[Senate Hearing 110-]
[From the U.S. Government Publishing Office]



 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2009

                              ----------                              


                        TUESDAY, APRIL 15, 2008

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF ANDREW C. VON ESCHENBACH, M.D., 
            COMMISSIONER
ACCOMPANIED BY:
        JOHN DYER, DEPUTY COMMISSIONER AND CHIEF OPERATING OFFICER, 
            FOOD AND DRUG ADMINISTRATION
        RICHARD TURMAN, DEPUTY ASSISTANT SECRETARY FOR BUDGET, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

                 OPENING STATEMENT OF SENATOR HERB KOHL

    Senator Kohl. Good morning to one and all. Today we welcome 
Dr. von Eschenbach, the FDA Commissioner; Mr. John Dyer, the 
Deputy Commissioner for Operations; and Mr. Richard Turman, the 
Deputy Assistant Secretary for Budget at HHS. We thank you for 
appearing this morning to discuss the FDA's budget for 2009.
    American consumers spend 20 cents of every dollar on 
products that are regulated by the FDA. Food, medicine, medical 
devices, vaccines, the blood supply, cosmetics, and veterinary 
products all fall within FDA jurisdiction. FDA has a 
responsibility to make sure that all of these are safe and 
effective.
    As you appreciate better than anyone else, it is, indeed, a 
daunting task that grows more complex every year. 
Unfortunately, your budget request does not keep pace with 
these huge responsibilities.
    For fiscal year 2009, the administration proposed an 
increase of $54 million, or just over 3 percent. It recommends 
modest increases for food safety and medical products. While 
that is a welcome contrast compared to cuts proposed for HHS 
and USDA, I find it hard to believe that this recommendation 
will achieve anywhere near the goals that FDA has set.
    The budget purports to hire over 200 additional FDA 
inspectors, as well as staff, but in reality, you do not 
request enough money to pay for the staff that you have now. 
Specifically, the budget clearly states that FDA needs $60 
million more than last year simply to maintain current staffing 
levels, but you only request $54 million new dollars.
    What this really suggests to me is that any additional 
money you claim to be for new food and medical safety 
activities will really be used to maintain current staff. There 
is no new money for food safety, medical products safety, as 
well as anything else.
    FDA recently published a food protection plan and import 
safety action plan. Both documents outline important steps 
needed to keep our food supply safe, and those steps will cost 
money. Serious work also needs to take place to ensure that the 
drugs, which FDA approves are indeed safe, and we need 
assurances that necessary follow-up will happen. We have all 
heard that 80 percent of the raw ingredients going into our 
medicines come from overseas. It would take FDA 13 years to 
inspect each of these plants just once.
    I know that you are aware of these issues and many more, 
and I believe you want to move in the right direction. But I 
also feel obliged to address your recent complaint that 
Congress has failed to give FDA the money it needs. That 
complaint seems a little specious to me. Congress gave FDA $90 
million more than you sought for the current year, and we 
provided $17 million more than you sought in fiscal year 2007. 
So I take issue with that complaint and we look forward to your 
comments and explanations.
    We have developed a good working relationship over the past 
several years, and I am sure that will continue this year. 
Although we seem to be far apart on how we would interpret this 
budget right now, we want to work with you to make sure that 
your agency, one that affects every single American every day, 
has the necessary funding to be effective, as we both think it 
should be.
    We will now turn to Senator Bennett for his opening 
statement, and following that, we look forward to hearing from 
you. Senator Bennett.

                 STATEMENT OF SENATOR ROBERT F. BENNETT

    Senator Bennett. Thank you very much, Mr. Chairman. You 
have covered many of the points that I wanted to highlight as 
well.
    The FDA's regulatory authority is vast. It encompasses 80 
percent of the food we eat, all animal and human drugs and 
medical devices, along with some other products, and 20 percent 
of all consumer expenditures go for some product that is 
regulated by the FDA. That is $1.5 trillion worth of 
expenditures. So this is a very important agency.
    And, Dr. von Eschenbach, I want to take this occasion--this 
will be your last appearance in defense of the budget--to thank 
you for the stewardship you have provided at this agency.
    We more often hear about problems connected with the agency 
than we do about the success in making the United States food 
and drug supply the safest in the world, as I believe that it 
is.
    But there have been problems and I expect we will hear 
about some of them, the widely reported recall of heparin 
because of contaminated ingredients that came from the supplier 
in China, the recall of peanut butter tainted by salmonella, 
followed by a massive pet food recall, also having to do with 
contaminated ingredients from China. As we look at those 
problems, we sometimes, as I say, lose sight of the fact that 
overall we do have the safest food and drug supply in the 
world.
    But I agree with the chairman that we need to pay attention 
to the amount of money that is required here and that the 
budget that has been submitted to us by the administration 
appears to me to be inadequate to meet those challenges. I have 
sat on your side of the table. I know the kinds of fights that 
go on in an executive agency between what you feel is your best 
judgment and what OMB feels is its best judgment and the very 
difficult position you get put in when you are sent up here to 
defend OMB's number when in your heart you might prefer a 
higher one. You need not comment on that. I will not put you in 
that box. But I have seen that kind of thing happen before. And 
I feel, with the chairman, it may be our responsibility to fix 
OMB's mistake here. I think you probably have more friends here 
than you might have at other places in town.
    It is not just money, however. You need leadership. You 
need good people. You need to be able to attract the right 
people and hold onto the right people. Those are some of the 
things we will be talking about.
    We have to take into consideration the comments that are 
made by the Science Board that concluded--and I quote--FDA can 
no longer fulfill its mission without ``substantial and 
sustained additional appropriations.'' That is something that 
we, I think, have to pay attention to even if some others do 
not.
    Well, we all benefit from a strong and well-funded FDA. It 
is an area where consumers, industry, and the Congress 
vigorously agree and where all must work together to see that 
we get the results that we want. I look forward to the 
testimony and working together with you, Mr. Chairman, to try 
to solve some of these problems.
    Senator Kohl. Thank you, Senator Bennett.
    Senator Dorgan, do you have a statement?
    Senator Dorgan. No, thank you.
    Senator Kohl. We will now ask Dr. von Eschenbach for your 
statement.

                 STATEMENT OF DR. ANDREW VON ESCHENBACH

    Dr. von Eschenbach. Chairman Kohl and Senator Bennett, 
Senator Dorgan, I am very gratified by your kind remarks and 
certainly your support. It is always an honor for me to appear 
before you.
    But today, it is also a special privilege for me to be 
accompanied by FDA leadership that you see sitting behind me, 
the center directors and the deputies, who provide the day-in-
and-day-out leadership of this incredible agency and who truly 
epitomize the over 10,000 FDA employees who bring dignity to 
the title and to the words ``public servant.''
    I am pleased to be here today joined by Mr. Turman and Mr. 
Dyer to present to you FDA's fiscal year 2009 budget request.
    As you have already indicated, the beginning of the 21st 
century has already witnessed FDA facing incredible challenges 
emanating from a rapidly and radically changing world. And 
these changes are, in fact, reshaping the way in which we must 
accomplish our mission to protect and promote the public 
health.

                    REQUEST FOR ADDITIONAL RESOURCES

    More than 2 years ago, when I first sat before you, I 
presented my initial request for increased resources that FDA 
needed to address these changes and last year requested even 
more additional resources. I trust you know that I will not 
disappoint you in your expectations that I am here today 
requesting even further increases in the FDA's budget.
    But I hope you will also recognize that this has never been 
for us an exercise simply to ask for more. We have attempted to 
be good stewards of these precious resources and have been 
creating detailed plans that communicate how FDA will deploy 
those resources to overcome the challenges we face and to 
provide regulatory oversight for the food and health products 
we regulate.
    These requests for additional resources and these plans, 
which is our strategic plan and food protection plan, et 
cetera, are part of a trajectory that we have been attempting 
to create that will continue to build over time to modernize 
the Food and Drug Administration of the 21st century.
    But Congress and the American people expect more than just 
plans and budgets. They deserve exceptional performance, and I 
believe we have also delivered. The list of recent 
accomplishments that appear in my written testimony reflects 
the universal determination within FDA to ensure the people we 
serve that they will always have access to safe and effective 
medical products, that we will safeguard the food that they 
eat, and address emerging threats to America's public health. 
What we have done and what we must do is only possible through 
your support, and we are deeply grateful for the support that 
you have provided and continue to provide us.
    I come here today asking for more support because the 
challenges that we are facing tomorrow compared to yesterday 
are, for sure, formidable. Our response to those challenges 
affects our entire enterprise.

              MODERNIZATION OF INFORMATION TECHNOLOGY (IT)

    For example, a global supply chain of food and medical 
products now requires FDA to expand its presence and reach 
beyond our borders. A complex regulatory pathway that is 
embracing innovative products from their production to 
consumption now requires us to modernize our infrastructure, 
particularly our FDA information technology. The need to always 
be a science-based and science-led agency in our decisionmaking 
now demands that we create the facilities that will support 
that kind of an infrastructure, including the completion of the 
construction of the consolidated campus for FDA at our new 
campus at White Oak. And I present to you a picture of that 
construction of that state-of-the-art facility that is in 
process and must, as a part of this trajectory, continue to be 
supported and completed.

                        BUDGET REQUEST INCREASE

    The 2009 budget request builds on the 2008 appropriation by 
proposing an additional 5.7 percent increase. That will result 
in a total budget of $2.4 billion, of which $1.8 billion would 
be in budget authority and $700 million in user fees.

                               USER FEES

    Last year, Congress reauthorized the Food and Drug 
Administration Amendments Act which provided direction to the 
agency with 125 new requirements in the bill's 11 titles, but 
it also reauthorized essential user fee programs for 
prescription drugs and medical devices.
    This year, the successful program to support animal drug 
review, the Animal Drug User Fee Act, expires on September 30, 
2008, and this 2009 budget recommends extending that program 
for an additional 5 years, and in addition, includes $48 
million for four new proposed user fee programs relating to 
generic drugs, generic animal drugs, the reinspection of 
facilities, and issuing export certificates for food and animal 
feed.

                   FOOD PROTECTION AND IMPORT SAFETY

    During 2009, we will continue to implement the food 
protection plan and our import safety action plan that we 
announced in 2007. And the subcommittee generously provided $56 
million for food protection in 2008, and we are requesting an 
additional $42 million in 2009, which will provide an 
additional 94 full-time equivalent staff to conduct food 
protection activities, including 68 to support our domestic and 
foreign inspections through our Office of Regulatory Affairs. 
We will continue to expand and support essential programs to 
protect and defend our food supply.

                          RAPID RESPONSE TEAMS

    We will also emphasize a priority that you championed, 
Senator Kohl, in deploying three more rapid response teams 
during fiscal year 2009, in addition to the six that we will 
deploy in 2008. And we will also improve the information 
technology systems that support risk assessment, research, 
inspection, and surveillance.

                    COST OF LIVING AND CRITICAL PATH

    And finally, there will be $12 million for the cost-of-
living increases for our essential staff.
    In 2008, the subcommittee appropriated increases for drug 
safety, critical path generic drug review, drug advertising 
review, and pandemic preparedness programs at FDA. Thanks to 
the commitment of this subcommittee, specifically Senator 
Bennett, we will commence 50 important critical path activities 
across all medical product programs. This is our effort to 
transform the design, development, testing, and use of medical 
products.

                             PRODUCT SAFETY

    We continue to address our need for product safety and 
development, including our ability to provide increased staff 
and oversight for targeted increases in blood and blood 
products, human tissue safety, criminal drug investigations, 
and device import safety, as well as animal drug grants under 
the Minor Use and Minor Species Animal Health Act.

                           PREPARED STATEMENT

    This $2.4 million contains essential resources on that 
trajectory to continue to build the FDA of the 21st century 
that will protect and promote the health and safety of the 
American public. And we are deeply grateful for your commitment 
to that continuous, ongoing effort to recreate and redefine and 
modernize the FDA.
    Thank you, Mr. Chairman. I look forward to your questions.
    [The statement follows:]

             Prepared Statement of Andrew C. von Eschenbach

Introduction
    Chairman Kohl and members of the subcommittee I am pleased to 
present the President's fiscal year 2009 budget request for the Food 
and Drug Administration (FDA). I am joined by Mr. John Dyer, FDA's 
Deputy Commissioner and Chief Operating Officer, and Mr. Richard 
Turman, Deputy Assistant Secretary for Budget at the Department of 
Health and Human Services.
    At the outset, I want to lay out the trajectory reflected in FDA's 
budgets during my tenure. When I first sat before you on behalf of the 
FDA 2 years ago, I presented a budget that recognized the need for 
additional resources so that FDA can accomplish its mission. Just as 
important, FDA also recognized the need to establish plans that define 
how to use our resources wisely.
    For the past 2 years, we requested additional resources to meet 
important public health challenges. We also developed detailed plans 
that communicate how we will deploy our resources to overcome the 
challenges that we face. However, you also expect performance while we 
are developing plans for the future, and we have delivered.
Recent FDA Achievements
    Thanks to funding appropriated by this subcommittee, FDA is 
achieving important public health milestones, and we thank you for your 
support. Since I appeared before you last year, FDA worked with 
Congress on the FDA Amendments Act (FDAAA) to extend key user fee 
programs including the Prescription Drug User Fee Act (PDUFA) and the 
Medical Device User Fee Act (MDUFMA), to reauthorize the Best 
Pharmaceuticals for Children Act and the Pediatric Research Equity Act. 
During the past year FDA also:
  --published comprehensive plans for food defense, food safety, and 
        import safety
  --negotiated and signed food and medical product safety agreements 
        with China
  --expanded FDA's capacity to detect radiological contamination of 
        food by 150 percent
  --launched a national initiative to strengthen State food safety 
        programs
  --issued a current good manufacturing practices rule for dietary 
        supplements
  --approved a second-generation smallpox vaccine to enhance U.S. 
        preparedness
  --approved the first U.S. vaccine for humans against H5N1, the avian 
        influenza virus
  --approved the sixth seasonal influenza vaccine, allowing 
        manufacturers to produce a record number of flu vaccine doses
  --approved a decellularized heart valve, a new drug-eluting stent, 
        and the first artificial cervical (neck) disk
  --approved new treatments for hypertension, Crohn's disease, cancer, 
        HIV, diabetes, Parkinson's, Fibromyalgia, leukemia, and blood 
        clotting disorders, including 22 new molecular entities and 18 
        orphan products
  --tentatively approved the 64th anti-retroviral product under the 
        President's Emergency Plan for AIDS Relief (PEPFAR)
  --issued more than 680 generic drug approvals or tentative approvals 
        during fiscal year 2007--a 30 percent increase from the 
        previous year
  --approved new tests for blood typing and to detect malaria, West 
        Nile Virus, certain breast cancers, respiratory viruses, and 
        other infections
  --identified Critical Path opportunities for generic drugs and 
        conducted Critical Path workshops on cancer clinical trials and 
        developing anti-cancer agents
  --proposed new standards and a new UVA rating for sunscreen products
  --released a report on science and regulatory issues associated with 
        nanotechnology
  --conducted enforcement actions to protect consumers against 
        unapproved drugs and devices and from unsafe dietary 
        supplements
  --identified 25 drugs products that must submit safety plans under 
        Title 9 of FDAAA.
    These are important public health accomplishments, and they 
demonstrate FDA's performance while we also prepare for the future.
    My FDA colleagues and I recognize that we have important work to do 
in all FDA program areas. We also have challenges that cut across all 
FDA programs, such as expanding FDA's reach beyond our borders, 
modernizing our Information Technology, and working with the General 
Services Administration to complete our new campus at White Oak.

FDA's 2009 Budget Request
    The President's fiscal year 2009 budget request for FDA builds on 
the fiscal year 2008 appropriation by proposing a 5.7 percent increase. 
FDA will focus its increased resources on protecting America's food 
supply and improving the safety of human and animal drugs, medical 
devices, and biologics--including vaccines, blood products, and human 
tissues.
    This increase will provide FDA with a budget of $2.4 billion, which 
consists of $1.8 billion in discretionary budget authority and $0.7 
billion in user fees. FDA user fee programs provide supplemental 
resources that not only allow FDA to review manufacturers' product 
applications but also ensure that Americans have access to safe and 
effective medical products.
    As I mentioned, Congress reauthorized user fee programs for 
prescription drugs and medical devices last year in FDAAA. This year, 
the successful program to support animal drug review, the Animal Drug 
User Fee Act (ADUFA), expires on September 30, 2008. We have engaged 
with stakeholders to develop proposals to extend this program for an 
additional 5 years. FDA published a draft proposal for ADUFA II in the 
Federal Register and conducted a public meeting with stakeholders on 
March 11, 2008.
    Finally, our budget includes $48 million for four proposed user 
fees related to reviewing generic drugs, reviewing generic animal 
drugs, reinspecting facilities, and issuing export certificates for 
food and animal feed.
FDA Food Protection Plan Investments
    On November 6, 2007, the administration issued the Import Safety 
Action Plan (ISAP), a comprehensive, strategic roadmap to strengthen 
import safety. In conjunction with this release, FDA released its Food 
Protection Plan (FPP), a comprehensive initiative to protect America's 
food supply.
    The FPP is a risk-based, production-to-consumption strategy to 
assure the safety of domestic and imported food. FDA's plan relies on 
three core elements--prevention, intervention, and response--and calls 
for ten new legal authorities. The plan is designed to identify 
potential food defense and food safety threats and to counteract those 
threats before they harm consumers.
    FDA has begun implementing the FPP and ISAP with the resources that 
the subcommittee appropriated in fiscal year 2008. In fiscal year 2009, 
FDA requests an additional $42 million to protect the food supply and 
to continue to implement our plan. These funds will allow FDA to 
advance important food defense and food safety priorities. Fiscal year 
2009 prevention activities include performing essential food research, 
determining the greatest threats of intentional and unintentional 
contamination to the food supply, and expanding food protection 
activities beyond our borders. Our intervention activities include 
conducting more risk-based inspections and surveillance and deploying 
new food defense and food safety screening tools. Fiscal year 2009 
response activities include establishing more rapid response teams, 
strengthening emergency response, and improving our ability to conduct 
food tracebacks.
    To achieve these objectives and safeguard American consumers, FDA 
will also improve IT systems that support our research, risk 
assessment, inspection, and surveillance. Finally, FDA's fiscal year 
2009 food protection initiative includes $12 million for the cost of 
living pay increase for FDA food safety and food defense programs. 
These funds allow FDA to retain its professional workforce that conduct 
food safety and food defense activities. Overall, our food protection 
investments for fiscal year 2009 support an additional 94 full-time 
equivalent (FTE) staff, including 68 FTE to conduct domestic and 
foreign inspections through FDA's field operations in the Office of 
Regulatory Affairs.

Investments for Safe and Effective Medical Products
    For fiscal year 2008, Congress appropriated increases for drug 
safety, Critical Path, generic drug review, drug advertising review, 
and pandemic preparedness programs at FDA. With these increases, FDA 
will strengthen medical product development, safety, and review 
activities that the subcommittee identified as fiscal year 2008 
priorities. I assure you that FDA will be a good steward of the funds 
you provide and that we will search for effective solutions to the 
public health challenges involving medical products.
    For fiscal year 2009, FDA is proposing a $17 million initiative for 
medical product safety and development, including funds for the cost of 
living pay increase. FDA is also proposing targeted increases for our 
medical product programs.
    With the fiscal year 2009 increase, FDA's Biologics Program will 
strengthen its ability to prevent, detect, and respond to emerging 
safety threats in blood and blood products. FDA will also improve 
tissue safety by expanding our program to educate industry about tissue 
processing and tissue safety technologies.
    In the Human Drugs Program, FDA will improve import safety by 
conducting additional investigations of criminal drug activity. The 
volume of drugs imported into the United States will likely increase by 
12 percent during fiscal year 2009, and the additional import volume 
creates a need for criminal investigators to support drug import 
surveillance.
    In the Device and Radiological Health Program, FDA will strengthen 
import safety by improving the ability of the ORA field operations to 
work on import issues with Customs and Border Protection and other 
agencies. Finally, in the Animal Drugs and Feed Program, FDA will 
provide targeted grants to stimulate the development of new animal 
drugs under the Minor Use and Minor Species Animal Health Act of 2004.

Implementing FDAAA
    In the fall of 2007, Congress enacted legislation reauthorizing 
prescription drug and medical device user fees, the Best 
Pharmaceuticals for Children Act and the Pediatric Research Equity Act. 
This legislation also grants new authorities to ensure the safety of 
the food supply and the safety and effectiveness of medical products--
drugs, devices, and biologics. As I mentioned previously, FDAAA also 
reauthorized user fees for prescription drug and medical device review.
    Implementing FDAAA is a formidable challenge. The legislation is 
complex, with eleven titles containing more than 125 new requirements.
    To cope with the breadth of this act, FDA launched a detailed 
implementation plan. And, in the spirit of transparency, the details of 
our progress to implement FDAAA appear on our website. Within FDA, we 
established working groups to confirm the scope of our FDAAA 
responsibilities and identify the actions and timetables necessary to 
conduct our new work. As you might expect, we are giving our first 
attention to FDAAA provisions that have the greatest implications for 
public health.
    The new law is barely 6 months old, but our accomplishments are 
already tangible. As of today, FDA published 20 Federal Register 
notices related to FDAAA. We are methodically working through the new 
law, giving priority attention to new standards that will have the 
greatest public health impact. Achieving all of the goals and 
objectives of this landmark legislation will require a sustained effort 
from many individuals inside and outside of FDA for years to come.

The Scope of FDA Challenges
    FDA will face many challenges in the 21st century. Thanks to the 
talented professionals who serve the American public at FDA, we are 
addressing many daunting challenges within all areas of our mission. We 
must modernize our workforce, our work plans, and the infrastructure 
that supports our mission to assure that we remain the gold standard 
for food and drug regulation.
    In this era of change, FDA has developed strategic plans to respond 
to high-profile challenges in priority areas. During the past 2 years, 
we presented comprehensive plans to Congress and the American public on 
food and import safety, and responded to the Institute of Medicine 
Report on drug safety.
    My colleagues and I at FDA are committed to our mission and 
committed to the changes necessary to protect America's public health. 
Thanks to your support, the FDA of the future--the near future--will 
better protect the public from the threats that we experience today. At 
the same time, FDA will better promote the discovery, development, and 
delivery of lifesaving products that improve the quality of our lives.

Conclusion
    The fiscal year 2009 request of $2.4 billion contains essential 
resources to protect and promote the health and safety of the American 
public. The funds that we request will allow FDA to strengthen the 
safety of the food supply, to assess, review, and approve new products, 
and to better predict--earlier and more accurately--the safety and 
effectiveness of drugs, biologics, and medical devices.
    With the fiscal year 2009 resources, FDA will work to ensure that 
Americans enjoy the benefits of personalized medicine, a safe and 
wholesome food supply, and the promise of a better, healthier future. 
Meeting these challenges is only possible with your leadership and with 
the support that you consistently demonstrate for the mission of the 
Food and Drug Administration.

    Senator Kohl. Thank you, Dr. von Eschenbach.
    Dr. von Eschenbach, how do you reconcile your statement 
about Congress not providing you with enough funding when, in 
fact, over the past 2 years, this committee has provided you 
with over $100 million more than you asked for?

                INCREASED PRODUCTS AND RESPONSIBILITIES

    Dr. von Eschenbach. Mr. Chairman, with great credit to you 
and to other Members of Congress, you have more recently been 
very, very generous in your support of the FDA. I think what we 
are both faced with is the realization that over the past 2 
decades the FDA has been immersed in this rapidly and radically 
changing world that has increased the scale and scope of the 
portfolio of products and responsibilities facing the FDA, as 
well as increasing complexity in the nature of those products 
and the nature of their production and their consumption. And I 
think it is in the context of that rapidly and radically 
changing world that over the past 2 decades the resources 
required have not kept pace with the needs.
    But I certainly commend you and other Members of Congress 
for your recent attention to our need to perhaps accelerate our 
ability to create that trajectory so that we can, in fact, 
bring the FDA up to the level of that we currently anticipate 
will be needed for this modern world.

                             SCIENCE BOARD

    Senator Kohl. Dr. von Eschenbach, we would be remiss if we 
did not discuss the FDA Science Board's recommendation for your 
budget. Their report states--and I quote--``FDA's resource 
shortfalls have resulted in a plethora of inadequacies that 
threaten our society including, but not limited to, inadequate 
inspections of manufacturers, a dearth of scientists who 
understand emerging new science and technologies, inability to 
speed the development of new therapies, an import system that 
is badly broken, a food supply that grows riskier every year, 
and an information infrastructure that was identified as a 
source of risk in every FDA center and function.'' This is a 
board full of experienced and knowledgeable people that was 
established at your request.
    So let us start with the overall number.
    Your budget requests a $54 million increase this year, but 
the Science Board recommends $375 million. Is your budget 
adequate? How do you respond to the Science Board's 
recommendations?
    Dr. von Eschenbach. Mr. Chairman, I was very gratified by 
the report by the Science Board, which I had convened in order 
to have an external, objective assessment of FDA's scientific 
infrastructure. I think what the report has pointed out is the 
need for change within FDA. We have attempted to address those 
changes based on a strategic plan for implementation of the 
needed changes over a period of time.
    The resources that are required will continuously need to 
be increased. I think the board reflects the fact that if we 
wish to accelerate the time line for that modernization effort 
and the implementation of many of the changes that are 
necessary to align the FDA with the modern rapidly and 
radically changing world around us, that level of support would 
be required.

                        ADDITIONAL $375 MILLION

    Senator Kohl. Could the FDA absorb an additional $375 
million in 1 year?
    Dr. von Eschenbach. No, sir. I do not believe it could 
absorb that in 1 single year. I do believe, however, that we 
have now put in place the trajectory that I indicated before in 
which we have plans which define time lines, outcomes, and 
deliverables so that there is the rational investment of those 
additional resources and the ability to demonstrate a return on 
that investment to the American people.
    I believe we could absorb significant increases in our 
budget and we are prepared to address how they would be applied 
if they were to be available. And we are doing that in the 
context of recognizing that our budget is one part of a larger 
portfolio of responsibilities to the American people that is 
reflected by both the President and the Congress.

                          NECESSARY RESOURCES

    Senator Kohl. Is the FDA underfunded, hugely underfunded, 
grossly underfunded? What would you tell the American people?
    Dr. von Eschenbach. I believe that from the perspective of 
our recognition of the changes that are occurring in the world 
around us, the need for the FDA to significantly change its 
strategies as to how it is addressing those changes, be they 
the incredible opportunities that are emanating from the 
discoveries in science and technology with new products such as 
will occur with regard to our ability to recognize the fruits 
of nanotechnology and regenerative medicine, all the way 
through to the recognition of the threats that are now 
emanating from globalization and the fact of our need to secure 
integrity of supply chain of these medical products from 
production to consumption, be it food or medical products, all 
of this is requiring a change within the Food and Drug 
Administration that is both strategic and a change that is also 
resource-dependent.
    So the answer is I believe that we have been eminently 
successful up to this point in time. We are the world's gold 
standard, but if we wish to continue that record of excellence, 
we must change as the world around us is changing and we must 
change from the perspective that as our portfolio is expanding, 
so are the need for our resources to meet those expectations in 
that portfolio.
    Senator Kohl. So in order to meet those expectations I 
think what you have said--I believe what you said--is that in 
order to discharge those responsibilities to the American 
people, the FDA is underfunded. Hugely underfunded, grossly 
underfunded. One could debate that, but underfunded.
    Dr. von Eschenbach. I believe that we need additional 
resources. I am presenting a budget today that asks for 
additional resources. I have asked for more additional 
resources. I believe we could and would apply any additional 
resources wisely and effectively, given the fact that, as I 
indicated in my opening statement, it is not simply a matter of 
asking for more. It has rather been our responsibility to 
define how we would spend more, spend it wisely and 
strategically, and be able to then assure a return on that 
investment by enhancing the American people's access to safer 
and more effective medical products and food.
    Senator Kohl. Thank you.
    Senator Bennett.

