplement FDA's 
resources and expertise and reduce review times for medical 
technologies. MDUFMA creates a predictable and adequate funding base 
for CDRH through a combination of industry-paid user fees and an 
increase in Congressional funding for the agency. Congress also passed 
MDUFSA last year to ensure the continuance of this critical program.
    Medical technology companies have already paid over $80 million in 
user fees and will add more than $150 million to CDRH resources during 
the first 5 years of the historic MDUFMA agreement. Although the 
additional appropriations did not materialize in the first 2 budget 
years of the MDUFMA agreement, Congress provided the nearly $26 million 
requested by the President for fiscal year 2005 and the President's 
inflationary requested amount for fiscal year 2006. This, along with 
the fiscal year 2007 request for an inflationary increase, maintains 
the MUDFMA program.
    CDRH must be funded adequately to ensure the goals of MDUFMA are 
met, maintain the United States' position in the rapidly advancing 
field of medical technology, and ensure patients' timely access to 
needed medical breakthroughs. AdvaMed requests that the fiscal year 
2006 Agriculture Appropriations bill fully fund CDRH at $229,334,000 to 
accomplish these important goals.
Additional Fees and Issues
    AdvaMed notes with interest that the President's budget calls for 
collecting some $22 million for re-inspection fees. We are interested 
to learn more about the nature of these fees and to which services 
currently provided by the FDA they will apply. As was discussed last 
year during crafting of MDUFSA, we are still working with the FDA to 
learn how the current device user fees are used and generally have 
concerns about additional fees being applied without better 
understanding of their use and reflection of costs for providing the 
intended services. AdvaMed believes any additional fees must be 
additive to the baseline and must be associated with clearly identified 
increased performance to benefit the fee payer above and beyond current 
performance.
    Additionally, AdvaMed is concerned that, as in years past, attempts 
will be made in the fiscal year 2007 appropriations process to alter 
FDA policy and procedures related to the regulation of new and existing 
devices. AdvaMed generally opposes such attempts to alter fundamental 
FDA regulatory policy for medical devices on appropriations bills. We 
stand ready to offer our expertise on such matters should the need 
arise in the coming months.
Background on the Medical Device User Fee Program
    America is on the cusp of an unprecedented revolution in medical 
technology driven by major private and public investments in scientific 
research and computer technology. Congress has also made a multi-
billion dollar commitment to double medical research at NIH and unravel 
the human genome. Medical technology companies also doubled research 
and development spending in the decade of the 90's.
    The vibrant medical technology sector has driven employment gains 
and a strong balance of trade much to the benefit of the American 
patient and economy over the last several years. At the same time, the 
growing number and complexity of new medical devices throughout the 
last decade, coupled with a drop in the absolute number of reviewers at 
CDRH has resulted in severe budget strain and increasing delays in 
approval of new medical technologies for patients.
    Prior to passage of MDUFMA, CDRH faced increasing challenges as a 
result of dwindling resources and accelerating innovation. Staff levels 
had dropped by 8 percent between 1995 and 2001. By 2001, the average 
total review time for premarket approval applications had risen to 411 
days, more than twice the statutory review time. An FDA science panel 
warned at the time that increasingly rapid advances in technology 
``threaten to overwhelm'' CDRH's limited resources.
    On October 26, 2002, President Bush signed MDUFMA, which was 
unanimously passed by Congress, into law to give CDRH additional 
resources and expertise to help provide timely patient access to new 
medical technologies. It established an industry-funded user fee 
program to provide up to $35 million each year to help the agency meet 
rigorous new performance goals.
    Key regulatory reforms in MDUFMA are designed to:
  --Eliminate bureaucratic delays in review of combination products by 
        establishing a new office to oversee these technologies
  --Authorize FDA to accredit third-party inspectors to audit medical 
        technology companies with a good track record of compliance;
  --Encourage timely, thorough premarket reviews by codifying the PMA 
        ``modular review'' program and extending the third-party review 
        program for 510(k)s;
  --Permit paperless device labeling and electronic facility 
        registration.
  --Strengthen FDA regulation of reprocessed disposable devices.
    From bioengineered organs and implantable artificial hearts to 
gene-based diagnostic tests and molecular imaging systems, America's 
medical technology companies are developing thousands of promising new 
tests and treatments. AdvaMed believes full implementation of MDUFMA 
will help ensure these advances reach the millions of patients who need 
them.
    The user fee provisions in the law set fees for premarket approval 
applications, supplements and 510(k) submissions. Under the original 
law, these fees, combined with funds from increased appropriations, 
will provide FDA's device program with more than $225 million in 
additional resources over the 5 years of the program. A letter 
agreement accompanying the bill sets review performance goals for the 
agency.
    To assure that these user fees would have an additive effect on the 
CDRH budget, MDUFMA requires CDRH receive a $15 million appropriations 
increase in each of the first 3 years of the program (fiscal year 2003, 
fiscal year 2004 and fiscal year 2005) for a total of $45 million by 
the end of fiscal year 2005, or the user-fee program terminates in 
fiscal year 2006. These funds are designed to allow CDRH to upgrade 
information technology and other infrastructure necessary to carry-out 
a user-fee program and to meet the performance goals.
    MDUFMA passed both houses of Congress on the last day of the 
regular session in October 2002. Owing to the extremely late timing of 
MDUFMA passage and a very tight budget climate, MDUFMA funding targets 
were not met in either of the first 2 years of the MDUFMA agreement. 
MDUFSA was passed last year to allow the program to continue despite 
the funding shortages in the early years of the program. MDUFSA also 
addressed the significant rate of increases in fees paid by industry. 
As Congress has struggled to provide its funding, industry paid user 
fees (per submission) that far exceed what was expected by MDUFMA. 
Increases of 35 percent, 15.7 percent and a projected 20 percent for 
fiscal year 2006 for individual PMA submissions were troubling to 
industry, and we appreciate the steps Congress took to limit the rates 
of increase until the program can be reauthorized in 2007.
    To maintain the MDUFMA program and protect investments made by the 
Agency, American consumers and a leading source of job growth in our 
economy, we ask Congress to again meet the President's fiscal year 2007 
budget request for CDRH.
Conclusion
    AdvaMed appreciates the Subcommittee's efforts last year and urges 
them to continue on this path to fully fund MDUFMA and ready FDA for 
the coming era of biomedical innovation and patients that await timely 
access to the coming dramatic breakthroughs in medicine. AdvaMed 
requests that the fiscal year 2007 Agriculture Appropriations, Rural 
Development, Food and Drug Administration and Related Agencies bill 
fully fund CDRH at $229,334,000 to accomplish these important goals. We 
have concerns about the inclusion of new fees for the FDA to carry out 
core mission activities and urge the committee to refrain from altering 
FDA policy and procedures related to the regulation of new and existing 
devices in the fiscal year 2007 appropriations process.
    AdvaMed thanks the committee for this opportunity to present our 
views and we look forward to working with you to help prepare FDA for 
the coming revolution in medical technology.

                          SUBCOMMITTEE RECESS

    Senator Bennett. Thank you very much.
    The subcommittee is recessed.
    [Whereupon, at 11:25 a.m., Tuesday, March 14, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]
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