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



 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2010

                              ----------                              


                         THURSDAY, MAY 21, 2009

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 2:14 p.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Herb Kohl (chairman) presiding.
    Present: Senators Kohl, Pryor, Brownback, and Bennett.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                      Food and Drug Administration

STATEMENT OF DR. JOSHUA M. SHARFSTEIN, ACTING 
            COMMISSIONER
ACCOMPANIED BY:
        PATRICK MCGAREY, DIRECTOR, OFFICE OF BUDGET FORMULATION AND 
            PRESENTATION, FOOD AND DRUG ADMINISTRATION
        NORRIS COCHRAN, DEPUTY ASSISTANT SECRETARY, OFFICE OF BUDGET, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
        DR. DAVID ACHESON, ASSOCIATE COMMISSIONER FOR FOODS, FOOD AND 
            DRUG ADMINISTRATION

                 OPENING STATEMENT OF SENATOR HERB KOHL

    Senator Kohl. Good afternoon. We welcome you to hearing. 
Thank you all for coming, and we begin by welcoming Dr. 
Sharfstein back, this time to represent the administration's 
fiscal year 2010 budget request for the Food and Drug 
Administration.
    We also are very happy to welcome Mr. Patrick McGarey from 
FDA and Mr. Norris Cochran from DHHS.
    We're also pleased to note that Dr. Hamburg, the new 
Commissioner, was confirmed by the Senate on Monday. I met with 
Dr. Hamburg a few weeks ago and I'm certain that she will do a 
great job.
    Dr. Sharfstein, I know that you don't need to be reminded 
of the importance of the agency that you represent. More than 
20 percent of all consumer spending is on products regulated by 
the FDA. It's imperative that this agency is successful in its 
mission because literally people's lives depend on it.
    Even though you haven't been on the job that long, you 
don't need to be reminded of the increased workload FDA has 
faced over the past decade or that the budget increases 
historically have not kept pace with this workload. The effects 
of this have been widespread.
    For example, you've inherited an agency where staff morale 
is low. There have been widely publicized drug safety and food 
safety problems resulting in low consumer confidence. Deserved 
or not, the FDA has earned a reputation for reacting to 
problems instead of preventing them, and there remains a 
perception the FDA is much too cozy with the industries that it 
regulates.
    However, we have hopefully turned the corner, at least when 
it comes to the FDA's funding. The numbers speak for 
themselves. As chairman I've pushed to help FDA's budget keep 
pace with the challenges.
    Of all the items funded by this subcommittee, FDA's 
increases are among the very highest. We recognize that the 
agency cannot continue to receive additional responsibilities 
without the proper resources to do the job.
    For 2010, I'm pleased to see a more realistic budget 
request from this administration. It shows me that you are as 
serious about fixing the FDA as we on this subcommittee are. I 
will let you go over the details, of course, but here's the big 
picture.
    The budget is $2.4 billion. This is an increase of nearly 
$300 million. These increases include more than $150 million 
for food safety and nearly $100 million for safer drugs and 
medical products.
    I think everyone in this room can agree that these are 
substantial numbers. Whether or not they are the right numbers 
remains to be seen. I have said before and will continue to say 
that the answers to all of FDA's problems do not lie simply in 
more money.
    We do not write blank checks. This money has to be spent 
intelligently and we must continue to question each step taken. 
No one expects a complete overhaul of the FDA to be done 
overnight, but we do expect results and, of course, we expect 
results soon.
    Dr. Sharfstein, you are new. Dr. Hamburg is new. This 
entire administration is new. You've inherited an FDA with lots 
of problems but also ample opportunity and full support for 
your efforts from this subcommittee.
    I'm committed to working with you during your tenure and I 
look forward to hearing, along with everyone else, your 
statement today, but before we get to that, we will be pleased 
to hear from Mr. Brownback.

                   STATEMENT OF SENATOR SAM BROWNBACK

    Senator Brownback. Thank you, Mr. Chairman. Welcome, panel. 
Appreciate you being here.
    I think the chairman's outlined some of the concerns that I 
have, as well. That is, you've had a substantial increase in 
the budget portfolio, and I want to know what you've done with 
it.
    I was looking here at the figures. The increase in FDA's 
appropriation is 39 percent since fiscal year 2006, and if the 
budget is enacted into law as requested, this year FDA will 
have grown by over 59 percent in 4 years in your budget. Well, 
we sure want to know what you're doing with that, when we'll 
see the results of that. So that's going to be at the core of 
what I'm interested in seeing that you do.
    Another piece that I think is important that we've done in 
differing degrees in the past is making drug availability and 
new drug development for patients who are terminally ill who 
don't have other options.
    Dianne Feinstein and I co-chair the Cancer Caucus in the 
Senate and, as many people, I have had cancer and I look at 
some of these things and the length of time that we're putting 
in studies on items for patients that don't have other options 
and it doesn't seem like we're getting the accessibility to a 
number of these when you're a terminally ill patient.
    In times past, we've worked with certain groups or 
individuals and certainly physicians to try to make earlier 
stage drugs available for terminally ill patients where they 
and their physician agree to the use of that, and I'm told and 
the research that I've seen--some of the early AIDS testing and 
the successes we had were because FDA worked with the community 
and said, look, we don't know what we're really dealing with 
here. We've got a Tier 1 trial that's going on that looks 
promising. We're going to let more people try this earlier. 
That was one of the ways that some of these treatments were 
discovered.
    I would love to see us try to figure a way that you could 
maintain safety but also get access to people who are 
terminally ill. It just seems almost cruel to me that in some 
cases you have cures that are waiting there but people die 
waiting for that to get approved. So I hope you can address 
some of that, as well.
    It's a very important agency and I look forward to working 
with you on my tenure on this subcommittee.
    Senator Kohl. Thanks a lot, Senator Brownback. We're 
pleased and honored to have with us today the former chairman 
and ranking member of this committee, Senator Bennett.

                 STATEMENT OF SENATOR ROBERT F. BENNETT

    Senator Bennett. Thank you very much, Mr. Chairman. I'm 
always delighted to be able to be here and particularly with 
respect to FDA, which is an agency that you and I worked 
together so well on to try to make sure that they got properly 
funded and properly taken care of.
    Dr. Sharfstein, as you and I have talked, you know that I'm 
a strong supporter of the Critical Path Initiative and it was 
started to address the concern about the rising failure rate of 
new medical products during development and the declining 
number of approvals and so on, and I think perhaps Senator 
Brownback was talking in that same area when I came in.
    This subcommittee has provided funding for the Critical 
Path Initiative over the past few years and in fiscal year 2008 
it was $7.5 million, of which $2.5 million was for Critical 
Path Partnership Grants. Fiscal year 2009 it's $16 million for 
Critical Path and $4 million for the Partnership Grants.
    Are you--have you been there enough to be able to give us 
some kind of evaluation of the Critical Path and where it's 
going and how you feel about it and what you might have in mind 
for it with respect to its future?
    Senator Kohl. This is the opening statement.
    Senator Bennett. Oh, I apologize. That's my opening 
statement and I'll ask that question.
    Senator Kohl. We're going to leave that question for you 
and think about it for awhile.
    Senator Bennett. Right.
    Senator Kohl. All right. Thank you so much, Senator 
Bennett, and Dr. Sharfstein, we'll take your statement at this 
time.

                 STATEMENT OF DR. JOSHUA M. SHARFSTEIN

    Dr. Sharfstein. Great. Thank you so much. Thank you, 
Chairman Kohl, Senator Brownback, Senator Bennett.
    I'm very happy to be here. I am Josh Sharfstein. I'm the 
Principal Deputy Commissioner and the Acting Commissioner but 
not for very long at the U.S. Food and Drug Administration.
    I am pleased to present the President's fiscal year 2010 
budget request for FDA.
    For today's hearing, I'm joined by Patrick McGarey, the 
Director of the Office of Budget Formulation at FDA, and Norris 
Cochran, the Deputy Assistant Secretary for Budget at the 
Department of HHS.
    In my testimony, I'm going to outline the budget request 
and some of the key policy initiatives. I will also just bring 
you a little bit up to date on what's going on on the flu 
situation, knowing that we had that discussion before but a 
sort of quick update there.
    Let me start by thanking the subcommittee for exactly what 
you spoke to, the fact that this subcommittee has been 
extraordinary in its support of FDA over the past several 
years.
    When I arrived at FDA, one of the first things I did is I 
asked each center to provide examples of how it's using the 
recent funding increases to promote public health. A key goal 
for FDA, and I've only been at FDA for several weeks really, 
but I think a key management goal is for us to be able to 
connect the investment of Federal dollars and taxpayer dollars 
to actual public health outcomes at the agency, and I got quite 
a lot back from different parts of FDA, and we have a document 
that we can share with the subcommittee that summarizes some of 
the things that we were able to pull together.

                         PUBLIC HEALTH OUTCOMES

    But as some examples, FDA, in the blood area, is developing 
a test to identify rare strains of HIV that aren't picked up on 
standard HIV testing and then deploy that test around the 
country. FDA is working around the world to train regulators to 
be able to do better device inspections so that the safety of 
imported medical devices is improved.
    FDA is developing the first hepatitis A test in food so you 
can actually identify hepatitis A in food which would allow for 
quicker identification of a problem, as well as develop rapid 
tests for food safety problems so we're not waiting for days 
with, you know, messages out to the public about particular 
foods. We can really identify the particular contaminant.
    FDA's developing, with the funding increases, a major 
national network on pet food problems that involves the states 
and localities and veterinarians so that we don't have a 
situation like with melamine where so much time goes by and so 
many animals die if there is a problem.
    And FDA is working with its research component at NCTR to 
improve the safety of pediatric anesthesia by developing new 
ways to measure the use of pediatric anesthesia and the impact 
on children.
    And then, of course, there's the flu which we talked about 
before, that the increase is directly related to our 
preparedness for flu, and, I think, right before I testified 
the last time, FDA had approved a facility that doubled and 
will eventually triple the domestic manufacturing capacity for 
the injectable flu vaccine and will have an immediate impact on 
our ability to prepare for the Fall, and that would not have 
been possible without the investments.

                             BUDGET REQUEST

    So let me take a step back and talk about the budget 
request overall for this year. It includes $3.2 billion to 
protect and promote the public health through advancing FDA's 
work. That includes an increase of $510 million for FDA 
programs which is a 19 percent increase over last year. It's a 
historic increase and demonstrates this administration's 
commitment to food safety, medical product safety and the 
health of the American public.
    It includes $295 million in budget authority and $215 
million in industry user fees, and this budget organizes these 
increases into two initiatives, in addition to its statutory 
increases and increases for infrastructure. The two initiatives 
are Safer Food Supply and Safer Medical Products.
    The budget also recommends for new user fees, including a 
user fee to facilitate the review of generic drugs, one to 
enhance FDA's ability to register and inspect feed and food 
manufacturing and processing facilities, one to allow FDA to 
reinspect facilities that fail to meet good manufacturing 
practice and other safety requirements, and one to allow FDA to 
collect fees when it issues export certifications for food and 
feed.
    The budget also recommends new authority for FDA to approve 
follow-on biologics for the regulatory pathway that protects 
patient safety and promotes innovation.
    Finally, the budget includes $5 million for FDA to develop 
policies to allow Americans to buy safe and effective drugs 
that are approved in other countries.

                               SAFE FOODS

    Let me just briefly give some of the highlights of the two 
initiatives. For Safe Foods, it's a $259 million increase which 
includes a $164 million in budget authority and $94 million in 
the user fees. This will ultimately increase the number of 
employees by about 600, and the funding will go to various 
efforts.
    One of them is to expand and strengthen the inspection, 
domestically and foreign, of facilities based on risk. More 
than 220 of the people to be hired will be additional 
inspectors.
    Another will be to, and in some ways more important, to 
implement a new strategic framework for an integrated national 
food safety system, so the Federal, State and local systems are 
not operating kind of just in their own world, so that it's 
truly one integrated system, and that's going to require an 
upfront investment but will have many different benefits 
because what we're able to do, if we can accomplish this, is 
leverage the existing investment in food safety at the State 
and local level and increase the quality of that work to the 
point where we can--the Federal Government and the States are 
really working as partners. I'm happy to talk more about that.
    FDA is planning to improve its understanding of food 
vulnerabilities and risks which will be the basis of a risk-
based system of inspection and to develop standards and 
regulations that build food protection into the complete life 
cycle from food production to food consumption.
    In addition, in terms of outbreaks, FDA is investing in 
actions to allow it to more quickly identify food outbreaks and 
trace the contamination to its source, to better communicate 
risks with the public and to expand the capacity of 
laboratories.
    And finally, FDA is making a major investment in 
information technology which will help us provide a much 
stronger base for all of FDA's efforts in food safety, identify 
key suppliers into the United States and be able to identify 
risks of the products that are coming in, so we don't feel like 
we have to do inspections on every single product. We can be 
more strategic about how we're using resources.

                         SAFER MEDICAL PRODUCTS

    As far as safer medical products, this effort both relates 
to the manufacture and the use of the products. It's $166 
million. It includes a $120 million in increased budget 
authority and about $50 million in generic drug user fees and 
reinspection user fees.
    It would have FDA hire about 300 more people and expand 
programs related to medical product safety and included in this 
are, again, increased numbers of inspections, both foreign and 
domestic.
    The Center for Biologics would hire additional safety 
experts for blood, tissue and vaccine safety teams and develop 
additional screening tests for emerging bloodborne diseases.
    The Center for Devices would implement the safety 
requirements that were called for in the Food and Drug 
Administration Amendments Act of 2007 which include analyzing 
adverse event information in children and inspiring more 
pediatric trials for medical devices.
    It also has a focus on eye medical devices which have been 
a cause of a number of outbreaks recently.

                             SAFE DRUGS USE

    The Center for Drugs would have funding to support how to 
best use risk evaluation mitigation strategies to minimize drug 
risks and promote safe drug use and would also conduct research 
on bioequivalent standards for generic forms of new products, 
such as metered dose inhalers, topical drugs and other 
different kinds of products.

                        ANIMAL BIOTECH PRODUCTS

    The Center for Veterinary Medicine would conduct scientific 
and risk evaluation of animal biotech products, regulate 
approvals for new animal biotech products, and coordinate 
United States and foreign regulation on animal health issues; 
and there'd be additional research funded through the National 
Center for Toxicological Research in Arkansas to analyze the 
consequences of human exposure to nano-scale materials, which 
is very important for this field moving forward.
    And again, there's a significant investment in information 
technology, including systems to help facilitate and streamline 
the approval process.

                        LEGISLATIVE INITIATIVES

    I'd just briefly mention that there are legislative 
initiatives that are implied by the budget. They include the 
Generic Drug User Fee Program and the Follow-On Biologic 
Pathway which would have to be approved by Congress.
    Let me just very, very briefly give you an update on the 
one area where I think--and this speaks to, I think, Senator 
Brownback's point, which is that I think you could look at this 
budget and say you've got a safer food supply as a goal and a 
safer medical supply as a goal and it's hard to argue with 
those things, but what about the fact that there are people who 
are dying who need new treatments which does not exactly fit 
under--you know, obviously fit under the safer part, and I 
think that's something that Dr. Hamburg and I take very 
seriously in this job.
    I think there is some connection insofar if we can develop 
the safety systems that give us more assurance that we have 
understanding of the products that gives more confidence for 
earlier approval of products because we can watch what's 
happening to them closer and not feel that everything rests on 
the approval decision.
    So I do think there's a connection, that you can have an 
approval with a plan to monitor it and have confidence in that 
and then that allows you to feel more comfortable about early 
approvals, but I also think that one of the things that's very 
important is for FDA not to think of itself as purely an agency 
that just sits back and waits for things to come through the 
door.
    When there are opportunities or challenges to public 
health, there are opportunities for science, we want to make 
sure that the agency is reaching out to the researchers and the 
companies that have particular breakthrough products that are 
available and facilitating the pathway to approval, talking to 
them early about what would be necessary to demonstrate safety 
and efficacy, and I think one of those--the example of that in 
the short time that I've been at FDA relates to the flu.