                           FUNDING ABSORPTION

    Senator Bennett. I would like to continue the line of 
questioning that the chairman has started down. You said you 
could not absorb $375 million in a single year. I think that is 
probably right. How much could you absorb? This is not asking 
you to break with OMB. This is just a theoretical question that 
you can answer in a scholarly kind of way. How much could you 
absorb?
    Dr. von Eschenbach. I believe that what we have attempted 
to do, Senator Bennett, in our planning process, both in our 
food protection plan, as well as in our strategic plan, and 
participating even in the larger agenda, like our import safety 
working group, our drug safety initiatives, across the context 
of food and medical products, enhancing safety, as well as 
rebuilding and recreating the infrastructure at FDA, we have 
laid our a series of initiatives, a series of opportunities. If 
additional funding was available, depending upon the level of 
funding, we would apply it to that portfolio of opportunities 
which we have outlined in these plans. We would do that 
initially around those opportunities having to do with assuring 
safety of food and of medical products.

                           BEYOND OUR BORDERS

    So, for example, we have embarked upon initiatives now 
recognizing that FDA must go beyond our borders. And 
establishing an FDA presence in geographic regions around the 
world is a new initiative to which we could apply new dollars 
and accelerate our ability to implement the establishment and 
support of those offices, which would enable us to, one, work 
with our partners in other parts of the world to build 
capacity, to assure quality being built into the production of 
food and medical products, as well as being able to enhance the 
completion of White Oak and our data center.

                           FUNDING ABSORPTION

    Senator Bennett. I am sure you would go through this 
orderly process. I am looking for a number. If we were to, in 
our wisdom, decide that OMB was wrong and we needed to add an 
extra $100 million to the amount that you have taken, just to 
pull a number completely out of the air, could you handle that? 
You said $375 million you could not handle. You said you could 
handle more than $54 million. I am looking for something ball 
park in between as to, yes, we could comfortably absorb and 
handle an extra $50 million, an extra $100 million. You get 
beyond that, we are looking at future years.
    It is an unfair question, but it is not because if we are 
moved to help you, we want to move in an area that is prudent 
rather than extravagant.
    Dr. von Eschenbach. First of all, I would certainly welcome 
an opportunity to present a scenario and portfolio of options 
given additional possible investment. Certainly just as you 
say, today I do believe we could absorb the $100 million that 
you referred to and do that quite rapidly and quite 
effectively. As we would get closer and closer to the larger 
number that you presented, I think it would require greater 
stewardship to be certain that we could implement those dollars 
as rapidly and as effectively as we need to.

                             CRITICAL PATH

    Senator Bennett. I appreciate your emphasis on safety, and 
I agree with that.
    But as you know, I am very much concerned about the 
critical path activities. You came to the University of Utah 
and testified at a hearing there, and we all got excited about 
the opportunities that are there. We provided $7.5 million in 
2008, and $2.5 million was made available for competitive 
critical path research grants. Is that one area where you are 
expecting, even with what you have asked us for, to make 
additional resources, or is that an area that would benefit 
tremendously if we were to go above the number you have 
suggested?
    Dr. von Eschenbach. Well, again, I think critical path is 
an excellent example of how we have tried to create this 
trajectory. We have, within critical path, 50 areas of 
opportunity for investment. They are a different grain size. As 
dollars are available to us, we can strategically apply them to 
those initiatives but do that in a way that is addressing the 
modernization of our drug development and medical product 
development process and also do it in a way that demonstrates a 
return on investment.

                                WARFARIN

    Let me give you one quick example of how we have utilized 
some of the resources you have already applied. In taking on 
our ability to look at the drug warfarin and use 
pharmacogenomic testing in order to be able to appropriately 
define the right dose for the right patient, that is now a part 
of FDA's labeling of that particular drug. That enabled us to 
begin to reduce the complications of either under-dosing 
patients experiencing clots or overdosing and having them 
unnecessarily bleed. And by getting that right dose based on 
our understanding of pharmacogenomics, that is projected to 
result in the savings of $1 billion per year for our health 
care system by the elimination of emergency room visits for the 
complications of an inappropriately dosed level of warfarin.
    So I see this as a strategic business plan as well as a 
strategic opportunity to transform the science, and with 
additional dollars, we would expand our investment in a variety 
of those initiatives across the critical path.

                         INFORMATION TECHNOLOGY

    Senator Bennett. And I see it as a business plan too. 
Unfortunately, in the way we structure Federal budgets, unlike 
businesses that I ran or businesses that the chairman ran 
before we came here, we still find things so that we do not 
recognize that there would be a billion dollar benefit, but it 
is in somebody else's budget. So we do not get credit for it as 
we think about it here.
    Let us talk about IT. You are spending roughly what--10 
percent of your budget--on IT right now, and the results are 
less than satisfactory. Talk to us about what has to be done to 
bring your IT capability up to where it needs to be.
    Dr. von Eschenbach. When I arrived at FDA, the two most 
critical areas I believe to address was our workforce 
development and our information technology infrastructure 
because we are, in fact, an information management business. 
With regard to the information technology, we are spending, 
according to benchmarks, about $200 million a year on IT. But 
the problem that we encountered was it was being spent on 
woefully inadequate equipment to kind of attempt to maintain it 
at huge cost, and we did not have the modern information 
systems running on that equipment.
    So we have been engaged in a transformation of our entire 
IT infrastructure, moving to modern servers and equipment, 
increasing their efficiency from what has been around 30 
percent to a 70 percent target, consolidating them so that we 
have shared activities across those servers, as well as 
implementing the Bioinformatics Board to redefine the programs 
that need to be operationalized on that IT infrastructure to 
create integration across the agency and information sharing, 
especially from our field to our centers. That is now an 
investment of about $247 million a year.

                  WHITE OAK AND INFORMATION TECHNOLOGY

    White Oak construction includes plans for our 
implementation and build-out of a data center at White Oak 
which will help us to continue our efforts to put FDA on a 
complete electronic infrastructure and move us away from paper.
    As we had more dollars to invest, we could accelerate the 
implementation of that IT strategic plan.
    Senator Bennett. So that brings us back to White Oak. What 
is your time line, and is the construction of White Oak, which 
is not just bricks and mortar, as you have just indicated, it 
is also massive increases in efficiency as you get the kind of 
data center that you are looking to from your IT investment 
there, proceeding more slowly because we are not putting enough 
money into it? Would it be completed more rapidly if we gave 
you more money? And what is your time line for getting it done?

                                  GSA

    Dr. von Eschenbach. Well, we obviously are dependent upon 
the appropriations that the General Services Administration, 
GSA, receives, and they are responsible for the bricks and 
mortar and maintaining that development on its time line for 
full completion by 2012. If those dollars were to fall off and 
construction slowed, that would create serious problems for us 
in terms of our transition into that consolidated facility from 
what are currently leased and widely dispersed facilities.
    More importantly, as you point out, are opportunities lost 
with regard to consolidation. We see White Oak as our 
opportunity to integrate our science more effectively by virtue 
of having modern state-of-the-art laboratories that are working 
in an interdependent fashion.
    Senator Bennett. Would you see savings if White Oak were 
finished in 2010? And could it be if more money went to GSA?
    Dr. von Eschenbach. I have not done a cost analysis in 
terms of savings by virtue of acceleration. I certainly can 
tell you that there are huge losses--we would sink a lot of 
cost if that time line was slowed down. So how much would we 
gain back?
    Senator Bennett. Yes.

                              DATA CENTER

    Dr. von Eschenbach. I certainly know by completion of such 
things like our data center would have a significant impact 
across the entire FDA operation, not just the White Oak campus.
    Senator Bennett. We need to do everything we can to get 
that finished in as logical a time as we can.
    Thank you very much. Thank you, Mr. Chairman.
    Senator Kohl. Thank you, Senator Bennett.
    Senator Dorgan.

                      HEPARIN--FOREIGN INSPECTIONS

    Senator Dorgan. Mr. Chairman, thank you very much.
    Dr. von Eschenbach, thank you. I want to ask about the 
issue of inspections of foreign properties, especially about 
the issue of heparin, if I might. Heparin is a blood thinner--
we are well familiar with it--commonly used by dialysis 
patients, recently pulled from the market after it was linked 
to some 62 deaths. Baxter Health Care, which markets heparin in 
the United States, indicated the allergic reactions appeared to 
be caused by a contaminant that was added in place of the 
active ingredient in heparin somewhere in the manufacturing 
process, they suspect, mostly in China. They have purchased the 
active ingredient for heparin from a company called SPL, which 
is based in Wisconsin, and they purchased pig intestines from 
Chinese pig farms and processed the intestines in China and 
Wisconsin.
    I am going to show you some charts. The Wall Street Journal 
did something about this. It published a series of photos of 
the Yvan Intestine and Casing factory which processes pig 
intestines used to make heparin. Now, I am not tracing this 
heparin to this place because none of us can know that or do 
that. But this shows the types of unsanitary conditions in 
which production maybe taking place. We will go down the list 
of these photographs. This is a place that is processing what 
is an active ingredient in heparin. This is processing pig 
intestines.
    My understanding is that the FDA inspected 1,222 plants in 
the United States in a year and conducted only 17 inspections 
of plants in China. Further, when we met with Baxter, we asked 
Baxter had the FDA ever inspected the plant in China that is 
using pig intestines to create the active ingredient in 
heparin. Baxter said that the FDA had scheduled an inspection 
but actually ended up inspecting the wrong factory.
    So 62 people are dead. We hear about the danger of re-
importing FDA-approved prescription drugs from Canada, which is 
beyond me, by the way. They do that routinely in Europe under 
something called parallel trading where they move FDA-approved 
drugs from country to country. But even though we hear about 
the danger of that, including from the FDA I might add, it 
appears to be the active ingredient in heparin, which may well 
have caused some 60-some deaths, is coming from areas in China 
where there have been no inspection.
    So tell me about that, 17 inspections in China, 1,100 
inspections in the United States.

                          GLOBAL SUPPLY CHAIN

    Dr. von Eschenbach. Senator, your question is very 
perceptive in that I think the heparin experience points out to 
us many of the principles that we have been discussing this 
morning. Let me try to succinctly address what is a very 
complex issue.
    We are engaged in now a global supply chain, and FDA, 
rather than it being a gatekeeper, is now invested in a 
strategy of being engaged in the total life cycle of products 
from production to consumption. That then requires us to look 
at that comprehensively and look at it from the point of view 
of prevention of problems, building quality in at the outset, 
intervention when there is a suspicion or concern, and response 
when there is evidence of an adverse event. So all parts of 
that equation must be emphasized and enhanced, our ability to 
respond rapidly and efficiently, as well as our ability to 
intervene but, most importantly, to begin to emphasize the 
front end, building quality in at the outset.
    Senator Dorgan. But, Dr. von Eschenbach----
    Dr. von Eschenbach. Inspections are important, and I 
completely concur with our need to enhance our foreign 
inspections.
    But this issue points out the fact that that inspection 
would not have detected the contamination of heparin because 
the contaminant is not detectable by our routine testing 
methods. And it was apparently, we suspect, done by virtue of 
economic fraud and, therefore, we had to devise new testing 
methods which now are being used around the entire world by our 
other agencies to address the problem.

                           ACTIVE INGREDIENTS

    Senator Dorgan. A fair point.
    But, Dr. von Eschenbach, these plants have not been 
inspected. My assumption is even if you could detect the active 
ingredient and the problems there, you would not allow this 
plant to process pig intestines and send an active ingredient 
in the U.S. drug supply. And my understanding is that 40 
percent of the active ingredients in the U.S. drug supply come 
from China and India, and I just described what we have here. 
Seventeen inspections in all of China in 1 year, 1,200 
inspections in this country.
    Now, Senator Bennett asked you the question about the 
resources needed. Is FDA only doing 17 inspections because they 
do not have the resources?

                           BEYOND OUR BORDERS

    Dr. von Eschenbach. FDA inspects all the factories or all 
sites of production for new active pharmaceutical ingredients 
for which an application is being submitted. It is the 
reinspections where we need to begin to expand our capacity. We 
are doing that in terms of, one, our initiative, FDA Beyond our 
Borders. We are in the process of working with the Chinese 
Government and we have signed memorandums of agreement to work 
directly with their regulatory agency. We are anticipating 
opening five FDA offices around the world. China will be our 
first with offices in Beijing, Guangzhou, which is the source 
of major food production, and in Shanghai where we have the 
port. We will work directly through that process to enhance 
inspections but, more importantly, to work to build, with our 
Chinese counterparts, systems that will assure quality in the 
production of these products long before they actually come 
into our supply chain.

                          FOREIGN INSPECTIONS

    Senator Dorgan. This comes from the Congressional 
Quarterly. It says the Food and Drug Administration wanted to 
inspect 3,249 factories overseas and it was able to inspect 212 
in all countries. You were able to inspect 6.5 percent of that 
which you wanted to inspect.
    Again, my point is if 40 percent of the active ingredients 
for prescription drugs comes from China and India and we have 
such a small amount of inspection going on and you say and 
everyone says we are in a global economy. Well, it does not 
look like we are in a global inspection system. Obviously, 
those patients who have died as a result of the heparin 
situation paid the price for that.

                             CANADIAN DRUGS

    But I want to make one final point that is related to this. 
We are not inspecting these foreign sources of the elements of 
prescription drugs, but here are two pill bottles of Lipitor. 
As you know, the FDA itself has been helpful to the 
pharmaceutical industry in recent years in saying, well, if 
U.S. consumers were allowed to reimport FDA-approved drugs from 
a Canadian drugstore where they are sold at fraction of the 
price, these two bottles--one is the U.S. bottle; the other is 
Canada--both made in the same place, put in the same size 
bottle, a couple different changes in the label. The only 
difference here--the same pill, same bottle, same company, FDA-
approved--is the U.S. consumer gets to pay twice the price. And 
yet, the FDA says, in assistance to the administration and the 
pharmaceutical industry, there is a problem with allowing the 
reimportation of a FDA-approved drug from Canada even while 
this occurs, such a miserable level of inspections 
internationally.
    Now, I am not laying this all at your feet, Dr. von 
Eschenbach because you have not been there all that long. But I 
do think it relates to the questions asked by the chairman and 
the ranking member about resources and what are we deciding to 
do to protect the health of the American people with respect to 
these issues.
    Dr. von Eschenbach. Senator, I think it is both resources 
and a completely different way of doing business. First of all, 
with regard to the process, we need to work more effectively 
and collaboratively with other regulatory agencies in other 
countries, but also with regard to the developers and suppliers 
of these drugs. They have an integral and important part to 
play in this as well.

                            TRACK AND TRACE

    We are embarking upon this in a more comprehensive way than 
just simply increasing the number of inspections, which we will 
do, but we will do that in a risk-based model. We will do that 
in a very tiered fashion so that electronically we are able to 
be aware of all of the things in a track and trace and then 
define where we need to target those specific inspections where 
we believe there is the greatest potential for risk.

                           ACTIVE INGREDIENTS

    Senator Dorgan. Now, last year I added report language to 
an appropriations bill that directs the FDA to tell us where 
are drugs made and where do the active ingredients come from. 
We have not yet received that. Is that on its way from the FDA 
to the Congress?
    Dr. von Eschenbach. We are in the process of--again, as we 
talked about earlier, our need for revamping and rebuilding of 
our information technology infrastructure to be able to create 
a system where we have product identification and we can 
actually track and determine all things that are coming----

                      UNITED STATES VERSUS CANADA

    Senator Dorgan. But is the report on its way to Congress on 
where active ingredients come from? That is a requirement.
    I have taken more time than I think I am allowed. One final 
question if I might.
    This issue of United States versus Canada. Canada has an 
almost identical chain of control of prescription drugs, as we 
do. Most everyone understands and agrees with that. Europe has 
had a parallel trading program for 20 years. If you are in 
Spain and want to buy a prescription drug from Germany, no 
problem. If you are in Italy and want to buy it from France, no 
problem. Why is it that the FDA seems to think Europe can do 
something that we cannot do?
    Dr. von Eschenbach. First of all, Senator, the report is in 
progress and I cannot tell you exactly when it will be 
delivered to Congress. But it is in process and it is being 
prepared for delivery.
    Let me separate this into two issues. One issue is how do 
we address the integrity of the supply chain of the development 
of that product. The second is how do we address the issue of 
the introduction of counterfeits into the supply chain with 
regard to reimportation. They are two completely different 
problems and require two completely different approaches 
because----
    Senator Dorgan. Europe has done that for two decades.
    Dr. von Eschenbach. I just returned from----
    Senator Dorgan. If they can do it, we can do it.

                              COUNTERFEITS

    Dr. von Eschenbach. I have just returned from some 
interactions with counterparts in which some of the 
transshipments through countries are detecting a significant 
degree of counterfeits being introduced into that process. We 
are addressing both of these, Senator, because they are both of 
critical importance to assuring the product that Americans use, 
when they take those drugs home and give them to their children 
or to themselves, that they are, in fact, getting the right 
product.
    Senator Dorgan. Mr. Chairman, you have been generous.
    Dr. von Eschenbach, would you be worried if a member of 
your family were taking a prescription drug that was FDA-
approved and purchased in a Canadian drugstore?
    Dr. von Eschenbach. If I purchased it in a Canadian 
drugstore and----
    Senator Dorgan. A registered pharmacy in Canada. FDA-
approved, registered pharmacy in Canada. Would you be worried 
about the efficacy of that drug?
    Dr. von Eschenbach. It would depend on the drug, but no, I 
would not. But that is different than me having that imported 
into the United States through a website.
    Senator Dorgan. That was not the question. You said no 
because, I assume, that the drugs for your family you would 
purchase in a registered Canadian pharmacy you feel has the 
same chain of command, almost identical to the United States. 
Is that----
    Dr. von Eschenbach. I have a high degree of respect for the 
Canadian system with regard to their own regulation of drugs. 
Yes, sir.
    Senator Dorgan. Thank you, Dr. von Eschenbach.
    Senator Kohl. Senator Reed.

                         INDOOR TANNING DEVICES

    Senator Reed. Thank you, Mr. Chairman. Thank you, 
Commissioner.
    By September 27, 2008, the FDA must submit a report to 
Congress on its labeling requirements for indoor tanning 
devices. What is your understanding of the science of the risk 
of tanning devices and what progress has FDA made on reviewing 
these labeling requirements that you are required to 
promulgate?
    Dr. von Eschenbach. We have been actively involved in 
preparing that report to Congress, Senator. It really looks at 
the issue of warning labels, as you have requested. Personally 
as a melanoma survivor, I obviously have great interest and 
concern about this even though I am not directly involved in 
the specifics of this issue. But we are addressing this and 
addressing this as a public health need.
    Senator Reed. Your last statement presumes that existing 
scientific evidence suggests this is a public health problem.
    Dr. von Eschenbach. The concern is certainly--the concern 
is always with regard to potential problems for over-exposure 
or over-use.
    Senator Reed. Some individuals and groups are suggesting 
that indoor tanning devices are actually palliative, not 
dangerous at all. For this reason, we are very eager for 
scientific evidence of their effects. Can you be more specific 
as to your progress? I presume if you are working towards this 
labeling, that there is some scientific predicate to labeling. 
Otherwise, you would come back to us and say the labeling is 
unnecessary.
    Dr. von Eschenbach. Well, the labeling needs to address the 
risks, as well as the benefits that may be associated with the 
use of this particular kind of device and the appropriate use 
of the device. And I believe that the Center for Devices and 
Radiologic Health is addressing this, both from the scientific 
perspective as well as from a consumer's understanding and 
appreciation of health messages associated with these products, 
and we will be presenting that report to Congress before 
September.

                               SUNSCREENS

    Senator Reed. Thank you very much, Commissioner.
    In a related matter, the FDA is in the process of 
finalizing its proposed rule on sunscreen products. Can you 
give us an estimate of when it will be completed? It has been 
pending for a while now.
    Dr. von Eschenbach. Yes, sir. It was a matter of addressing 
the issue of adding the UVA component to the UVB standards with 
regard to the rule so that we now have two test methods for UVA 
and the inclusion of the appropriate warning statements. That 
proposed rule is in process, and I cannot give you an exact 
date of when it will be presented, but it is an issue that is 
being actively worked on for finalization.
    Senator Reed. Can you give an estimate? Within this quarter 
or next quarter?
    Dr. von Eschenbach. I would be reluctant to give you an 
estimate and then not be able to assure that, Senator. But I 
will assure you that this is not something that is being 
ignored. It is being given appropriate attention and the 
expectation is to finish this.

                             GENERIC DRUGS

    Senator Reed. Thank you.
    We all recognize that generic drugs play an important role 
in the health care system today. I have been told that there 
are about 1,400-1,500 generic drug applications currently 
pending, with 570 or so pending over 180 days. Do you need 
increased funding for these generic reviews? Do you need 
something to expedite their approval?
    Dr. von Eschenbach. We are both blessed and challenged by 
the success that we have achieved with regard to bringing 
generic drugs to the American people. This year we received 880 
applications--in 2007, rather. And we have approved 682, which 
was a 33 percent increase in 2007 over 2006. So the track 
record is extraordinary, but because the funnel has increased 
so significantly, that has continued to create the backlog 
issue.

                               NEW STAFF

    Now, we have approached that on a variety of fronts. One 
is, as you indicated, applying additional resources. So we have 
hired approximately 40 new staff to address generic drug 
review. We are also beginning to attempt to try to prioritize 
the review process to get the first generics and also beginning 
to address things like process improvement, as well as 
enhancement of our infrastructure, specifically IT, work with 
the people who are creating these drug applications to get 
better quality into the applications so that they go through 
the regulatory process in a lot more efficient way. And I think 
the net effect of all of that would be to continue to enhance 
our productivity and reduce the backlog.
    Senator Reed. Thank you, Mr. Chairman.

                            ADDITIONAL STAFF

    Senator Kohl. Thank you, Senator Reed.
    Dr. von Eschenbach, going back to a comment I made in my 
opening statement, you say that your budget provides funding 
for increased activities for food safety and medical product 
safety and that you will hire several hundred additional staff 
this year. But the budget request is not enough to even pay for 
the staff that you now have. So how do you equate your 
intentions with respect to additional staff when you do not 
have money to even pay for the staff that you now have?
    Dr. von Eschenbach. Well, we are on the trajectory to 
increased staff. We do, in fact, have to absorb additional 
costs associated with that staff over and above what we 
currently have available to us in the budget. So it is perhaps 
slowing it down a little bit, but the trajectory is still very 
positive and we are still increasing the number of staff that 
we have. It is just we will not do it at the rate that we had 
anticipated because of needing to absorb the cost of living of 
$34 million that you indicated.
    So the simple answer to your question, Senator, is we have 
to make accommodations in the pace with which we will bring 
those people on board in order to stay within our budget 
framework, but it will not be a negative. It will not be a 
deficit. It will be just not as rapid an accrual of those 
numbers as we had anticipated. We will just have to push it off 
a little bit.
    Senator Kohl. I appreciate that, but what I think I and 
others are taking from what you are saying is that the lack of 
the necessary funding will, in fact, have a severe impact on 
your ability to do the things that you are saying you want to 
do.
    Dr. von Eschenbach. There are a very large number of 
important initiatives that we have identified that are part of 
what I consider to be the essential modernization of the FDA. 
Depending upon available resources, we would be able to 
implement many of those initiatives in as an effective way as 
possible. So I do agree with you from the perspective that 
there is much to be done and we are prepared to do it, and with 
support, we would implement those programs in a strategic way 
but also with great stewardship, recognizing how precious these 
resources are and how many other needs there are across the 
entire Federal Government.

                              CHINA OFFICE

    Senator Kohl. Dr. von Eschenbach, can you provide us with a 
status update of the office that you are trying to open in 
China? How many FDA employees do you anticipate working there, 
and what do you intend their focus to be?
    Dr. von Eschenbach. We anticipate a total of 13 individuals 
that will be making up our China office. Eight of those will be 
full-time FDA employees. Five of them will be locally employed 
staff. That will be give us great opportunity with regard to 
our ability to integrate effectively locally.

                         OTHER FOREIGN OFFICES

    We also look forward to offices in India, the Middle East, 
Latin America, and Europe. And I have been engaged in 
conversations with governments and counterparts, as has 
Secretary Leavitt, in all of those areas. It is a balance 
between their willingness to welcome us and accept us at the 
government level. We have not yet secured that welcome from 
China officially, but we certainly have great interest and 
enthusiasm on the part of the ministers and government 
officials in China with whom we have discussed this. So I 
anticipate that it will occur.
    We really look forward to the China office being fully 
implemented within this fiscal year, and we are laying the 
groundwork and would like very much to begin to develop the 
other sites as rapidly as possible.

                           POST-MARKET SAFETY

    Senator Kohl. Dr. von Eschenbach, you noted in your 
statement several new medical devices that FDA approved last 
year. Post-market safety of medical devices obviously is an 
important issue for patients. But the number of staff in the 
FDA devices program is, in fact, decreasing this year. So can 
you comment on how you plan to continue improving these 
important devices, as well as ensuring their safety after they 
have been approved with the very minimal funding increases and, 
in fact, while at the same time losing staff?
    Dr. von Eschenbach. We are doing a number of things, 
Senator, one of which, as I had indicated earlier, is this 
ability to create much greater integration and interdependence 
across programs. For example, in this regard, I believe we 
could effectively enhance the performance in post-market 
surveillance, whether it is drugs or devices, by virtue of our 
information technology infrastructure and our ability to do 
much more effective post-market surveillance. We look forward 
to being able to continue to streamline and enhance the very 
effective programs that are already underway in the Center for 
Devices and Radiologic Health with regard to working with the 
industry in post-market surveillance.
    So I think it is a combination of building the trajectory, 
as I have indicated before, finding ways to leverage currently 
ongoing resources or programs like IT, and continue to make 
strategic investments, especially as user fees contribute to 
this opportunity. And we expect our user fee program to 
increase. In 2009, there will be $52.5 million in this 
particular area. So we do look forward to growth, but it is 
going to come in different ways.
    Senator Kohl. Senator Bennett.

                            CLOSING REMARKS

    Senator Bennett. Thank you very much, Mr. Chairman. I think 
all of the issues I have on my list have been covered either by 
you or Senator Dorgan or in my previous questions.
    So let me again thank Dr. von Eschenbach and his team for 
their willingness to serve in what must occasionally be a 
somewhat contentious atmosphere, and I wish them well.
    Senator Kohl. I want to associate myself with Senator 
Bennett's statements. I think it has been a good hearing. I 
think we have brought out very clearly, number one, the huge 
and expanding responsibilities the FDA has and, number two, the 
lack of satisfactory funding to carry out your 
responsibilities. Clearly, there is a very important job that 
we need to work together to achieve.
    In fact, it is clear to us that you cannot carry out the 
responsibilities you have in a way that I believe would satisfy 
you without the necessary and adequate funding. I think there 
are plenty of professional people on your staff, most 
importantly yourself, who can and would get the job done with 
adequate funding, but without the funding, it is pretty hard to 
do the job that you need to do.
    If you want to respond to that statement, that would be 
fine. You could make a comment or two and then we will close 
the hearing.
    Dr. von Eschenbach. I would just close, Mr. Chairman, with 
echoing what I know is both your sentiments and Senator 
Bennett's sentiments. This country and this agency is truly 
blessed by the people of the Food and Drug Administration. I 
have the privilege every day to witness their sacrifice, their 
commitment, and their unbelievable performance, given the 
nature of the challenges that they are burdened with every 
single day. If we were to talk about resources, it is resources 
that are not about programs. It is resources about people. And 
the Food and Drug Administration's most precious asset, this 
Nation's most precious asset, are these incredible individuals.
    We need more of them. We need more of them with new and 
different skill sets that are going to be aligned with the 
challenges of the 21st century, new science that is emerging, 
new technologies that are emerging, new complexity in the 
production and consumption of products. One needs only to go 
and walk through a supermarket and realize that with the 
exception of meat and chicken, every other thing in that 
supermarket is their responsibility to assure to the American 
people the quality of those products.
    Every dollar that you choose to invest is, I believe, my 
responsibility to use to nurture and support that workforce. We 
need a fellowship program that will be able to create the 
intellectual capital of tomorrow. We need career development 
for the people that are already there. We are going to hire 
over 700 new people, which I believe is a wise use of the 
resources that you will make available to us.
    But if I was to leave you with one final word, it would be 
I do not believe that there is any greater investment the 
American people could make than to invest in the people who 
make up the Food and Drug Administration.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Kohl. Thank you very much. That is a fine 
statement. You made a fine appearance here this morning. We 
thank you, as well as Mr. Dyer and Mr. Turman for being here. 
And at this time we will close the hearing.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

                Questions Submitted by Senator Herb Kohl

                   FDA SCIENCE BOARD RECOMMENDATIONS

    Question. If additional funding was provided to FDA this year above 
your request level, what are the top 3 most pressing needs you would 
address?
    Answer. On November 6, 2007, the administration released its Action 
Plan for Import Safety. The Action Plan for Import Safety recognizes 
FDA's central role in ensuring the safety of America's food supply and 
the safety and effectiveness of medical products, regardless of where 
the food and medical products are produced.
    Implementing the Action Plan for Import Safety is a top FDA 
objective, and FDA has three priorities to achieve that objective: FDA 
Beyond Our Borders, building a modern IT infrastructure, and risk-based 
science.
    Beyond Our Borders is a core element of the Action Plan for Import 
Safety. Beyond Our Borders includes establishing offices in China, 
India, and other locations. The FDA Beyond Our Borders initiative also 
relies on greater collaboration with foreign regulators, the use of 
third parties to provide information about the compliance of regulated 
industry with FDA standards, and greater FDA direction to regulated 
industry to ensure that their global activities meet FDA standards.
    FDA foreign inspections and import exams are also an essential part 
of the Beyond Our Borders Initiative. In addition to providing greater 
deterrence, FDA will better target inspections to firms and products 
that pose the greatest risk to consumers.
    Consistent with recommendations in the Action Plan for Import 
Safety, FDA must modernize its IT systems. Improving FDA's IT will help 
the agency target inspections to foreign firms whose products pose the 
greatest risk. IT improvements will allow FDA to better predict the 
firms and products that pose the highest risk imports.
    Under the Action Plan for Import Safety, FDA must also strengthen 
its capacity to conduct the science that supports risk-based 
inspections. FDA risk-based science is essential to assure that imports 
are safe. and to assure that FDA scientists stay ahead of those who 
accidentally or intentionally defeat FDA oversight of imports. The 
Action Plan for Import Safety requires a strong FDA program of risk-
based science and laboratory support so that FDA can ensure the safety 
of imports for patients and consumers.
    Question. Please provide a professional judgment budget, regardless 
of constraints faced by FDA due to DHHS or OMB, on additional funding 
needed by the Agency that could reasonably be expended, in fiscal year 
20009.
    Answer. The following document is an assessment of immediate 
resource needs based on a professional judgment analysis, without 
regard to the competing priorities that FDA, the President, and the 
President's advisors must consider as budget submissions to the 
Congress are developed. As the response indicates, the amounts 
identified are in addition to amounts appropriated to FDA in fiscal 
year 2008.
    [The information is attached.]

           FDA FISCAL YEAR 2009 PROFESSIONAL JUDGMENT ESTIMATE
                          [Dollars in millions]
------------------------------------------------------------------------
                                            Fiscal year
                                               2009             FTE
------------------------------------------------------------------------
Food Protection.........................            $125             259
Safer Drugs, Devices, and Biologics.....             100             160
Modernizing FDA Science and Workforce...              50              71
                                         -------------------------------
      Total.............................             275             490
------------------------------------------------------------------------

    The amounts identified in this document support three strategic 
investment areas--protecting our food supply, assuring safer drugs, 
devices, and biologics, and modernizing the essential infrastructure of 
FDA's science and workforce. The amounts are in addition to amounts 
appropriated to FDA in fiscal year 2008. Investing in these three 
strategic areas will permit FDA to rapidly achieve important public 
health goals that cut across strategic components of the Agency.
    This document responds to the request for the FDA's professional 
judgment concerning resource needs. The document and was developed 
without regard to the competing priorities that the President and his 
advisors must consider as budget submissions to the Congress are 
developed.

                   FDA FISCAL YEAR 2009 BUDGET AMENDMENT: FOOD PROTECTION PLAN (+$125 MILLION)
----------------------------------------------------------------------------------------------------------------
Core Elements and Strategic Activities                FPP Output                     Amount             FTE
----------------------------------------------------------------------------------------------------------------
Prevention:
    1.1 Promote Increased Corporate     Increase FDA presence beyond our             $16,000,000              24
     Responsibility to Prevent           borders, including increased
     Foodborne Illnesses: FDA will       training for food safety best
     ensure the safety of imports by     practices abroad. Offices in four
     increasing FDA's presence beyond    additional countries with 7/8 FDA             5,000,000               2
     our borders and building capacity   FTE and 4/5 foreign nationals per
     with foreign partners.              country/region. Yields FDA presence           5,000,000               3
                                         in five countries or regions of the
                                         world.
                                        Increase technical assistance on food
                                         standards in at least 3 of the
                                         countries accounting for the major
                                         share of imports.
                                        Develop systems and tools for an
                                         international information exchange
                                         database related to inspections and
                                         quality.
    1.2 Identify Food Vulnerabilities   Increase capacity to collect &                 5,000,000              10
     and Assess Risks: FDA will          interpret data for risk-based
     conduct risk-based prevention to    prevention for products of greatest           7,000,000              20
     better protect America's food       concern.
     supply. FDA will better            Research and develop risk-based
     understand food safety and food     prevention strategies based on
     defense risks and use this          scientific data and protocols.
     understanding to define the
     optimum preventive controls to
     establish.
    1.3 Expand Understanding and Use    Develop and validate rapid detection           5,000,000              10
     of Effective Mitigation Measures:   technologies and assays (see 2.3 for
     FDA will develop and validate       deploying technologies and assays);
     rapid detection tools to quickly    For high risk foods, commence work
     detect and mitigate a potential     to develop two new priority tools
     problem.                            and to validate two test methods for
                                         toxic chemicals or microbes
                                         developed by industry.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         43,000,000              69
                                                                              ----------------------------------
Intervention:
    2.1 Inspections and Sampling Based  20,000 more import food exams at the           6,000,000              36
     on Risk: FDA will apply risk        port of entry \1\ ($300 each).               13,500,000              50
     analysis to set priorities for     800 more foreign food production and/
     food inspections and                or processing facility inspections            6,500,000              33
     interventions.                      and support for foreign inspections
                                         \1\ (uc=$16.7K).
                                        800 more domestic food safety
                                         inspections \1\ (uc=$8k).
    2.2 Enhance Risk-Based              Integrate and assimilate risk-based           10,000,000              15
     Surveillance of Imported Foods at   information into data systems.
     the Border: FDA will design and
     build risk-based algorithms to
     conduct inspections and detect
     food risks. Understanding the
     risks defines the number and
     types of inspections and tests
     needed to ensure that preventive
     controls are working.
    2.3 Better Detect Food System       Improve signal detection of                    5,000,000               5
     Signals that Indicate               intentional and unintentional
     Contamination: FDA will deploy      chemical and microbial contamination.         5,000,000               5
     rapid detection technologies and   Deploy 1-2 rapid detection assays to
     assays and build laboratory         test high risk foods. Acquire
     infrastructure for faster           advanced technology and deploy such          11,000,000              10
     testing. FDA will deploy state-of-  equipment to FDA field and conduct
     the-art technology to improve the   technology transfer to industry.
     integration of incoming signals    Build high throughput rapid detection
     and achieve faster mitigation and   technology into laboratory
     response.                           infrastructure.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         57,000,000             154
                                                                              ----------------------------------
Response:
    3.1 Improve Immediate Answer. FDA   Develop and implement a system for            10,000,000              20
     will enable real-time               traceback from product consumption
     communication of lab results. FDA   back to the source of production
     will develop protocols to           using, for example, electronic               10,000,000               6
     facilitate tracebacks of            pedigrees and industry applied
     foodborne illnesses. FDA will       technologies of bar coding and radio
     rapidly detect and respond          frequency identification.
     foodborne outbreaks.               Enhance interoperable information
                                         technology networking system between
                                         FDA and Federal, State, and local
                                         testing labs.
    3.2 Improve Risk Communications to  Create a health hazards alert                  5,000,000              10
     the Public, Industry, and Other     communication system using multiple
     Stakeholders: FDA will enhance      media outlets to quickly inform a
     risk communication though           broad cross section of the public.
     aggressive, targeted food safety
     campaigns that disseminate clear
     and effective messages with
     regular updates through a variety
     of media to all target audiences.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         25,000,000              36
                                                                              ----------------------------------
        GRAND TOTAL, Food Protection    .....................................        125,000,000             259
         Plan.
----------------------------------------------------------------------------------------------------------------
\1\ FDA will hire and train additional field inspectors throughout fiscal year 2009. As a result, by fiscal year
  2010, the proposed investment will allow FDA to increase its inspection and surveillance capacity by the
  number of inspections identified in this FPP output


       FDA FISCAL YEAR 2009 BUDGET AMENDMENT: ENSURING SAFE AND EFFECTIVE MEDICAL PRODUCTS (+$100 MILLION)
----------------------------------------------------------------------------------------------------------------
          Strategic Activity                            Output                       Amount             FTE
----------------------------------------------------------------------------------------------------------------
Safer Drugs, Devices, and Biologics:
    1.1 Science to Improve Medical      Establish a unique device                     $7,500,000              17
     Product Safety and Development:     identification system to track
     Use new science and analysis to     devices, facilitate recalls, and             14,000,000              10
     improve the safety of medical       support inventory management during
     products. In some cases, new        disasters and terrorism response.
     science creates opportunities to   Implement FDAAA safety requirements
     leverage advances from one          related to pediatric drugs and
     product area to promote safety in   devices, postmarket study
     a different area.                   commitments, clinical trials, active
                                         drug surveillance, labeling and safe
                                         use of drugs.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         21,500,000              27
                                                                              ----------------------------------
    1.2 Data Analysis Tools to          Build Regulated Product Information           15,000,000  ..............
     Identify Safety Issues: Develop     Data Warehouse that will enable
     and implement quantitative          intelligence sharing with other              15,000,000               6
     decision-making tools to assess     regulatory agencies.
     the safety and effectiveness of    Data access and analysis for active
     drugs, biologics, and devices       safety surveillance with development
     throughout their lifecycle.         of scientific methods of data mining
                                         for signals of adverse events.
                                                                              ----------------------------------
      Sub-Total.......................  .....................................         30,000,000               6
                                                                              ----------------------------------
    1.3 Risk-Based Inspection and       250 more foreign medical product              11,200,000              50
     Compliance: Strengthen field        facility inspections \1\                     10,800,000              18
     operations to better protect        (uc=$45.000).
     public health. The sheer volume    Increase FDA's presence beyond our             4,400,000              14
     of products, manufacturing          borders to five countries or regions          7,500,000               5
     plants, distributors, and           of the world.
     importers demands a more robust    250 more domestic medical product              6,600,000              35
     inspection force with better        inspections (uc=17.7K).                       3,000,000  ..............
     capacity to reach the community    Improve lab infrastructure and tools           5,000,000               5
     that FDA regulates.                 for rapid analysis of product/
                                         ingredient content.
                                        Increase import exams (10,000) and
                                         sampling/laboratory analysis (300).
                                        IT systems to achieve an integrated
                                         inventory database.
                                        Improve risk communications to public
                                         and industry.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         48,500,000             127
                                                                              ----------------------------------
        GRAND TOTAL, Medical Product    .....................................        100,000,000             160
         Safety and Effectiveness.
----------------------------------------------------------------------------------------------------------------
\1\ FDA will hire and train additional field inspectors throughout fiscal year 2009. As a result, by fiscal year
  2010, the proposed investment will allow FDA to increase its inspection and surveillance capacity by the
  number of inspections identified in this output


           FDA FISCAL YEAR 2009 BUDGET AMENDMENT: MODERNIZING FDA SCIENCE AND WORKFORCE (+50 MILLION)
----------------------------------------------------------------------------------------------------------------
          Strategic Activity                            Output                       Amount             FTE
----------------------------------------------------------------------------------------------------------------
Modernizing FDA Science and Workforce:
    1.1 Science Leadership and          Strengthen programs of emerging               $5,000,000              15
     Coordination: FDA will enhance      science in Centers and at the
     science programs across the         National Center for Toxicological            27,000,000              40
     agency, especially in emerging      Research and enhance integration.
     areas such as nanotechnology and   Strengthen capacity to support
     tissue engineering. FDA will        nanotechnology, cell and gene
     establish mechanisms to access      therapies, robotics, genomics and
     the best scientific knowledge and   proteomics, Critical Path
     expertise to modernize its          initiatives, and advanced
     regulatory science. FDA will        manufacturing technologies.
     strengthen its capacity to
     support emerging areas of science
     and manufacturing that are
     essential to regulating FDA
     products.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         32,000,000              55
                                                                              ----------------------------------
    1.2 Investments to Support Science- Expand science training and                    4,000,000               8
     Based Regulation: FDA will          professional development for career           4,000,000               8
     upgrade its science capacity by     employees.                                   10,000,000  ..............
     providing more training and        Launch Science Fellows Program and
     professional development support    initiate recruitment of first 500
     for FDA science staff. FDA will     fellows.
     create an Agency-wide 2-year       Improve facilities outside of the
     Science Fellows Program intended    Washington region to support FDA's
     to include up to 2,000 trainees     mission and enable these facilities
     to develop a new cadre of           to accept new food and medical
     emerging leaders in regulatory      product technologies.
     science. FDA will upgrade
     facilities that do not adequately
     support FDA's current or future
     mission.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         18,000,000              16
                                                                              ----------------------------------
        GRAND TOTAL, Modernizing FDA    .....................................         50,000,000              71
         Science and Workforce.
----------------------------------------------------------------------------------------------------------------

                               PAY COSTS

    Question. If you plan to ``absorb'' the pay costs that you haven't 
actually paid for in the budget, what will you cut to do it?
    Answer. The fiscal year 2009 President's Budget for FDA includes an 
increase of $25 million for the cost-of-living increase for FDA 
employees. The cost-of-living increase allows FDA to retain the 
professional workforce that performs FDA's public health mission. FDA 
will cover its fiscal year 2009 cost increases through a combination of 
strategies, reducing operating costs, and adjusting its hiring plan.

                           OVERSEAS STAFFING

    Question. I understand that FDA has also expressed interest in 
opening other overseas offices to deal with the large and continually 
growing number of imported products--including one in India. Again, 
however, I don't see this reflected in the budget. Is this something 
you are considering? If so, where, and what would the cost be?
    Answer. FDA has agreements in place and we are making final 
arrangements for offices in China. FDA is also planning to establish 
additional offices in India, and is exploring the possibility of 
opening offices in three additional regions. The President's fiscal 
year 2009 budget provides $3.1 million to establish the office in 
China. We have not developed specific estimates for additional offices 
by location because developing these estimates requires significant 
discussions with the host countries and the Department of State. The 
cost to establish additional foreign offices will depend on the office 
location, the activities that FDA staff will perform at the location, 
and the number of staff that FDA assigns to the location.

                          FOOD PROTECTION PLAN

    Question. Last year, we provided you with a $56 million increase 
for food safety, and attached some very specific directives, including 
hiring additional inspectors, forming rapid response teams, and 
contracting with the National Academy of Sciences on a food safety 
study. You talked in your statement about what you have planned for 
2009--can you provide us with specifics on how the money we've already 
given you has been spent?
    Answer. With the funding provided in the January 1, 2008 increase, 
FDA has undertaken additional food safety activities. These funds were 
used to support planning and the initial stages of implementation of 
several Food Protection Plan initiatives. These initiatives include the 
FDA hiring surge, the Food Protection Plan, and the Import Safety 
Action Plan.
    FDA was granted direct hire authority in April 2008 and will hire 
161 new FTEs to work in food safety. The Office of Regulatory Affairs--
ORA--completed a 3-year plan to increase State inspections and will 
hire an additional 77 new FTEs with the fiscal year 2008 appropriation 
and an additional 53 new FTE with the funds from the Consolidated 
Appropriations Act, 2008, which will be available on July 1, 2008 to 
conduct food field exams, inspections, and sample collections. These 
investigators will conduct critical activities such as import food 
field exams and assist senior investigators in performing high risk 
food inspections.
    The Center for Food Safety and Applied Nutrition, known as CFSAN, 
hired one new FTE with the fiscal year 2008 appropriation and will hire 
an additional 28 new FTEs with the funds from the Consolidated 
Appropriations Act, 2008, which will be available on July 1, 2008 to 
assist with food safety work aimed at developing guidance to minimize 
microbial food safety hazards, developing best practices for preventive 
controls that rapidly determine the source of food contamination, 
developing risk ranking models for imported and domestic foods, 
providing technical assistance to foreign countries on Good 
Agricultural Practices, and continuing research to improve 
surveillance, sampling and traceback activities and other tools to 
rapidly detect and minimize the public health impact of foodborne 
pathogens, toxins, and other contaminants that threatens the U.S. food 
supply.
    In addition, CFSAN is working with the Western Center for Food 
Safety at the University of California Davis to focus on the interface 
between food protection and the agricultural production of commodities. 
FDA has met with the National Academy of Sciences and discussed a 
statement of work for a comprehensive study of the gaps in public 
health protection provided by the United States' food safety system. In 
addition, FDA issued a Request for Applications for forming rapid 
response teams. Also, the Office of Crisis Management will hire two new 
FTEs with the fiscal year 2008 appropriation to assist FDA in quickly 
responding to food safety threats.
    Question. You said as part of your statement that during the past 
year that FDA has expanded its capacity to detect radiological 
contamination of food by 150 percent. We discussed at length last year 
the importance of being able to identify contaminants in the food 
supply as quickly as possible and provided money for those activities--
can you further discuss your achievements in that regard?
    Answer. In fiscal year 2007, FDA, through the Food Emergency 
Response Network, also known as FERN, awarded cooperative agreement 
grants to three additional State FERN radiological laboratories. These 
three labs increased the number of FDA's FERN cooperative agreement 
radiological laboratories to five. This is the basis of the statistic 
that FDA expanded its capacity to detect radiological contamination of 
food by 150 percent.
    These five labs are geographically distributed and uniformly 
equipped with the latest detection equipment for responding to 
radiological contamination in foods. The cooperative agreements also 
provide funds to purchase reagents, supplies, and personnel. The model 
used for the development of these laboratories follows that of the FERN 
chemistry cooperative agreement labs. State FERN chemistry labs are 
fully equipped and trained to run FDA's FERN chemistry methods that are 
used to screen large numbers of samples. FDA used the FERN chemistry 
cooperative agreement labs very successfully to identify melamine 
contamination. FERN labs screened large numbers of plant protein 
samples in a short time frame.
    The radiological labs participate in Federal and State surveillance 
sampling programs to monitor the food supply, and are involved in 
developing and validating contamination detection methods. Using FERN 
rapid screening methods, the labs also serve to dramatically increase 
the surge capacity of the laboratory network to respond to terrorist 
attack or a national emergency involving the food supply. The increased 
capacity to rapidly test large numbers of samples of foods that may be 
radiologically contaminated allows FDA's FERN laboratories to respond 
quickly to food supply events to protect public health and mitigate 
disruption of the distribution of important foods.

                          FIELD EXAMS/SAMPLES

    Question. The budget States that FDA plans to perform additional 
20,000 import field exams for food this year, but at the same time, the 
percent of import lines physically examined is going to decrease from 
the 2007 level. I know the number of import lines is growing rapidly, 
but this is a perfect example of your budget not keeping up with your 
mission. What does a ``field exam'' actually entail, and why is the 
percentage of imports physically examined actually decreasing?
    Answer. As displayed in the fiscal year 2009 Congressional 
Justification (CJ), import physical exams are the total of import field 
exams and import laboratory sample analyses. A field exam is a visual 
examination of food to determine whether it complies with FDA 
requirements. The field exam involves actual physical examination of 
the food for admissibility factors such as storage or in transit 
damage, inadequate refrigeration, rodent or insect activity, lead in 
dinnerware, odor, and compliance with labeling requirement. A field 
exam cannot be used to test for microbiological or chemical 
contamination. As a result, FDA also conducts import sampling and 
analysis to test for such contamination.
    In fiscal year 2009, FDA plans to perform an additional 20,000 
import food field exams and an additional 75 food import lab sample 
analyses. In addition, FDA electronically screens all FDA-regulated 
products offered for import into the United States for a variety of 
risk factors. FDA electronically screens 100 percent of human food and 
animal feed prior notice submissions which are required for all food 
and feed imports.
    In fiscal year 2007, the percent of import lines examined was 1.28 
percent. For fiscal year 2008, FDA estimates that it will examine 1.13 
percent of import lines. For fiscal year 2009, the estimate rises to 
1.26 percent. Between fiscal year 2007 and fiscal year 2009, FDA is 
experiencing a decline in the percent of import lines physically 
examined at the same time that the number of import field exams is 
increasing due to the rapidly rising volume of food imports.
    FDA will continue to focus resources on products that pose the 
highest potential risks to the United States. The benefit of physical 
exams comes from the quality and targeting of review activities, not 
from the volume of imports analyzed. The quality of import screening is 
a better measure of FDA's import strategy than simply focusing on the 
number of items physically examined.

                       THIRD PARTY CERTIFICATIONS

    Question. The Food Protection Plan mentions in several places FDA's 
interest in expanding third-party certifications for domestic and 
international inspections and examinations. How would these work, and 
why is it cheaper than having FDA employees actually do the work?
    Answer. The universe of domestic and foreign food establishments 
subject to FDA inspection is immense and is expected to see continued 
rapid growth. Third party certification programs, when correctly 
designed and implemented, allow FDA to accredit independent third 
parties, or to recognize entities that accredit third parties. FDA 
plans to use information gathered from third party inspections to 
evaluate compliance with FDA requirements and to allocate inspection 
resources more effectively. This would allow FDA to gather more 
information about manufacturers, especially foreign manufacturers, in a 
much more resource efficient way. Using third party certification 
programs allows FDA to leverage and benefit from the inspections 
conducted by others. FDA is working to develop standards that a 
certification organization must meet to receive FDA recognition.

                             GENERIC DRUGS

    Question. In your statement, you note that in fiscal year 2007, 
generic drug approvals or tentative approvals increased by 30 percent 
over the previous year, even though it's taking longer, on average, to 
approve a generic. If the generic drug user fees you propose in your 
budget are not adopted by the authorizing committee, how much of an 
increase in funding for generic drug approval do you think would be 
necessary to continue making gains?
    Answer. The increased resources recently provided by Congress have 
enabled FDA to hire more scientific review staff and achieve a 33 
percent increase in the number of approvals and tentative approvals--
from a total of 510 in fiscal year 2006 to 682 in fiscal year 2007.
    In both fiscal year 2008 and fiscal year 2009, we hope to remain 
near the fiscal year 2007 performance level with a target of 700 ANDA 
approvals and tentative approvals, a slight increase over the 682 
approval actions in fiscal year 2007.
    A key performance measure of our generic application review process 
is the total number of ANDA actions, which include ``approvals,'' 
``tentative approvals,'' ``not approvables,'' and ``approvable'' 
actions. Under the fiscal year 2009 President's budget, we expect to be 
able to increase the number of total ANDA actions to 1900, an increase 
of 7 percent over fiscal year 2008 and fiscal year 2007.
    We expect to be able to continue making performance gains in the 
generic drug review process with additional funding. Additional 
resources, like those envisioned under a user fee program, would give 
us additional staff enabling us to decrease ANDA action time, possibly 
resulting in more actions taken on ANDAs in a given year. Under such a 
program we would establish a new performance measurement structure 
around review performance targets, similar to the user fee program for 
new drug applications. We would also plan to use resources to increase 
our capacity to address other critical activities that are part of a 
complete generic drug review. This includes the scientific and legal 
components, and conduct of pre-approval inspections to ensure that 
manufacturing processes and facilities--often located in foreign 
countries--will deliver drug products that meet our quality standards. 
We recognize, however, that it would take a few years to ramp up such a 
program in order for us to see significant performance gains.

                         MEDICAL PRODUCT SAFETY

    Question. Could you update us on your progress in this area?
    Answer. FDA plans to use the funding increase for the Medical 
Product Safety and Development Initiative to support priority 
activities in the Biologics, Human Drugs, Device and Radiological 
Health, and Animal Drugs and Feed Programs.
    In the Biologics Program, the resources in this initiative will 
allow FDA to strengthen essential infrastructure, including laboratory 
capacity and review expertise to prevent, detect, and respond to 
emerging safety threats in blood and blood products.
    In the Biologics Program, the resources in this initiative will 
also allow FDA to strengthen medical and microbiologic review and 
acquire greater epidemiologic expertise to conduct adverse event 
analysis and safety investigations. FDA will also improve tissue safety 
by conducting workshops to educate industry about tissue processing and 
tissue safety technologies.
    In the Device and Radiological Health Program, FDA will strengthen 
import safety by improving the ability of the ORA field operations to 
work on import issues with Customs and Border Protection and other 
agencies. FDA will also leverage information from other sources to 
conduct stronger risk-based entry review of medical devices.
    In the Animal Drugs and Feed Program, the resources in this 
initiative will allow FDA to provide grants to stimulate development of 
new animal drugs under the Minor Use and Minor Species Animal Health 
Act of 2004.