                             H1N1 FLU VIRUS

    And we've talked a little bit about what the agency has 
done with the flu, but we're still operating in an incident 
command management structure where we have dedicated teams and 
we're really focused on what would it take to best protect the 
public if the flu were to become a major problem, and even 
though, since we last spoke, I think maybe concern for this 
particular wave of the flu may have diminished somewhat, I 
think there's still considerable concern that when the regular 
flu season hits, that it could come back pretty strongly and 
that we have to be thinking a step ahead and all the teams that 
I discussed before are still working and I'll just give you a 
very brief update.

                             ANTIVIRAL TEAM

    The antiviral team is out knocking on the doors of 
companies that have potential products that could be used to 
treat severely old people with flu, and they're trying to 
identify pathways, some of which are experimental pathways, to 
make those products available in case there are a lot of people 
who are sick.

                             SHORTAGE TEAM

    The shortage team is already reaching out to the IV 
suppliers, the makers of antibiotics as well as the makers of 
antivirals, to make sure that there's an adequate supply if 
there were to be a major stress on the medical system this 
fall.

                              VACCINE TEAM

    The vaccine team has really been doing a tremendous amount 
of work pulling together the basic protocols with other 
regulatory agencies and the companies to study vaccines. They 
are also continuing to work with the various strains of the 
virus so it can be produced into a vaccine strain.

                               BLOOD TEAM

    The blood team is working to monitor the blood supply. 
There have not been any concerns there.

                            DIAGNOSTIC TEAM

    The diagnostic team is working aggressively with companies 
and the CDC to identify more diagnostics. That test that FDA 
approved in the first like 72 hours of its work has now been 
distributed to, I think, more than 40 States and over a 100 
countries and has really made a big difference to the world's 
ability to identify this and has really reduced the level of, I 
think, anxiety which is one reason why the World Health 
Organization has not gone all the way up to a Level Six 
pandemic designation.

                        CONSUMER PROTECTIVE TEAM

    And finally, the consumer protection team has been working 
and has issued more than 30 warning letters, and I'll just tell 
you one of the most recent ones cited a company that was 
selling a formula that said will kill the virus within a few 
hours and automatically eliminate all your symptoms, and there 
was another one that said scientifically proven only to kill 
swine flu and bird flu but also MRSA, SARS, malaria, anthrax, 
TB, Bubonic plaque and sexually-transmitted diseases. So those 
products are getting some enforcement action and are coming off 
the Internet.

                           PREPARED STATEMENT

    So I think that, in conclusion, this is a time of 
opportunity, of incredible challenge for the agency, but also a 
time of opportunity. This budget really does support the 
agency's ability to move forward and protect the public, but I 
think we realize that we're going to have to deliver. We're the 
new team at FDA and that we're going to have to come back and 
demonstrate what these increased resources are doing for the 
health of the American people and look forward to working with 
you to accomplish that.
    [The statement follows:]

             Prepared Statement of Dr. Joshua M. Sharfstein

                              INTRODUCTION

    Chairman Kohl, Ranking Member Brownback and members of the 
Subcommittee, I am Dr. Joshua M. Sharfstein, Principal Deputy 
Commissioner and Acting Commissioner at the U.S. Food and Drug 
Administration. I am pleased to present the President's fiscal year 
2010 budget request for the Food and Drug Administration (FDA). For 
today's hearing, I am joined by Patrick McGarey, FDA's Director of the 
Office of Budget Formulation and Presentation and Norris Cochran, 
Deputy Assistant Secretary for Budget at the Department of Health and 
Human Services.
    In my testimony today, I will outline FDA's fiscal year 2010 budget 
request and the policy initiatives that we are advancing in our budget. 
I will also summarize recent developments related to the 2009-H1N1 Flu 
Virus outbreak and describe how FDA's budget for pandemic preparedness 
allowed us to prepare for and respond to the 2009-H1N1 Flu Virus.

                        RECENT FUNDING INCREASES

    The funding that this subcommittee appropriated to FDA for fiscal 
year 2008 and fiscal year 2009 demonstrates your strong commitment to 
the public health mission of FDA and the health of the American public. 
Thank you for your support.
    When I arrived at FDA, I asked each FDA center to provide examples 
of how they are using the recent funding increases to promote public 
health and achieve mission priorities. A key goal for FDA is to 
directly connect the investment of Federal dollars to public health 
outcomes.

                        FDA 2010 BUDGET REQUEST

Overview
    The President's fiscal year 2010 budget request for FDA includes 
$3.2 billion to protect and promote the public health. The budget 
contains an increase of $510.6 million for FDA programs, which is a 19 
percent increase compared to the fiscal year 2009 budget. This is an 
historic increase in the FDA budget and demonstrates the 
administration's commitment to food safety, medical product safety, and 
the health of the American public.
    The fiscal year 2010 increase of $510.6 million includes increases 
of $295.2 million in budget authority and $215.4 million in industry 
user fees. The FDA budget organizes these increases into initiatives 
for fiscal year 2010. Our two major initiatives are Protecting 
America's Food Supply and Safer Medical Products. The budget also 
includes $74.4 million for statutory increases for user fee programs in 
current law and increases for infrastructure to support FDA's mission.
    The FDA fiscal year 2010 budget recommends four new user fees. The 
new user fees will facilitate the review of generic drugs, enhance 
FDA's ability to register and inspect food and feed manufacturing and 
processing facilities, allow FDA to reinspect facilities that fail to 
meet good manufacturing practices and other safety requirements, and 
allow FDA to collect fees when it issues export certifications for food 
and feed.
    The fiscal year 2010 budget also recommends new authority for FDA 
to approve generic biologics through a regulatory pathway that protects 
patient safety and promotes innovation. Finally, the budget also 
includes $5 million for FDA to develop policies to allow Americans to 
buy safe and effective drugs from other countries.

                 DETAILS OF THE FISCAL YEAR 2010 BUDGET

Supply Chain Safety and Security
    The globalization of the manufacturing and supply of foods and 
medical products that FDA regulates and Americans consume poses unique 
and demanding challenges for FDA. In the complex and rapidly changing 
environment driven by globalization, FDA cannot rely solely on 
traditional approaches--inspection and sampling at the U.S. border--to 
protect Americans and ensure the safety of foods. Rapid globalization 
requires that FDA implement new approaches and conduct a broader range 
of activities to effectively regulate the supply chain for foods and 
medical products.
    Supply Chain Safety and Security is an overarching principle that 
applies to both food and medical products. Supply Chain Safety and 
Security holds all segments of industry accountable for ensuring that 
their products meet U.S. safety standards.
    Key components of this initiative include: identifying products and 
processes at high risk for earlier and more comprehensive attention; 
establishing reasonable and effective regulations and other standards; 
increasing FDA inspections; increasing effective third-party 
inspections; and collaborating with local, state and international 
partners.

Protecting America's Food Supply
    For fiscal year 2010, FDA proposes an increase of $259.3 million 
for food safety activities. This increase includes $164.8 million in 
budget authority and $94.4 million in three new user fees: Food 
Inspection and Registration User Fees, Reinspection User Fees related 
to food facilities, and Export Certification User Fees for food and 
feed products.
    To outline the key investments with the new fiscal year 2010 
resources:
  --FDA will hire 678 additional full-time equivalent staff to expand 
        programs and activities that protect America's food supply.
  --FDA will fund the cost of living pay adjustment for FDA 
        professionals that conduct food product program activities. 
        (+$12.9 million)
  --FDA will increase domestic and foreign risk-based inspections, 
        conduct more audits of controls designed to prevent 
        contamination, establish three additional high volume 
        laboratories, and conduct more food safety intervention, 
        sampling and surveillance through our Office of Regulatory 
        Affairs. The fiscal year 2010 budget increase will allow FDA to 
        hire more than 220 additional investigators. When fully trained 
        and deployed, the new investigators will enable FDA to conduct 
        the following additional field activities, based on the fiscal 
        year 2010 increases in budget authority and user fees proposed 
        in this initiative:
    --4,000 additional domestic food safety inspections
    --100 additional foreign food and feed inspections
    --20,000 additional import food and feed field exams
    --3,000 additional samples for analysis in FDA laboratories. 
        (+$101.7 million)
  --FDA will begin to implement a new strategic framework for an 
        integrated national food safety system. Under this framework, 
        FDA will build and expand existing programs and relationships 
        with its regulatory partners: our Federal, State, local, tribal 
        and territorial partners. This will allow FDA to increase 
        information sharing and improve the quantity and quality of 
        food safety data that FDA receives from its food safety 
        partners. (+$14.6 million)
  --FDA will work with all stakeholders to better ensure that food 
        protection is built into the complete lifecycle, from food 
        production to food consumption. (+$6.0 million)
  --FDA will improve its understanding of food and feed vulnerabilities 
        and risks. This will include improving FDA's ability to use 
        baseline data to measure the impact of food safety efforts and 
        to track the status of foodborne illnesses in the United 
        States. Achieving a better understanding of vulnerabilities and 
        risks will allow FDA to adjust food and feed safety priorities 
        and ensure that food programs achieve the best health benefit 
        for the American public. (+$4.0 million)
  --FDA will improve its ability to detect signals of contamination and 
        also improve its ability to collect and analyze adverse events 
        for food and feed. (+$9.8 million)
  --FDA will respond more quickly to foodborne outbreaks and will 
        improve its ability to quickly trace contamination to its 
        source. (+$12.2 million)
  --FDA will improve risk communication during a food safety event so 
        that the public can respond promptly to FDA alerts and protect 
        themselves from harm. (+$1.6 million)
  --FDA will increase the capacity of the Food Emergency Response 
        Network by establishing three new laboratories for chemical 
        analysis. (+$3.3 million)
  --FDA will further develop an integrated genomic data base for 
        Salmonella and conduct research to reduce knowledge gaps. 
        (+$0.8 million)
  --FDA will charge fees to cover the cost of reinspecting FDA-
        regulated facilities that fail to meet good manufacturing 
        practices or other FDA requirements. (+$15.3 million)
  --FDA will charge fees to cover the cost of issuing export 
        certificates for food and feed. (+$4.2 million)
  --FDA will upgrade and integrate information technology systems, 
        including systems that we use to screen, sample, detain and 
        take enforcement actions against imported food and feed 
        products that violate FDA safety standards. (+$49.9 million)

Safer Medical Products
    There are three components of FDA's Safer Medical Products 
initiative. Like the food safety initiative, the first component relies 
on the principle of supply chain safety and security. The goal is to 
protect American patients from contamination or other manufacturing 
flaws that could harm patients. The second component will address 
patient-product interactions that generally do not relate to 
manufacturing flaws. FDA will improve the safety of human drugs, 
vaccines, blood and other biological products, medical devices, and 
animal drugs and medicated feed by hiring additional safety experts to 
analyze adverse events associated with these products. FDA will also 
identify safety problems through active surveillance of third party 
healthcare data. The third component focuses on increasing access to 
affordable generic drugs, granting FDA new authority to approve generic 
biologics, and allowing Americans to buy safe and effective drugs from 
other countries.
    For fiscal year 2010, FDA proposes an increase of $166.4 million 
for medical product safety. This increase includes $119.9 million in 
budget authority and $46.6 million for Generic Drug User Fees and 
Reinspection User Fees related to medical product facilities.
    To outline the key investments with the new fiscal year 2010 
resources:
  --FDA will hire 346 additional full time equivalent staff and expand 
        programs and activities related to medical product safety.
  --FDA will fund the cost of living pay adjustment for FDA 
        professionals that conduct medical product program activities. 
        (+$16.7 million)
  --FDA will improve the safety and security of foreign and domestic 
        sources of ingredients, components, and finished products 
        throughout the supply chain--including their eventual use by 
        patients in America--through increased inspections and through 
        activities conducted by the Office of Regulatory Affairs. 
        (+$12.2 million)
  --FDA's Center for Biological Research and Evaluation (CBER) will 
        hire additional safety experts for its blood, tissue and 
        vaccine safety teams. This will strengthen the ability of 
        safety teams to analyze emerging safety threats. CBER will 
        modernize blood, tissue and vaccine standards to improve 
        product safety and quality. CBER will also provide increased 
        training to support product development and improve product 
        safety. (+$5.7 million)
  --CBER will develop new screening tests for emerging blood-borne 
        diseases. CBER will review vaccine and tissue data to identify 
        safety signals. CBER will also develop quality systems for 
        product testing and lot release of biological products and will 
        provide additional support for safe development and 
        manufacturing of cell, gene and tissue therapies. (+$2.3 
        million)
  --CBER will provide increased technical support to FDA field 
        operations as they conduct foreign and domestic inspections of 
        biologic products. (+$1.3 million)
  --FDA's Center for Devices and Radiological Heath (CDRH) will 
        implement safety requirements related to the FDA Amendments Act 
        (FDAAA). To support FDAAA safety activities, CDRH will collect 
        and analyze adverse event information related to medical 
        devices from pediatric hospitals. CDRH will conduct a pediatric 
        medical trials workshop to address unmet pediatric device 
        needs. CDRH will improve device safety by hiring experts to 
        evaluate software used in medical devices. CDRH will hire staff 
        to provide technical support to FDA foreign offices and to 
        support FDA field operations as they conduct foreign and 
        domestic device manufacturing inspections. (+$9.5 million)
  --CDRH will develop new safety tests and strengthen postmarket safety 
        reviews of ophthalmic medical devices. CDRH will also develop 
        and validate new clinical trial methods for imaging devices. 
        (+$1.7 million)
  --FDA's Center for Drug Evaluation and Research (CDER) will evaluate 
        how best to use Risk Evaluation and Mitigation Strategies to 
        minimize drug risks and promote safe drug use. (+$3.4 million)
  --CDER will also conduct research on bioequivalence standards for 
        generic forms of novel products such as metered dose inhalers, 
        topical drugs and complex dosage forms such as liposome 
        products. (+$2.5 million)
  --CDER will identify and improve enforcement against Internet sites 
        that expose consumers to unapproved products and fraud. (+$2.0 
        million)
  --FDA's Center for Veterinary Medicine will conduct scientific and 
        risk evaluation of animal biotechnology products, regulate 
        approvals for new animal biotechnology products, and coordinate 
        United States and foreign regulation on animal health issues 
        within FDA's jurisdiction. (+$0.5 million)
  --FDA's National Center for Toxicological Research (NCTR) will 
        conduct studies to analyze the consequences of human exposure 
        to nanoscale materials. These studies will provide the 
        scientific basis for issuing FDA guidance on the safe and 
        effective use of nanoscale particles in the products that FDA 
        regulates. ($1.0 million)
  --NCTR will develop noninvasive techniques to better understand the 
        risks of anesthetic use in children. (+$0.2 million)
  --FDA will develop policies to allow Americans to buy safe and 
        effective drugs from other countries. (+$5.0 million)
  --FDA will provide greater access to affordable generic drugs and 
        improve the productivity of generic drug review through a new 
        user fee program. (+$36.0 million)
  --FDA will strengthen the safety of the supply chain through a new 
        user fee program to charge fees to cover the cost of 
        reinspecting FDA-regulated facilities that fail to meet good 
        manufacturing practices or other FDA requirements. (+$10.6 
        million)
  --FDA will modernize and enhance information technology, including 
        systems that we rely on to collect, store and analyze the large 
        volume of regulatory, scientific, and risk based information 
        necessary to assure the safety and effectiveness of medical 
        products. (+$40.1 million)

Legislative Initiatives for Safe, Affordable Drugs
    The budget request supports greater access to affordable generic 
drugs, recommends new authority to approve generic biologics, and 
allows Americans to buy safe and effective drugs from other countries.
    In the coming years, patents will expire on more than a dozen 
blockbuster brand-name drugs that account for tens of billions of 
dollars in prescription spending annually. Generic competition for 
these drugs will likely be very strong. It is imperative that FDA have 
the resources to ensure the safety, quality, and therapeutic 
equivalence of generic drugs and allow Americans to benefit from the 
savings from lower cost generic drugs. To meet this priority, FDA's 
fiscal year 2010 budget includes $36 million in new user fees to 
support drug review for new generic products.
    The administration will also accelerate access to affordable 
generic biologics by working with Congress to establish a workable and 
scientifically sound regulatory pathway for approval of generic 
versions of biologic drugs.