                          DRUG SAFETY--IMPORTS

    Question. In your statement, you note that the volume of drugs 
imported into the United States will likely increase by 12 percent 
during fiscal year 2009, but your budget for the Human Drugs Program--
not including user fees--is only increasing by 1.3 percent. If you add 
in user fees, the increase is 8.5 percent. And this money is mostly for 
approving drugs, not monitoring them. How will you keep up?
    Answer. FDA will continue to apply a risk-based approach to 
identify drug production and distribution activities of greatest 
concern, and focus resources on those activities. In addition, FDA is 
working to design an integrated drug registration and listing system 
that provides comprehensive, accurate, and up-to-date information. This 
system must cover each entity that produces and distributes drugs, each 
drug product that these entities produce and distribute, and each 
participant in the product's chain of custody--from manufacturing, 
through shipping and importation, to final distribution. Every 
participant in the drug production and distribution system, including 
excipient and component suppliers, active pharmaceutical ingredient 
suppliers, and finished dosage manufacturers must be known to FDA and 
responsible for the supply chain that precedes them and the quality of 
their products.

                            MERCURY TESTING

    Question. Although FDA laboratory tests for element violations, 
including mercury, have declined by about 30 percent between 2003 and 
2006, and the number of positive tests has declined to zero in 2005 and 
2006, FDA issued a warning on eating fish, especially tuna fish, 
because of mercury contamination.
     Why did FDA alert consumers to mercury poisoning risks in fish and 
at the same time reduce the number of tests for mercury and other metal 
in imported fish?
    Answer. FDA's advisory to pregnant women, women who might become 
pregnant, nursing mothers, and young children is designed to ensure 
that fetuses and young children are not excessively exposed to 
methylmercury. According to the Centers for Disease Control and 
Prevention National Health and Nutrition Examination Survey, also known 
as NHANES, more than 95 percent of women of childbearing age are 
exposed to methylmercury below thresholds of safety designed to protect 
the fetus. Per NHANES, the remaining women still retain margins of 
safety. In effect, the advisory recommends that, as a matter of 
prudence, these remaining women increase their margins of safety. FDA 
is completing a risk assessment to better understand the risk to these 
individuals and to the population as a whole.
    Because NHANES data identify the extent to which Americans are 
exposed to methylmercury, FDA's sampling program is primarily designed 
to learn the range of methylmercury concentrations in commercial fish 
species, including the highest and lowest concentrations and the mean 
concentration. We can then compare new results against these known 
values. In recent years, all our samples have been within the known 
ranges.
    FDA uses sampling results to predict how exposures to methylmercury 
would be affected by changes in fish consumption. After the consumer 
advisory published in 2004, FDA increased its annual sampling levels to 
ensure the safety of fish consumption. After FDA completed this 
testing, and based on the results of this testing, FDA testing levels 
returned to levels that reflected the rate of sampling that FDA 
conducted prior to issuing the advisory.

                          FOOD PROTECTION PLAN

    Question. On February 7, 2008, FSIS officials wrote to officials at 
FDA offering to free up FSIS inspection dollars to assist in the FDA 
Food Protection Plan. How did FDA respond to this letter?
    Answer. On February 7, 2008, FSIS officials wrote to officials at 
FDA and stated, ``FSIS personnel may be available to help provide 
coverage as an effective governmental presence in the riskiest FDA 
plants.'' In a February 21, 2008 letter, FSIS officials clarified, 
``this statement was not meant to suggest the FSIS employees would 
definitely be available to do this work. In point of fact, we have no 
reason to believe at this time, that any of the initiatives that we are 
undertaking will result in employees being available to provide 
inspection at FDA plants.'' In light of the clarification that FSIS 
provided, FDA did not respond to the letter in writing. Instead, FDA is 
conducting regular monthly meetings with FSIS on how to best leverage 
resources and work cooperatively to ensure a safe food supply for all 
Americans.

                                ESTRIOL

    Question. On January 9, 2008, FDA announced that it was banning the 
use of estriol in compounded estrogens prescribed for decades by 
doctors for the treatment of menopause symptoms in women. Please 
provide the committee with documentation of specific adverse events 
from the use of estriol during the past three decades, as well as 
details of specific scientific and medical research supporting the 
FDA's decision to ban estriol.
    Answer. FDA has not banned estriol. Our January 9, 2008 action was 
aimed at false and misleading claims of certain compounding pharmacies 
that offer estriol products without a valid investigational new drug 
application, also known as an IND. Except in rare instances, 
compounding pharmacies do not report adverse events to FDA. However, 
the absence of evidence of a risk does not demonstrate the absence of 
the risk. One of the reasons we are encouraging IND submissions for 
estriol products is so that we will receive any adverse event 
information for these products.
    Question. How many women are potentially affected by the FDA 
decision to ban estriol? What does the FDA estimate it will cost these 
women to return to their doctors and get a prescription for an 
alternative treatment?
    Answer. FDA does not know how many women are potentially affected 
by FDA's decision to require health care practitioners to obtain INDs 
for compound estriol products. This is due, in part, to the fact that 
FDA has imperfect information about both the number of compounding 
pharmacies and the scope of pharmacy compounding operations. In 
general, there is no requirement for pharmacies to register or list 
with FDA.
    We do not have information about the costs that women incur in 
connection with compounded or approved estrogen therapies. However, 
because healthcare providers can continue to treat patients under an 
FDA-sanctioned IND, FDA does not believe there is a need for women to 
return to their health care providers for alternative new prescriptions 
and treatments when they are receiving estrogen therapy under an FDA-
sanctioned IND.
    Question. I understand that the FDA action on estriol will not 
restrict access to this medication as a doctor can continue to 
prescribe estriol if he or she files an investigational new drug 
application (IND). FDA has further indicated that it is developing a 
simplified or streamlined IND for doctors. Can you give the committee 
specific information on this issue, including detailed information on 
the proposed simplified process, including if the development of this 
simplified process would be subject to notice and comment rulemaking?
    Answer. Your understanding is correct. No drug containing estriol 
has been approved by FDA, and the safety and effectiveness of estriol 
is unknown. Therefore, physicians may not prescribe estriol, and 
pharmacies may not compound drugs under a physician's prescription that 
contain estriol, unless they have an FDA-sanctioned IND application.
    An IND is an application submitted by a physician who both 
initiates and conducts an investigation, and under whose immediate 
direction the investigational drug is administered or dispensed. A 
physician might submit an IND to propose studying an unapproved drug, 
or for an approved product to study use in a new indication or in a new 
patient population.
    Regulations describing the IND requirements can be found at 21 CFR 
312, and detailed instructions for IND applications can be found on the 
FDA website. FDA also provides pre-IND consultations and assistance in 
developing applications.
    An IND must generally contain information in three broad areas: 
Animal Pharmacology and Toxicology Studies, Manufacturing Information, 
and Clinical Protocol and Investigator information. In the clinical 
protocol section, the Investigator must also give a commitment to 
obtain informed consent from the research subjects, obtain review of 
the study by an institutional review board and agree to adhere to the 
IND regulations.
    We would like to clarify that there is no official streamlined or 
simplified IND process; however, we use our discretion in determining 
how much and what type of information is appropriate for an 
application. For example, in the case of estriol, preclinical animal 
toxicology and pharmacology data might not be necessary because the 
product has already been used in humans. INDs can cover research 
involving several patients, so that a physician need not submit 
separate INDs for individual patients. These types of decisions in 
evaluating IND applications would not be made through the rule-making 
process.
    Question. If the FDA's assertion is correct, and an IND process can 
be developed that is simple and that will not discourage physicians 
from writing prescriptions containing estriol, can you estimate how 
many doctors would submit the simplified IND? Since the FDA is required 
to review every application for an IND, can you also estimate the cost 
and time required for the FDA to review these submissions, and the 
effect this would have on the agency's ability to process other INDs?
    Answer. As FDA does not know how many women are potentially 
affected by FDA's decision, we cannot estimate how many doctors would 
submit an IND. Without knowing how many INDs the FDA will receive we 
cannot estimate the total cost and time required for the FDA to review 
these submissions, nor how it would affect FDA's ability to process 
other INDs.
    Question. INDs require well-controlled, randomized clinical studies 
including a placebo or control arm. Is the FDA suggesting that some 
women would receive a placebo without their knowledge?
    Answer. INDs do not require that well-controlled, randomized 
clinical studies be conducted. One of the objectives of the IND 
requirement is to help assure the safety and rights of subjects. There 
are various ways for conducting clinical trials, and not all methods 
require use of placebo controls. FDA is not suggesting that a woman 
would receive a placebo, and certainly not without informed consent 
which would inform her of that possibility.

                                REPORTS

    Question. Please provide monthly updates on the status of all 
outstanding reports requested as part of the report accompanying Public 
Law 110-161.
    Answer. I will be happy to provide a status report of all 
outstanding reports.
    [The information follows:]

------------------------------------------------------------------------
                  REPORT                               STATUS
------------------------------------------------------------------------
BSE.......................................  Transmitted to Congress
                                             5.20.08
Diacetyl..................................  Transmitted to Congress
                                             3.25.08
Folic.....................................  Transmitted to Congress
                                             5.20.08
Food Safety Quarterly (1st Q).............  In Clearance Process
Food Safety Quarterly (2nd Q).............  HHS Awaiting FDA Draft
Foreign Drugs (Interim)...................  In Clearance Process
Foreign Drugs (Final).....................  In Clearance Process
Front Label Symbols.......................  In Clearance Process
GAO Recommendations.......................  In Clearance Process
Ketek.....................................  In Clearance Process
Mammography IOM Recommendations...........  In Clearance Process
Med Guide.................................  Not due until Dec 08
Methamphetamine...........................  Transmitted to Congress
                                             4.22.08
Microbial Resistance......................  Transmitted to Congress
                                             1.2.08
National Research Initiative..............  In Clearance Process
OIG Recommendations.......................  In Clearance Process
Post Marketing Studies....................  In Clearance Process
Removing Food Safety from GAO High Risk     In Clearance Process
 List.
Women's Health (Quarter 1)................  Transmitted to Congress
                                             4.14.08
Women's Health (Quarter 2)................  HHS Awaiting FDA Draft
------------------------------------------------------------------------

          POST-MARKET SURVEILLANCE OF SILICONE BREAST IMPLANTS

    Question. When the FDA approved the use of silicone breast implants 
in 2006, I understand that it included a requirement that all women who 
receive these implants must participate in a post-approval study to 
ensure that these implants were safe. However, I understand that 
participation in these studies is now discretionary. What is the status 
of the post-market safety studies of silicone breast implants, and what 
authority does FDA have to require that manufacturers conduct the 
studies?
    Answer. When the FDA approved the use of silicone breast implants 
in 2006, FDA required Mentor Corporation and Inamed Corporation, which 
is now named Allergan, to conduct post approval studies, also known as 
PAS, to answer particular questions. FDA allowed the companies the 
opportunity to develop different study designs and other protocol 
elements to meet this requirement. The goals were to design studies 
that would minimize bias in the study results and in which the subject 
enrollment goals could be achieved. The participation could be 
voluntary or mandatory. The companies proposed the specific study 
designs to answer those questions and submitted them for FDA approval. 
Allergan proposed, and FDA approved, a study with voluntary 
participation. Mentor originally proposed, and FDA approved, a study 
where participation was mandatory in order for women to obtain the 
Mentor product.
    In April 2007 FDA approved Mentor's request to amend the 
MemoryGelTM Large Post-Approval Study protocol to allow for 
voluntary instead of mandatory participation of study subjects to 
address concerns regarding enrollment.
    The status of Allergan's and Mentor's postmarket studies of 
silicone breast implants and conditions is summarized in a table that I 
would be happy to provide for the record.
    [The information follows:]

STATUS OF ALLERGAN'S AND MENTOR CORPORATION'S SILICONE GEL-FILLED BREAST
                IMPLANT POSTMARKET STUDIES AND CONDITIONS
------------------------------------------------------------------------
       Approval Condition              Allergan             Mentor
------------------------------------------------------------------------
Core Post-Approval Study........  Reporting status:   Reporting status:
                                   On time \2\.        On time 2
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Large Post-Approval Study.......  Reporting status:   Reporting status:
                                   On time \1\.        On time \1\
                                  Study Status:       Study Status: On
                                   Overdue \3\ (12-    time \3\
                                   month patient
                                   enrollment target
                                   was not met).
Device Failure Studies..........  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Focus Group Study...............  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Informed Decision Process.......  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Adjunct Study...................  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
------------------------------------------------------------------------
\1\ Reporting status for Larger Post-Approval Study is ``On time'' if 15-
  month report was received by the February 16, 2008 due date.
\2\ Reporting status is ``on time'' if 12-month report for a post-
  approval study other than the Larger Post-Approval Study was received
  by November 17, 2007 due date.
\3\ Study progress status for a post-approval study condition is ``On
  time'' if patient enrollment and follow-up targets have been met and
  ``Overdue'' if the interim enrollment target was not met.

    FDA may require that manufacturers conduct studies under 21 CFR 
section 814.82 or 21 CFR Part 822.

                                 MDUFMA

    Question. As you know, the President's budget calls for increased 
funding for the medical device user fee program, and the Congress has 
provided inflationary increases to fully fund the program in the past. 
How the agency is doing in regards to meeting the performance goals 
associated with the user fee program with the funding it has gotten to 
date?
    Answer. FDA continues to succeed in improving the process for the 
review of medical device applications and meeting the performance goals 
first established under the Medical Device User Fee and Modernization 
Act of 2002, known as MDUFMA. Title II of the Food and Drug 
Administration Amendments Act of 2007 continued MDUFMA performance 
goals.
    MDUFMA requires close collaboration with stakeholders and increased 
communication with applicants. FDA is working to clarify its regulatory 
requirements and make its decisions more transparent through new 
guidance, educational materials, and meetings. We continually seek to 
enhance the efficiency and flexibility of our review processes. These 
efforts help applicants improve the quality of their submissions, and 
help FDA provide timelier, better-focused reviews. Our ultimate 
objective is to make important new medical devices available to 
patients and healthcare providers earlier, while continuing to ensure 
the quality, safety, and effectiveness of those devices.
    I would be happy to provide for the record a table that summarizes 
FDA's performance on the goals established for the fiscal year 2003-
fiscal year 2007 receipt cohorts, showing results achieved through 
March 31, 2008. The goals applicable to the fiscal year 2008 receipt 
cohort have been in place for only 6 months, so it is too early for 
statistical measures to provide useful insights into our progress 
towards achieving those goals. FDA has, however, taken action to ensure 
that we are well positioned to achieve the goals for fiscal year 2008-
fiscal year 2012. FDA is developing and implementing a new interactive 
review process that will contribute to better communication with 
applicants and more rapid resolution of review questions.
    [The information follows:]

                                                 QUARTERLY REPORT ON PROGRESS TOWARDS ACHIEVING MEDICAL DEVICE PERFORMANCE GOALS SUMMARY TABLES
                                                                         [Actions through March 31, 2008--Data for FDA]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Performance Goals and Actual Performance to Date
                                                                                   -------------------------------------------------------------------------------------------------------------
                                                                                      Fiscal Year 2003      Fiscal Year 2004      Fiscal Year 2005      Fiscal Year 2006      Fiscal Year 2007
                    Activity                              Review Time Goal         -------------------------------------------------------------------------------------------------------------
                                                                                                 Actual                Actual      Goal      Actual      Goal      Actual      Goal      Actual
                                                                                       Goal     Percent      Goal     Percent    Percent    Percent    Percent    Percent    Percent    Percent
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMAs, Panel-Track Supplements, Premarket
 Reports:
    FDA decision (approval, approvable,          320 days.........................  .........       91.8  .........       91.7  .........       87.7         80       83.7         90        100
     approvable pending GMP inspection, not
     approvable.
    FDA decision--Percent within 180 days......  180 days.........................  .........       44.9  .........       37.5  .........       29.8  .........       36.7         50       41.2
Expedited PMAs:
    FDA decision (approval, approvable,          300 days.........................  .........        100  .........       92.3         70       83.3         80        100         90  .........
     approvable pending GMP inspection not
     approvable.
180-day PMA Supplements:
    FDA decision (approval, approvable,          180 days.........................  .........       94.1  .........       95.3         80       95.0         80       97.0         90       92.8
     approvable pending GMP inspection not
     approvable.
510(k)s:
    FDA decision (SE/NSE)......................  90 days..........................  .........       76.1  .........       83.9         75       91.1         75       91.6         80       92.7
Biologics Licensing Applications (BLAs):
    Review and act on standard original BLAs     10 months........................  .........  .........  .........        100  .........        100         75       97.7         90       97.7
     (issue ``complete action'' letter).
    Review and act on priority ordinal BLA       6 months.........................  .........  .........  .........  .........  .........  .........         75  .........         90  .........
     submissions (issue ``complete action''
     letter).
BLA Supplements:
    Review and act on standard BLA efficacy      10 months........................  .........        100  .........  .........  .........  .........         75  .........         90  .........
     supplements (issue ``complete action''
     letter).
    Review and act on priority BLA efficacy      6 months.........................  .........  .........  .........  .........  .........  .........         75  .........         90  .........
     supplements (issue ``complete action''
     letter).
    Review and act on BLA manufacturing          4 months.........................  .........  .........  .........  .........  .........  .........         75  .........         90  .........
     supplements that require prior approval
     (issue ``complete action'' letter).
BLA Resubmissions, BLA Supplement
 Resubmissions:
    Review and act on a Class I resubmission to  2 months.........................  .........  .........  .........  .........         75        100         80  .........         90        100
     an original BLA or BLA efficacy supplement
     (issue ``complete action'' letter).
    Review and act on a Class 2 resubmission to  6 months.........................  .........        100  .........         80         75        100         80        100         90        100
     an original BLA or BLA efficacy supplement
     (issue ``complete action'' letter).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Question. What criteria does the agency use to determine the 
allocation and priority for the distribution of any increase in staff 
across FDA components, including offices, divisions, or branches 
resulting from the medical device user fees and related Congressional 
appropriations?
    Answer. The Food and Drug Administration Amendments Act of 2007, 
known as FDAAA, was signed into law on September 27, 2007. FDAAA 
reauthorized FDA's authority to collect fees from the medical device 
industry under the Medical Device User Fee and Modernization Act, also 
known as MDUFMA. The activities that comprise the medical device review 
process are defined in MDUFMA. Medical device review components within 
FDA receive increased allocations from device user fee collections, as 
defined by MDUFMA.
    FDA allocates medical device user fees and other medical device 
appropriations to best achieve FDA's public health objectives, device 
performance goals, and other expectations established under MDUFMA, as 
amended. The allocation between the Center for Devices and Radiological 
Health (CDRH) and the Center for Biologics Evaluation and Research 
(CBER) is based on the workload balance between the two centers. FDA 
estimates the percent of the device review workload performed by CDRH 
and CBER, and allocates MDUFMA resources accordingly. Field resources 
are allocated among FDA district offices by the Office of Regulatory 
Affairs according to each district's projected workload. The Centers 
and ORA apportion their individual resource allocations to their 
offices, divisions, and branches.

                            ADDITIONAL TOOLS

    Question. Despite the increased funding the FDA has received over 
the last 5 years in appropriations and user fees to hire more FTEs, we 
know the demands on staff remain very high. I am aware that there are 
additional tools, such as third party reviews, third party inspections, 
and the CDRH fellowship program to augment the work of the Agency. Can 
you discuss benefits and/or shortfalls of these programs?
    Answer. These three programs--third-party review of 510(k) 
premarket notifications, third-party establishment inspections, and the 
Medical Device Fellowship Program--provide FDA with important tools 
that can help us better achieve our public health objectives.
    The purpose of the program permitting third-party review of certain 
510(k) premarket notifications is to improve the efficiency and 
timeliness of FDA's 510(k) process. This is the process by which most 
medical devices receive marketing clearance in the United States. Under 
the program, FDA has accredited third-parties that are authorized to 
conduct the primary review of 510(k)s for eligible devices. Persons who 
are required to submit 510(k)s for these devices may elect to contract 
with an Accredited Person and submit a 510(k) directly to the 
Accredited Person. The Accredited Person conducts the primary review of 
the 510(k), then forwards its review, recommendation, and the 510(k) to 
FDA. By law, FDA must issue a final determination within 30 days after 
receiving the recommendation of an Accredited Person. 510(k) submitters 
who do not wish to use an Accredited Person may submit their 510(k)s 
directly to FDA. FDA data shows that third-party reviews are somewhat 
more rapid than an FDA review in some instances. Third-party 510(k)s 
submitted to FDA are also exempt from any medical device user fee that 
would otherwise apply.
    As of April 15, 2008, FDA has accredited 16 third-party 
organizations to conduct quality systems inspections of certain medical 
device establishments. Individuals from eight of these organizations 
have completed FDA's training requirements and FDA has cleared these 
individuals to conduct independent inspections. Through April 15, 2008, 
accredited organizations have conducted six inspections. Although few 
inspections have been conducted to date, changes specified by the Food 
and Drug Administration Amendments Act of 2007, also known as FDAAA, 
have the potential to eliminate certain obstacles to manufacturers' 
participation in FDA's programs for inspections by accredited third 
parties.
    CDRH established the Medical Device Fellowship Program, also known 
as MDFP, to increase the range and depth of collaborations between CDRH 
and the outside scientific community. The MDFP offers short and long-
term fellowship opportunities for individuals interested in learning 
about the regulatory process and sharing their knowledge and experience 
in the many specialized fields that concern medical devices. Physicians 
with clinical or surgical expertise, engineers in biomedical, 
mechanical, electrical and software areas, and individuals from many 
other scientific disciplines have participated in the fellowship 
program. Opportunities are available for students in many other areas 
as well. This collaboration improves FDA's review processes, postmarket 
surveillance, and science base, all of which contribute to efforts to 
ensure patients and health care professionals have timely and continued 
access to safe and effective medical devices.

                          GUIDANCE DEVELOPMENT

    Question. The rules and processes for FDA regulatory decision-
making are necessarily complex. Since it is not possible for FDA and 
Congress to anticipate every situation in statute and regulation, the 
issuance of guidance documents by FDA is essential to helping industry 
keep abreast of current agency thinking. Given that lack of adequate 
guidance often results in the need for meetings with submitters, extra 
rounds of submissions, and other inefficiencies, do you believe that 
putting up-front resources into guidance development will reap 
efficiency and provide industry with broad access to FDA thinking on a 
timely and meaningful basis?
    Answer. The agency makes extensive use of guidances to the extent 
possible. FDA's Good Guidance Practices have been in effect for more 
than 7 years. Under Good Guidance Practices, FDA centers made available 
draft and final guidance documents, for comment and use, covering a 
broad spectrum of topics. These guidances include technical guidances 
that may recommend the best means for producing clinical trial data. 
FDA guidances also include non-technical guidances, called Level 1 
guidances that provide more complex scientific information or provide 
initial interpretations of statutory and regulatory requirements. 
During 2007, we published 95 Federal Register Notices alerting the 
public to the availability of draft and final guidances. While the 
recommendations in the guidances are not legally binding, these 
recommendations do provide the agency's current thinking on an issue to 
industry and the public. FDA believes that the guidances that we issue 
are very useful and that resources that FDA devotes to developing 
guidances are a worthwhile investment.
                                 ______
                                 

            Questions Submitted by Senator Dianne Feinstein

                            FOOD SAFETY GAPS

    Question. As you are well aware, gaps in our food safety system 
have been exposed and people have become sick and worse have died from 
contaminated products like spinach and peanut butter. Yet, the Food and 
Drug Administration has only asked for a slight increase in funding for 
fiscal year 2009. With the increase in food imports, and the changing 
structure of our food supply system in the United States, I am 
concerned that the Food and Drug Administration (FDA) is neither 
prepared nor taking steps to adapt to the changes to be effective in 
protecting our food supply.
    Dr. von Eschenbach, can you tell me how many inspectors are 
currently employed at the Food and Drug Administration? What percentage 
is that of the total FDA workforce?
    Answer. In fiscal year 2008, the Office of Regulatory Affairs, also 
known as ORA, currently estimates that it will have 1,218 
investigators. Investigators represent approximately 12 percent of the 
total 9,975 FTE FDA workforce in fiscal year 2008.
    In fiscal year 2009, ORA currently estimates that it will have 
1,300 investigators. Investigators represent approximately 12 percent 
of the total 10,501 FTE FDA workforce in fiscal year 2009. It should be 
noted that the ORA hiring initiative is on-going in fiscal year 2008 
and that ORA is still developing hiring plans based on the fiscal year 
2009 requested increase. As a result, these figures are estimates and 
may change as hiring is completed.
    Question. Can you tell me how many inspectors currently employed at 
the Food and Drug Administration are dedicated solely to food 
inspection?
    Answer. In fiscal year 2008, ORA estimates 587 investigators will 
perform work in the Foods Program. Many field investigators are cross-
trained and may perform work in multiple programs as work priorities 
change or emergencies arise. For fiscal year 2009, ORA currently 
estimates that approximately 650 investigators will perform work in the 
Foods program. It should be noted that the ORA hiring initiative is on-
going in fiscal year 2008 and that ORA is still developing hiring plans 
based on the fiscal year 2009 requested increase. Consequently, these 
figures are estimates and may change as hiring is completed. Additional 
field staff in the foods program will support the fiscal year 2009 
performance increases of 20,000 additional import food field exams and 
50 additional foreign food inspections.
    Question. Where are the FDA inspectors located? Please be specific.
    Answer. ORA field staff are dispersed throughout the United States. 
More than 85 percent of ORA's staff works in five Regional Offices, 20 
District Offices, 13 Laboratories, and 168 Resident Posts and Border 
Stations. As a separate entity within ORA, Office of Criminal 
Investigations personnel are located throughout the field organization 
in 30 Field Offices, Resident Offices, and Domiciles, which are located 
throughout the U.S. FDA maintains offices and staff in Washington, 
D.C., the U.S. Virgin Islands, Puerto Rico, and in all States except 
Wyoming.
    I would be happy to provide a table that highlights this 
information. The information provided in the following table 
specifically provides ORA's geographic distribution of facilities which 
includes the locations of FDA investigators nationwide.
    [The information is attached.]

                                      GEOGRAPHIC DISTRIBUTION OF FACILITIES
----------------------------------------------------------------------------------------------------------------
        Building Name           Center              City                   State          OP DIV Subdivision
----------------------------------------------------------------------------------------------------------------
Resident Post--Mobile, AL....  ORA....  2100--MOBILE................  1--AL.........  SOUTHEAST (ATLANTA)
Resident Post--Montgomery, AL  ORA....  2130--MONTGOMERY............  1--AL.........  SOUTHEAST (ATLANTA)
Resident Post--Birmingham, AL  ORA....  350--BIRMINGHAM.............  1--AL.........  SOUTHEAST (ATLANTA)
Resident Post--Anchorage, AK.  ORA....  130--ANCHORAGE..............  2--AK.........  PACIFIC (OAKLAND)
Border Station--Nogales, AZ..  ORA....  330--NOGALES................  4--AZ.........  SOUTHWEST (DALLAS)
Border Station--Nogales, AZ..  ORA....  330--NOGALES................  4--AZ.........  SOUTHWEST (DALLAS)
Border Station--San Luis, AZ.  ORA....  417--SAN LUIS...............  4--AZ.........  SOUTHWEST (DALLAS)
Border Station--San Luis, AZ.  ORA....  417--SAN LUIS...............  4--AZ.........  SOUTHWEST (DALLAS)
Resident Post--Phoenix, AZ...  ORA....  490--TEMPE..................  4--AZ.........  SOUTHWEST (DALLAS)
Resident Post--Tucson, AZ....  ORA....  530--TUCSON.................  4--AZ.........  SOUTHWEST (DALLAS)
Resident Post--Little Rock,    ORA....  2320--LITTLE ROCK...........  5--AR.........  SOUTHWEST (DALLAS)
 AR.
District Office W/Lab--San     ORA....  10--ALAMEDA.................  6--CA.........  PACIFIC (OAKLAND)
 Francisco.
Border Station--Calexico, CA.  ORA....  520--CALEXICO...............  6--CA.........  PACIFIC (OAKLAND)
Border Station--Calexico, CA.  ORA....  520--CALEXICO...............  6--CA.........  PACIFIC (OAKLAND)
Resident Post--Fresno, CA....  ORA....  1370--FRESNO................  6--CA.........  PACIFIC (OAKLAND)
Irvine Regional Laboratory--   ORA....  1713--IRVINE................  6--CA.........  PACIFIC (OAKLAND)
 Security Gate House.
Resident Post--San Pedro, CA.  ORA....  1970--LONG BEACH/San Pedro..  6--CA.........  PACIFIC (OAKLAND)
Resident Post--Canoga Park,    ORA....  1970--CANOGA PARK...........  6--CA.........  PACIFIC (OAKLAND)
 CA.
Resident Post--Nisco Pacific   ORA....  810--COMPTON................  6--CA.........  PACIFIC (OAKLAND)
 Warehouse--Compton, CA.
Resident Post--LAX (El         ORA....  1980--LOS ANGELES...........  6--CA.........  PACIFIC (OAKLAND)
 Segundo).
Regional Field Office--        ORA....  2480--OAKLAND...............  6--CA.........  PACIFIC (OAKLAND)
 Pacific--Oakland.
Resident Post--Ontario, CA...  ORA....  2550--ONTARIO...............  6--CA.........  PACIFIC (OAKLAND)
Border Station--Otay Mesa, CA  ORA....  2610--OTAY..................  6--CA.........  PACIFIC (OAKLAND)
Resident Post--Sacramento, CA  ORA....  3150--SACRAMENTO............  6--CA.........  PACIFIC (OAKLAND)
Resident Post--Otay Mesa, CA.  ORA....  3260--SAN DIEGO.............  6--CA.........  PACIFIC (OAKLAND)
Resident Post--San Diego, CA.  ORA....  3260--SAN DIEGO.............  6--CA.........  PACIFIC (OAKLAND)
Resident Post--San Jose, CA..  ORA....  3340--SAN JOSE..............  6--CA.........  PACIFIC (OAKLAND)
Resident Post--San Francisco   ORA....  3730--SAN FRANCISCO.........  6--CA.........  PACIFIC (OAKLAND)
 Airport, CA.
Resident Post--Stockton, CA..  ORA....  3770--STOCKTON..............  6--CA.........  PACIFIC (OAKLAND)
Border Station--Tecate, CA...  ORA....  3835--TECATE................  6--CA.........  PACIFIC (OAKLAND)
Resident Post--Carson, CA....  ORA....  602--CARSON.................  6--CA.........  PACIFIC (OAKLAND)
District Office W/Lab--Denver  ORA....  600--DENVER.................  8--CO.........  SOUTHWEST (DALLAS)
Resident Post--Bridgeport, CT  ORA....  80--BRIDGEPORT..............  9--CT.........  NORTHEAST (NEW YORK)
Resident Post--Hartford, CT..  ORA....  280--HARTFORD...............  9--CT.........  NORTHEAST (NEW YORK)
Resident Post--Wilmington, DE  ORA....  490--WILMINGTON.............  10--DE........  CENTRAL (PHILADELPHIA)
Resident Post--Boca Raton, FL  ORA....  290--BOCA RATON.............  12--FL........  SOUTHEAST (ATLANTA)
Resident Post--Fort Myers, FL  ORA....  1070--FORT MYERS............  12--FL........  SOUTHEAST (ATLANTA)
Resident Post--Jacksonville,   ORA....  1510--JACKSONVILLE..........  12--FL........  SOUTHEAST (ATLANTA)
 FL.
District Office--Florida.....  ORA....  1895--MAITLAND..............  12--FL........  SOUTHEAST (ATLANTA)
Resident Post--Miami, FL--     ORA....  2010--MIAMI.................  12--FL........  SOUTHEAST (ATLANTA)
 Import.
Resident Post--Miami, FL--     ORA....  2010--MIAMI.................  12--FL........  SOUTHEAST (ATLANTA)
 Domestic.
Resident Post--Tallahassee,    ORA....  2940--TALLAHASSEE...........  12--FL........  SOUTHEAST (ATLANTA)
 FL.
Resident Post--Tampa, FL.....  ORA....  2950--TAMPA.................  12--FL........  SOUTHEAST (ATLANTA)
District/Region--Atlanta.....  ORA....  280--ATLANTA................  13--GA........  SOUTHEAST (ATLANTA)
Resident Post--Savannah, Ga..  ORA....  4910--SAVANNAH..............  13--GA........  SOUTHEAST (ATLANTA)
Resident Post--Tifton, GA....  ORA....  5490--TIFTON................  13--GA........  SOUTHEAST (ATLANTA)
Resident Post--Honolulu, HI..  ORA....  2400--HONOLULU..............  15--HI........  PACIFIC (OAKLAND)
Resident Post--Boise, ID.....  ORA....  160--BOISE..................  16--ID........  PACIFIC (OAKLAND)
Border Station- Eastport, ID.  ORA....  445--EASTPORT...............  16--ID........  PACIFIC (OAKLAND)
Resident Post--Bensenville,    ORA....  740--BENSENVILLE............  17--IL........  CENTRAL (CHICAGO)
 IL.
District Office--Chicago.....  ORA....  1670--CHICAGO...............  17--IL........  CENTRAL (CHICAGO)
Regional Field Office--        ORA....  1670--CHICAGO...............  17--IL........  CENTRAL (CHICAGO)
 Central--Chicago.
Resident Post--Gurnee, IL....  ORA....  3670--GURNEE................  17--IL........  CENTRAL (CHICAGO)
Resident Post--Hinsdale, IL..  ORA....  3980--HINSDALE..............  17--IL........  CENTRAL (CHICAGO)
Resident Post--Mount Vernon,   ORA....  5900--MT VERNON.............  17--IL........  CENTRAL (CHICAGO)
 IL.
Resident Post--Peroia, IL....  ORA....  6850--PEORIA................  17--IL........  CENTRAL (CHICAGO)
Resident Post--Springfield,    ORA....  8220--SPRINGFIELD...........  17--IL........  CENTRAL (CHICAGO)
 IL.
Resident Post--Evansville, IN  ORA....  1480--EVANSVILLE............  18--IN........  CENTRAL (CHICAGO)
Resident Post--Indianapolis,   ORA....  2210--INDIANAPOLIS..........  18--IN........  CENTRAL (CHICAGO)
 IN.
Resident Post--South Bend, IN  ORA....  4580--SOUTH BEND............  18--IN........  CENTRAL (CHICAGO)
Resident Post--Davenport, IA.  ORA....  2080--DAVENPORT.............  19--IA........  SOUTHWEST (DALLAS)
Resident Post--Des Moines, IA  ORA....  2260--DES MOINES............  19--IA........  SOUTHWEST (DALLAS)
Resident Post--Sioux City, IA  ORA....  7850--SIOUX CITY............  19--IA........  SOUTHWEST (DALLAS)
District Office--Kansas City.  ORA....  3080--LENEXA................  20--KS........  SOUTHWEST (DALLAS)
Resident Post--Wichita, KS...  ORA....  5880--WICHITA...............  20--KS........  SOUTHWEST (DALLAS)
Resident Post--Louisville, KY  ORA....  2090--LOUISVILLE............  21--KY........  CENTRAL (PHILADELPHIA)
Resident Post--Baton Rouge,    ORA....  150--BATON ROUGE............  22--LA........  SOUTHEAST (ATLANTA)
 LA.
Resident Post--Lafayette, LA.  ORA....  1230--LAFAYETTE.............  22--LA........  SOUTHEAST (ATLANTA)
Mandeville Square Shopping     ORA....  1400--MANDEVILLE............  22--LA........  SOUTHEAST (ATLANTA)
 Center.
Metairie Center..............  ORA....  1545--METAIRIE..............  22--LA........  SOUTHEAST (ATLANTA)
Resident Post--Shreveport, LA  ORA....  2130--SHREVEPORT............  22--LA........  SOUTHEAST (ATLANTA)
Resident Post--Augusta, Me...  ORA....  160--AUGUSTA................  23--ME........  NORTHEAST (NEW YORK)
Border Station--Calais, ME...  ORA....  1250--CALAIS................  23--ME........  NORTHEAST (NEW YORK)
Border Station--Houlton, ME..  ORA....  3750--HOULTON...............  23--ME........  NORTHEAST (NEW YORK)
Border Station--Houlton, ME..  ORA....  3750--HOULTON...............  23--ME........  NORTHEAST (NEW YORK)
District Office--Baltimore...  ORA....  50--BALTIMORE...............  24--MD........  CENTRAL (PHILADELPHIA)
Resident Post--Dundalk, MD--   ORA....  50--BALTIMORE...............  24--MD........  CENTRAL (PHILADELPHIA)
 Import.
District Office--New England.  ORA....  1275--STONEHAM..............  25--MA........  NORTHEAST (NEW YORK)
Resident Post--Worchester, MA  ORA....  1520--WORCESTER.............  25--MA........  NORTHEAST (NEW YORK)
Resident Post--Boston, MA....  ORA....  120--BOSTON.................  25--MA........  NORTHEAST (NEW YORK)
Detroit District Office--      ORA....  1260--DETROIT...............  26--MI........  CENTRAL (CHICAGO)
 Office.
Border Station--Detroit, MI..  ORA....  1260--DETROIT...............  26--MI........  CENTRAL (CHICAGO)
Resident Post--Grand Rapids,   ORA....  2010--GRAND RAPIDS..........  26--MI........  CENTRAL (CHICAGO)
 MI.
Resident Post--Kalamazoo, MI.  ORA....  2520--KALAMAZOO.............  26--MI........  CENTRAL (CHICAGO)
Border Station--Bluewater      ORA....  4060--PORT HURON............  26--MI........  CENTRAL (CHICAGO)
 Bridge, MI.
Border Station--Sault Ste      ORA....  4480--SAULT STE MARIE.......  26--MI........  CENTRAL (CHICAGO)
 Marie, MI.
Resident Post--International   ORA....  3480--INTERNATIONAL FALLS...  27--MN........  CENTRAL (CHICAGO)
 Falls, MN.
District Office--Minneapolis.  ORA....  4760--MINNEAPOLIS...........  27--MN........  CENTRAL (CHICAGO)
Resident Post--Jackson, MS...  ORA....  1220--JACKSON...............  28--MS........  SOUTHEAST (ATLANTA)
Resident Post--St Louis, MO..  ORA....  7080--ST LOUIS..............  29--MO........  SOUTHWEST (DALLAS)
Resident Post--Springfield,    ORA....  7460--SPRINGFIELD...........  29--MO........  SOUTHWEST (DALLAS)
 MO.
Resident Post--Helena MT.....  ORA....  590--HELENA.................  30--MT........  PACIFIC (OAKLAND)
Border Station--Sweetgrass,    ORA....  1125--SWEETGRASS............  30--MT........  PACIFIC (OAKLAND)
 MT.
Resident Post--Omaha, NE.....  ORA....  3620--OMAHA.................  31--NE........  SOUTHWEST (DALLAS)
Resident Post--Las Vegas, NV.  ORA....  120--LAS VEGAS..............  32--NV........  PACIFIC (OAKLAND)
Resident Post--Reno, NV......  ORA....  170--RENO...................  32--NV........  PACIFIC (OAKLAND)
Resident Post--Concord, NH...  ORA....  70--CONCORD.................  33--NH........  NORTHEAST (NEW YORK)
Resident Post--Elizabeth, NJ.  ORA....  860--ELIZABETH..............  34--NJ........  CENTRAL (PHILADELPHIA)
Resident Post--North           ORA....  2140--NORTH BRUNSWICK.......  34--NJ........  CENTRAL (PHILADELPHIA)
 Brunswick, NJ.
District Office--New Jersey..  ORA....  2498--PARSIPPANY............  34--NJ........  CENTRAL (PHILADELPHIA)
Resident Post--Voorhees, NJ..  ORA....  3465--VOORHEES..............  34--NJ........  CENTRAL (PHILADELPHIA)
Resident Post--Albuerque, NM.  ORA....  30--ALBUQUERQUE.............  35--NM........  SOUTHWEST (DALLAS)
Border Station--Columbus, NM.  ORA....  200--COLUMBUS...............  35--NM........  SOUTHWEST (DALLAS)
Border Station--Santa Teresa,  ORA....  735--SANTA TERESA...........  35--NM........  SOUTHWEST (DALLAS)
 NM.
Resident Post--Albany, NY....  ORA....  50--ALBANY..................  36--NY........  NORTHEAST (NEW YORK)
Border Station--Alexandria     ORA....  90--ALEXANDRIA BAY..........  36--NY........  NORTHEAST (NEW YORK)
 Bay, NY.
Resident Post--Binghamton, NY  ORA....  540--BINGHAMTON.............  36--NY........  NORTHEAST (NEW YORK)
Import Office--Buffalo, NY...  ORA....  750--BUFFALO................  36--NY........  NORTHEAST (NEW YORK)
Resident Post--Long Island,    ORA....  1050--CENTRAL ISLIP.........  36--NY........  NORTHEAST (NEW YORK)
 NY.
Border Station--Champlain, NY  ORA....  1080--CHAMPLAIN.............  36--NY........  NORTHEAST (NEW YORK)
Resident Post--New Windsor,    ORA....  4130--NEW WINDSOR...........  36--NY........  NORTHEAST (NEW YORK)
 NY.
District/Region/Regional Lab-- ORA....  4170--JAMAICA...............  36--NY........  NORTHEAST (NEW YORK)
 New York.
Border Station--Ogdensburg,    ORA....  4420--OGDENSBURG............  36--NY........  NORTHEAST (NEW YORK)
 NY.
Resident Post--Rochester, NY.  ORA....  5230--ROCHESTER.............  36--NY........  NORTHEAST (NEW YORK)
Border Station--Massena, NY..  ORA....  5275--ROOSEVELTOWN..........  36--NY........  NORTHEAST (NEW YORK)
Resident Post--Syracuse, NY..  ORA....  6010--SYRACUSE..............  36--NY........  NORTHEAST (NEW YORK)
Resident Post--White Plains,   ORA....  6670--WHITE PLAINS..........  36--NY........  NORTHEAST (NEW YORK)
 NY.
Border Station--Peace Bridge.  ORA....  750--BUFFALO................  36--NY........  NORTHEAST (NEW YORK)
Border Station--Lewiston       ORA....  3220--LEWISTON..............  36--NY........  NORTHEAST (NEW YORK)
 Bridge.
Resident Post--Arden, NC.....  ORA....  131--ARDEN..................  37--NC........  SOUTHEAST (ATLANTA)
Resident Post--Charlotte, NC.  ORA....  870--CHARLOTTE..............  37--NC........  SOUTHEAST (ATLANTA)
Resident Post--Greensboro, NC  ORA....  1940--GREENSBORO............  37--NC........  SOUTHEAST (ATLANTA)
Resident Post--Greenville, NC  ORA....  1950--GREENVILLE............  37--NC........  SOUTHEAST (ATLANTA)
Resident Post--Raleigh, NC...  ORA....  3750--RALEIGH...............  37--NC........  SOUTHEAST (ATLANTA)
Resident Post--Wilmington, NC  ORA....  5060--WILMINGTON............  37--NC........  SOUTHEAST (ATLANTA)
Resident Post--Fargo, ND.....  ORA....  1020--FARGO.................  38--ND........  CENTRAL (CHICAGO)
Border Station--Pembina, ND..  ORA....  2500--PEMBINA...............  38--ND........  CENTRAL (CHICAGO)
Resident Post--Brunswick, OH.  ORA....  1085--BRUNSWICK.............  39--OH........  CENTRAL (PHILADELPHIA)
District Office/Forensic       ORA....  1610--CINCINNATI............  39--OH........  CENTRAL (PHILADELPHIA)
 Chemistry--Cincinnati.
Resident Post--Columbus, OH..  ORA....  1800--COLUMBUS..............  39--OH........  CENTRAL (PHILADELPHIA)
Resident Post--Toledo, OH....  ORA....  8120--TOLEDO................  39--OH........  CENTRAL (PHILADELPHIA)
Resident Post--Oklahoma City,  ORA....  3550--OKLAHOMA CITY.........  40--OK........  SOUTHWEST (DALLAS)
 OK.
Resident Post--Tulsa, OK.....  ORA....  4780--TULSA.................  40--OK........  SOUTHWEST (DALLAS)
Resident Post--Beaverton, OR.  ORA....  180--BEAVERTON..............  41--OR........  PACIFIC (OAKLAND)
Resident Post--Portland        ORA....  1650--PORTLAND..............  41--OR........  PACIFIC (OAKLAND)
 Airport, OR.
Resident Post--Harrisburg, PA  ORA....  3500--HARRISBURG............  42--PA........  CENTRAL (PHILADELPHIA)
District Office/Region W/Lab-- ORA....  6540--PHILADELPHIA..........  42--PA........  CENTRAL (PHILADELPHIA)
 Philadelphia.
Resident Post--Pittsburgh, PA  ORA....  6600--PITTSBURGH............  42--PA........  CENTRAL (PHILADELPHIA)
Resident Post--Scranton, PA..  ORA....  7460--SCRANTON..............  42--PA........  CENTRAL (PHILADELPHIA)
Resident Post--Providence, RI  ORA....  57--EAST PROVIDENCE.........  44--RI........  NORTHEAST (NEW YORK)
Resident Post--Charleston, SC  ORA....  410--CHARLESTON.............  45--SC........  SOUTHEAST (ATLANTA)
Resident Post--Columbia, SC..  ORA....  520--COLUMBIA...............  45--SC........  SOUTHEAST (ATLANTA)
Resident Post--Greenville, SC  ORA....  1040--GREENVILLE............  45--SC........  SOUTHEAST (ATLANTA)
Resident Post--Sioux Falls,    ORA....  2450--SIOUX FALLS...........  46--SD........  CENTRAL (CHICAGO)
 SD.
Resident Post--Chattanooga,    ORA....  400--CHATTANOOGA............  47--TN........  SOUTHEAST (ATLANTA)
 TN.
Resident Post--Knoxville, TN.  ORA....  1300--KNOXVILLE.............  47--TN........  SOUTHEAST (ATLANTA)
Resident Post--Memphis, TN...  ORA....  1620--MEMPHIS...............  47--TN........  SOUTHEAST (ATLANTA)
District Office--Nashville...  ORA....  1760--NASHVILLE.............  47--TN........  SOUTHEAST (ATLANTA)
Resident Post--Memphis, TN...  ORA....  1620--MEMPHIS...............  47--TN........  SOUTHEAST (ATLANTA)
Resident Post--Austin, TX....  ORA....  330--AUSTIN.................  48--TX........  SOUTHWEST (DALLAS)
Border Station--Brownsville,   ORA....  940--BROWNSVILLE............  48--TX........  SOUTHWEST (DALLAS)
 TX.
Border Station--Los Tomates/   ORA....  940--BROWNSVILLE............  48--TX........  SOUTHWEST (DALLAS)
 Brownsville, TX.
Border Station--Los Tomates,   ORA....  940--BROWNSVILLE............  48--TX........  SOUTHWEST (DALLAS)
 TX.
District/Sw Imports--Dallas..  ORA....  1730--DALLAS................  48--TX........  SOUTHWEST (DALLAS)
Regional Office--Dallas, TX..  ORA....  1730--DALLAS................  48--TX........  SOUTHWEST (DALLAS)
Resident Post--DFW Airport,    ORA....  1730--DALLAS................  48--TX........  SOUTHWEST (DALLAS)
 TX (Grapevine).
Border Station--Del Rio, TX..  ORA....  1820--DEL RIO...............  48--TX........  SOUTHWEST (DALLAS)
Border Station--Eagle Pass,    ORA....  2030--EAGLE PASS............  48--TX........  SOUTHWEST (DALLAS)
 TX.
Border Station--Bota, TX (El   ORA....  2190--EL PASO...............  48--TX........  SOUTHWEST (DALLAS)
 Paso).
Resident Post--El Paso, TX...  ORA....  2190--EL PASO...............  48--TX........  SOUTHWEST (DALLAS)
Border Station--El Paso, TX..  ORA....  2190--EL PASO...............  48--TX........  SOUTHWEST (DALLAS)
Border Station--El Paso, TX..  ORA....  2190--EL PASO...............  48--TX........  SOUTHWEST (DALLAS)
Border Station--Ysletta, TX..  ORA....  2190--EL PASO...............  48--TX........  SOUTHWEST (DALLAS)
Resident Post--Fort Worth, TX  ORA....  2450--FORT WORTH............  48--TX........  SOUTHWEST (DALLAS)
Resident Post--Houston, TX...  ORA....  3280--HOUSTON...............  48--TX........  SOUTHWEST (DALLAS)
Border Station--USBS Columbia  ORA....  3899--LAREDO................  48--TX........  SOUTHWEST (DALLAS)
 Import Dock, Laredo, TX.
Border Station--USBS J&L       ORA....  3899--LAREDO................  48--TX........  SOUTHWEST (DALLAS)
 Bldg. 2 Admin.
Border Station--Laredo World   ORA....  3899--LAREDO................  48--TX........  SOUTHWEST (DALLAS)
 Trade Bridge, TX.
Border Station--Pharr, TX....  ORA....  5330--PHARR.................  48--TX........  SOUTHWEST (DALLAS)
Border Station--Pharr, TX....  ORA....  5330--PHARR.................  48--TX........  SOUTHWEST (DALLAS)
Border Station--Rio Grande     ORA....  5780--RIO GRANDE CITY.......  48--TX........  SOUTHWEST (DALLAS)
 City, TX.
Resident Post--San Antonio,    ORA....  6090--SAN ANTONIO...........  48--TX........  SOUTHWEST (DALLAS)
 TX.
Resident Post--Salt Lake       ORA....  1700--SALT LAKE CITY........  49--UT........  SOUTHWEST (DALLAS)
 City, UT.
Border Station--Highgate       ORA....  245--HIGHGATE SPRINGS.......  50--VT........  NORTHEAST (NEW YORK)
 Springs, VT.
Resident Post--Falls Church,   ORA....  930--FALLS CHURCH...........  51--VA........  CENTRAL (PHILADELPHIA)
 VA.
Resident Post--Norfolk, VA--   ORA....  1760--NORFOLK...............  51--VA........  CENTRAL (PHILADELPHIA)
 Import.
Resident Post--Norfolk, VA--   ORA....  1760--NORFOLK...............  51--VA........  CENTRAL (PHILADELPHIA)
 Import.
Resident Post--Richmond, VA..  ORA....  2060--RICHMOND..............  51--VA........  CENTRAL (PHILADELPHIA)
Resident Post--Roanoke VA....  ORA....  2100--ROANOKE...............  51--VA........  CENTRAL (PHILADELPHIA)
Prior Notice Center..........  ORA....  2034--RESTON................  51--VA........  HEADQUARTERS
Border Station--Blaine, WA...  ORA....  150--BLAINE.................  53--WA........  PACIFIC (OAKLAND)
District Office/Regional Lab-- ORA....  170--BOTHELL................  53--WA........  PACIFIC (OAKLAND)
 Seattle.
Resident Post--Oroville, WA..  ORA....  1610--OROVILLE..............  53--WA........  PACIFIC (OAKLAND)
Resident Post--Seattle, WA...  ORA....  1960--SEATTLE...............  53--WA........  PACIFIC (OAKLAND)
Resident Post--Spokane         ORA....  2110--SPOKANE VALLEY........  53--WA........  PACIFIC (OAKLAND)
 Valley, WA.
Resident Post--Tacoma, WA....  ORA....  2230--TACOMA................  53--WA........  PACIFIC (OAKLAND)
Resident Post--Morgantown, WV  ORA....  1840--MORGANTOWN............  54--WV........  CENTRAL (PHILADELPHIA)
Resident Post--Green Bay, WI.  ORA....  2000--GREEN BAY.............  55--WI........  CENTRAL (CHICAGO)
Resident Post--Madison, WI...  ORA....  2780--MADISON...............  55--WI........  CENTRAL (CHICAGO)
Resident Post--Wauwatosa, WI.  ORA....  5130--WAUWATOSA.............  55--WI........  CENTRAL (CHICAGO)
Resident Post--Aguada, PR....  ORA....  20--AGUADA..................  RQ--PR........  SOUTHEAST (ATLANTA)
Resident Post--Ponce, PR.....  ORA....  760--PONCE..................  RQ--PR........  SOUTHEAST (ATLANTA)
San Juan--New Administration   ORA....  930--SAN JUAN...............  RQ--PR........  SOUTHEAST (ATLANTA)
 Building.
Resident Post--St. Thomas, VI  ORA....  900--ST. THOMAS.............  VQ--VI........  SOUTHEAST (ATLANTA)
Parklawn Building--Rockville,  ORA....  5600--Rockville.............  MD............  24--MD HEADQUARTERS
 Maryland.
----------------------------------------------------------------------------------------------------------------