Current Law User Fees
    FDA user fee programs facilitate enhanced premarket review 
performance and the timely availability of safe and effective medical 
devices, human and animal drugs, biological products, and other FDA-
regulated products. The fiscal year 2010 budget request includes 
increases of $74.4 million for existing user fee programs, as 
authorized by law. The increases expand the available options for 
treating and curing diseases and other health problems.

Annual Cost of Living Adjustment
    FDA can only achieve its mission and fulfill its responsibilities 
if it has sufficient resources to pay the scientific, professional, and 
technical staff required to conduct food safety and medical product 
safety programs. The ongoing experience with the outbreak of 2009-H1N1 
Flu Virus demonstrates the importance of maintaining pay rates to 
attract and retain top-notch scientists and professionals. The fiscal 
year 2010 budget includes $29.5 million for the annual cost of living 
adjustment for employees in FDA's food and medical product programs.
    Delivering the FDA mission is a personnel-intensive effort. FDA 
performs its public health mission through a highly trained 
professional workforce. Personnel and related costs account for 78 
percent of FDA's annual expenditures. To maintain its strong science 
and regulatory capability, FDA must employ, train, develop, and retain 
highly trained professionals to perform the mission critical work of 
protecting public health.

Infrastructure to Support FDA Operations
    Like the annual cost of living adjustment, the fiscal year 2010 
budget increase to pay higher rental costs and other costs for the 
buildings that FDA occupies will allow FDA to perform its public health 
mission. FDA's fiscal year 2010 budget contains $14.0 million in budget 
authority for increased GSA rent and related costs of the space that we 
occupy.

                    FDA 2009-H1N1 FLU VIRUS RESPONSE

    FDA plays a vital role in preparing for, and responding to, public 
health challenges such as the one presented by the 2009-H1N1 Flu Virus. 
FDA is part of the team led by the Department of Health and Human 
Services.
    Since the beginning of the 2009-H1N1 Flu Virus outbreak on 
Thursday, April 23, FDA has worked closely with HHS, our sister HHS 
agencies, other U.S. government agencies, the World Health Organization 
(WHO), and foreign governments.
    As soon as we became aware of the 2009-H1N1 Flu Virus outbreak, I 
asked Dr. Jesse Goodman, FDA's Acting Chief Scientist and Deputy 
Commissioner for Scientific and Medical Programs, to coordinate and 
lead FDA's efforts on the 2009-H1N1 Flu Virus. Dr. Goodman leads an 
incident management approach that includes seven substantive teams. The 
teams are cross-cutting and include staff from across FDA as needed. 
The teams include: Vaccine Team, Antiviral Team, In Vitro Diagnostics 
Team, Personal Protection Team, Blood Team, Shortage Team, and the 
Consumer Protection Team. These teams work with the Office of the 
Assistant Secretary for Preparedness and Response (ASPR), the Centers 
for Disease Control and Prevention (CDC), other HHS agencies, and 
national and international partners.
    FDA's management approach to respond to the outbreak is flexible 
and likely to change over time. It has already changed in response to 
evolving events.

Emergency Use Authorizations
    Under the Project Bioshield Act of 2004 (Public Law 108-276), 
Congress added section 564 to the Federal Food, Drug, and Cosmetic Act. 
Section 564 establishes criteria that permit the FDA Commissioner to 
issue an Emergency Use Authorization, following a determination and 
declaration of a public health emergency. An Emergency Use 
Authorization allows the use of an unapproved product or of an approved 
product for an unapproved use.
    On Sunday, April 26, 2009, the Acting HHS Secretary issued a 
determination that a public health emergency exists involving 2009-H1N1 
Flu Virus. In the days that followed, the Acting Secretary issued 
declarations under section 564 justifying emergency use of certain 
antivirals, in vitro diagnostics, and personal respiratory protection 
devices.
    Based on the Acting Secretary's actions, and using our authority 
under the Project BioShield Act, on April 27, 2009, FDA issued four 
Emergency Use Authorizations in response to requests from the CDC. Two 
of these Emergency Use Authorizations extend the circumstances in which 
two FDA-approved drugs, Relenza and Tamiflu, can be used to treat and 
prevent the 2009-H1N1 Flu Virus. A third Emergency Use Authorization 
makes available a test for diagnosing infection with the virus. The 
fourth authorizes the emergency use of certain personal respiratory 
protection devices, specifically certain disposable respirators 
certified by CDC's National Institute for Occupational Safety and 
Health, known as N95 respirators. The emergency use authorization for 
N95 respirators only relates to requirements under the Federal Food, 
Drug and Cosmetic Act, not other requirements such as the standards for 
safety in the workplace administered by the Department of Labor. On May 
2, FDA issued a fifth Emergency Use Authorization for a first tier test 
for patient specimens with suspected 2009-H1N1 infection. Taken 
together, these authorizations allow CDC and State and local responders 
to take actions that help meet the medical and public health threat.
    All seven of the FDA teams are working to ensure a comprehensive 
response to the 2009- H1N1 Flu Virus. I would like to highlight FDA's 
work in two areas, developing a vaccine and protecting consumers.

Developing an H1N1 Vaccine
    FDA's Vaccine Team is working to facilitate the availability of a 
safe and effective vaccine to protect the public from the 2009-H1N1 Flu 
Virus as soon as possible, in the event that a vaccine is needed to 
protect the American public. Members of the team are working 
collaboratively with CDC and other partners in efforts to grow and 
genetically engineer the 2009-H1N1 Flu Virus in the laboratory for 
possible use in a vaccine. FDA is also beginning to prepare reagents 
that will be essential to help manufacturers produce and test the 
vaccine.
    In a related development, on May 6, FDA announced that it approved 
a new manufacturing facility to produce influenza virus vaccines. The 
facility, located in Swiftwater, Pennsylvania, is owned and operated by 
Sanofi Pasteur and will greatly increase vaccine production capability. 
The facility is approved for seasonal influenza vaccine production, and 
the facility could also be used to produce vaccine against the new 
2009-H1N1 influenza strain.
    As we work to develop a safe and effective vaccine, FDA is also 
participating in the analysis of whether an H1N1 Flu Virus vaccine 
should be deployed later this year to protect the American public. 
Decisions about whether to deploy an H1N1 vaccine will be independent 
of the decision to produce a vaccine.

Protecting Consumers
    FDA's H1N1 Flu Virus consumer protection team works to safeguard 
consumers from fraudulent and potentially dangerous FDA-regulated 
products or other promotions for products that claim to diagnose, 
prevent, mitigate, treat, or cure the 2009-H1N1 Flu Virus. Deceptive 
products are being sold over the Internet take advantage of the 
public's concerns about H1N1 influenza and their desire to protect 
themselves and their families. The fraudulent products come in all 
varieties and could include dietary supplements or other food products, 
or products purporting to be drugs, devices or vaccines.
    FDA has an aggressive strategy to identify, investigate, and take 
action against individuals or businesses that wrongfully promote 
products in an attempt to take advantage of this current public health 
emergency. FDA issued warning notices to more than 30 Internet sites 
that we believe are wrongfully promoting products to consumers. We have 
also invited the public to voluntarily report suspected criminal 
activity, Websites and other promotions for products that claim to 
diagnose, prevent, mitigate, treat or cure the 2009-H1N1 influenza 
virus.

Fiscal Year 2006 Influenza Pandemic Funding
    As I mentioned in my May 7, 2009 testimony, during fiscal year 2006 
this subcommittee had the foresight to appropriate $20 million to FDA 
for pandemic influenza preparedness in an emergency supplemental 
appropriation. FDA invested pandemic influenza supplemental funding in 
three key areas that are critical to America's preparedness for an 
influenza pandemic: strengthening our capacity to expedite the 
development of flu vaccines, conducting essential monitoring and 
inspection of flu vaccine manufacturers, and conducting FDA-wide 
pandemic planning and preparedness activities. This $20 million 
supplemental became part of FDA's base resources and allowed FDA to 
achieve a higher state of preparedness for events like 2009-H1N1 Flu 
Virus outbreak. Because of the work begun in 2006, FDA is better 
prepared for today's response to the 2009-H1N1 Flu Virus.

                               CONCLUSION

    Our fiscal year 2010 budget of $3.2 billion will allow FDA to 
strengthen the safety of the food supply and to anticipate and address 
safety signals that emerge from the use of the drugs, biologics and 
medical devices that FDA regulates. Our fiscal year 2010 increase will 
allow the dedicated professionals at FDA to help ensure that Americans 
benefit from a safe and wholesome food supply and from medical products 
that sustain and improve their lives. Achieving our mission is possible 
because of your support for the work of the Food and Drug 
Administration.
    Thank you very much for the opportunity to testify. I welcome your 
ideas and your questions.

    Senator Kohl. Thank you very much, Dr. Sharfstein. You've 
been the Acting Director now for some 6 or 8 weeks. Very soon 
Dr. Hamburg will come become the Director and you will be 
bumped down to Number 2. Are you looking forward to that, Dr. 
Sharfstein?
    Dr. Sharfstein. I think, with the possible exception of Dr. 
Hamburg herself, I may have been the most happy person to see 
her confirmed by the Senate.
    Senator Kohl. You mean you don't like having to respond to 
us directly?
    Dr. Sharfstein. You know, I was very, very pleased to be 
able to represent the agency at this hearing, I'll tell you 
that, but it is--and it has been a tremendous honor and I think 
I have had the incredible opportunity to get to know Dr. 
Hamburg over the last couple months and I'm just really excited 
to work for her.
    Senator Kohl. Good. If asked for your judgment on the 
adequacy of this budget request, what would you say? Is it 
enough?
    Dr. Sharfstein. I think it's enough for major progress for 
FDA.

                           SUPPLEMENTAL FUNDS

    Senator Kohl. All right. Last year FDA was provided with a 
$150 million in supplemental funds. As of March 31 only $30 
million has been obligated. These funds expire now in just 4 
months.
    Can you expect to responsibly spend this additional money 
in that brief period of time and how?
    Dr. Sharfstein. Sure. I do believe we can expect to 
responsibly spend that, and I'm going to ask Patrick McGarey to 
talk about some of the details, but before I do that, I think 
it's important to note that there are a couple major efforts 
that are going forward to spend that money, one of which has 
been the hiring.

                             HIRING AND IT

    FDA has hired quite a number of new staff and that is 
continuing pretty briskly, but the other major one is 
information technology investments and what is going on now is 
that the agency has been working to best define those 
investments and then it will make those investments and it will 
lock up the money, but the thinking, the thought behind those 
investments is what's the reason that it wasn't spent yet, but 
it will be spent and it will be put into, you know, kind of the 
contracts and other vehicles that will bring those investments 
about, and those are things that seem pretty basic in some 
cases.
    People can file their submissions electronically and then 
people can file for adverse events reports electronically and 
the agency can have a better opportunity to investigate things 
or things that are really essential to kind of have FDA in a 
modern regulatory agency's position, and I think that the 
agency's been doing the right thing to think carefully about 
those investments and I know Dr. Hamburg is going to want to 
take a look at them and then when we're really sure that's when 
we'll pull the trigger on tying up those funds.
    Patrick, is there anything else you want to mention?
    Mr. McGarey. You covered it very well. We expect, with our 
IT investments, which are the heaviest piece, to launch in the 
coming quarter--excuse me--that the IT investments will launch 
in the coming quarter and there will be a large amount that 
will move into priority IT areas. I think that just buttresses 
what Dr. Sharfstein said.

                          STRATEGIC FRAMEWORK

    Senator Kohl. All right. Dr. Sharfstein, does the $14.6 
million ``strategic framework'' for food safety include 
implementation of FDA's Food Protection Plan? Can you provide 
some detail on this? In particular, will the FDA need to change 
its structure or its current activities?
    Dr. Sharfstein. $14.6 million, I think, relates to what 
we'd like to do with States and localities, and this is a 
multiyear investment. It's really to transform FDA's 
relationship with States and localities on food safety so that 
when the State--I recently met with a company that said on 
Monday they get a Federal inspection, sometimes Tuesday they 
get a State inspection, on Wednesday they get a local 
inspection and sometimes they're done by the same person, you 
know, who just pulls out a different clipboard and is, you 
know, checking stuff down.
    We hear all this about there not being enough inspectors 
but what's going on, and it's a fair question, and I think it's 
very clearly understood that there's not the kind of 
coordination. By coordination, I don't mean just the FDA hiring 
the State contractors which is what goes on now, to a certain 
extent, but really it's an integrated system where if the State 
goes out, FDA has confidence that that inspection is good.
    And there was really a report that was funded by the Robert 
Wood Johnson Foundation that really set out a vision for that 
kind of system and this is really a big step, this $14.6 
million, to start to move to that. It's going to require FDA to 
develop a significant training capacity. It's going to require 
States to want to engage. There's some money in there for the 
States to be able to spend money, to hire people, to upgrade 
their level of food inspections, and I think that is going to 
pay off a lot.
    There's something like $700 million of States and 
localities spending on food inspections now, but if FDA doesn't 
have the confidence and if there are gaps in those inspections 
or they're not at the right, you know, level, then that money 
is not being spent as well as it should be.
    If we can invest some in increasing the training and we can 
give some money to States to be able to do it, then we're 
leveraging that $700 million to really strengthen the overall 
food safety system.
    Now to your point on the FDA's organization, I think that's 
something that I know Dr. Hamburg and I are going to look at 
very seriously. I think it's clear that the responsibilities 
for food are stretched over different areas of FDA.
    One thing that I've done since I began is every morning at 
7:45 I bring everyone related to food, that's the Office of 
Regulatory Affairs, the Associate Commissioner for Food, the 
SIFSAN, the Center for Veterinary Medicine, together and we 
have met on different food safety issues and that includes 
active outbreaks as well as policy issues.
    On Thursdays we do a call with USDA and on Friday we do a 
call with CDC, I think since day three on the job. So I think 
that we've started the process of pulling the food together, 
and I think we're going to be looking with Dr. Hamburg's 
confirmation at structural issues that could facilitate that.
    Senator Kohl. Good. Senator Brownback.
    Senator Brownback. Thank you, Mr. Chairman. I appreciate 
that.

                               ACCESS ACT

    On the new drug--this Access Act, I put this bill forward 
with various co-sponsors, bipartisan bill, over a number of 
years.
    Why can't the agency do this? It just seems almost inhumane 
what we're doing to some people that don't have another option, 
and I want you to have safe drugs out there. There's no 
question about it, but if somebody's in a terminal situation 
with cancer or another disease and there is something here that 
they could try that's showing some promise early, they're in 
many cases not able to get into clinical trials because they're 
not healthy enough to get into clinical trials, why can't we do 
this? Why can't you do that?
    Dr. Sharfstein. Thank you. I think that's an absolutely 
reasonable question to ask, and I have, you know, met with 
patients who have faced incredible challenges and sometimes 
it's been experimental therapies that have been the things that 
have saved their lives.