    Question. Who inspects FDA regulated products if no FDA inspector 
is present at a port where products are being imported?
    Answer. FDA has commissioned approximately 9,900 Customs and Border 
Protection, also known as CBP, employees to inspect food shipments that 
require prior notice data submission under the provisions of the 
Bioterrorism Act if FDA is not present to do so. However, regarding the 
admissibility of all FDA regulated commodities, much of FDA's work in 
screening and inspecting import shipments occurs at locations other 
than ports of entry.
    Entry data for shipments of FDA-regulated products are transmitted 
electronically by CBP to FDA. FDA screens each entry line 
electronically against certain criteria for admissibility. Many of the 
shipments of FDA-regulated products are designated by the electronic 
screening system for admissibility review by FDA employees.
    Entry reviewers often request additional documentation from the 
importers to determine if a product should be allowed entry or should 
be set up for examination. The reviewers allocate inspectional 
resources to best cover products that appear to pose the highest risk. 
The remaining products are allowed to proceed without examination.
    With the exception of truck ports, most entry reviewers are located 
in district offices and resident posts, not at the port of entry. They 
may review entries for a dozen or more ports. The entry reviewers issue 
assignments to investigators requesting a field examination and/or 
sampling to be conducted on specific import entries.
    If the shipment arrives when FDA is not present, unless 
specifically instructed to hold the shipment at the port for FDA's 
examination, CBP will issue a conditional release of the cargo and 
allow it to move to its destination. Such movement is done under bond 
and is permitted under Section 801(b) of the Food, Drug, and Cosmetic 
Act. If FDA decides to physically examine these goods, the work will be 
performed at the destination of the goods.
    Question. If non-FDA inspectors are conducting inspections, what 
and how much training have they been given to inspect food?
    Answer. By the phrase non-FDA inspectors, we assume that you are 
referring to inspections conducted by State personnel under contract 
with FDA. State personnel that conduct these inspections attend ORA 
sponsored inspection training courses with ORA personnel and receive 
the same training courses as ORA investigators. State personnel also 
receive on-the-job training by FDA. For example, State personnel join 
FDA investigators on FDA inspections as observers. To conduct 
inspections on behalf of FDA, State personnel attend the same training 
courses, participate in joint training inspections, and then perform an 
inspection in which they are audited by FDA. After State inspectors 
pass the initial field audit, they are re-audited over a 3-year cycle. 
In addition, State personnel have access to online training courses 
developed by ORA-University. These courses serve as classroom courses 
and continuing education.
    FDA is also implementing the Manufactured Food Regulatory Program 
Standards under which the State will assess its program against a set 
of uniform standards. The uniform standards are the key elements of a 
State program, such as regulatory foundation, staff training, risk 
based inspections, quality assurance, foodborne illness/defense 
preparedness and rapid response, compliance and enforcement, education 
and outreach, resource management, and laboratory resources.
    In addition to receiving FDA provided training, the State 
inspectors must also meet their individual State requirements to 
conduct food inspections.
    Question. According to the Congressional Research Service, the FDA 
inspects only about 1 percent of all FDA regulated imports. Does this 1 
percent include both paper and physical inspections? If not, how much 
of FDA regulated imports get physical inspections?
    Answer. As displayed in the fiscal year 2009 Congressional 
Justification, or CJ, import physical exams are the total of import 
field exams and import laboratory sample analyses. A field examination 
is a visual examination of the product to determine whether the product 
complies with FDA requirements. It involves actual physical examination 
of the product for admissibility factors such as storage or in transit 
damage, inadequate refrigeration, rodent or insect activity, lead in 
dinnerware, odor and label compliance. A field exam cannot be used to 
test for microbiological or chemical contamination. As a result, FDA 
also conducts sampling and analysis to test for such contamination. 
Based on the fiscal year 2009 CJ, 0.82 percent of imports will be 
physically examined in fiscal year 2009.
    In addition, FDA electronically screens all FDA-regulated products 
offered for import into the United States. FDA also electronically 
screens 100 percent of human food and animal feed import prior notice 
submissions and, as targeted, based on risk, performs intensive manual 
reviews on a subset of those prior notices.
    FDA will continue to focus resources on products that pose the 
highest potential bioterrorism risks to the United States. The benefit 
of physical exams comes from the quality and targeting of review 
activities, not from the volume of imports analyzed. The quality of 
import screening is a better measure of FDA's import strategy than 
simply focusing on the items physically examined.
    Prior Notice Security Reviews are only performed on human food and 
animal feed imported products and are performed as a requirement of the 
Bioterrorism Act which requires human food and animal feed importers to 
give FDA ``prior notice'' of their imported product being offered for 
entry into the U.S. Prior Notice Security Reviews are performed by 
Prior Notice Center Reviewers using electronic databases, law 
enforcement data and other information sources to determine whether or 
not the shipment poses a significant security risk to the United States 
food supply. A significant difference between a field exam and the 
Prior Notice Security Review is that the Prior Notice Security Review 
is conducted on food and animal feed products ``only'' while a field 
exam is conducted on all FDA regulated products. Field exams are 
physical examinations of an imported product while Prior Notice 
Security Reviews use electronic data bases to assess security threats.
    Question. What is the budget in FDA for food safety oversight and 
how is that broken down between the budget spent on domestic and 
imported food safety oversight and inspection?
    Answer. Rather than trying to inspect all imports, FDA recommends 
targeted risk-based inspections to focus resources where they are most 
needed and will provide the greatest benefit to American consumers. ORA 
resources for food safety oversight in the fiscal year 2009 
Congressional Justification include $358.1 million in the Field Foods 
program and $37 million in the Field Animal Drugs and Feeds program. 
These figures represent ORA's food protection resources for both human 
and animal food. In the Field Foods program, approximately 45 percent 
of these resources are allocated to domestic food safety oversight and 
inspection. The remaining 55 percent are allocated to import and 
foreign food safety oversight and inspection. In the Field Animal Drugs 
and Feeds program, approximately 78 percent of these resources are 
allocated to domestic food safety oversight and inspection. The 
remaining 22 percent of these resources are allocated to import and 
foreign food safety oversight and inspection.
    Question. How many inspectors are needed to handle the volume of 
foods being imported? What would that cost?
    Answer. The fiscal year 2009 Congressional Justification estimates 
that ORA will physically examine approximately 1.26 percent of food 
imports. The physical exam percentage is a combination of import field 
exams and import laboratory samples analyzed. In fiscal year 2009, ORA 
estimates allocating approximately 305 FTE and $50 million to perform 
the import food field exams and collect food import samples for 
analyses. This estimate does not include laboratory resources to 
analyze the import samples. Also, this figure does not include 
resources to electronically review the imported products that are not 
physically examined, as well as resources for the Prior Notice Center. 
Finally, these numbers do not include Center or Agency overhead costs.
    Funding increases requested in the fiscal year 2009 CJ will allow 
ORA to perform an additional 20,000 import food field exams, as well as 
50 additional foreign food inspections, and an additional 75 food 
import lab sample analyses.
    Question. How many inspectors are needed by product line to handle 
the volume of all FDA regulated imports?
    Answer. Rather than trying to inspect all imports, FDA recommends 
targeted risk-based inspections to focus resources where they are most 
needed and will provide the greatest benefit to American consumers. 
Because FDA recommends a targeted risk-based approach to inspections 
rather than inspecting 100 percent of FDA-regulated products, we have 
not estimated the cost of inspecting all imported foods. The fiscal 
year 2009 Congressional Justification (CJ) estimates that ORA will 
physically examine approximately 0.82 percent of all FDA-regulated 
imported products. This includes foods, cosmetics, human drugs, 
biologics, animal drugs and feeds, and medical device and radiological 
health imported products. The physical exam percentage is a combination 
of import field exams and import laboratory samples analyzed. In fiscal 
year 2009, ORA estimates allocating approximately 351 FTE and $57.5 
million to perform the import field exams and collect import samples 
for analyses across all field program areas. This estimate does not 
include laboratory resources to analyze the import samples. Also, this 
figure does not include resources to electronically review the imported 
products that are not physically examined, as well as resources for the 
Prior Notice Center. Finally, these numbers do not include Center or 
Agency overhead costs.
    Question. What level of funding is needed to handle all the volume 
of FDA regulated imports?
    Answer. Rather than trying to inspect all imports, FDA recommends 
targeted risk-based inspections to focus resources where they are most 
needed and will provide the greatest benefit to American consumers. 
Because FDA recommends a targeted risk-based approach to inspections 
rather than inspecting 100 percent of FDA-regulated products, we have 
not estimated the cost of inspecting all FDA-regulated imports. The 
fiscal year 2009 Congressional Justification estimates that ORA will 
physically examine approximately 0.82 percent of all FDA-regulated 
imported products. This includes foods, cosmetics, human drugs, 
biologics, animal drugs and feeds, and medical device and radiological 
health imported products. The physical exam percentage is a combination 
of import field exams and import laboratory samples analyzed. In fiscal 
year 2009, ORA estimates allocating approximately 351 FTE and $57.5 
million to perform the import field exams and collect import samples 
for analyses across all field program areas. This estimate does not 
include laboratory resources to analyze the import samples. Also, this 
figure does not include resources to electronically review the imported 
products that are not physically examined, as well as resources for the 
Prior Notice Center. Finally, these numbers do not include Center or 
Agency overhead costs.
    Funding increases requested for fiscal year 2009 in the Field Drugs 
Program will increase the Office of Criminal Investigations capacity to 
investigate criminal import violations. Funding increases requested in 
the Field Device Program will be directed towards the improvement of 
strategic information-sharing between FDA and regulatory partners, such 
as U.S. Customs and Border Protection. This activity directly supports 
intervention recommendations made by the Interagency Working Group on 
Import Safety in the Import Safety Action Plan.
    Question. What level of funding is needed to handle all other FDA 
regulated activities outside of imports?
    Answer. Rather than trying to inspect all imports, FDA recommends 
targeted risk-based inspections to focus resources where they are most 
needed and will provide the greatest benefit to American consumers. 
Because FDA recommends a targeted risk-based approach to inspections 
rather than inspecting 100 percent of FDA-regulated products, we have 
not estimated the cost of inspecting FDA-regulated products that are 
not imported. With the requested funding in the fiscal year 2009 
Congressional Justification, the Office of Regulatory Affairs estimates 
that it will allocate $200.7 million and 1,224 FTE for FDA domestic 
inspections in fiscal year 2009 and award $15.7 million to the States 
for State contract inspections. These resources will allow ORA to 
inspect approximately 24 percent of the domestic inventory for which 
the Field has a recurring inspectional obligation. The domestic 
inventory estimate includes firms in all five field program areas: 
Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Devices and 
Radiological Health. The inventory estimate includes firm types such as 
manufacturers, repackers, relabelers, warehouses, blood banks, and 
bioresearch monitoring facilities. This estimate does not include 
mammography facilities because all mammography facilities are inspected 
annually using user fee funds. Finally, these funding estimates do not 
include Center or Agency overhead costs.
    Question. Why does the OASIS database not accurately track volume 
or make it easily to ascertain the volume of goods coming from a given 
country?
    Answer. There are three primary ways to measure the amounts of 
imported goods: declared value, quantity, as measured by weight, 
volume, or piece count, and count of entry lines. None of these 
measures is ideal. Importers are not required to provide FDA with 
either the value or the quantity of goods in an entry line, and often 
they do not. When quantity data are provided, entry filers sometimes 
make significant errors. Those errors can badly distort aggregate data. 
Entry lines can be counted precisely, but the value and quantity of the 
goods in any given line can vary enormously.
    FDA uses the count of entry lines as the best available option. For 
the reasons given above, aggregation of data on declared value or 
quantity is not feasible.
    Question. To protect the public from food borne illness from both 
domestic and imported products, what is the FDA doing to change the way 
it does business?
    Answer. In November 2007, FDA released the Food Protection Plan, 
also known as the FPP, to address both food safety and food defense for 
domestic and imported products. The plan is integrated with the 
Administration's Import Safety Action Plan. The FPP is an integrated 
strategy that focuses on risks over a product's life cycle from 
production to consumption. The FPP targets resources to achieve maximum 
risk reduction and address both unintentional and deliberate 
contamination. The FPP relies on science and modern technology systems.
    FDA was granted direct hire authority in April 2008 and will hire 
161 new FTEs to work in food safety. The Office of Regulatory Affairs 
has completed a 3-year plan to increase State inspections and will hire 
77 new FTEs with the fiscal year 2008 appropriation and an additional 
53 new FTE with funds from the Consolidated Appropriations Act, 2008, 
which will be available on July 1, 2008 to conduct food field exams, 
inspections, and sample collections. The Center for Food Safety and 
Applied Nutrition will hire one new FTE with the fiscal year 2008 
appropriation and will hire an additional 28 new FTEs with the funds 
from the Consolidated Appropriations Act, 2008, which will be available 
on July 1, 2008 to assist with food safety work aimed at protecting the 
Nation's imported and domestic food supply from both unintentional and 
deliberate contamination. The Office of Crisis Management will hire two 
new FTEs with the fiscal year 2008 appropriation to assist FDA in 
quickly responding to food safety threats. In addition, FDA is focusing 
on the interface between food protection and the agricultural 
production of commodities. FDA officials have also met with the 
National Academy of Science and discussed a statement of work for a 
comprehensive study of the gaps in public health protection provided by 
the United State's food safety system.

                            BREAST IMPLANTS

    Question. The Food and Drug Administration approved silicone gel 
breast implants, manufactured by Mentor, in November 2006. This 
approval came with rigorous post approval conditions, including 
mandatory enrollment in longitudinal studies.
    Following the approval of silicone gel breast implants manufactured 
by Allegan, the FDA made this enrollment in longitudinal studies 
optional.
     What is the reason for this change? What specific data was 
presented to justify this change?
    Answer. In November 2006, both Allergan and Mentor Corporation 
received FDA approval to market their silicone gel-filled breast 
implants in the United States, subject to requirements to conduct post 
approval studies, also known as PAS, to answer particular questions. 
FDA allowed the companies the opportunity to develop different study 
designs and other protocol elements to meet this requirement. The goals 
were to design studies that would minimize bias in the study results 
and in which the subject enrollment goals could be achieved. The 
participation could be voluntary or mandatory. The companies proposed 
the specific study designs to answer those questions and submitted them 
for FDA approval. Allergan proposed, and FDA approved, a study with 
voluntary participation, while Mentor originally proposed, and FDA 
approved, a study where participation was mandatory in order for women 
to obtain the Mentor product.
    In April 2007 FDA approved Mentor's request to amend the 
MemoryGelTM Large Post-Approval Study protocol to allow for 
voluntary instead of mandatory participation of study subjects. 
Mentor's request reported that the company received many complaints 
from Institutional Review Boards--IRBs, hospitals, and other 
institutions, questioning the appropriateness of requiring patients to 
become subjects in a PAS in order to receive an approved device. Mentor 
indicated that mandatory PAS participation might not be consistent with 
standard PAS practice, and that several complainants indicated that in 
keeping with good clinical practice, patient participation should be 
voluntary. The concerns had also made it difficult for Mentor to obtain 
the IRB approval required to commence the study at a number of sites, 
slowing overall progress of the study.
    Based on FDA's assessment of the supplement and principles of good 
study design, FDA approved the amendment to the MemoryGelTM 
Large Post-Approval Study protocol which changed the enrollment type 
from mandatory to voluntary and thus allows women access to this 
approved device without requiring participation in a research study. 
The change increases participation of women who meet the PAS inclusion 
criteria by eliminating barriers to IRB approval and patient 
enrollment.
    The key points underlying FDA's decision are as follows. First, 
there is no scientific rationale for requiring mandatory subject 
participation. Mandatory and voluntary subject participation were 
acceptable alternative approaches to design the PAS. Second, 
participation in the post-approval study for Allergan's comparable 
silicone gel-filled breast implants is voluntary. Third, Mentor's 
request to allow voluntary participation of women who receive the 
MemoryGelTM implant is acceptable as an alternative study 
design and is justified to allow women access to this approved device 
without requiring participation in a research study and to potentially 
increase participation of women who meet the PAS inclusion criteria. 
Fourth, IRB participation and support is critical for the success of 
the Post-Approval Studies Program. In the silicone breast implant 
studies, the role of IRBs is even more important because the studies 
are long-term and involve tens of thousands of subjects.
    Question. How many patients are currently enrolled in longitudinal 
studies of silicone gel breast implants made by Allegan and Mentor? 
What percentage of women who have received implants since the November 
2006 approval are enrolled in these studies?
    Answer. FDA believes this information about enrollment in ongoing 
studies is confidential commercial information protected from public 
disclosure by statute and regulation. It cannot be disclosed for the 
record absent permission from the companies. We apologize for any 
inconvenience this may cause. FDA does not have information regarding 
the percentage of women who have received implants since the November 
2006 approval that are enrolled in these studies.
    Question. What other changes have been made to the post approval 
study requirements?
    Answer. In May 2007, FDA approved a protocol change for the Large 
Post-Approval Study, requested by Mentor, that allows the company to 
enroll Canadian patients who receive the MemoryGel silicone breast 
implant in addition to the U.S. study participants. The November 17, 
2006, approval order states that Mentor will enroll in this study. 
Mentor requested this protocol change to meet Health Canada's post-
approval conditions for the MemoryGel Silicone gel-filled Breast 
Implant. Mentor will use the FDA MemoryGel PAS protocol for the 
Canadian MemoryGel participants. The sponsor plans to perform the 
analysis twice, once on all study participants and a second time based 
only on U.S. study participants.
    Question. Are Mentor and Allergan currently in full compliance with 
the post approval requirements?
    Answer. The status of Allergan's and Mentor's postmarket studies of 
silicone breast implants and conditions is summarized in a table that I 
am pleased to provide for the record. Both Mentor Corporation and 
Allergan started enrolling patients in February 2007 as required by 
their respective approval orders and both firms have complied with the 
reporting requirements. The table below identifies the status of 
individual approval conditions that Allergan and Mentor must meet.
    [The information follows:]

STATUS OF ALLERGAN'S AND MENTOR CORPORATION'S SILICONE GEL-FILLED BREAST
                IMPLANT POSTMARKET STUDIES AND CONDITIONS
------------------------------------------------------------------------
       Approval Condition              Allergan             Mentor
------------------------------------------------------------------------
Core Post-Approval Study........  Reporting status:   Reporting status:
                                   On time \2\.        On time 2
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Large Post-Approval Study.......  Reporting status:   Reporting status:
                                   On time \1\.        On time \1\
                                  Study Status:       Study Status: On
                                   Overdue \3\ (12-    time \3\
                                   month patient
                                   enrollment target
                                   was not met).
Device Failure Studies..........  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Focus Group Study...............  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Informed Decision Process.......  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
Adjunct Study...................  Reporting status:   Reporting status:
                                   On time \2\.        On time \2\
                                  Study Status: On    Study Status: On
                                   time \3\.           time \3\
------------------------------------------------------------------------
\1\ Reporting status for Larger Post-Approval Study is ``On time'' if 15-
  month report was received by the February 16, 2008 due date.
\2\ Reporting status is ``on time'' if 12-month report for a post-
  approval study other than the Larger Post-Approval Study was received
  by November 17, 2007 due date.
\3\ Study progress status for a post-approval study condition is ``On
  time'' if patient enrollment and follow-up targets have been met and
  ``Overdue'' if the interim enrollment target was not met.

    Question. Based on the post approval data already reported by 
Mentor and Allergan, what findings has the FDA made regarding the 
safety of silicone gel breast implants?
    Answer. FDA's review of the 12-month reports submitted by Allergan 
and Mentor for the six conditions of approval indicates that the 
results regarding the safety of the silicone gel breast implants 
presented in these reports are consistent with the data available at 
the time of approval. The studies are continuing to allow FDA to 
evaluate long-term device safety.
    Question. Does the FDA have the necessary resources to enforce 
these post-approval requirements?
    Answer. In 2005, CDRH transferred the responsibility for post-
approval study oversight from the premarket staff of the Office of 
Device Evaluation and the Office of In Vitro Diagnostics to the 
postmarket staff of the Office of Surveillance and Biometrics, also 
known as OSB.
    The fiscal year 2003-2005 cohort approval commitments for the 
silicone breast implants focuses on three areas: ensuring the 
timeliness of the study execution, ensuring that the FDA-approved 
protocols are properly implemented, and making sure that the studies 
are progressing well and provide meaningful results that can guide 
regulatory actions.
    OSB has two project managers who are fully dedicated to overseeing 
manufacturer compliance with post-approval study commitments. They 
enable OSB to acknowledge receipt of study reports, monitor compliance 
with reporting requirements, and contact the manufacturer when the 
reports are not received as scheduled.
    In 2006, OSB instituted an automated tracking system to monitor PAS 
study commitments. The project managers use this tracking system to 
make sure manufacturers send PAS study progress reports on time and 
that we review these reports in a timely manner.
    Two OSB epidemiologists serve as the lead reviewers for post-
approval commitments and review the study reports to make sure the 
studies are progressing well. A multi-disciplinary post market team of 
scientists is available as consultants to the epidemiologists.
    The FDA Post-Approval Studies Website went live in April 2007. The 
site documents the status of PAS studies for the two implants. A user 
can search for information by the device name or manufacturer and view 
a description of the study, the reporting schedule, and status of the 
studies--such as whether the study is On Time or Overdue. The site is 
maintained by the project managers for Post-Approval Studies and 
updated once a month. I would be happy to provide the website address.
    [The information follows:]
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/
pma_pas.cfm.
                                 ______
                                 

            Questions Submitted by Senator Robert F. Bennett

                 HEPARIN AND DRUG FACILITY INSPECTIONS

    Question. Dr. von Eschenbach, the recent recall of the blood 
thinning drug Heparin has opened our eyes to some possible gaps in the 
agency's inspection processes. The recall has been particularly 
troubling because FDA has tied 62 deaths directly to the use of 
contaminated Heparin. The Chinese company that prepared the 
contaminated ingredient should have been inspected by FDA before 
product approval, but it was not. FDA stated that the agency thought 
the company had been inspected, but realized after the recall started 
that it had not received the required pre-approval inspection. The 
reason the company was not inspected is because the company's name is 
similar to another facility in China that had passed FDA inspection. 
FDA admits that the agency confused the names of the facilities on the 
drug application.
    Can you help me understand how something like this could happen? I 
understand that manufacturers of active drug ingredients must be 
inspected prior to drug approval, how does FDA miss one?
    Answer. Under section 505 of the Federal Food, Drug, and Cosmetic 
Act, prior to approval of a new drug application, abbreviated new drug 
application, or certain manufacturing supplements, FDA determines that 
the methods used in, and the facilities and controls used for, the 
manufacture, processing, and packing of the applicant's drug are 
adequate to preserve the drug's identity, strength, quality, and 
purity. Our policy has been, and continues to be that we approve drugs 
after verifying that this standard is met based upon a recent 
inspection of the manufacturing facility or facilities named in the 
application. If we have a recent, satisfactory inspection on record for 
a given facility named in the application, we generally will not 
conduct a new pre-approval inspection of that facility prior to 
approving the application. However, even if there is a recent 
inspection, we will inspect again if we determine that the 
circumstances warrant it.
    In this situation, FDA learned in January 2008 that Baxter received 
FDA approval to use the active pharmaceutical ingredient (API) 
manufacturer, Changzhou SPL in Changzhou, China, although FDA did not 
conduct a pre-approval inspection of the plant. The plant subsequently 
shipped product to Baxter. As FDA has acknowledged, FDA's failure to 
inspect the plant was the result of human error. FDA staff entering 
data into a database confused the name of the Changzhou plant with 
another plant that had a similar name and had been previously 
inspected.
    Question. What are you doing to make sure this doesn't happen 
again?
    Answer. Process improvements in CDER are already underway that will 
prevent future data entry errors like this. These improvements include 
additional training for those who perform data entry on which 
inspection assignments hinge, hiring new staff dedicated to this data 
entry, and putting procedures in place that will provide FDA with the 
necessary data from drug manufacturers in a user-friendly way. In 
addition, efforts are underway to centralize all FDA's Information 
Technology, or IT, systems to meet the challenges of the FDA in the 
21st century. Coupled with resource planning and development 
activities, FDA's Office of Information Management has undertaken 
detailed succession planning to ensure that the IT organization that 
FDA is building for the 21st century remains reliable in support of 
FDA's mission and is sufficiently flexible to accommodate the science 
and technology advances of the future.
    Question. In media calls, the agency stated that the mix-up 
occurred because the company in question has a name similar to another 
Chinese company that had previously passed FDA inspection. From what 
I've heard, it appears that manufacturers of active drug ingredients 
are identified by name and not by some standardized system, for 
instance, numerically. Why? Do you think they should be identified 
using a standardized system?
    Answer. A unique numerical identifier for each registered facility 
can be helpful for assuring FDA that the firm is the same entity of 
record in FDA databases, that the physical location of the facility is 
valid, and that the firm is still engaged in FDA-regulated business. 
Unique identifiers already in use at FDA, such as the Firm 
Establishment Indicator number, or FEI, could be used for these 
validation purposes. However, the FEI falls short of providing high-
quality validation because it is not implemented with a rigorous 
validation protocol. For example, inter-agency computer applications 
can lead to the creation of new FEIs during importations when 
information is conflicting or missing. Having a unique identifier is 
useful only if the software and policy procedures use it for rigorous 
validation.
    Although FDA has an ongoing effort to strengthen its own identity 
validation software, there are benefits of partnering with third party 
organizations that are in the business of uniquely identifying and 
collecting business information on companies. First, the commercial 
firms succeed by maintaining high-quality firm identifiers (including 
address) and business information. When a firm terminates business, the 
identifier is no longer valid. Second, the third party business 
databases offer rapid validation tools electronically. Finally, the 
third party databases provide business relationships not routinely 
visible to FDA that are often an aid during supply chain and other 
investigations.

                       FDA INTERNATIONAL OFFICES

    Question. Currently, close to 15 percent of the food consumed in 
the United States is imported and the percentage is rising every year. 
In addition, the volume of prescription drugs imported into the United 
States is expected to increase by 12 percent during fiscal year 2009. 
It is clear that the global marketplace is having a significant impact 
on the products regulated by FDA. And, FDA currently does not have any 
staff located abroad.
    In the fiscal year 2009 budget, FDA States that it will establish 
an office in China to better protect consumers from unsafe products. In 
addition, the fiscal year 2008 appropriations bill provided funding to 
increase domestic and import food inspectors, including international 
inspectors. I understand you've been working with the Chinese 
government to have employees stationed there.
    What is the status of these discussions? When do you believe the 
first FDA employees will be stationed in China? And, how many employees 
do you expect will be stationed there?
    Answer. The discussions with the Chinese Government concerning 
stationing FDA employees there are being handled by the U.S. Embassy. 
However, Secretary Leavitt and I have had discussions with their 
Chinese counterparts, who have signaled support. At this point, we are 
waiting for the Ministry of Foreign Affairs to endorse the proposal.
    FDA has received approval from the Department of State to station 
eight employees in China. FDA expects that it will station the first 
FDA employee, the Country Director for the FDA Office, in Beijing by 
the end of calendar year 2008. FDA also plans to make additional hires 
for China offices during 2009.
    Question. You have mentioned in public statements that China is not 
the only country FDA would like to place employees. In what other 
countries are you looking to locate employees, and have you begun 
negotiations with those countries?
    Answer. FDA has agreements in place and we are making final 
arrangements for offices in China. FDA has conducted general 
discussions about FDA foreign offices with India and Jordan.

                          OVERALL FDA FUNDING

    Question. Many people have said that FDA needs more money, 
including FDA's own Science Board. Specifically, the Science Board said 
that ``FDA can no longer fulfill its mission without substantial and 
sustained additional appropriations.'' The Science Board suggested that 
an increase of $375 million in fiscal year 2009 is necessary to help 
FDA fulfill its mission.
    Dr. von Eschenbach, you appear to agree with the notion that FDA 
needs more money. In an interview with the Wall Street Journal earlier 
this year, you said ``to do what [FDA] needs to do requires 
substantially more dollars than what has been invested in the FDA thus 
far.'' You also go on to state you wanted more out of the budget 
process this year than what finally ended up in the budget request.
    While $375 million in 1 year may be more than we can come up with, 
this subcommittee is determined to help FDA in any way it can.
    What do you think of the Science Board's assessment?
    Answer. On December 3, 2007, the FDA Science Board accepted the 
report of its subcommittee entitled, ``FDA Science and Mission at 
Risk.'' The subcommittee report reveals a number of areas that 
recommend increased investment. FDA takes this report seriously. The 
need to improve science at FDA is not in question. Nor is there any 
question that we must make a significant investment in improving the 
science.
    FDA is keenly aware that we must develop comprehensive solutions to 
face an ever-changing scientific and technological landscape. We look 
forward to working with Congress and other stakeholders to strengthen 
the scientific base at FDA and ensure that in the next 100 years, FDA 
retains its reputation and preeminence as the gold standard through the 
use of cutting edge science and technology.
    Question. Does FDA need more money than is requested in the 
President's budget?
    Answer. FDA's fiscal year 2009 budget request of an additional 
$50.7 million in budget authority and $78.9 million in user fees for 
programs to protect America's food supply and for medical product 
safety and development reflects the competing priorities the President 
and the President's advisors must consider as budget submissions to the 
Congress are developed. In light of these competing priorities, FDA's 
fiscal year 2009 budget request is the amount designated to allow FDA 
to achieve its public health priorities.
    Question. How much would you suggest is necessary in fiscal year 
2009 to help FDA meet its demands and which program areas would benefit 
most from additional resources?
    Answer. The following document is an assessment of immediate 
resource needs based on a professional judgment analysis, without 
regard to the competing priorities that the agency, the President, and 
the President's advisors must consider as budget submissions to the 
Congress are developed. As the response indicates, the amounts 
identified are in addition to amounts appropriated to FDA in fiscal 
year 2008.
    [The information is attached.]

           FDA FISCAL YEAR 2009 PROFESSIONAL JUDGMENT ESTIMATE
                          [Dollars in millions]
------------------------------------------------------------------------
                                            Fiscal year
                                               2009             FTE
------------------------------------------------------------------------
Food Protection.........................            $125             259
Safer Drugs, Devices, and Biologics.....             100             160
Modernizing FDA Science and Workforce...              50              71
                                         -------------------------------
      Total.............................             275             490
------------------------------------------------------------------------

    The amounts identified in this document support three strategic 
investment areas--protecting our food supply, assuring safer drugs, 
devices, and biologics, and modernizing the essential infrastructure of 
FDA's science and workforce. The amounts are in addition to amounts 
appropriated to FDA in fiscal year 2008. Investing in these three 
strategic areas will permit FDA to rapidly achieve important public 
health goals that cut across strategic components of the Agency.
    This document responds to the request for the FDA's professional 
judgment concerning resource needs. The document and was developed 
without regard to the competing priorities that the President and his 
advisors must consider as budget submissions to the Congress are 
developed.

                   FDA FISCAL YEAR 2009 BUDGET AMENDMENT: FOOD PROTECTION PLAN (+$125 MILLION)
----------------------------------------------------------------------------------------------------------------
Core Elements and Strategic Activities                FPP Output                     Amount             FTE
----------------------------------------------------------------------------------------------------------------
Prevention:
    1.1 Promote Increased Corporate     Increase FDA presence beyond our             $16,000,000              24
     Responsibility to Prevent           borders, including increased
     Foodborne Illnesses: FDA will       training for food safety best
     ensure the safety of imports by     practices abroad. Offices in four
     increasing FDA's presence beyond    additional countries with 7/8 FDA             5,000,000               2
     our borders and building capacity   FTE and 4/5 foreign nationals per
     with foreign partners.              country/region. Yields FDA presence           5,000,000               3
                                         in five countries or regions of the
                                         world.
                                        Increase technical assistance on food
                                         standards in at least 3 of the
                                         countries accounting for the major
                                         share of imports.
                                        Develop systems and tools for an
                                         international information exchange
                                         database related to inspections and
                                         quality.
    1.2 Identify Food Vulnerabilities   Increase capacity to collect &                 5,000,000              10
     and Assess Risks: FDA will          interpret data for risk-based
     conduct risk-based prevention to    prevention for products of greatest           7,000,000              20
     better protect America's food       concern.
     supply. FDA will better            Research and develop risk-based
     understand food safety and food     prevention strategies based on
     defense risks and use this          scientific data and protocols.
     understanding to define the
     optimum preventive controls to
     establish.
    1.3 Expand Understanding and Use    Develop and validate rapid detection           5,000,000              10
     of Effective Mitigation Measures:   technologies and assays (see 2.3 for
     FDA will develop and validate       deploying technologies and assays);
     rapid detection tools to quickly    For high risk foods, commence work
     detect and mitigate a potential     to develop two new priority tools
     problem.                            and to validate two test methods for
                                         toxic chemicals or microbes
                                         developed by industry.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         43,000,000              69
                                                                              ----------------------------------
Intervention:
    2.1 Inspections and Sampling Based  20,000 more import food exams at the           6,000,000              36
     on Risk: FDA will apply risk        port of entry \1\ ($300 each).               13,500,000              50
     analysis to set priorities for     800 more foreign food production and/
     food inspections and                or processing facility inspections            6,500,000              33
     interventions.                      and support for foreign inspections
                                         \1\ (uc=$16.7K).
                                        800 more domestic food safety
                                         inspections \1\ (uc=$8k).
    2.2 Enhance Risk-Based              Integrate and assimilate risk-based           10,000,000              15
     Surveillance of Imported Foods at   information into data systems.
     the Border: FDA will design and
     build risk-based algorithms to
     conduct inspections and detect
     food risks. Understanding the
     risks defines the number and
     types of inspections and tests
     needed to ensure that preventive
     controls are working.
    2.3 Better Detect Food System       Improve signal detection of                    5,000,000               5
     Signals that Indicate               intentional and unintentional
     Contamination: FDA will deploy      chemical and microbial contamination.         5,000,000               5
     rapid detection technologies and   Deploy 1-2 rapid detection assays to
     assays and build laboratory         test high risk foods. Acquire
     infrastructure for faster           advanced technology and deploy such          11,000,000              10
     testing. FDA will deploy state-of-  equipment to FDA field and conduct
     the-art technology to improve the   technology transfer to industry.
     integration of incoming signals    Build high throughput rapid detection
     and achieve faster mitigation and   technology into laboratory
     response.                           infrastructure.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         57,000,000             154
                                                                              ----------------------------------
Response:
    3.1 Improve Immediate Answer. FDA   Develop and implement a system for            10,000,000              20
     will enable real-time               traceback from product consumption
     communication of lab results. FDA   back to the source of production
     will develop protocols to           using, for example, electronic               10,000,000               6
     facilitate tracebacks of            pedigrees and industry applied
     foodborne illnesses. FDA will       technologies of bar coding and radio
     rapidly detect and respond          frequency identification.
     foodborne outbreaks.               Enhance interoperable information
                                         technology networking system between
                                         FDA and Federal, State, and local
                                         testing labs.
    3.2 Improve Risk Communications to  Create a health hazards alert                  5,000,000              10
     the Public, Industry, and Other     communication system using multiple
     Stakeholders: FDA will enhance      media outlets to quickly inform a
     risk communication though           broad cross section of the public.
     aggressive, targeted food safety
     campaigns that disseminate clear
     and effective messages with
     regular updates through a variety
     of media to all target audiences.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         25,000,000              36
                                                                              ----------------------------------
        GRAND TOTAL, Food Protection    .....................................        125,000,000             259
         Plan.
----------------------------------------------------------------------------------------------------------------
\1\ FDA will hire and train additional field inspectors throughout fiscal year 2009. As a result, by fiscal year
  2010, the proposed investment will allow FDA to increase its inspection and surveillance capacity by the
  number of inspections identified in this FPP output


       FDA FISCAL YEAR 2009 BUDGET AMENDMENT: ENSURING SAFE AND EFFECTIVE MEDICAL PRODUCTS (+$100 MILLION)
----------------------------------------------------------------------------------------------------------------
          Strategic Activity                            Output                       Amount             FTE
----------------------------------------------------------------------------------------------------------------
Safer Drugs, Devices, and Biologics:
    1.1 Science to Improve Medical      Establish a unique device                     $7,500,000              17
     Product Safety and Development:     identification system to track
     Use new science and analysis to     devices, facilitate recalls, and             14,000,000              10
     improve the safety of medical       support inventory management during
     products. In some cases, new        disasters and terrorism response.
     science creates opportunities to   Implement FDAAA safety requirements
     leverage advances from one          related to pediatric drugs and
     product area to promote safety in   devices, postmarket study
     a different area.                   commitments, clinical trials, active
                                         drug surveillance, labeling and safe
                                         use of drugs.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         21,500,000              27
                                                                              ----------------------------------
    1.2 Data Analysis Tools to          Build Regulated Product Information           15,000,000  ..............
     Identify Safety Issues: Develop     Data Warehouse that will enable
     and implement quantitative          intelligence sharing with other              15,000,000               6
     decision-making tools to assess     regulatory agencies.
     the safety and effectiveness of    Data access and analysis for active
     drugs, biologics, and devices       safety surveillance with development
     throughout their lifecycle.         of scientific methods of data mining
                                         for signals of adverse events.
                                                                              ----------------------------------
      Sub-Total.......................  .....................................         30,000,000               6
                                                                              ----------------------------------
    1.3 Risk-Based Inspection and       250 more foreign medical product              11,200,000              50
     Compliance: Strengthen field        facility inspections \1\                     10,800,000              18
     operations to better protect        (uc=$45.000).
     public health. The sheer volume    Increase FDA's presence beyond our             4,400,000              14
     of products, manufacturing          borders to five countries or regions          7,500,000               5
     plants, distributors, and           of the world.
     importers demands a more robust    250 more domestic medical product              6,600,000              35
     inspection force with better        inspections (uc=17.7K).                       3,000,000  ..............
     capacity to reach the community    Improve lab infrastructure and tools           5,000,000               5
     that FDA regulates.                 for rapid analysis of product/
                                         ingredient content.
                                        Increase import exams (10,000) and
                                         sampling/laboratory analysis (300).
                                        IT systems to achieve an integrated
                                         inventory database.
                                        Improve risk communications to public
                                         and industry.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         48,500,000             127
                                                                              ----------------------------------
        GRAND TOTAL, Medical Product    .....................................        100,000,000             160
         Safety and Effectiveness.
----------------------------------------------------------------------------------------------------------------
\1\ FDA will hire and train additional field inspectors throughout fiscal year 2009. As a result, by fiscal year
  2010, the proposed investment will allow FDA to increase its inspection and surveillance capacity by the
  number of inspections identified in this output


           FDA FISCAL YEAR 2009 BUDGET AMENDMENT: MODERNIZING FDA SCIENCE AND WORKFORCE (+50 MILLION)
----------------------------------------------------------------------------------------------------------------
          Strategic Activity                            Output                       Amount             FTE
----------------------------------------------------------------------------------------------------------------
Modernizing FDA Science and Workforce:
    1.1 Science Leadership and          Strengthen programs of emerging               $5,000,000              15
     Coordination: FDA will enhance      science in Centers and at the
     science programs across the         National Center for Toxicological            27,000,000              40
     agency, especially in emerging      Research and enhance integration.
     areas such as nanotechnology and   Strengthen capacity to support
     tissue engineering. FDA will        nanotechnology, cell and gene
     establish mechanisms to access      therapies, robotics, genomics and
     the best scientific knowledge and   proteomics, Critical Path
     expertise to modernize its          initiatives, and advanced
     regulatory science. FDA will        manufacturing technologies.
     strengthen its capacity to
     support emerging areas of science
     and manufacturing that are
     essential to regulating FDA
     products.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         32,000,000              55
                                                                              ----------------------------------
    1.2 Investments to Support Science- Expand science training and                    4,000,000               8
     Based Regulation: FDA will          professional development for career           4,000,000               8
     upgrade its science capacity by     employees.                                   10,000,000  ..............
     providing more training and        Launch Science Fellows Program and
     professional development support    initiate recruitment of first 500
     for FDA science staff. FDA will     fellows.
     create an Agency-wide 2-year       Improve facilities outside of the
     Science Fellows Program intended    Washington region to support FDA's
     to include up to 2,000 trainees     mission and enable these facilities
     to develop a new cadre of           to accept new food and medical
     emerging leaders in regulatory      product technologies.
     science. FDA will upgrade
     facilities that do not adequately
     support FDA's current or future
     mission.
                                                                              ----------------------------------
        Sub-Total.....................  .....................................         18,000,000              16
                                                                              ----------------------------------
        GRAND TOTAL, Modernizing FDA    .....................................         50,000,000              71
         Science and Workforce.
----------------------------------------------------------------------------------------------------------------

                               PAY COSTS

    Question. The budget request includes a net increase request of $54 
million in budget authority. The increase is supposed to fund pay costs 
and increases in food safety and medical product safety. However, the 
budget also states that the pay and benefits need for fiscal year 2009 
is slightly more than $59 million, approximately $5 million more than 
the request.
    It is apparent that maintaining current staff levels will consume 
your entire request amount in fiscal year 2009. Since this is the case, 
how will you accomplish the food safety and medical product safety 
activities promised in the budget? Will you be forced to cut back in 
other areas?
    Answer. The fiscal year 2009 President's Budget provides staff for 
FDA to perform its public health mission and provide inspectors, 
medical and consumer safety officers, food safety technologists, 
medical product reviewers, postmarket safety experts, and other public 
health experts to safeguard the American public and implement the food 
and medical product safety activities outlined in the budget.
    The President's fiscal year 2009 budget contains $25 million to pay 
the cost of living increase for FDA employees. FDA will cover fiscal 
year 2009 cost increases through a combination of strategies, including 
reducing operating costs and the design of its hiring plan.

                             IT INVESTMENTS

    Question. Dr. von Eschenbach, in a recent speech to the Food and 
Drug Law Institute you mentioned that FDA's information technology 
infrastructure is ``adequately funded at $200 million a year, but [it] 
remains antiquated, unreliable, and beset by high-cost maintenance.'' 
You said that FDA's IT infrastructure is essentially ``a quilt of 
patched-together hardware, and fragmented software packages.''
    In addition, one of the findings in the recent Science Board report 
was that ``FDA lacks information technology capability and capacity to 
support monitoring of drug and food safety and is particularly 
challenged in the regulation of products based on new science.'' The 
Science Board goes on to recommend the development and execution of a 
comprehensive IT modernization plan.
    FDA's budget for fiscal year 2008 is about $2.2 billion. According 
to your numbers, the agency is spending about 10 percent of its budget 
on IT.
    How is it possible that your IT systems are in such shambles if the 
agency is regularly spending about 10 percent of your budget on IT? 
Based on your statement, you appear to agree that $200 million a year 
is ``adequate''.
    Answer. We concur that FDA faces many challenges maintaining its 
current management information system while also upgrading its IT 
services to meet the challenges of the 21st century. However, FDA has 
made great strides since fiscal year 2004, and has accelerated its 
progress during fiscal year 2007 to centralize FDA-wide IT resources. 
FDA activities will result in strengthening FDA's base operations, 
eliminating duplicative systems, standardizing processes and 
procedures, and generally improving the efficiency of FDA IT systems.
    Starting in 2004, the FDA Business Framework established and 
implemented the Bioinformatics Board, also known as the BIB. The BIB 
provides strategic direction, coordinates FDA business processes, and 
harmonizes information management initiatives. The BIB governance 
structure operates with five Business Review Boards to harmonize FDA 
business processes across strategic lines of business. The five 
Business Review Boards address Pre-Market Activity, Post-Market Safety, 
Product Quality and Compliance, Administrative Services, and Scientific 
Computing and Computational Science.
    FDA progress coordinating the management of information systems 
matured in 2007 with the creation of the Chief Operating Officer 
position and the elevation of the Chief Information Officer. These 
actions signified the importance and criticality of Information 
Management at FDA. At the same time, the Business Review Board 
identified 5-year goals and strategic objectives for five FDA-wide 
Information Technology initiatives.
    The first initiative is the Information and Computing Technologies 
for the 21st Century, which is designed to provide modernized servers 
and analysis mechanisms to meet Bioinformatics requirements.
    The second initiative is updating MedWatch, which is a system 
created to provide a portal for adverse event reporting and consumer 
complaints.
    The third initiative is the Harmonized Inventory Project, an 
exciting endeavor to clean up legacy data and provide one source of 
truth for registration and listing information.
    The fourth initiative is the creation of a Common Electronic 
Document Room to facilitate data sharing across all of the FDA business 
lines.
    Finally, the FDA Advanced Submission Tracking and Review System, 
upon completion, will move data across applications throughout the 
continuum of the product lifecycle, from pre-approval through 
consumption, creating a close loop system encompassing all FDA business 
lines.
    In summary, these initiatives not only lay the foundation for 
integrating disparate existing systems across the FDA, but they also 
align with recently enacted legislation and action plans.
    Continuing in 2008 and beyond, FDA will achieve business driven IT 
that is managed as an FDA IT investment portfolio. FDA will standardize 
approaches to developing systems to increase interoperability, minimize 
redundancy by centralizing IT and obtain economies of scale across FDA. 
FDA will deliver the systems and functionality to implement FDA 
Amendments Act, Import Safety Action Plan, and the Food Protection 
Plan.
    These advances at FDA have raised Information Technology to a 
corporate level resource that is being directed, governed, and managed 
across FDA by the Bioinformatics Board and the CIO. This approach 
enables business driven IT support and services that allow FDA to 
achieve its mission of promoting and protecting public health.
    Question. If you were to prioritize areas where IT investment could 
be made, what would those areas be and how much would you invest?
    Answer. FDA's Business Review Board identified 5-year goals and 
strategic objectives for five FDA-wide Information Technology 
initiatives. The five initiatives are Information and Computing 
Technologies for the 21st Century, MedWatch, the Harmonized Inventory 
Project, a Common Electronic Document Room, and the FDA Advanced 
Submission Tracking and Review System. These are long-term IT projects 
and FDA is still evaluating the resource requirements to accomplish 
these IT priorities.

                        CRITICAL PATH ACTIVITIES

    Question. Last year, you joined us in Utah for a subcommittee 
hearing on FDA's critical path initiative. During the hearing we 
discussed ways that FDA can work with universities and non-profit 
organizations to optimize drug dosing for certain patients, thus 
minimizing adverse events and helping people get the drug that is right 
for them. In the fiscal year 2008 appropriations bill, the Committee 
provided $7.5 million for the critical path initiative, of which $2.5 
million was made available for competitive critical path research 
grants.
    Could you update us on your progress in this area?
    Answer. FDA has awarded more than $3 million in grants and 
contracts so far this year to external organizations to support a 
variety of critical path activities, including efforts in support of 
personalized medicine.
    For example, we renewed and extended our contract with the Critical 
Path Institute, C-Path. As you know, C-Path was co-founded by the 
University of Arizona and Stanford Research Institute, International, 
as a neutral ground for supporting collaborations on education and 
training in applied research and regulatory sciences. FDA and C-Path 
executed a memorandum of understanding that lays out the general 
parameters for these collaborations. One of these collaborations, the 
Predictive Safety Testing Consortium--PSTC--was announced in March 2006 
to develop and qualify preclinical safety biomarkers. Although that 
effort will continue, significant progress already has been made. FDA 
and our European counterpart, the European Medicines Agency (EMEA) 
currently are reviewing the validity of seven new tests, or biomarkers, 
to detect drug-induced kidney damage. The PSTC was able to bring 
together 190 international scientists to share scientific data and 
generate a novel simultaneous submission to both regulatory bodies.
    We look forward to the possibility of further transatlantic 
cooperation for safer medical products. We hope for similar, continued 
advancements from our five working groups: Kidney Toxicity, Liver 
Toxicity, Blood Vessel Toxicity, Carcinogenicity, and Muscle Toxicity.
    Question. Are there any particularly promising critical path 
projects that you would like the Committee to know about?
    Answer. We would like to share four important projects with you 
today.
    FDA is developing and implementing a single electronic portal for 
the receipt of all adverse event reports coming into the Agency--
MedWatchPLUS. A 5-year contract was awarded to SRA International, Inc. 
in early 2008 for the integration of the MedWatchPlus portal and the 
FDA Adverse Event Reporting System, our new harmonized adverse events 
reporting system. This effort is critical for public health; it will 
greatly improve the quality and consistency of the adverse event 
reports that we receive. We are also working on a related effort with 
the National Institutes of Health to develop an electronic reporting 
questionnaire that will greatly reduce the burden on the healthcare 
community and the public when they report to us through the new portal.
    FDA is working to explore the possibility of collaborating to 
create a national, integrated, electronic system for monitoring medical 
product postmarket safety. This Sentinel System would enable FDA to 
capitalize on the capabilities of multiple, existing data systems to 
augment the Agency's current postmarket monitoring capability.
    C-Path is helping launch a large collaboration dedicated to 
advancing progress against major diseases, initially Alzheimer's and 
Parkinson's. The Coalition Against Major Diseases, CAMD, will enable 
FDA, industry, academic scientists, government agencies, and healthcare 
providers to share pooled data on the natural history of diseases. With 
these data we will generate a quantitative disease progression model 
that can be made available for all to use in designing clinical trials 
to more efficiently evaluate new therapies. This effort will be similar 
to our collective attack on HIV/AIDS.
    Finally, the Clinical Trials Transformation Initiative, CTTI, is a 
collaborative endeavor with Duke University and other academic and 
industrial Critical Path partners. The aim is to improve the efficiency 
and safety of clinical trials by incorporating new information 
technology and monitoring systems.

                          FOOD SAFETY RESEARCH

    Question. In the fiscal year 2008 appropriations bill, the 
Committee provided $3 million for food safety research under the 
National Research Initiative at USDA. We directed the Department of 
Agriculture and FDA to work together to develop food safety research 
priorities that benefit both USDA and FDA.
    How is this effort progressing? Have you identified research 
priorities and started the process of awarding research grants?
    Answer. The FDA and USDA's Cooperative State Research, Education, 
and Extension Service, also known as CSREES, have met on several 
occasions to discuss FDA's broad food safety research priorities in 
relation to how these priorities would benefit USDA. FDA's priorities 
from these discussions are incorporated in two of the current 
priorities that CSREES announced in their request for proposal, also 
known as an RFP. Fiscal year 2008 research priorities will address 
human enteric viruses or microbial toxins in the areas associated with 
seafood and in the areas of fresh fruits, nuts, and vegetables.
    For fiscal year 2008, CSREES' Food Safety Program's review panel 
met April 22 through 24, 2008, to rank proposals received. One FDA 
scientist participated as a member of the review panel. Awards will be 
made based on normal CSREES extramural and contract procedures. FDA has 
had additional discussions with CSREES regarding establishing a more 
formal process for seeking FDA's input into the development of next 
year's RFPs, and FDA is currently moving forward with those 
arrangements.
    Question. What are the food safety research priorities for FDA?
    Answer. FDA's Food Protection Plan emphasizes the need to know the 
science underpinning how and where food becomes contaminated and the 
associated risks. The Food Protection Plan also highlights the use of 
science to determine optimal interventions to reduce the likelihood of 
contamination and harm. The Center for Food Safety and Applied 
Nutrition, known as CFSAN, the Center for Veterinary Medicine, known as 
CVM, and the National Center for Toxicological Research, known as NCTR, 
work collaboratively to advance research in the food safety arena.
    The following information describes the CFSAN food safety research 
priorities. FDA periodically updates its research priorities to reflect 
the changing needs of food programs. CFSAN is currently updating its 
research priorities since the center successfully completed a cycle of 
research focused on food defense issues. The center is initiating 
research to support our Food Protection Plan. These priorities include 
addressing issues related to the prevention, intervention and response 
components of the Food Protection Plan. Priority regulatory activities 
that will require substantial research support are likely to include 
work in chemical and microbiological sampling and detection methods, 
interventions to prevent the contamination of produce and dairy 
products, assessing the safety of dietary supplements, research to 
support dietary guidelines, conducting of evidenced-based evaluation of 
health claims, and developing and disseminating guidance to 
stakeholders for food safety concerns. CFSAN will address these 
research needs through intramural and extramural research, Centers of 
Excellence partnership programs, and our established interactions with 
research agencies such as USDA's Cooperative State Research, Education, 
and Extension Service, USDA's Agricultural Research Service, and the 
National Institutes of Health.
    The following information describes the CVM food safety research 
priorities. In the area of antimicrobial safety, CVM is developing 
rapid methods such as microarray and biomarkers to screen foodborne 
pathogens for genetic relatedness. CVM is also developing rapid methods 
to screen for the carriage of resistance genes in order to measure the 
migration of resistance genes from the animal production environment to 
humans where they can cause intestinal illness. This information will 
help assess the risk associated with antimicrobial use in food-
producing animals. CVM's National Antimicrobial Resistance Monitoring 
System, or NARMS, provides ongoing monitoring data on the antimicrobial 
susceptibility patterns in common foodborne bacteria. This information 
can be used to alert the veterinary medical community and regulatory 
officials about emerging resistance problems that may compromise drug 
efficacy.
    In the area of animal feed safety, CVM is developing and validating 
methods for detecting prohibited proteins from the United States and 
European Union sources in animal feeds. The methods will provide 
Federal and State investigators with rapid and sensitive tools for 
enforcing the FDA Feed Ban, thus preventing the spread of BSE in cattle 
and the possible outbreak of variant Creutzfeldt-Jakob disease in 
humans. We are also conducting residue depletion and toxicity studies 
associated with melamine and cyanuric acid in animal feeds. Information 
from these investigations will aid in assuring the safety of animals 
consuming contaminated feed and humans consuming animal products.
    In the area of drug residues and chemical contaminants, CVM is 
developing methods for use in Federal and State regulatory laboratories 
to detect illegal drug residues in animal-derived foods such as 
aquaculture products and honey. Methods are being developed to detect 
illegal residues, natural toxins, and dangerous contaminants in animal 
feeds. Significant progress has been made in developing methods to 
detect melamine and cyanuric acid in feeds, and to develop methods 
capable of testing for a variety of contaminants in distillers' grains, 
a byproduct of the ethanol industry frequently used as a component of 
animal feeds.
    NCTR provides research that supports FDA's food safety priorities 
in three specific areas. NCTR is conducting research to develop, 
validate, and implement test methods to rapidly detect chemical and 
microbial contamination of food. The results of this research are 
evaluated for application in the FDA Office of Regulatory Affairs field 
laboratories as well as in commercial food facilities. NCTR research 
also assesses the biological activity of food contaminants. This 
research includes determining the toxic effects of the contaminants, 
evaluating methods to neutralize the contaminant, and investigating 
pathways of antimicrobial resistance. NCTR develops tools that assist 
FDA to identify high-risk products, and thereby facilitate optimal use 
of inspection resources. These tools include statistical models and 
methods to evaluate the risk potential of imported and domestic 
products. NCTR is also collaborating to develop a database that 
contains genetic information about bacterial strains that can be used 
to differentiate between pathogens and nonpathogens and facilitate 
tracing pathways of contamination.

                     GENERIC DRUG CITIZEN PETITIONS

    Question. Dr. von Eschenbach, you've mentioned in public statements 
that one significant challenge posed by the Food and Drug 
Administration Amendments Act is the 180-day deadline for FDA to take 
final action on certain citizen petitions related to the approval of 
generic drugs. You've stated that meeting this new deadline will 
require significant new efforts and additional resources.
     For the past 2 years, this subcommittee has provided FDA with more 
money than was requested in the budget for generic drug review. Is it 
possible to use these resources to assist with the review of citizen's 
petitions?
    Answer. FDA recognizes the value of the subcommittee's interest and 
support for the Generic Drug Review program, as represented by the 
additional resources provided for generic drug review during the last 2 
years. The increased funding has been instrumental in ensuring that FDA 
can continue its performance in expanding the availability of high-
quality generic drug products and providing consumers and healthcare 
providers with information on the safety and effectiveness of generic 
drugs.
    The staff hired with the new funding that FDA received in recent 
years is not specifically focusing on reviewing citizen petitions. 
However, increased staff helps to ensure that the Office of Generic 
Drugs has the expertise necessary to reviewing citizen petitions.
    Question. Do you have an estimate of how much would be necessary to 
meet this new deadline? If so, how much?
    Answer. Review of Citizen Petitions subject to Section 914 of the 
Food and Drug Administration Amendments Act of 2007 involves the work 
of experts in several offices throughout FDA, including CDER's Office 
of Regulatory Policy, Office of Generic Drugs, and the Office of New 
Drugs, as well as the Office of Chief Counsel. We estimate that a total 
of 40 additional FTEs would be needed to adequately staff all of these 
offices for this purpose.