                           EXPERMENTAL DRUGS

    I think that there are three different issues that I want 
to tease out. The first is communication. There are--FDA has 
the responsibility to make the pathways that are available to 
get experimental drugs as widely available as possible. So 
FDA--it's very important that there are different mechanisms 
that doctors and companies can use to access drugs in the pre-
approval stage and it's important and one of the things we'll 
be focusing on is making sure that those mechanisms are as 
widely available as possible. That's just one of three points I 
want to make.
    The second one is data, and I've been impressed and I've 
talked to people on all sides of this issue, had extensive 
conversations with people who are very strong supporters of 
your legislation, and I've also met with people who have 
different views on it, and the one thing that struck me is how 
little data we have on what the barriers are, what the point of 
the barrier is, and what I mean by that is I'd like to know, 
walking into this discussion, of 500 patients with severe, you 
know, life-threatening illness who want experimental drugs who 
can't--you know, what percent get them either by enrolling in a 
trial or, you know getting them through one of the existing 
pathways at FDA?
    What percent is it that the company is not willing to apply 
for an IND or some mechanism or they are applying and FDA is 
not granting it, and so, I mean, to me having some basic data 
to understand this, and what I've found is that people around 
this issue on all sides all agree that there is need for more 
data there, and some of that, I believe, exists within FDA, and 
we should be able to get that.
    We should--I would like to know when people do apply for 
these INDs what the rate of approval is and when we're 
approving them and when not and why. So I think that that's got 
to be part of what informs policy.
    Senator Brownback. And you're going to start shaping that 
database?
    Dr. Sharfstein. Yes, I do want--one of the goals is to get 
data that allow us to identify the point, the rate-determining 
step. I'm not sure exactly what that is.
    And the third thing is flexibility and I think both Dr. 
Hamburg and I are going to go into this with an open mind about 
it. I do understand the issue that it's very important for 
there to be data about the effectiveness of new drugs because 
without that data, you----
    Senator Brownback. It's the Wild West on the Internet 
without that data.
    Dr. Sharfstein. Right.
    Senator Brownback. I mean, it's just people putting all 
sorts of things out there and when you're in that type of 
situation you're willing to listen to about anything.
    Dr. Sharfstein. Well, there's a very, you know, disturbing 
report in the Chicago Tribune about an approach that people are 
using for autism that a lot of people feel like is potentially 
dangerous to kids and, you know, you have to--FDA has a 
responsibility on both sides, a responsibility that people 
aren't exposing themselves to, you know, risk without benefit 
but also where there is benefit and people can make a 
reasonable decision to help them do that, at the same time 
understanding the need for, you know, real evidence about the 
products.
    Senator Brownback. I hope we can work with you and the 
incoming Director of the FDA to maybe get some of these 
specific steps taken care of so we can make it more accessible.
    Dr. Sharfstein. I'll tell you, I talked to David Kessler 
before I took this job and what he said to me was when he looks 
back on his time at FDA, the thing that he's most proud of is 
getting the medications for HIV patients.
    Senator Brownback. Yeah. It was a fabulous move and they 
really sped it up and thankfully because they did people lived 
and now we're slowing it down for a lot of others and people 
die.
    I can get you the studies from the groups and I'm sure 
you've seen these numbers of tens of thousands of people dying 
waiting for a drug to get on the market and in many cases that 
is eventually approved and then they die waiting and that's 
what just--you look at it and you think that's just cruel.
    But I hope you can work with us on this because I thought 
what Kessler did was spot on when he looked at this real crisis 
that was existing and we've got a cancer crisis now. I hope you 
can work with this on that.
    Thanks, Mr. Chairman.
    Senator Kohl. Thank you very much, Senator Brownback.
    Senator Pryor is here from Arkansas. Senator Pryor, you 
have a full 5 minutes.

                                  NCTR

    Senator Pryor. Thank you very much, Mr. Chairman. Thank you 
for your leadership on this.
    Let me ask, if I may, Dr. Sharfstein, about an FDA facility 
that's actually located in my State, the NCTR, National Center 
for Toxicological Research. Are you familiar with that center?
    Dr. Sharfstein. Yes, not only that, I think its director is 
behind me here.
    Senator Pryor. Great. And----
    Dr. Sharfstein. I'm looking forward to visiting.
    Senator Pryor. Good. Well, I know that the administration's 
asked for $1 million to do some nano research there, to 
research the effects of nano technology which I think is 
important research, and I think it needs to be done because 
obviously nano technology offers a lot of promise in the 
future, but we need to be very clear about the health risks 
before we go forward.
    And my question for you is, if you know, is $1 million 
enough to do an adequate job or at least get an adequate start 
on that research?
    Dr. Sharfstein. Let me just check. I think that the money 
actually pays for some pretty important equipment. I think it 
is going to pay for if not an electron microscope then the 
actual materials to support the electron microscope and an 
electron microscopy technician.
    So it allows the--it's sort of an investment in the ability 
of NCTR to do critical research on nano technology, and I think 
your point is extremely important and this is, I think, a point 
that is very important for FDA generally. This is a new field 
and if there's an unforeseen safety problem, it could really 
hurt the field, but by having good data and doing sensible 
regulation, then we provide confidence to that field. It can 
grow. It can become a big, you know, improve--you know, could 
create all sorts of products that are beneficial to public 
health.
    So this is not a situation where regulation and the, you 
know, interests of industry are at odds. In fact, if we can do 
sensible regulation, we establish safety, then you could 
imagine that, you know, 20 years from now people would be 
looking back and seeing it as just the birth of a whole 
movement in nano technology.
    Senator Pryor. Right. And the other part is not just nano 
products generally but I know there's some real potential for 
medical breakthroughs using nano technology.
    Recently, I saw that there was an announcement that you can 
somehow get carbon nano tubes and they think that they can be a 
very accurate treatment for cancer that doesn't harm the rest 
of the body but then again, I think the other health research 
needs to be done on that.
    You have a very promising technology, you know, very 
promising development with nano technology. You just need to 
make sure that it's not harming others.
    Dr. Sharfstein. Well, I agree, and I think this is an area 
where you have something that's so promising. Part of FDA's job 
is not just to sit back and see what happens but to really 
engage in the conversations and try to facilitate.
    Senator Pryor. Right. That's right. You mentioned in your 
testimony a few moments ago that you have a consumer team at 
FDA and you're doing warning letters to companies that are 
selling, I guess, sounds like maybe miracle cures on the H1N1?
    Dr. Sharfstein. Correct.
    Senator Pryor. And I'm just interested in that. I think you 
said you sent out 31 letters, and is it possible for you to 
provide the committee with copies of those letters so that we 
could know who's out there doing that?
    I'm chair of the Consumer Subcommittee over in the Commerce 
Committee. So I'd like to get those. Is there any real update 
on that or is there any status report you want to give us?

                            WARNING LETTERS

    Dr. Sharfstein. Yes, I think the latest information I have 
is that there were 36 warning letters and we'd be happy to 
provide them to you, and I think there's 69 products cited in 
the warning letters, and I mentioned a couple of them, one of 
which says that independent tests show this product is hundreds 
of times more effective at killing the flu virus than the most 
potential antiviral prescription medications known. It's the 
only one that actually kills the virus and automatically 
eliminates all symptoms. That's one.
    [The information follows:]

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/
default.htm

    Senator Pryor. Right.
    Dr. Sharfstein. The other says it's good for swine flu, 
bird flu, MRSA, SARS, malaria, anthrax, TB, Bubonic plaque and 
sexually-transmitted diseases.
    So I think that there's a whole list of them and, you know, 
on the one hand, maybe if it's totally harmless, you know, you 
think, well, you know, why waste--why spend resources in that 
direction, but the truth is somebody who's sick and maybe they 
don't even have swine flu, somebody who's sick may be turning 
to products because of the claims that they're making and not 
going to the doctor and potentially getting worse, and, you 
know, it's important that people not be misled by inappropriate 
information.
    Senator Pryor. Right. I would encourage, if you could, you 
to work with the Consumer Product Safety Commission, even 
though you're talking about drugs. They have a lot of expertise 
in tracking that and trying to prevent those types of scams and 
rip-offs.

                            DRUG IMPORTATION

    One last question, if I may, and that is about importing 
drugs. There's been a question here in years past about how 
safe imported drugs are into this country and as I understand 
it, the president is trying to work with stakeholders to 
develop a policy on imported drugs.
    Do you know anything about?
    Dr. Sharfstein. Sure. So there are two issues. I think a 
lot of drugs in the United States--drug supplies are imported 
now in the sense that they're manufactured abroad or they have 
materials that are manufactured abroad and there's a whole 
issue of safety there that's very important to deal with.
    The second issue is the purchase of drugs that are approved 
in other countries, so not drugs that are FDA-approved but 
drugs that are approved, say, by the regulatory authority in 
Canada, for example, and whether it is appropriate, safe, to 
design a system that would permit importation of drugs approved 
in other countries as opposed to the importation of U.S. drugs 
which happens all the time.
    And what the budget has is $5 million for FDA to develop a 
framework and a policy that could permit that to be done 
safely. So I think--so basically, we would spend some time 
thinking through what the challenges to that kind of system 
would be and try to design an approach to solve those 
challenges and I think one of the benefits to this is that some 
of the issues there are going to be relevant to the first 
problem, too.
    So no matter what we find, it's going to be helpful to us. 
If we are trying to understand more about how to trace the 
pedigree of drugs so that we can be sure we're getting true 
drugs from other countries, that's going to help us understand 
how to do that well in the United States, too.
    So I think there's a crossover benefit of that project.
    Senator Pryor. Okay. Thank you, Mr. Chairman.
    Senator Kohl. Thanks a lot, Senator Pryor. Senator Bennett.

                             CRITICAL PATH

    Senator Bennett. Thank you very much, Mr. Chairman, and my 
question will come as a great surprise.
    Tell me about the Critical Path and what you see and what 
your attitude is and what you think the ongoing attitude will 
be.
    Dr. Sharfstein. So I think--thank you. I think the Critical 
Path has been a very important effort by FDA and it's something 
that I believe Dr. Hamburg supports, and I certainly support.
    I think the question is what is the Critical Path going to 
mean and in talking to the people who run it and in talking to 
Dr. Goodman, who's now the Acting Chief Scientist and is here, 
I think that we see the Critical Path as a way to do very 
important partnerships that permit breakthroughs in diagnostics 
and in treatment and so there's a lot of important work.
    It's not just the job of the Critical Path to think about 
basic treatment. That's the job of FDA. I mean that's the job 
of a lot of different people.
    Senator Bennett. Sure.
    Dr. Sharfstein. The role of the Critical Path is to think 
of partnerships and one of the examples of that is this study 
that is one of the things that was funded by the support that 
we have received in increases in the last couple of years, that 
FDA is facilitating working with partners that design and 
conduct a large trial to compare the benefits of extended anti-
platelet therapy versus aspirin alone in patients receiving 
stents, and this is a study that will really answer some pretty 
important questions. It's being overseen by the Critical Path 
team because of the nature of the partnership that's there.
    So I think that what I also liked about the Critical Path 
particularly is that it naturally is connecting its investments 
to the outcome, and I think that's something that, in general, 
FDA needs to do better. We're getting all this money. What are 
we delivering?
    And what I like about the Critical Path and I've got the 
report you may have seen, Projects Receiving Critical Path 
Support in Fiscal Year 2008, and what it does is say, look, you 
gave us this money, here's what we're doing and if it works, 
here is what we're going to get for it, and I think that that 
is--it's important to--the Critical Path serves the role of 
pushing that thinking all the way into FDA.
    So I think that you're going to see support for that at FDA 
and I think I'd like to have a very clear philosophy 
articulated and then lots of clear things that we're delivering 
on that benefits the public health.

                                TOBACCO

    Senator Bennett. Thank you. An unrelated question. There is 
a very strong push going on, which I expect will probably 
succeed in this Congress, to give FDA jurisdiction over 
tobacco.
    I've always resisted that on the grounds that FDA is an 
agency that has as its goal determining whether or not things 
are safe and you can determine whether or not tobacco is safe 
or healthy in an afternoon. But now you're going to 
``regulate'' tobacco and it's a new role for FDA.
    Do you have any idea as to exactly what FDA would do with 
respect to regulating tobacco, and how much of a burden it will 
put on FDA personnel if the bill with respect to tobacco and 
FDA passes?
    I clearly am one who wants to do everything I can to get 
people to stop smoking because it's one of our biggest health 
problems in the United States. My concern has absolutely 
nothing to do with that. It has to do with FDA as the suitable 
agency, but it looks like I'm going to be overruled and I 
probably will end up voting for the bill anyway because I don't 
want to be accused of being in favor of big tobacco simply 
because no other agency presents itself as the one to deal with 
it. So you're going to get stuck with it.
    Now, do you have any insight for us as to how it's going to 
work and what you're going to do?
    Dr. Sharfstein. Thank you, and I think it's--obviously 
given the circumstances and the legislation moving forward, I 
totally understand the question.
    To your point about the--it being a little unusual for FDA 
to be regulating something that is clearly unsafe, I think that 
the bigger picture is that FDA is a public health agency and 
takes a lot of steps in terms of regulating products to improve 
the public health, and I think that's the approach that would 
have to be taken for tobacco, which is the leading cause of 
preventable death and also one of the least regulated products 
in the market.
    I do think that the--we're going to have to read very 
carefully the bill that's passed by Congress, and I think what 
we would do is going to depend on the final shape of the 
legislation and still hasn't gone to the Senate Floor, and I 
know there may be all sorts of amendments and changes and, you 
know, our job is to implement the legislation that Congress has 
passed.
    So I think that there is a budding science, science that I 
think we can expect to grow over time, about what about tobacco 
may be responsible for different adverse problems that result 
from tobacco and as that science grows, FDA will be in a 
position to make different types of tobacco products less 
harmful, and I think that's one area that the bill definitely 
contemplates as it's written now, to allow the agency to 
establish performance standards in different areas, but that's 
going to depend on the scientific findings and the approach the 
FDA would take to this is going to be, you know, weighing the 
risk and the benefit of different approaches for things, as the 
FDA often has to do, in completely different contexts.
    As far as the burden question, I think that's obviously a 
fair question because FDA has a lot to do. Otherwise, I think 
that it is--I think that the administration believes, Dr. 
Hamburg believes, and I believe that the FDA is the right 
agency for this task, given the experience the FDA has in 
regulation and some of the expertise in particular elements.
    Even if it's not, you know, cigarettes, when you have a 
toxicology issue, if you have toxicologists, they can helpful. 
They can help you figure out what the right team to have there 
is.
    I think the bill has got to provide adequate resources and 
the current version does for the agency to do the work and with 
that, I think what Dr. Hamburg has said is that we have to be--
you know, the agency already has to be able to do more than one 
thing well at once, and this is going to be another thing but 
it's a very important thing.
    In the big picture, it's going to improve the health of 
Americans and for that reason, I think it's important.
    Senator Bennett. Thank you very much. I'm encouraged.
    Thank you, Mr. Chairman.

                            SAFE DRUG USAGE

    Senator Kohl. Thanks very much, Senator Bennett.
    Dr. Sharfstein, the FDA recently acknowledged that 
prescription drug information provided to consumers at the 
pharmacy can be very bewildering and not easily understood. 
Your budget proposes $3.4 million to promote safe drug usage.
    Will these funds be used to address that problem I just 
described, and what process and time table will FDA be using to 
make sure that consumers get streamlined easy-to-understand 
language when they buy their prescription drugs?
    Dr. Sharfstein. Thank you. It's a very good question 
because there's information that comes about drugs from 
multiple different sources. You see the ads, the handouts which 
can be like, you know, the actual package inserts which can be 
very small print and difficult to understand, then there's 
things that people get in the pharmacy. Sometimes they're 
approved by FDA and sometimes they're not and they can be 
potentially misleading sometimes. So I think the point you're 
raising is important.
    The Safer Drug Initiative has a goal of working 
collaboratively with a lot of external partners, including 
pharmacies, to get better information and instructions to 
people. It relates not just to information but also things like 
how to keep medicines at home, how not to let kids into 
medicines and a whole bunch of other things that can have a big 
impact on health if they're followed through on.
    As far as the particular projects and timing, I think I 
might want to ask Dr. Woodcock, who is here, the head of the 
Center for Drugs, to answer that, if that's okay, or if you 
prefer, we can provide more of an answer.
    Dr. Woodcock. Hi. I'm Janet Woodcock. Yes, we agree, and as 
you alluded to, at a recent public meeting we talked about the 
survey that had been done, a scientific survey by contractors 
of consumer information that is given to people when they fill 
prescriptions, and it did not meet the criteria for usefulness 
for patients that had been established.

                               MED GUIDES

    So we are going to be going through the next year through a 
process and we're going to look not just at that consumer 
information but, as Dr. Sharfstein alluded to, to med guides 
and to patient package inserts and all these different forms of 
information that people can get and try to craft something that 
is maximally useful to people who fill prescriptions and have 
to take medicine.
    Senator Kohl. That's good. Thank you.
    Senator Brownback.
    Senator Brownback. Thanks, Mr. Chairman.

                        COST OF DRUG DEVELOPMENT

    Dr. Sharfstein, just one final comment area. I'm very 
troubled about the cost of developing a new drug nowadays and 
I'm hearing now pharmacy schools, University of Kansas School 
of Pharmacy is one of the top in a number of different surveys, 
the top pharmacy school in the country, saying that the cost of 
drugs, the cost of developing a drug is so high now that whole 
categories are not even particularly being focused on because 
there's not a big enough patient pool to support the research 
dollars that's necessary, in the hundreds of millions, I 
suppose even billions, of dollars, to bring out some new drugs.
    I very much appreciate the focus on safety and we need to 
have that, but now if we're shutting off to the side a 
potential drug development because it only had 300,000 patients 
or 1 million potential patients and you spread the costs of $1 
billion drug over them and they're saying we can't do it, I 
would hope that you and the new team that comes in at FDA would 
look at this and say this is a major problem for us because now 
we're going to have whole areas where we're not even going to 
be researching what you put--how you try to treat this and if 
you get it, you know, God save you.
    I'm hopeful it becomes better. I really hope you look at 
that and I also want to invite you out to the KU Pharmacy 
School. I just toured there not long ago and I think they're 
doing some really fascinating work on screening throughputs of 
different compounds on a very rapid basis and I'm sure you're 
familiar with the technique.
    I was impressed with it, though, and the way they're 
looking at these items, and I do hope you really get on top of 
that cost issue because it's going to kill people if we don't 
get on top of it.
    Dr. Sharfstein. Thank you. I know that Dr. Hamburg has a 
special interest in orphan drugs and drugs for diseases that 
don't, you know, affect as many people as sort of the major 
drugs.
    I know in the last couple years FDA's approved a couple 
drugs under the Orphan Drug Program, including a drug for 
Huntington's disease and a drug for Hunter's disease, and I 
remember taking care of kids with that. But it's something that 
requires and will get attention from us to understand what 
needs to happen.
    I was just at an event for the National Organization of 
Rare Diseases and, you know, I heard from everybody the concern 
that you're raising and I think both Dr. Hamburg and I are 
going to be very interested.
    I think that when you think about FDA, the role of FDA, 
it's both about benefit and risk. In other words, we want to 
maximize the benefit, we want to help get drugs to people who 
need them and at the same time we want to reduce the safety 
concerns, and both parts of that equation are very important to 
us.
    Senator Brownback. I want to invite you out and we'll give 
you a cholesterol-free steak,----
    Dr. Sharfstein. Okay. Sounds good.
    Senator Brownback [continuing]. Top quality. Thanks, Mr. 
Chairman.

                            ADDITIONAL STAFF

    Senator Kohl. Thanks a lot, Senator Brownback.
    Dr. Sharfstein, will you tell us a little bit about your 
plus-up in staff by quite a few hundred and what you're going 
to let them or direct them to be doing?
    Dr. Sharfstein. Sure. In the fiscal year 2010 budget, you 
mean?
    Senator Kohl. Yes.
    Dr. Sharfstein. Let's see. I think that the total number--
--
    Senator Kohl. It says here you have 678 additional staff to 
work on food safety and some few more hundred to work on 
medical product safety.
    Can you confirm that and tell the American public that you 
really are adding people to work on the issues of food safety 
and food inspection and----
    Dr. Sharfstein. Yes, the--for foods, it'll be about 220 
more inspectors as well as analysts and a total of about 600 or 
so of people to work on foods. For medicines, it's going to be 
about, as I said, 300 more people and that includes a lot of 
scientists who will be working to make sure that drugs, 
vaccines, tissues, devices, are safer and we understand the 
opportunities for new novel products better.
    So I think that these investments, we should see and we 
should be able to explain clearly to you and to anyone who asks 
how we're using these investments not just to hire people and 
not just to get inspections, for example, but to actually 
deliver results that matter to people.
    Senator Kohl. Your Rapid Response Program, how's that 
working?
    Dr. Sharfstein. For food safety?
    Senator Kohl. Yeah. The food outbreaks.
    Dr. Sharfstein. Food outbreaks?
    Senator Kohl. Yes.
    Dr. Sharfstein. I think that I'm familiar with how we 
responded to the food outbreaks that I've been involved in, but 
I might ask David Acheson to come forward and talk about that 
particularly.
    I'm not sure what part of that is referred to as the Rapid 
Response Program.
    What we have done and I've seen is that FDA has been 
working very closely with the States and localities. We are 
involved with CDC and with the industry when there's an issue 
and it's moved very quickly so that we're able to narrow the 
scope of the pistachio recall very quickly and the scope of the 
alfalfa sprout very quickly. It was because of coordinated 
action among those different groups.
    And let me see if--it would be Dr. Acheson.
    Senator Kohl. We have just a minute or so before we have to 
end.

                             RAPID RESPONSE

    Dr. Acheson. Good afternoon. I'm David Acheson, Associate 
Commissioner for Foods.
    I think you're probably referring to the Rapid Response 
Teams that we're putting out in the States.
    Senator Kohl. That's correct.
    Dr. Acheson. And we've now got six of those funded with the 
machinery operating to fund another three. This is all part of 
the integrated FDA-State-local systems that are--this is 
obviously focused on response and that's clearly at the end of 
the spectrum, but that's beginning to work very well and bear 
good fruit, and we're targeting working with the States much 
earlier in these situations and not waiting until it's later.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Kohl. Thank you. Well, Dr. Sharfstein, we want to 
thank you and your staff for being here today.
    I believe the FDA is going to become increasingly 
responsive to all the important needs in our society under your 
direction along with Dr. Hamburg, and we are looking forward to 
working with you.
    [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'S NEW PLAN FOR FOOD SAFETY AND STATES' ROLE

    Question. What do you think is the appropriate role of States in 
this effort? It appears that funding for State contract inspections is 
increasing very slightly. Should that number go up?
    Answer. For fiscal year 2010, FDA is requesting funding for a new 
strategic framework for an integrated national food safety system. A 
system that has adequate Nation-wide coverage will require 
implementation across multiple years. For fiscal year 2010, FDA is 
requesting $14.61 million to begin to build the FDA infrastructure for 
the system.
    The States will play a central role in the strategic framework for 
an integrated national food safety system. FDA's fiscal year 2010 
investment in infrastructure is essential to help establish the 
standards, training, accreditation and oversight programs that are 
integral to an effective system, to leverage State regulatory programs, 
and to ensure consistent standards among regulatory partners.
    Question. What percent of FDA food inspections are carried out by 
State inspectors through a contract?
    Answer. During fiscal year 2008, FDA and our State partners 
conducted 16,125 domestic food inspections. Of this amount, State 
inspectors under contract to FDA conducted 8,777 inspections, or 54 
percent of the total. If animal feed inspections are added to the count 
of food inspections, State inspectors under contract to FDA conducted 
14,489 or 60 percent of the 24,037 domestic food and animal feed 
inspections. FDA also has responsibility over FDA-regulated products 
entering the United States. During fiscal year 2008, FDA inspected 152 
foreign food establishments and completed 100,718 import field exams.
    Question. What percent of FDA medical product inspections are 
carried out by State inspectors through a contract?
    Answer. During fiscal year 2008, FDA and our State partners 
conducted 13,588 domestic medical product inspections. Of this amount, 
State inspectors under contract to FDA conducted 7,652 inspections, or 
56 percent of the total. The State contract inspections consist of 13 
medical device inspections and 7,639 medical product mammography 
facility inspections conducted as part of the Mammography Quality 
Standards Act. In the case of non-mammography inspections, State 
inspectors conducted less than 1 percent of non-mammography inspections 
during fiscal year 2008.
    Question. The budget says this new system may require new 
authorities, including multi-year budget authority. I don't see this 
request in the budget. Can you elaborate?
    Answer. FDA is requesting $14.61 million to begin to build the FDA 
infrastructure for an integrated national food safety system. These 
funds will allow FDA to establish the standards, training, 
accreditation and oversight programs that are integral to an effective 
system. FDA cannot establish an integrated national food safety system 
during a single fiscal year. We hope to continue to build this system 
over time.
    Question. Recent reports have highlighted FDA's failure to properly 
audit State inspection programs. Is there funding in the budget to 
increase these audits?
    Answer. Yes, the request to increase funding to enhance our audit 
program for State inspections is part of the funding request for the 
Integrated National Food Safety System. Enhancing our audit program 
will allow FDA to increase the audit staff conducting oversight of 
State food safety inspections.
    Question. Will all of the additional food inspections be carried 
out by FDA inspectors, or will some of them be through State and other 
contracts?
    Answer. Additional food inspections will be carried out by FDA 
investigators. The fiscal year 2010 budget increase will allow FDA to 
hire additional investigators to increase the number of domestic and 
foreign inspections that FDA conducts.
    For the fiscal year 2010 budget increase, FDA estimates that it 
will hire approximately 126 more investigators with Budget Authority 
and approximately 96 more investigators with Food Inspection and 
Facility Registration User Fees to conduct domestic and foreign food 
safety inspections. Due to the time that it will take to train the new 
FDA investigators, FDA will not achieve the increase in domestic 
inspections until the end of 2012. FDA will achieve an increase in 
foreign inspections associated with the additional investigators by the 
end of fiscal year 2012. The fiscal year 2010 budget increase will 
allow FDA to use Budget Authority to conduct 2,000 domestic and 50 
foreign inspections. In addition, FDA will also use Food Inspection and 
Facility Registration User Fees to conduct an additional 2,000 domestic 
and 50 foreign inspections. This will achieve a total of 4,000 
additional domestic food safety inspections in fiscal year 2012 and 100 
additional foreign food safety inspections in fiscal year 2012.

                          RAPID RESPONSE TEAMS

    Question. The budget includes $12 million to accelerate responses 
to food borne outbreaks. What specifically will this money be for?
    Answer. The $12.1 million increase that you identify will allow FDA 
to increase its laboratory capacity to support food safety activities. 
These funds will not be used to increase the number of rapid response 
teams. The $12.1 million will allow FDA to fund three additional 
chemistry labs for the Food Emergency Response Network--FERN--and 
provide additional support to State microbiology laboratories in the 
FERN system.
    Question. How many rapid response teams have been created 
throughout the country, and where?
    Answer. At this time, there are six rapid response teams. The teams 
are in California, Florida, Massachusetts, Michigan, Minnesota, and 
North Carolina. FDA is in the process of awarding cooperative 
agreements to establish three additional rapid response teams before 
the end of 2009.
    Question. Please provide a summary of the activities of the rapid 
response teams to date.
    Answer. All teams completed initial developmental activities, which 
included training and an assessment of their response capacities. By 
July of 2009, all teams will have participated in 2-day FDA sponsored 
training sessions. By September, all teams are due to complete their 
Manufactured Foods Regulatory Program Standards Assessments.
    The participating States are at varying stages of their plans to 
acquire additional team members, to provide training to support team 
objectives and to initiate practice exercises to prepare the team. 
Additional training opportunities consist of other courses provided by 
FDA and relevant courses supplied through other qualified sources. All 
States are meeting the milestones set out under the cooperative 
agreements.
    The six participating States entered into the Rapid Response Teams 
pilot cooperative agreements with FDA with varying degrees of 
established team experience and structure. Several States had already 
invested in developing team structures while others are using the 
resources available through the FDA agreements to initiate teams this 
year. These different experience levels across the six State teams have 
yielded some States with the capability to activate teams in this first 
year of the agreement. States with developed and practiced teams have 
deployed them in response to State level incidents and incidents under 
FDA jurisdiction, such as the coordinated response to Salmonella in 
peanut butter earlier this year. The remaining States continue to 
obtain training, develop procedures, and prepare for practice 
exercises.

                             GENERIC DRUGS

    Question. Even though Congress has provided increases over the last 
few years for generic drug review, the backlog of applications 
continues to grow. The user fee being proposed has been proposed in 
previous budgets, but never authorized. Do you think this year will be 
different? If the user fees aren't enacted, is the budget for generic 
drugs adequate?
    Answer. Although generic drug user fees have been proposed in 
previous budgets, FDA plans to reengage the generic drug industry in 
user fee discussions this year to make progress on this important 
proposal. Our aim will be to develop a user fee program that provides 
the FDA generic drug program with the resources needed to modernize and 
enhance the capacity of the generic drug review process and to ensure 
timely patient access to safe and effective new generic drugs. FDA 
believes that the resources in the fiscal year 2010 proposed generic 
drug user fee program are necessary to reduce the review backlog and 
ensure patient access to safe and affordable generic drugs.

                NEW AUTHORITIES REQUESTED IN THE BUDGET

    Question. There are no details in the budget regarding the new 
authority for generic biologics. What is the status of this, and is 
there an associated cost?
    Answer. The fiscal year 2010 Budget supports the creation of a new 
regulatory pathway under the Public Health Service Act for FDA approval 
of ``generic biologics,'' a term that refers to follow-on biological 
products that are highly similar to--or biosimilar--and may be 
substitutable or interchangeable for a previously approved biological 
product. As I mentioned in my testimony, establishing a generic 
biologics pathway will require new legislation.
    FDA has approved follow-on versions of certain protein products 
under the existing abbreviated approval pathways in the Federal Food, 
Drug, and Cosmetic Act. However, the majority of protein products now 
on the market have been licensed as biological products under the 
Public Health Service Act, which does not contain analogous abbreviated 
approval pathways.
    Safe and effective generic biologics may prove to be a critical 
element to lowering costs for American consumers and the healthcare 
system more broadly. FDA would require additional resources to augment 
our existing capabilities for regulatory activities associated with a 
generic biologics program, and anticipates the need for significant 
additional analytical testing capabilities. Depending on the scope and 
requirements of any legislation establishing a generic biologics 
pathway, we expect that there will be a large workload in the early 
phase of a generic biologics program in our pre-application 
activities--including meeting with industry and providing advice--as 
well as developing policy and procedures, publishing guidance, and 
promulgating regulations. We also anticipate receiving some 
applications for review shortly after enactment of legislation, with an 
increasing number of applications for review in subsequent years.
    Question. What is the administration's plan to get the 4 new user 
fees you mention in your statement authorized? What are the results if 
that doesn't happen?
    Answer. FDA plans to work with the administration, with Congress 
and with stakeholders to authorize the four new user fee programs 
proposed in the fiscal year 2010 budget. In the event that our efforts 
are not successful, FDA will rely on existing funding in the form of 
budget authority to conduct the four program activities without the 
benefit of additional user fees.

           ADDITIONAL STAFF REQUESTED IN THE BUDGET/PAY COSTS

    Question. How many additional staff has FDA hired with the 
increases provided in the supplemental and the fiscal year 2009 
increases?
    Answer. FDA has hired 859 additional staff from the funds provided 
in the fiscal year 2008 supplemental and the fiscal year 2009 budget 
authority and user fee increases. As of May 18, 2009, there were 720 
hires on board with 139 staff scheduled to start soon thereafter.
    Question. Although the budget includes nearly $30 million for pay 
costs, it also includes a chart that says FDA will have to absorb an 
additional $33 million to fully fund pay costs. How were these numbers 
developed? If you are only provided the $30 million requested, where 
will the rest of the money come from?
    Answer. The Administration developed the estimate of the total pay 
cost for FDA based on the estimate of the annual pay adjustment for 
civilian and military employees and the estimate of the numbers of FDA 
employees who would receive a pay increase. FDA will cover any 
shortfall in the fiscal year 2010 of the annual pay adjustment through 
a combination of strategies, including reducing operating costs and 
adjusting when it conducts hiring.

                       FDA REGULATION OF TOBACCO

    Question. As you know, Congress is currently considering a bill 
that would require FDA to regulate tobacco. The bill is proposed to be 
funded through user fees. However, will there be start-up costs 
required before the user fees are collected? I don't see any in the 
budget request.
    Answer. In order to begin implementation of this important program 
FDA will borrow $5 million from its fiscal year 2009 budget authority. 
This modest sum is necessary to establish a process to calculate the 
amount of user fees due, issue bills, and collect fees from covered 
manufacturers and importers of tobacco products. We estimate that we 
will need approximately four staff to establish the user fee program 
and there will be associated expenses to adapt our existing IT systems 
to include billing and collection of these fees. In addition to 
establishing the user fee program, we would also use these borrowed 
funds to hire a small number of staff, perhaps 10 or 12 individuals, to 
begin the work entrusted to the new Center for Tobacco Products. FDA 
will repay the borrowed funds within 6 months or as soon as sufficient 
user fees are collected.