            IMPLEMENTATION OF THE FDA AMENDMENTS ACT OF 2007

    Question. Congress passed, and the President signed into law, the 
Food and Drug Administration Amendments Act last September. The act is 
very broad. It reauthorized and expanded FDA's drug and device user 
fees and included provisions related to food safety, drug safety, 
research on pediatric products, and advisory committees. According to 
FDA's implementation plan, the act included 125 separate clauses or 
provisions that require action.
    How are the agency's implementation plans progressing? What would 
you consider the greatest implementation challenge for the agency?
    Answer. FDA efforts to implement the Food and Drug Administration 
Amendments Act, also known as FDAAA, are proceeding well. After FDAAA 
passed last year, we determined that there were approximately 125 
provisions which FDA needed to implement or would have a role in 
implementing. These provisions, however, represent many more individual 
tasks. For example, one provision may take thirty individual tasks to 
accomplish while another provision may require only two or three tasks. 
As we implement the provisions, additional tasks are added as the full 
impact of a provision is not always obvious at the outset of 
implementation.
    There are several challenges in implementing FDAAA. The complexity 
and breadth of the provisions coupled with various specific deadlines 
pose an enormous challenge to FDA--one that I believe agency employees 
are doing their best to meet.
    Question. Are you meeting the deadlines set forth in the 
legislation?
    Answer. At the current time we have been able to meet almost all of 
the specific deadlines required by FDAAA.

                   MEDICAL DEVICE REVIEW PERFORMANCE

    Question. As you know, I've been very interested in the medical 
device user fee program and I have asked many questions about the 
performance of the program since it was enacted. In addition, this 
subcommittee has shown a significant amount of support for this program 
by providing inflationary increases to fully fund the program.
    Can you tell us how the agency is doing in regards to meeting the 
performance goals associated with the user fee program?
    Answer. FDA continues to succeed in improving the process for the 
review of medical device applications and meeting the performance goals 
first established under the Medical Device User Fee and Modernization 
Act of 2002, known as MDUFMA. Title II of the Food and Drug 
Administration Amendments Act of 2007 continued MDUFMA performance 
goals.
    MDUFMA requires close collaboration with stakeholders and increased 
communication with applicants. FDA is working to clarify its regulatory 
requirements and make its decisions more transparent through new 
guidance, educational materials, and meetings. We continually seek to 
enhance the efficiency and flexibility of our review processes. These 
efforts help applicants improve the quality of their submissions, and 
help FDA provide more timely, better-focused reviews. Our ultimate 
objective is to make important new medical devices available to 
patients and healthcare providers earlier, while continuing to ensure 
the quality, safety, and effectiveness of those devices.
    I would be happy to provide for the record a table that summarizes 
FDA's performance on the goals established for the fiscal year 2003-
fiscal year 2007 receipt cohorts, showing results achieved through 
March 31, 2008. The goals applicable to the fiscal year 2008 receipt 
cohort have been in place for only 6 months, so it is too early for 
statistical measures to provide useful insights into our progress 
towards achieving those goals. FDA has, however, taken action to ensure 
that we are well positioned to achieve the goals for fiscal year 2008-
fiscal year 2012. FDA is developing and implementing a new interactive 
review process that will contribute to better communication with 
applicants and more rapid resolution of review questions.
    [The information follows:]

                                                 QUARTERLY REPORT ON PROGRESS TOWARDS ACHIEVING MEDICAL DEVICE PERFORMANCE GOALS SUMMARY TABLES
                                                                         [Actions through March 31, 2008--Data for FDA]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Performance Goals and Actual Performance to Date
                                                                                   -------------------------------------------------------------------------------------------------------------
                                                                                      Fiscal Year 2003      Fiscal Year 2004      Fiscal Year 2005      Fiscal Year 2006      Fiscal Year 2007
                    Activity                              Review Time Goal         -------------------------------------------------------------------------------------------------------------
                                                                                                 Actual                Actual      Goal      Actual      Goal      Actual      Goal      Actual
                                                                                       Goal     Percent      Goal     Percent    Percent    Percent    Percent    Percent    Percent    Percent
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMAs, Panel-Track Supplements, Premarket
 Reports:
    FDA decision (approval, approvable,          320 days.........................  .........       91.8  .........       91.7  .........       87.7         80       83.7         90        100
     approvable pending GMP inspection, not
     approvable.
    FDA decision--Percent within 180 days......  180 days.........................  .........       44.9  .........       37.5  .........       29.8  .........       36.7         50       41.2
Expedited PMAs:
    FDA decision (approval, approvable,          300 days.........................  .........        100  .........       92.3         70       83.3         80        100         90  .........
     approvable pending GMP inspection not
     approvable.
180-day PMA Supplements:
    FDA decision (approval, approvable,          180 days.........................  .........       94.1  .........       95.3         80       95.0         80       97.0         90       92.8
     approvable pending GMP inspection not
     approvable.
510(k)s:
    FDA decision (SE/NSE)......................  90 days..........................  .........       76.1  .........       83.9         75       91.1         75       91.6         80       92.7
Biologics Licensing Applications (BLAs):
    Review and act on standard original BLAs     10 months........................  .........  .........  .........        100  .........        100         75       97.7         90       97.7
     (issue ``complete action'' letter).
    Review and act on priority ordinal BLA       6 months.........................  .........  .........  .........  .........  .........  .........         75  .........         90  .........
     submissions (issue ``complete action''
     letter).
BLA Supplements:
    Review and act on standard BLA efficacy      10 months........................  .........        100  .........  .........  .........  .........         75  .........         90  .........
     supplements (issue ``complete action''
     letter).
    Review and act on priority BLA efficacy      6 months.........................  .........  .........  .........  .........  .........  .........         75  .........         90  .........
     supplements (issue ``complete action''
     letter).
    Review and act on BLA manufacturing          4 months.........................  .........  .........  .........  .........  .........  .........         75  .........         90  .........
     supplements that require prior approval
     (issue ``complete action'' letter).
BLA Resubmissions, BLA Supplement
 Resubmissions:
    Review and act on a Class I resubmission to  2 months.........................  .........  .........  .........  .........         75        100         80  .........         90        100
     an original BLA or BLA efficacy supplement
     (issue ``complete action'' letter).
    Review and act on a Class 2 resubmission to  6 months.........................  .........        100  .........         80         75        100         80        100         90        100
     an original BLA or BLA efficacy supplement
     (issue ``complete action'' letter).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Question. What criteria does the agency use to determine the 
allocation and priority for the distribution of any increase in staff 
across FDA components, including offices, divisions, or branches 
resulting from the medical device user fees and related Congressional 
appropriations?
    Answer. The Food and Drug Administration Amendments Act of 2007, 
known as FDAAA, was signed into law on September 27, 2007. FDAAA 
reauthorized FDA's authority to collect fees from the medical device 
industry under the Medical Device User Fee and Modernization Act, also 
known as MDUFMA. The activities that comprise the medical device review 
process are defined in MDUFMA. Medical device review components within 
FDA that conduct activities that are included in the review process, as 
defined by MDUFMA, receive increased allocations from device user fee 
collections.
    FDA allocates medical device user fees and other medical device 
appropriations to best achieve FDA's public health objectives, device 
performance goals, and other expectations established under MDUFMA, as 
amended. The allocation between the Center for Devices and Radiological 
Health, or CDRH, and the Center for Biologics Evaluation and Research, 
or CBER, is based on the workload balance between the two centers. FDA 
estimates the percent of the device review workload performed by CDRH 
and CBER, and allocates MDUFMA resources accordingly. Field resources 
are allocated among FDA district offices by the Office of Regulatory 
Affairs according to each district's projected workload. The Centers 
and ORA apportion their individual resource allocations to their 
offices, divisions, and branches.
    Question. Even though the devices center has received significant 
increases over the past few years, I understand that the demands on 
staff are very high. Are there additional tools, such as third party 
reviews, third party inspections, or fellowship programs available to 
augment the work of the center? Please discuss the benefits of these 
programs and why they are important.
    Answer. These three programs--third-party review of 510(k) 
premarket notifications, third-party establishment inspections, and the 
Medical Device Fellowship Program--provide FDA with important tools 
that can help us better achieve our public health objectives.
    The purpose of the program permitting third-party review of certain 
510(k) premarket notifications is to improve the efficiency and 
timeliness of FDA's 510(k) process. This is the process by which most 
medical devices receive marketing clearance in the United States. Under 
the program, FDA has accredited third-parties that are authorized to 
conduct the primary review of 510(k)s for eligible devices. Persons who 
are required to submit 510(k)s for these devices may elect to contract 
with an Accredited Person and submit a 510(k) directly to the 
Accredited Person. The Accredited Person conducts the primary review of 
the 510(k), then forwards its review, recommendation, and the 510(k) to 
FDA. By law, FDA must issue a final determination within 30 days after 
receiving the recommendation of an Accredited Person. 510(k) submitters 
who do not wish to use an Accredited Person may submit their 510(k)s 
directly to FDA. FDA data shows that third-party reviews are somewhat 
more rapid than an FDA review in some instances. Third-party 510(k)s 
submitted to FDA are also exempt from any medical device user fee that 
would otherwise apply.
    As of April 15, 2008, FDA has accredited 16 third-party 
organizations to conduct quality systems inspections of certain medical 
device establishments. Individuals from eight of these organizations 
have completed FDA's training requirements and FDA has cleared these 
individuals to conduct independent inspections. Through April 15, 2008, 
accredited organizations have conducted six inspections. Although few 
inspections have been conducted to date, changes specified by the Food 
and Drug Administration Amendments Act of 2007, also known as FDAAA, 
have the potential to eliminate certain obstacles to manufacturers' 
participation in FDA's programs for inspections by accredited third 
parties.
    CDRH established the Medical Device Fellowship Program, also known 
as MDFP, to increase the range and depth of collaborations between CDRH 
and the outside scientific community. The MDFP offers short and long-
term fellowship opportunities for individuals interested in learning 
about the regulatory process and sharing their knowledge and experience 
in the many specialized fields that concern medical devices. Physicians 
with clinical or surgical expertise, engineers in biomedical, 
mechanical, electrical and software areas, and individuals from many 
other scientific disciplines have participated in the fellowship 
program. Opportunities are available for students in many other areas 
as well. This collaboration improves FDA's review processes, postmarket 
surveillance, and science base, all of which contribute to efforts to 
ensure patients and health care professionals have timely and continued 
access to safe and effective medical devices.

            ROLE OF PHYSICIANS IN MEDICAL DEVICE DEVELOPMENT

    Question. As you know, I've been very interested in the medical 
device user fee program and I have asked many questions about the 
performance of the program since it was enacted. In addition, this 
subcommittee has shown a significant amount of support for this program 
by providing inflationary increases to fully fund the program.
    The role of physicians in medical device development and 
utilization is often not well understood. Can you comment on the role 
that physicians play in the development of new technologies? Does FDA 
ever require device companies to train physicians in the use of new 
technologies?
    Answer. A physician may play any number of roles in product 
development and use, including developer, researcher, investigator, 
instructor, as well as end user. For example, a physician may identify 
a problem in medical care, which could initiate the development of a 
new device. Physicians may also be involved in the conduct of research 
on a device, including serving as primary investigators, on 
Institutional Review Board committees, or as monitors of large clinical 
trials. A physician serving as an investigator may participate in data 
collection and data analysis for a device premarket submission and may 
also represent the company in presenting this information to FDA. Once 
a device is cleared or approved for marketing, physicians may also have 
a role in teaching other physicians about device use, for example, as a 
means of promoting safe and effective use.
    Yes, FDA has required training as a condition of approval included 
in premarket approval application orders. For example, carotid stent 
approval orders require that labeling specify the training requirements 
that apply to practitioners before they may use these stents. Also, 
many firms voluntarily provide training for physicians.

                  OFFICE OF GENERIC DRUGS PRODUCTIVITY
 
   Question. The subcommittee is sympathetic to the workload that the 
Office of Generic Drugs (OGD) is facing. We all understand and 
appreciate that generic drugs are cost-effective alternatives that save 
consumers billions of dollars a year and we appreciate the work that 
OGD is doing.
    With respect to FDA's performance goals, in your most recent budget 
justification, you indicate two factors have served to lower your 
productivity. You said that the move to the White Oak campus is 
``expected to cause a disruption in productivity.'' You also indicated 
that working under a Continuing Resolution during the First Quarter in 
fiscal year 2008 has caused a delay in hiring and training new staff at 
OGD.
    Given that you have now announced OGD's move to White Oak, please 
provide the Committee with an update on your projected productivity at 
OGD? In addition, we would appreciate your providing an update on the 
number of new staff hired and trained with the funding the Committee 
provided last year.
    Answer. OGD will remain in its current Metro Park North buildings 
for the immediate future. OGD currently occupies three buildings on 
that the Metro Park North complex.
    Overall productivity remains high. However, it is still difficult 
to keep pace both with the incoming applications and with other matters 
requiring OGD resources such as Citizen Petitions, lawsuits challenging 
the approval of generic drugs, and providing guidance to the industry.
    In the period from October 1, 2007 through April 15, 2008, OGD has 
been able to hire 31 new staff representing a variety of scientific and 
clinical expertise. These new hires are undergoing training. Once that 
training is completed, OGD expects them to make significant 
contributions to review performance.

                    GENERIC DRUG APPLICATION ACTIONS

    Question. You have advised the Committee that the OGD target is 
1,900 actions for fiscal year 2009, including approvals, tentative 
approvals, not approvable, and approvable actions on applications. You 
have also said that your target approval time for the fastest 70 
percent of original generic drug applications approved for the fiscal 
year 2003-2005 cohort is 17.8 months, an increase of 1.8 months from 
the fiscal year 2002-2004 cohort of 16.0 months. This, of course, is 
contrasted with the statutory review time of 6 months.
    Will the new staff you have hired and trained affect these 
projected times?
    Answer. OGD believes that it will make the goal of 1,900 actions in 
fiscal year 2009. The Office is on track to exceed the fiscal year 2008 
goal of 1,780 actions. As recently hired staff becomes fully trained, 
OGD will be more confident in its ability to reach these goals. Current 
performance is based on many overtime hours.
    The fiscal year 2003-2005 cohort approval time is 16.6 months. The 
cohorts for subsequent years are not sufficiently populated to make a 
determination. OGD does know that its yearly median time to approval 
has increased due to the escalating workload. OGD continues to endeavor 
to take first action (approval, not approval, or tentative approval) 
within the statutory timeframe but the volume of applications often 
thwarts OGD efforts.
    As background regarding Abbreviated New Drug Application (ANDA) 
review times, the Food, Drug, and Cosmetic Act states in section 
505(j)(5)(A), ``Within 180 days of the initial receipt of an 
application under paragraph (2) . . . the Secretary shall approve or 
disapprove the application.'' Therefore, either an approval or not 
approval or similar action not resulting in approval is considered by 
FDA to be an action that meets this statutory timeframe. FDA makes 
every attempt to meet this statutory timeframe. However, for a number 
of reasons it is not always possible to do so. After receiving a 
disapproval action, manufacturers frequently resubmit applications that 
address the deficiencies identified in the disapproval action.
    Question. Can you provide the Committee with information on the 30 
percent of generic drug applications that are outside your ``70 percent 
measure'' . . . For example, could you provide us with information on 
the most speedily approved and the most delayed in approval ANDAS (e.g. 
how fast ANDAs outside the 70 percent cohort have been approved, and 
how long others have been delayed)?
    Answer. Generally, the quickest ANDA approvals or tentative 
approvals have been applications submitted under the President's 
Emergency Plan for AIDS Relief (PEPFAR). Traditionally, the review of 
these applications is expedited.
    In general, applications that take longer to review and approve are 
from less experienced manufacturers, cover highly complex products or 
dosage forms, or are related to products that are the subject of 
Citizen Petitions challenging FDA's approval requirements for the 
drugs. Applications can also take longer to approve if concerns are 
raised during facility inspections. For example, applications from one 
firm were on hold for about 2 years because the manufacturer had been 
unable to address inspection issues. These cases can delay a number of 
applications and affect the overall average time to approval. In 
addition, delays are often caused by the applicants themselves. For 
internal business reasons, firms may not place high priority on certain 
applications and may not respond to deficiency letters in a timely 
fashion. This can considerably delay approval time.
    Also, please note that some applications may never be approved 
because the applicant cannot demonstrate to OGD that the proposed 
product meets all of the requirements for approval. It is important to 
understand that part of OGD's mission is fulfilled by preventing 
inferior, unsafe, and dangerous products from entering the market. 
Whether a product is approved and how quickly it is approved is 
controlled by both OGD and other supporting FDA organizations, and the 
applicants themselves. Poor submissions or inadequate proposed products 
can result in substantial delays to approval time or in a proposed 
product never being approved.
    Question. How long have the oldest ANDAs which are still under 
review been pending before the FDA?
    Answer. There are two unapproved applications for a product that 
were submitted 8 and 9 years ago. However, that product has a long and 
complicated regulatory history that has affected the review of the 
applications. The next oldest applications were received about 4 years 
ago. Action on those applications has not occurred because FDA must 
consider issues raised in citizen petitions that relate to the 
approvability of the products.
    Also, please note that some applications may never be approved, 
because the applicant cannot demonstrate to OGD that the proposed 
product meets all of the requirements for approval. It is important to 
understand that OGD's mission is fulfilled by preventing inferior, 
unsafe, and/or dangerous products from entering the market. Whether a 
product is approved and how quickly it is approved is controlled by 
both OGD (and other supporting FDA organizations) and the applicants 
themselves. Poor submissions and/or inadequate proposed products can 
result in substantial delays to approval time or a proposed product 
never being approved.
    Let me now turn to one example of what appears to be an extremely 
long delay in approval of an Abbreviated New Drug Application that has 
been brought to my attention. We are aware that the agency has had 
under review for several years one or more ANDAs with respect to 
enoxaparin, a low molecular weight heparin, which, some scientists 
believe has a better safety profile.
    Question. Given the recent heparin recall, without revealing any 
confidential information, could you outline the efforts the agency is 
making to approve generic substitutes on a priority basis, if any? Is 
the agency close to giving final approval to generic alternatives?
    Answer. OGD has not approved an abbreviated application for 
enoxaparin. Therefore, the Office may not discuss the manner in which 
any review is handled nor may OGD indicate how close any potential 
approval might be. OGD will expedite the review of any new applications 
for heparin in an effort to alleviate a possible shortage situation. 
However, we cannot comment on the existence or status of pending 
applications.
    Question. If a shortage of any drug becomes critical, what steps is 
the agency taking to make certain adequate alternative supplies are 
available to patients? Are generic alternatives included in these 
steps?
    Answer. It has been the practice in OGD to expedite reviews of 
applications for products that may prevent or remedy potential 
shortages or in matters affecting the public health. This practice is 
reflected in a Manual for Policies and Procedures for OGD which states: 
``Certain applications may be identified at the time of submission for 
expedited review. These include products to respond to current and 
anticipated public health emergencies, products under special review 
programs such as the President's Emergency Plan for AIDS Relief 
(PEPFAR), products for which a nationwide shortage has been identified 
. . . ''
                                 ______
                                 

              Questions Submitted by Senator Arlen Specter

                         GENERIC BIOEQUIVALENCE

    Question. The FDA's Office of Generic Drugs has not provided a 
public process for the development of new bioequivalence methods for 
locally acting drugs. Bioequivalence is used to ensure that a generic 
drug will be equivalent to a brand name drug. FDA should not develop 
new scientific methods without transparency, or use those methods to 
review drug applications until the methods have undergone public and 
peer review.
    In a May 1, 2007 policy statement, the FDA stated that the 
development of ``methods for the assessment of bioequivalence of 
locally acting drugs'' is an area where ``additional discussion and 
collaboration about the science'' are needed. The expected result of 
that statement would be an open public process when developing new 
bioequivalence methods for locally acting drugs. However, the approval 
process for Vancocin and Lidoderm continue to be developed without 
transparency.
    Generic drugs are an important part of our healthcare system. 
Currently, over 60 percent of the prescriptions written in the United 
States are for generic drugs. Critical to ensuring the safety and 
effectiveness of generic drugs is the science used to establish 
bioequivalence of these generic drugs. I have spoken with you on a 
number of occasions regarding the need for a public process for 
development of new bioequivalence methods for locally acting drugs. 
Further, I have sent five letters regarding this issue. They were sent 
on: December 29, 2006, April 3, 2007, September 26, 2007, and March 28, 
2009. On March 28, I sent two letters one regarding locally acting 
drugs the other specifically on Lidoderm.
    Will you commit to developing a process that ensures public review 
of the data and rationale behind new bioequivalence methods for locally 
acting drugs before those new methods are used to review or approve 
generic products?
    Answer. In response to your April 3, 2007 letter, FDA advised that 
notice-and-comment rulemaking is not necessary to ensure that the 
standards applied by FDA to the approval of generic vancomycin products 
are scientifically sound and have been thoroughly reviewed by 
appropriate medical and technical experts. Since the passage of the 
Hatch-Waxman amendments in 1984, FDA determined the bioequivalence 
criteria for hundreds of products without notice-and-comment 
rulemaking. These products included products to treat cancer, HIV/AIDS, 
and other serious diseases. Just as in assessing whether the sponsor of 
an innovator drug has submitted adequate studies to establish that its 
product is safe and effective, FDA relies on the most up-to-date and 
rigorous science available in assessing whether an Abbreviated New Drug 
Application, known as an ANDA, sponsor has submitted adequate evidence 
of bioequivalence.
    FDA can obtain public input regarding applicable bioequivalence 
criteria through a number of mechanisms. Currently, whenever possible, 
FDA is making bioequivalence recommendations available to industry as 
guidance, to assist in the development of new generic products. The 
guidance is initially available in draft and public comment is invited. 
FDA develops guidance based on procedures set forth in regulations 
which establish Good Guidance Practices. As a general matter, these 
regulations provide for a process by which the public can comment on 
draft guidance and suggest alternative methods. FDA has also sought 
input from the Advisory Committee for Pharmaceutical Science on 
recommendations for bioequivalence studies for locally acting drugs 
related to the products you mentioned. We are considering holding an 
additional Advisory Committee meeting in the near future at which these 
issues will be examined. As we have stated in the past, we continue to 
consider your concerns as we address these scientific challenges.

                              PRE-EMPTION

    In recent years, the FDA has made clear in final and proposed 
regulations, and in amicus briefs submitted to courts, the agency 
believes its decisions regarding approval of drugs, medical devices, 
and the labels on the drugs and devices pre-empt State law tort claims 
against manufacturers. On this basis, many courts are dismissing 
negligence and failure to warn claims against drug and device 
manufacturers if the FDA has approved the device, drug or label. Some 
argue that State tort claims are the only means for consumers to seek 
redress for injuries caused by insufficient warnings on drugs or 
malfunctioning devices.
    Question. Given the FDA's unsatisfactory track record of making 
certain that drugs are safe and that consumers or physicians are warned 
of all possible consequences of taking drugs, how can you justify the 
FDA's recent attempts at asserting pre-emption of State tort claims? 
What is the harm in allowing the injured, or families of those who have 
died, from seeking redress based on State law?
    If the courts continue relying on rules and regulations issued by 
the FDA and dismiss cases on pre-emption grounds, the FDA really needs 
to ensure that it is making the correct decisions. The American people 
will be counting on the FDA more than ever before.
    Answer. FDA shares your concerns about drug safety and the ability 
of consumers to seek redress for injuries caused by drugs and devices. 
However, FDA is also concerned that State product liability lawsuits 
that challenge FDA's careful determination of safety, efficacy, and 
appropriate labeling can have detrimental effects on public health in a 
number of ways. Examples of detrimental effects include limiting 
patient and doctor choices, decreasing patient access to beneficial 
drugs, and creating confusion over warnings or statements that can 
deter the use of beneficial drugs.
    It is vital to public health that labeling neither underwarns nor 
overwarns. The public health risks associated with overwarning can be 
as great as the health risks associated with underwarning. Overwarning 
can cause patients not to use beneficial medical products and doctors 
not to prescribe them. Underutilization of a product based on 
dissemination of scientifically unsubstantiated warnings, so as to 
deter patients from undertaking beneficial, possibly lifesaving 
treatment, could frustrate the purposes of Federal regulation as much 
as overutilization resulting from a failure to disclose a drug's 
scientifically demonstrable adverse effects. Further, allowing 
unsubstantiated warnings may also diminish the impact of valid warnings 
by creating an unnecessary distraction and making even valid warnings 
less credible.
    In making these crucial balancing decisions, FDA abides by 
standards set forth in regulations and guidance documents that are 
issued through a public process. FDA is the scientific regulatory body 
that is publicly accountable for effectively executing its mission of 
protecting and promoting the public health. FDA believes that State 
court actions that undermine FDA decisions may have the consequence of 
serving to hinder, rather than help, public health.
    Question. Does the FDA have the resources to adequately protect 
consumers of drugs and medical devices? Given the recent, highly 
publicized safety issues with drugs and medical devices, how can you 
assure the American people that the drugs they are prescribed are safe 
enough to justify pre-empting State law and denying access to the 
courts when people are injured or killed?
    Answer. Congress has charged FDA with the responsibility to ensure 
that drugs, biologics, and devices are safe and effective, and that the 
labeling of these products adequately informs users of the risks and 
benefits of the products. FDA considers not only complex clinical 
issues related to the use of a product in study populations, but also 
practical public health issues about the use of a product in day-to-day 
clinical practice. FDA examines the nature of the disease or condition 
for which the product will be indicated, and the need for risk 
management measures to help assure that the product maintains a 
favorable benefit-risk balance. FDA believes, based on the authority 
that Congress has given it and the scientific expertise that resides in 
the Agency, that it is uniquely qualified to make important judgments 
about the safety, effectiveness, and labeling of medical products.
    FDA extensively reviews drugs and devices for safety and efficacy 
using standards specified in the law. FDA doctors, chemists, 
statisticians, microbiologists, pharmacologists, and other experts 
evaluate whether a product is safe and effective. In addition to its 
comprehensive pre-market review of medical product safety and efficacy, 
FDA engages in post-market surveillance to detect and respond to 
emerging information about products after they have been on the market. 
Manufacturers must review and report to FDA any adverse events 
associated with use of a drug in humans, and must periodically submit 
any significant new information that may affect FDA's previous 
conclusions about the safety, effectiveness, or labeling of a drug. 
Device sponsors have similar obligations. FDA is currently modernizing 
its post-marketing surveillance and risk communication efforts through 
implementation of the Food and Drug Administration Amendments Act of 
2007 and other major initiatives. FDA believes its teams of scientists 
are unsurpassed in ensuring that labeling meets patients' needs.
    On September 27, 2007, the President signed the Food and Drug 
Administration Amendments Act into law, also known as FDAAA. FDAAA 
reauthorized two important user fee programs, the Prescription Drug 
User Fee Act, also known as PDUFA, and the Medical Device User 
Modernization Act, also known as MDUFMA. PDUFA and MDUFMA provide FDA 
with the resources to assure the safety and effectiveness of human 
drugs and medical devices. For fiscal year 2008, FDA will receive 
$459.4 million in PDUFA fees and $48.4 million in MDUFMA fees. These 
additional resources will help FDA to achieve its mission of assuring 
the safety and effectiveness of human drugs and medical devices.

                         CONCLUSION OF HEARINGS

    Senator Kohl. This hearing is recessed.
    [Whereupon, at 11:05 a.m., Tuesday, April 15, the hearings 
were concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]