                         ANTIBIOTIC RESISTANCE

    Question. I understand that FDA has tested penicillin to see 
whether or not its use in animals results in antibiotic-resistance 
bacteria that can be transferred to people. Are the results of these 
tests available? Does FDA intend to test other previously approved 
antibiotics currently being used for non-therapeutic reasons in 
livestock?
    Answer. Although FDA has not conducted tests on penicillin, FDA has 
conducted a review of all available information relevant to assessing 
the safety of using the penicillin class of antimicrobial drugs in the 
feed of food-producing animals. FDA is also reviewing information about 
other classes of antimicrobial drugs as it is broadly concerned about 
the use of all medically-important antimicrobial drugs for production 
or nontherapeutic purposes in food-producing animals.

                     ADULTERATED POMEGRANATE JUICE

    Question. What activities has FDA undertaken, or does FDA have 
planned, in order to prevent adulterated pomegranate juice from 
entering U.S. commerce?
    Answer. FDA is planning to conduct testing of imported pomegranate 
juice to determine if it is pure pomegranate or contains other 
materials. We anticipate issuing the assignment to test pomegranate 
juice in the next 3 to 6 months.

                NATIONAL ANTIMICROBIAL MONITORING SYSTEM

    Question. What amount is provided in the fiscal year 2010 budget 
for NARMS?
    Answer. The estimated fiscal year 2010 budget for NARMS will remain 
at the same level it was funded in fiscal year 2009. The fiscal year 
2009 amount is $6.7 million.
    Question. Please describe the activities undertaken with NARMS 
funding.
    Answer. A key component of the FDA strategy is to assess 
relationships between antimicrobial use in agriculture and subsequent 
human health consequences is the National Antimicrobial Resistance 
Monitoring System--NARMS. NARMS is a collaborative effort between FDA's 
Center for Veterinary Medicine--CVM, the U.S. Department of 
Agriculture--USDA, the Centers for Disease Control and Prevention--CDC, 
and public health laboratories in all 50 States. NARMS monitors 
antimicrobial susceptibility/resistance within two categories of 
enteric bacteria: zoonotic bacterial pathogens--Salmonella and 
Campylobacter--and commensal--not usually pathogenic--bacteria--
Escherichia coli and Enterococcus.
    NARMS uses comparable testing methods at CDC--human isolates, FDA--
retail meat isolates, and USDA--food animal slaughter isolates. Samples 
are tested to determine changes in the susceptibility or resistance of 
certain enteric bacteria to selected antimicrobial drugs of human and 
veterinary importance in order to guide intervention efforts to 
mitigate resistance dissemination. The antimicrobial drugs tested are 
selected based on their importance in human and animal medicine. Annual 
Executive Reports summarizing data from all three NARMS components are 
posted on the FDA NARMS homepage.
    NARMS Salmonella and Campylobacter isolates are subjected to 
further molecular fingerprinting. This information is submitted to the 
CDC PulseNet database for use in epidemiological foodborne outbreak 
investigations. The information provides public health officials a 
better understanding of the dynamics of foodborne illness attribution 
in the United States.
    FDA continues to maximize cooperation and communication between 
FDA, USDA, and CDC to increase efficient use of limited resources in 
database development, testing methods and sampling strategies.
    In 2007, the FDA Science Board subcommittee evaluated NARMS. The 
program has evolved into a mission-critical tool for FDA. New pilot 
projects have proven worthwhile and merit further development, and the 
on-farm data can help to better link the human and animal health 
interface. NARMS scientists continue to address and implement many FDA 
Science Board recommendations.

           METHICILLIN-RESISTANCE STAPHYLOCOCCUS AEREUA--MRSA

    Question. Please provide a summary of activities FDA is undertaking 
regarding MRSA.
    Answer. An important role for FDA is providing information on 
clinical trial designs to study drugs for the treatment of infections 
due to methicillin-resistant staphyloccus aureus, or MRSA. As part of 
these efforts, on November 18, 2008, the FDA Anti-Infective Drugs 
Advisory Committee convened to provide advice concerning clinical trial 
designs for testing new drugs for complicated skin infections, 
including those caused by MRSA. The Advisory Committee recommendations 
focused on feasible non-inferiority trial designs that would provide 
informative data regarding safety and efficacy. FDA also meets with 
pharmaceutical industry sponsors to provide guidance concerning drug 
development programs, including those for new drugs targeting MRSA.
    FDA reviews investigational new drug applications, or INDs, and 
reviews and approves new drug applications, or NDAs, and biological 
license application or BLAs, for products for the treatment of MRSA. 
FDA conducts research focused in identifying potential vaccine 
components that can protect against various forms of MRSA disease and 
on developing animal models that can be used to evaluate the protective 
capabilities of these vaccines.
    In addition, FDA has cleared more than ten diagnostic tests for 
detection or screening for MRSA. We continue to actively work with 
industry as they develop their devices to assure that safe and 
effective devices to detect MRSA are cleared through FDA in an 
expedient manner. We are also actively involved with clinicians, 
laboratory experts, and governmental agencies to determine changes in 
antibiotic resistance and determine what testing is necessary to detect 
changes in resistance.
    Question. Is funding provided in the budget for FDA to test for the 
presence of MRSA in the swine herd? Is this an appropriate activity for 
FDA to undertake?
    Answer. Although the fiscal year 2010 budget does not include 
specific funding to test for the presence of MRSA in the swine herd, 
FDA agrees that MRSA needs to be studied. FDA is working closely with 
USDA and CDC to address issues relating to the prevalence of MRSA.
    FDA is in the midst of a pilot study that is testing retail meat 
samples for MRSA and will use the results of this study to determine 
the correlation, if any, to clinical cases of infection.

                     OFFICE OF COSMETICS AND COLORS

    Question. Please provide a history of the budget authority funding 
amounts for the Office of Cosmetics and Colors for the past 5 years.
    Answer. The 5-year budget authority funding history for the Office 
of Cosmetics and Colors (OCAC) cosmetics program and the companion 
program in FDA's field component, the Office of Regulatory Affairs 
(ORA), appears in the following chart. OCAC current cosmetics 
activities include developing regulations, guidance, and policy, 
providing direction to the field program, conducting safety 
assessments, administering the Voluntary Cosmetic Registration Program 
(VCRP), and participating in international harmonization activities. 
During fiscal year 2007, CFSAN centralized all cosmetics compliance and 
research components into offices outside OCAC, with one office focused 
entirely on compliance and a second office focused entirely on 
research. Compliance and research staff from OCAC were realigned to 
these offices and are reflected under the column titled ``Other CFSAN 
Cosmetics FTEs'' in the following table. OCAC also has a color 
certification program, which is exclusively supported by user fees and 
not supported by appropriated funds. We estimate that the color 
certification program will collect $7.7 million in fiscal year 2009.
    The ORA activities in the field cosmetics program include 
inspections and field exams, sample analyses for contaminants and non-
permitted ingredients, and evaluations for labeling compliance.

                                                       COSMETICS PROGRAM FIVE YEAR FUNDING HISTORY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               CFSAN                             ORA                      Total
                                                              ------------------------------------------------------------------------------------------
                         Fiscal Year                                            OCAC     Other CFSAN
                                                                Dollars in   Cosmetics    Cosmetics    Dollars in      FTE       Dollars in      FTE
                                                                 millions       FTEs         FTEs       millions                  millions
--------------------------------------------------------------------------------------------------------------------------------------------------------
2005.........................................................         $3.4           28      ( \1\ )         $1.8           14         $5.1           42
2006.........................................................          3.4           27      ( \1\ )          1.7           12          5.1           39
2007.........................................................          2.3           10            7          1.9           13          4.2           30
2008.........................................................          3.8           13            8          2.3           14          6.1           35
2009.........................................................          5.0           15            8          2.9           15          7.9           37
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Not available.

    Question. Is the funding level in the President's budget adequate?
    Answer. The fiscal year 2010 President's Budget provides $8,204,000 
for the FDA cosmetics program. As in other product areas that FDA 
regulates, changes in technology and the increasingly global nature of 
the industry present challenges to FDA regulation of the cosmetics 
industry. FDA will continue to assess the risks to public health of 
cosmetic products and [the administration will] seek additional 
resources where necessary.

    DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY

    Question. How much of the funding provided in fiscal year 2009 has 
been obligated?
    Answer. Fiscal year 2009 is the first year of the Pediatric Device 
Grants Program. As of May 2009, none of the $2 million appropriated for 
pediatric device consortia grants has been obligated. The due date for 
grant applications is June 15. FDA plans to make grant awards by 
September 30, 2009.
    Question. How many applications were received for this program, and 
what was the total?
    Answer. We will know how many applications we received after the 
June 15 closing date for program applications. Based on inquiries from 
potential applicants, we expect to receive at least six applications.
    Question. Of the total applications received, how many were funded?
    Answer. Pediatric Device grants will be awarded on a competitive 
basis. FDA will review the grant applications scored by a panel of 
experts in mid-July. Shortly thereafter, we will know how many are 
funded.
    Question. What types of activities are these grants funding?
    Answer. Once FDA makes grant awards in September, we will be happy 
to provide you with more specific information on the activities funded. 
The goal of this grants program is to promote pediatric device 
development by providing grants to nonprofit consortia. The consortia 
will facilitate the development, production, and distribution of 
pediatric medical devices by encouraging innovation, mentoring and 
managing pediatric device projects, and providing assistance and advice 
to innovators and physicians on business development.

                          COST OF INSPECTIONS

    Question. What is the average cost of a foreign and domestic food 
inspection and medical product inspection?
    Answer. FDA estimates the average total cost for a domestic food 
inspection would be $9,700 and $24,400 for a foreign food inspection in 
fiscal year 2010. We also estimate the average total cost for a 
domestic medical product inspection would be $20,300 and $41,900 for a 
foreign medical product inspection in fiscal year 2010. The inspection 
cost figures include inspectional time, compliance review, supervisory 
oversight, and general administrative costs for all applicable FDA 
offices.
    The numbers of hours FDA investigators spend on a food or medical 
product inspection can vary from just a few hours to well over 100 
hours due to the different types of products, manufacturing processes 
and numbers of quality systems to cover during any one inspection. Food 
inspections include, but are not limited to, food safety, low acid 
canned foods, acidified foods, seafood HACCP, and interstate travel 
sanitation. Medical product inspections include, but are not limited 
to, pre-approval and pre-market inspections of medical devices and 
human/animal drugs, bioresearch monitoring inspections for biologics, 
medical devices, and human/animal drugs, blood banks, donor centers, 
source plasma, human tissue processors, post-market GMP surveillance 
for biologics, drugs and devices, medical gas, radiological health, and 
adverse drug events.
    The figures above do not include the costs to the agency to collect 
and test a sample of a product or to conduct any actions that may 
result from problems the agency identifies during an inspection, such 
as a recall or a follow up inspection to see that appropriate actions 
were taken to correct a violation.

                             CRITICAL PATH

    Question. Please provide a list of all projects funded through the 
Critical Path Initiative, and their amounts, in fiscal year 2009.
    Answer. I am providing a complete list of all Critical Path (CP) 
projects that received FDA support during fiscal year 2009. So far, 98 
specific projects received approximately $34,675,000 of support, 
including $16 million specifically designated to support CP projects. 
The list reflects the breadth and depth of the Critical Path Initiative 
and also underscores our need to continue funding this important 
Initiative. In addition, almost $12 million of the 2009 total of 
$34,675,000 supported the Sentinel Initiative, a long-term effort to 
increase medical product safety. Sentinel will fulfill some of the 
requirements of section 905 of FDAAA and enable FDA to build a system 
to actively monitor the safety and efficacy of FDA-regulated products.

                               FERN LABS

    Question. Please provide a list and description of all of the FERN 
labs.
    Answer. I would be happy to provide that for the record.

------------------------------------------------------------------------
                                                              States
------------------------------------------------------------------------
Chemistry Cooperative Agreement Labs:
    Arizona Department of Health Services..............              AZ
    Arkansas Department of Health......................              AR
    California Animal Health & Food Safety--CAHFS......                CA
    California Department of Public Health, Food and                   CA
     Drug Laboratory Branch............................
    Colorado Department of Public Health...............                CO
    Commonwealth of Virginia Division of Consolidated                VA
     Laboratory Services...............................
    Connecticut Agricultural Experiment Station........                CT
    Consumer Analytical Laboratory Ohio Department of                OH
     Agriculture.......................................
    Florida Department of Agriculture and Consumer                   FL
     Services..........................................
    Minnesota Department of Agriculture................              MN
    Nebraska Department of Agriculture.................              NE
    New Hampshire Public Health Laboratories...........              NH
    University Hygienic Laboratory--Iowa...............              IA
    Wisconsin Department of Agriculture................              WI
Radiological Cooperative Agreement Labs:
    Maryland Department of Health and Mental Hygiene...              MD
    Health Research/NY Department of Health............              NY
    Texas Department of State Health Services                        TX
     Laboratory........................................
    Washington State Public Health Laboratory..........              WA
    Wisconsin State Laboratory of Hygiene..............              WI
------------------------------------------------------------------------

    Question. Are these labs utilized when there is a food safety 
outbreak? How?
    Answer. Yes, FDA has used FERN labs to support several recent food 
safety outbreak investigations. FDA-funded FERN Chemistry labs analyzed 
more than 200 samples of protein products for the presence of melamine 
in 2007. These samples were supplied to the FERN labs by an FDA Protein 
Surveillance assignment written specifically for the FERN chemistry 
labs. In 2008, FERN chemistry laboratories tested for melamine 
contamination of milk products. FERN labs tested nearly 300 samples to 
clear the FDA lab backlog of samples.
    FDA also collaborates with other FERN labs that are not receiving 
FDA funding to respond to food safety outbreaks. In 2006, FERN 
laboratories provided support to State labs for the E. coli O157:H7 
Spinach outbreak. A rapid FERN method was provided to State labs, as 
well as reagents to support the method. Labs were used to test suspect 
foods. Last summer, FERN laboratories tested 290 samples for Salmonella 
during the jalapeno peppers outbreak. These samples were provided to 
the FERN labs through an FDA assignment. This year, FERN laboratories 
provided test results to FDA to assist product tracking in the 
Salmonella in peanut butter outbreak. This rapid reporting of State 
sample results had a significant impact on the investigation of this 
outbreak.
    Question. FDA's belief that FERN labs are underutilized? What 
additional roles could or should they play?
    Answer. FDA is continuing to develop the role of FERN labs to 
respond to food safety outbreaks. Throughout the year, FERN 
laboratories participate in a variety of activities, including but not 
limited to training to build capability, proficiency testing to assess 
individual lab capability, and collaboration on current methods and 
equipment use. In addition, FDA used FERN laboratories to analyze 
samples during large-scale surveillance assignments or during public 
health emergencies. Specifically in 2008, FERN chemistry cooperative 
agreement laboratories played an important role in the FDA response to 
melamine contamination by analyzing more than 300 milk-related food 
samples for the presence of melamine.
                                 ______
                                 

            Questions Submitted by Senator Dianne Feinstein

                            COSMETIC SAFETY

    Question. I am particularly interested in your agency's ability to 
ensure that personal care products and food and drink packaging do not 
contain dangerous chemicals. Most Americans think the FDA regulates 
cosmetics the same way it regulates food and drugs. However, the 
reality is that the $50 billion cosmetics industry is one of the least 
regulated industries in the country.
    Under current law, cosmetics companies may use unlimited amounts of 
virtually any ingredient, including chemicals linked to cancer, 
reproductive and developmental harm, hormone disruption and other 
adverse health impacts, with no pre-market safety assessment. The FDA 
does not have the authority to require product recalls and must go to 
court to remove misbranded and adulterated products from the market. 
The FDA also lacks the authority to require manufacturers to register 
their cosmetic establishments, file data on ingredients, or report 
cosmetic-related injuries. As a result, cosmetics sold in the United 
States contain ingredients and impurities with known health hazards 
including lead, mercury, hydroquinone, coal tar, formaldehyde, 1,4-
dioxane, acrylamide, toluene and phthalates.
    Given this situation, would you support efforts to give FDA the 
authority, resources and staff it needs to ensure that cosmetics and 
their ingredients are substantiated for safety before they are marketed 
to consumers?
    Answer. The Administration has not taken a position on giving FDA 
additional authority and resources for the regulation of cosmetics. 
However, we would be happy to work with you and other Members of 
Congress on legislative proposals that offer additional public health 
protection for consumers.
    Question. Can you tell me the staff size and current fiscal year 
budget of the Office of Cosmetics and Colors?
    Answer. The Office of Cosmetics and Colors (OCAC) has two major 
components, each responsible for a different program. The OCAC Color 
Certification Program is staffed with 32 FTEs and is supported 
exclusively by user fees, not by appropriated funds. We estimate that 
the Color Certification Program will collect $7.7 million in fiscal 
year 2009. The total fiscal year 2009 budget for the OCAC Cosmetics 
Program is approximately $5.0 million. This amount supports 15 FTEs and 
includes $1.6 million in operating funds. Finally, in fiscal year 2009, 
FDA's ORA has been allocated a budget of $2,866,500 and approximately 
15 FTEs for its activities in support of the cosmetics program.
    Question. In October of 2007, the Campaign for Safe Cosmetics, a 
coalition of public health advocates, released a report showing that 61 
percent of the lipsticks tested contained lead. In November of 2007, I 
joined my colleagues Senators John Kerry and Barbara Boxer in 
requesting that the FDA test a variety of lipsticks for lead, release 
the testing results publically, and if lead is found, take immediate 
steps to reduce the level of lead in these cosmetics. Despite numerous 
requests, we have not been informed of the results of any testing. Has 
that testing been completed, and if so, will you release the results in 
a timely and publically accessible format?
    Answer. FDA scientists developed and validated a highly sensitive 
method to analyze total lead content in lipstick. FDA applied the new 
method to the same selection of lipsticks evaluated by the Campaign for 
Safe Cosmetics. The results of FDA's work to develop this method and 
conduct initial testing have been accepted for publication in the peer-
reviewed Journal of Cosmetic Science and will be published in the July/
August 2009 issue. We will also be posting information on our website.
    Although FDA found lead in all of the lipsticks tested, the levels 
detected were within the range that would be expected from lipsticks 
formulated with permitted color additives and other ingredients 
prepared under good manufacturing practice conditions. FDA does not 
believe the lead levels we have found in our testing represent a safety 
concern. Nevertheless, FDA will continue to monitor the situation. We 
are also planning a broad-based survey that will examine a wider range 
of lipsticks than has been tested so far. When that testing is 
complete, FDA will make the results publicly available. If, at any 
time, FDA determines that a safety concern for lead in lipstick exists, 
FDA will advise the industry and the public and will take appropriate 
action under the authority of the Federal Food, Drug, and Cosmetic--
FD&C--Act to protect the health and welfare of consumers.
    Question. Under current law, registering cosmetics manufacturing 
facilities with the FDA is voluntary, even though this process would 
allow the FDA to better understand the breadth of the industry it is 
charged with regulating. A GAO study submitted to Congress in 1990 
estimated that about 40 percent of facilities had in fact registered. 
What is the current estimate of the number of manufacturing facilities 
creating products for sale in the United States? What percentage of 
those facilities has registered with the FDA? How many inspections of 
cosmetics manufacturing facilities were conducted by the FDA in the 
last fiscal year?
    Answer. Information provided by the two primary U.S. cosmetic trade 
associations indicates that there are approximately 3,500 cosmetic 
manufacturing facilities in the U.S. associated with their 
organizations. FDA does not have independent data to confirm that 
estimate. In addition to manufacturing facilities that are members of 
the two primary cosmetic trade associations, there also are facilities 
that are not members of either of the associations. Consequently, it is 
very difficult to say with any degree of certainty how many cosmetic 
manufacturing facilities there are in operation in the United States at 
any given time. There are 761 cosmetic manufacturing facilities 
registered in FDA's Voluntary Cosmetic Registration Program (VCRP). If 
the estimate of 3,500 cosmetic manufacturing facilities covered all 
U.S. manufacturing facilities, the VCRP data would indicate a 
registration rate of 22 percent. The actual registration rate is likely 
lower. In fiscal year 2008, FDA conducted 88 inspections of domestic 
cosmetic manufacturing facilities.
    Question. The safety of chemicals used in cosmetics is not 
determined by the FDA, but rather a voluntary process conducted by an 
industry funded panel--the Cosmetics Ingredients Review--CIR--Program. 
In over 3 decades since its creation, CIR has evaluated only 11 percent 
of the 12,500 ingredients used in cosmetics; the vast majority of 
ingredients have not been assessed for safety by FDA, CIR or any other 
publicly accountable body. At the CIR, ``insufficient data'' to assure 
safety is not considered a rationale for recommending restricted use of 
a chemical. Does any other FDA program allow lack of evidence to be 
construed as proof of safety? Does the FDA have a plan for generating 
safety studies on unstudied chemicals used in cosmetics?
    Answer. While there are approximately 15,500 cosmetic ingredients 
listed in the International Cosmetic Ingredient Dictionary and 
Handbook, many of these are not commonly used in cosmetics in the 
United States today. FDA estimates that approximately one third of the 
products on the U.S. market are filed in FDA's Voluntary Cosmetic 
Registration Program (VCRP) database. The VCRP data indicate 
approximately 3,200 ingredients that are each listed in at least 10 
products. These 3,200 ingredients represent a high percentage of the 
ingredients used in marketed cosmetics. The Cosmetics Ingredients 
Review (CIR) Program has reviewed the safety of more than 1,400 
ingredients. Because ingredients are selected for review based in part 
on their frequency of use, many of the commonly used ingredients have 
been evaluated by the CIR. Many of the less common ingredients have 
also been evaluated by the CIR.
    Under the law, cosmetic products and ingredients--except color 
additives--are not subject to FDA pre-market approval. For FDA to 
prohibit use of a particular cosmetic ingredient or limit the 
conditions in which it can be used because the ingredient is 
adulterated requires scientific evidence establishing that the 
substance is harmful under its conditions of use or evidence that it is 
adulterated for other reasons. FDA cannot prohibit the use of an 
ingredient based solely on a CIR conclusion that there are insufficient 
data to establish its safety. The burden of proof rests with FDA to 
demonstrate that an ingredient is adulterated because it is unsafe or 
for other reasons before it can be prohibited.
    FDA uses resources available to the cosmetics program to evaluate 
the safety of cosmetic products and ingredients when a possible human 
health risk is indicated. FDA evaluates data and information from a 
variety of sources. The sources that FDA relies on include: adverse 
event reports, FDA's laboratory research, other published scientific 
literature, information considered and conclusions reached by the CIR 
Expert Panel, and data and other information provided to FDA by a 
variety of stakeholders. FDA's evaluations include consideration of 
routes of exposure and possible vulnerable populations.
    Question. In 1989, the FDA prioritized 130 chemicals for review out 
of 884 chemicals that were both listed in the Registry of Toxic Effects 
of Chemical Substances and could be used in cosmetics. Of those 130 
highest-priority chemicals, how many has the FDA substantiated for 
safety? How many has the CIR assessed? Has the FDA requested and 
reviewed the safety data from CIR's safety assessments? Of those 130 
chemicals, how many have been restricted or banned from use?
    Answer. We were not able to locate any FDA documents that match the 
description you provided of a list of 130 chemicals prioritized for 
review. In the absence of such a document or a list of specific 
chemicals to which your questions pertain, we cannot provide numerical 
answers to the questions posed. We can only provide some general 
information.
    FDA does not substantiate the safety of cosmetic ingredients. It is 
the responsibility of the cosmetic manufacturer or distributor that 
introduces a cosmetic product into the marketplace to substantiate the 
safety of the finished product and its ingredients before it markets 
the cosmetic product. FDA does, however, investigate and evaluate 
ingredient safety when we receive reports of adverse events, become 
aware of results from scientific studies that indicate a potential for 
harm to consumers, or receive other information that raises questions 
about safety. FDA's safety assessments incorporate data and information 
from a variety of sources and include consideration of routes of 
exposure and possible vulnerable populations.
    FDA participates in the CIR review process as a liaison member with 
non-voting status. As a participant, we receive and review the same 
information as the voting members of the Expert Panel. We also have the 
opportunity to comment on the studies at the open CIR meetings.
    Question. I am also very concerned about the continued use of 
Bisphenol A in food and beverage packing. As you know, this chemical 
has been linked to a variety of health problems, including breast 
cancer, prostate cancer, and altered brain development. What is your 
time table for re-reviewing the safety assessment of BPA that FDA staff 
presented to the Science Advisory Board in October 2008?
    Answer. In the fall of 2008, FDA scientists presented to the 
Science Board a draft safety assessment of the use of Bisphenol A--
BPA--in the manufacture of food contact materials. The Science Board 
raised questions about whether the FDA's review had adequately 
considered the most recent available scientific literature. We have 
been carefully considering the Science Board comments, as well as 
reviewing newly available publications. During the summer of 2009, FDA 
scientists will review the science of BPA. We intend to report on the 
findings of this review in late summer or early fall of this year.
    Question. On May 16, 2009, the Milwaukee Journal Sentinel described 
repeated contacts between Bisphenol A industry officials and FDA staff. 
As the FDA reviews the science on the risks of BPA, how will you ensure 
that FDA staff working on the safety assessment does not further 
coordinate their research with the chemical industry? Do you plan to 
take steps to provide independent scientists with equal access to FDA 
officials?
    Answer. Independent scientists have already met several times with 
FDA officials in the last several months on BPA. The current review of 
BPA will benefit from input from a variety of sources and the best 
available scientific evidence.
    Question. What is your assessment of the current process FDA uses 
to determine the safety of food additives in packaging? How could this 
process be improved prospectively? Considering the current list of 
approved additives includes chemicals such as phthalates, mercury, and 
formaldehyde, does the FDA have any plans to reevaluate the list?
    Answer. By law, food additives in packaging must be approved for 
their use prior to marketing. This requirement, which has been in 
existence since 1958, has provided a very high standard of consumer 
protection, and is one of the most rigorous statutory and regulatory 
schemes for authorizing food packaging materials in the world.
    It is true that scientific information and knowledge are constantly 
evolving. We do monitor the scientific literature and undertake re-
reviews of additives based on emerging data and information. We are 
committed to improving and modernizing our ability to adequately 
monitor the world-wide literature on the many thousands of compounds 
that are used in food contact applications, so that we can make 
appropriate decisions in as timely a way as possible.
    Question. A New York Times article that appeared on May 15 entitled 
``For Frozen Entrees, ``eat and Eat'' ``Isn't Enough,'' explains that 
frozen food, such as Pot Pies, require additional cooking and testing 
on the part of the consumer before they are considered safe to eat. I 
am very concerned about placing the burden of assuring food safety on 
consumers, many of whom purchase these products for convenience and 
with the belief that they are safe to eat. Does the Food and Drug 
Administration allow frozen entrees such as Pot Pies to contain harmful 
pathogens at the time of purchase by the consumer?
    Answer. Ordinarily, FDA considers a frozen entree to be a ``ready-
to-eat'' food that may not contain pathogens at the time of purchase by 
the consumer, irrespective of whether the product label includes 
cooking instructions, because some consumers eat such foods without 
thorough cooking. According to section 402(a)(1) of the Federal Food, 
Drug, and Cosmetic Act 21 U.S.C.  342(a)(1), a food is deemed to be 
adulterated if it contains any poisonous or deleterious substance--such 
as a pathogen--that may render it injurious to health. The law 
prohibits introduction of adulterated food into interstate commerce, 
and FDA consider regulatory action on a case by case basis.
    Question. What steps does the FDA take to make sure that producers 
reduce or eliminate the presence of pathogens in frozen entrees?
    Answer. FDA has established current Good Manufacturing Practice--
cGMP--in Manufacturing, Packing, or Holding Human Food regulations--21 
CFR part 110, which require that food is processed under safe and 
sanitary conditions. The regulation, 21 CFR 110.80(a)(2), specifically 
requires that ``Raw materials and other ingredients shall either not 
contain levels of microorganisms that may produce food poisoning or 
other disease in humans, or they shall be pasteurized or otherwise 
treated during manufacturing operations so that they no longer contain 
levels that would cause the product to be adulterated within the 
meaning of the act. Compliance with this requirement may be verified by 
any effective means, including purchasing raw materials and other 
ingredients under a supplier's guarantee or certification.'' In 
addition, 21 CFR 110.80 States ``All reasonable precautions shall be 
taken to ensure that production procedures do not contribute 
contamination from any source. Chemical, microbial, or extraneous-
material testing procedures shall be used where necessary to identify 
sanitation failures or possible food contamination.'' These two 
provisions are designed to prevent, reduce, or eliminate the presence 
of pathogens in food.
    Question. Does the FDA currently conduct inspections of food labels 
for frozen entrees that contain raw or uncooked ingredients, to ensure 
that the labels clearly indicate that the foods may contain pathogens 
without proper preparation?
    Answer. There is currently no requirement for this type of 
statement for FDA-regulated foods. FDA inspection instructions do not 
address the presence of this type of statement.
    Question. As you know, the Food and Drug Administration announced 
in March 2009 that some patients with ALS to would be allowed to access 
the drug Iplex under an Investigational Drug Application--IND. Because 
this disease can progress rapidly, timely access to treatments may 
potentially make a difference in a patient's outcome. Since the FDA's 
announcement in March, what progress has been made on beginning a 
clinical trial of the drug, or establishing a lottery system to give 
patients access to a clinical trial?
    Answer. FDA continues to work proactively with the sponsor, Insmed, 
on the development and initiation of a well-designed clinical trial of 
Iplex in ALS patients.
    Question. When do you anticipate that FDA will grant final approval 
for a clinical trial to begin?
    Answer. When an investigational new drug application, or IND, is 
submitted, FDA has a maximum of 30 days to determine if the protocol 
may proceed. However, after this period of review, it is entirely up to 
the sponsor when to initiate the clinical trial.
    Question. How many patients will ultimately be able to enroll in 
the clinical trial?
    Answer. It is not known at this time how large the clinical trial 
would be, because the number of patients that can be enrolled in it is 
directly related to the length of the trial proposed and the existing 
supply of the drug at the time the trial begins. Insmed, the sponsor, 
has indicated that the supply of this drug is very limited.
                                 ______
                                 

            Question Submitted by Senator Richard J. Durbin

                                  GAO

    Question. In January 2009, GAO released a report recommending that 
FDA take further actions to improve oversight and consumer 
understanding of dietary supplements. Two of GAO's recommendations 
called for FDA to issue guidance: first to clarify when an ingredient 
is considered a new dietary ingredient, the evidence needed to document 
the safety of new dietary ingredients, and appropriate methods for 
establishing ingredient identity; and second, to clarify when products 
should be marketed as either dietary supplements or food. Does FDA plan 
to issue guidance to address these recommendations?
    Answer. FDA agrees that guidance would be helpful to clarify when 
an ingredient is considered a new dietary ingredient (NDI) the evidence 
needed to document the safety of NDIs, and appropriate methods for 
establishing the identity of an NDI. The Agency held a public meeting 
in November 2004 to seek public comment on several issues related to 
the NDI requirements of Section 413(a)(2) of the Federal, Food, Drug, 
and Cosmetic Act (21 U.S.C. 350b(a)(2)). FDA specifically asked for 
information that would enable the Agency to identify ways to assist 
submitters of NDI notifications to ensure that they contain the 
information the Agency needs to evaluate the notification. FDA has 
reviewed the information submitted by interested parties on this 
subject and has developed draft guidance addressing NDI issues and a 
draft proposed rule to amend the NDI notification requirements of the 
Federal Food, Drug, and Cosmetic Act. The guidance and proposed rule 
are currently undergoing internal FDA review.
    As we noted in our comment to the GAO July 2000 report, FDA's 
Dietary Supplement Strategic Plan recognized the need to clarify the 
boundaries between dietary supplements and conventional foods, 
including conventional foods with added dietary ingredients. As we 
noted when the Plan was released in January 2000, FDA acknowledged its 
inability to set timeframes for all the activities listed in the Plan 
because of resource limits. FDA will consider this recommendation and 
the priority and timing to implement this recommendation in light of 
all of the priorities that compete for available resources.
                                 ______
                                 

              Questions Submitted by Senator Sam Brownback

   TUBERCULOSIS: DRUG RESISTANT TB AND DIAGNOSTIC TESTS FOR CHILDREN

    Question. The subcommittee has provided more than $23 million in 
the past 2 years to support the Critical Path Initiative, an FDA 
initiative that has many facets including helping speed the development 
of safe drugs and the development of diagnostic tests to help with the 
delivery of drugs or diagnose certain conditions.
    As you may know, I am concerned about global health problems, 
especially the growing threat of Tuberculosis and drug resistant 
Tuberculosis. The first recommendation in an Institute of Medicine 
November 2008 White Paper on drug resistant TB is for in-country 
diagnostic tests, including rapid genetic tests able to diagnose drug 
resistant organisms.
    The need for improved diagnostic tests and effective therapies is 
even more critical for children with TB. The standard tests for 
diagnosis of TB, sputum smears and culture, are not practical for 
children who cannot reliably produce sputum. As a result they remain 
undiagnosed, untreated and a source of infection for others. The 
Critical Path Initiative seems like a logical fit for FDA to help with 
this situation.
    Does FDA currently have any critical path projects that address the 
threat of Tuberculosis and drug resistant TB?
    Answer. Yes, the Critical Path Initiative--CPI--is working to 
advance the use of multi-drug resistant TB as a platform for 
demonstrating effectiveness of new TB drugs. This is a novel approach 
for tackling the scientific challenge of proving drug effectiveness 
when you have a complex treatment regimen, requiring new TB drugs to be 
tested in combination with older drugs.
    CPI has begun exploring possible collaborations with several goals 
in mind. For example, FDA is hoping to collaborate on identifying novel 
scientific pathways for obtaining safety data on new TB drugs without 
co-administration with other drugs. One option might be to obtain 
safety data on a new TB drug during use in prevention trials.
    FDA is also exploring possible collaborations with the Bill Gates 
Foundation that will facilitate TB drug and diagnostic development by 
creating innovative trial designs and trial logistics. The goal is to 
develop shorter treatment regimens and new diagnostic tools that can be 
used in all patients, including children. FDA has developed the CPI 
biomarker qualification process as a mechanism for incorporating new 
diagnostics in clinical trials. And to facilitate international 
marketing application and approval, FDA is collaborating with the 
European Medicines Agency to reach similar regulatory recommendations 
on drug development in multi-drug resistant TB.
    Question. Would additional funding for critical path programs make 
it possible to work with the industry to accelerate the development of 
new and more effective drugs or diagnostic tests for TB?
    Answer. If FDA received increased resources for critical path 
activities related to tuberculosis, we would consider beginning large-
scale training program that would give local public health staff in 
developing countries the capabilities they need to develop and submit 
sufficient, high-quality scientific data to FDA to support application 
evaluation and approval. Other options include bringing together 
collaborative initiatives among drug, vaccine, and diagnostic 
developers and other experts in the field to speed development of new 
therapies in all populations and subpopulations. This effort is 
especially critical because development of new diagnostic tests is 
growing at a tremendous pace now. Preliminary test results using new 
genomic methods to identify drug resistant TB are very promising, and 
these need to be tested in large populations so they can be 
incorporated into clinical trials and clinical practice. Rapid, 
reliable tests that can easily be used to diagnose tuberculosis in 
adults and children are also required. The development of these 
products depends on access to communities where TB is common and where 
high-quality studies can be performed.
    The Bill Gates Foundation and World Health Organization are heavily 
involved in this area, and FDA is actively encouraging manufacturers to 
participate. Additional Critical Path funding could be used to foster 
collaborations with all stakeholders with the goal of moving TB 
diagnostic tests to market faster.

        POLICY PROPOSALS: DRUG IMPORTATION AND GENERIC BIOLOGICS

    Question. The President plans to propose two new policy changes for 
FDA. One will allow the importation of prescription drugs from foreign 
countries. The second will allow FDA to approve generic biologics. The 
budget requests $5 million for the development of policies associated 
with prescription drug importation. Very few details have been provided 
about these policy proposals or to support the funding request related 
to the drug importation policy. Can you provide any additional details 
on these proposals?
    Answer. Regarding details related to drug importation, the fiscal 
year 2010 budget includes $5 million for FDA efforts to allow Americans 
to buy safe and effective drugs approved in other countries. FDA 
intends to spend these funds in fiscal year 2010 to assess the 
feasibility, practicability, and implementation needs of a drug 
importation program.
    The fiscal year 2010 Budget supports the creation of a new 
regulatory pathway under the Public Health Service Act for FDA approval 
of ``generic biologics,'' a term that refers to follow-on biological 
products that are highly similar to--or biosimilar--and may be 
substitutable or interchangeable for a previously approved biological 
product. As I mentioned in my testimony, establishing a generic 
biologics pathway will require new legislation.
    FDA has approved follow-on versions of certain protein products 
under the existing abbreviated approval pathways in the Federal Food, 
Drug, and Cosmetic Act. However, the majority of protein products now 
on the market have been licensed as biological products under the 
Public Health Service Act, which does not contain analogous abbreviated 
approval pathways.
    Safe and effective generic biologics may prove to be a critical 
element to lowering costs for American consumers and the healthcare 
system more broadly. FDA would require additional resources to augment 
our existing capabilities for regulatory activities associated with a 
generic biologics program, and anticipates the need for significant 
additional analytical testing capabilities. Depending on the scope and 
requirements of any legislation establishing a generic biologics 
pathway, we expect that there will be a large workload in the early 
phase of a generic biologics program in our pre-application 
activities--including meeting with industry and providing advice--as 
well as developing policy and procedures, publishing guidance, and 
promulgating regulations. We also anticipate receiving some 
applications for review shortly after enactment of legislation, with an 
increasing number of applications for review in subsequent years.
    Question. Given that these proposals are being associated with 
reduced health care costs for Americans, do you believe that these will 
be included in the President's health care reform proposal? Are the 
policies developed enough at this time to be considered as a part of 
the health care debate?
    Answer. Regarding drug importation, the fiscal year 2010 budget 
request is intended to conduct assessments to determine the 
feasibility, practicability, and implementation needs of a drug 
importation program.
    Regarding generic biologics, the fiscal year 2010 Budget supports 
the creation of a new regulatory pathway under the Public Health 
Service Act for approval of generic biologics. Safe and effective 
generic biologics may prove to be a critical element to lowering costs 
for American consumers and the healthcare system more broadly.
    Question. Let's say both proposals are passed this year, does the 
fiscal year 2010 request provide appropriate resources to enact the new 
policies?
    Answer. Regarding drug importation, the fiscal year 2010 request is 
not intended to provide resources to enact any new policy. Rather, the 
budget request is intended to determine whether and what programs might 
be feasible, practical, and what would be needed for implementation.
    Regarding generic biologics, the fiscal year 2010 request is not 
intended to provide resources to enact a new policy on generic 
biologics, given that creation of a generic biologics pathway would 
require new legislation. Although the administration budget proposal 
describes user fees as a financing structure to cover certain costs of 
a new generic biologics pathway, the current proposal indicates that 
precise collection levels would be negotiated for each year, including 
fiscal year 2010.

                          PERFORMANCE RESULTS

    Question. We have made significant investments in FDA. Since 2006, 
FDA's appropriation has increased by 39 percent. If the fiscal year 
2010 budget is enacted as requested, FDA's appropriation will have 
increased by 59 percent in 4 years. This is a significant amount of 
money and we expect FDA to be accountable for these resources and show 
results. What is your plan for showing tangible outcomes for the 
resources we have made available?
    Answer. FDA's plan for showing tangible outcomes for the resources 
Congress has made available is to track our progress toward specific 
milestones and report our accomplishments to Congress on a regular 
basis. FDA is reporting accomplishments on a monthly basis for its 
expenditures of fiscal year 2008 Supplemental funding. For expenditures 
of the funding increases FDA received in the fiscal year 2009 Omnibus 
bill, we report accomplishments on a quarterly basis.
    Question. I expect that FDA's goals will be something to strive for 
and not something that can be easily attained, do you share this 
expectation?
    Answer. Where our goals are specific, FDA should meet them or have 
a good explanation for failing to do so. Where our goals are 
aspirational, FDA should be able to demonstrate concrete progress 
towards improving the health of the American people.

                           TOBACCO REGULATION

    Question. Congress is likely to pass a bill this year that will 
give FDA authority to regulate tobacco. The administration supports 
this effort. We've mentioned that FDA currently regulates 20 percent of 
all consumer expenditures. Adding more to this already daunting job is 
not an easy task.
    The authorizing committee has tried to make sure that industry user 
fees, and not appropriated dollars, are used to support tobacco 
regulation. However, until the fee is collected, which could be months 
after enactment of the tobacco bill, FDA will be permitted to use 
appropriated funding to start the process of regulating tobacco. The 
Appropriations Committee has provided funding for very specific food 
safety and medical product safety activities. We do not want to see 
these efforts unnecessarily delayed because FDA shifts its focus to 
tobacco.
    What assurance can you give me that any appropriated funding 
directed to tobacco will not delay critical activities we have funded? 
What is the minimum amount of appropriated dollars necessary to get the 
tobacco user fee program started?
    Answer. In order to begin implementation of this important program 
FDA will borrow $5 million from its fiscal year 2009 budget authority. 
This modest sum is necessary to establish a process to calculate the 
amount of user fees due, issue bills, and collect fees from covered 
manufacturers and importers of tobacco products. We estimate that we 
will need approximately 4 staff to establish the user fee program and 
there will be associated expenses to adapt our existing IT systems to 
include billing and collection of these fees. In addition to 
establishing the user fee program, we would also use these borrowed 
funds to hire a small number of staff, perhaps 10 or 12 individuals, to 
begin the work entrusted to the new Center for Tobacco Products. The 
agency would repay the borrowed funds within 6 months or as soon as 
sufficient user fees are collected. We have identified sources for 
these funds where borrowing and repaying the funding will not affect 
other FDA activities.
    After this initial start up period, 100 percent of FDA activities 
related to tobacco will be funded through the collection of user fees 
from the tobacco industry.
    Question. FDA has a limited leadership team that's currently 
struggling to keep up with the agency's current mission. How do you 
intend to make sure that tobacco regulation does not hinder this 
leadership team's ability to work on food safety and medical product 
safety issues?
    Answer. The creation of this center will not distract the agency 
from its other activities and or hinder its ability to work to improve 
the safety of food and medical products. The agency is working to 
recruit a strong director for the Center for Tobacco Products who will 
have our full support in implementing the Family Smoking Prevention and 
Tobacco Control Act. After the initial start up period, 100 percent of 
FDA activities related to tobacco will be funded through the collection 
of user fees from the tobacco industry.

                 FOOD SAFETY, WHITE HOUSE WORKING GROUP

    Question. As a member of the White House Food Safety Working Group, 
what priorities have you outlined regarding food borne pathogens?
    Answer. From E. coli O157:H7 in spinach to Salmonella in peanut 
butter, food-borne pathogens are the most significant cause of food 
borne illness outbreaks. In the White House Food Safety Working Group, 
or WHFSWG, FDA has advocated for requirements for wide scale adoption 
of preventive controls by the food industry, in addition to supporting 
specific actions to reduce food borne pathogens such as Salmonella 
Enteritidis in shell eggs and E. coli O157:H7 in leafy greens. 
Effective preventive controls can reduce or eliminate foodborne 
pathogens. FDA has also suggested an enhanced public health 
surveillance infrastructure to help determine a baseline for pathogens 
of public health significance in foods, determine the source and 
respond more quickly when pathogens appear to be linked to foodborne 
illness, and prioritize the development and use of rapid detection 
methods for foodborne pathogens. In addition, FDA has recognized the 
agency's need to provide better information to consumers on the steps 
they can take to minimize these hazards, including thorough cleaning 
and cooking of foods and appropriate handling practices to reduce the 
likelihood of cross contamination.
    Question. There has been discussion that there should be on-farm 
testing of livestock for food borne pathogens; is this something you 
support and if so could you elaborate?
    Answer. Foodborne pathogens in livestock create at least two 
potential issues: contamination of the meat or other products from 
livestock and contamination of crops when the pathogens are spread 
through the waste of the livestock. USDA has preventive control 
programs in slaughterhouses to address the first issue. The second 
issue requires study of the microbial ecology of the farm environment, 
and standards for the safe production of produce. It is premature to 
say whether testing would be the most effective approach at this point.

                     USE OF ANTIBIOTICS IN ANIMALS

    Question. Antibiotics have been used to treat and prevent disease 
or promote growth in animals for more than 50 years. Like physicians 
and their patients, veterinarians and their clients share 
responsibility for the proper use of antibiotics. Antibiotics are tools 
used by veterinarians and producers to quickly address clinical and 
sub-clinical disease and keep animals healthy and productive. 
Antibiotics used by producers are approved by the FDA after they 
undergo rigorous review for safety to animals, humans and the 
environment. Producers have a vested interest in using antibiotics 
responsibly and view the use of antibiotics very seriously, yet there 
are attempts by some to eliminate antibiotic use on the farm. Animals 
get sick. Our producers and veterinarians need the tools to keep them 
healthy. What do you plan to do with the animal antibiotic approval 
process?
    Answer. In 2003, FDA implemented new policies for evaluating 
antimicrobial drug safety as part of the new animal drug approval 
process. At that time, FDA issued Guidance for Industry--GFI--#152, 
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to 
their Microbiological Effects on Bacteria of Human Health Concern. This 
guidance describes a risk-based assessment process for evaluating 
antimicrobial resistance concerns associated with the use of 
antimicrobial new animal drugs in food-producing animals. The guidance 
also describes recommended measures for mitigating such risk. FDA 
believes the assessment process described in this guidance has been a 
very effective approach for addressing antimicrobial resistance 
concerns for food animal products being evaluated for FDA approval. The 
agency has no plans to make any significant changes to this preapproval 
assessment process as this time.
    FDA recognizes the importance of maintaining the availability of 
effective antimicrobial drugs for treating, controlling, and preventing 
disease in animals. However, the agency believes it is critically 
important that antimicrobial drugs be used as judiciously as possible 
in an effort to minimize resistance development. The agency is 
currently considering strategies for addressing this issue.

          NATIONAL ANTIMICROBIAL RESISTANCE MONITORING SYSTEM

    Question. The National Antimicrobial Resistance Monitoring System--
NARMS--is a critical tool for the entire food chain. How do you ensure 
the money is used appropriately and goes towards NARMS surveillance and 
not other activities? Please provide, for the record, a distribution of 
NARMS funding by activity.
    Answer. As you indicate in your question, the National 
Antimicrobial Resistance Monitoring System--NARMS--is a critical tool 
for the entire food chain. We take this responsibility and the use of 
funds designated to this public health tool, very seriously. FDA has 
established financial safeguards--for example, auditing and reporting--
in our funding allocation and expenditure financial system to ensure 
that funds intended for NARMS and other critical programs are expended 
on those activities only.
    The following is a distribution of NARMS funding by activity for 
fiscal year 2008, the last year that actual amounts for a fiscal year 
are available.

                        [In millions of dollars]
------------------------------------------------------------------------

------------------------------------------------------------------------
USDA.................................................               1.4
CDC..................................................               1.8
FDA..................................................               3.5
                                                      ------------------
      Total..........................................               6.75
------------------------------------------------------------------------

                         PERSONALIZED MEDICINE

    Question. In your testimony, you State that FDA ``will address 
patient-product interactions that generally do not relate to 
manufacturing flaws.'' In the past we've called this effort 
``personalized medicine''--trying to make sure certain populations that 
are genetically predisposed to a bad reaction to a treatment are 
screened in advance and not given the treatment.
    This initiative has an alternate goal too. In some cases, certain 
populations are genetically predisposed to have an overwhelmingly 
positive reaction to a treatment. We also want to be able to find these 
patients and make sure they get the treatment that is best for them.
    What is your vision for this proposal? Will FDA engage industry 
during the drug development or clinical trials process to help isolate 
these unique populations? Or, will FDA work with industry to conduct 
studies after approval?
    Answer. Our vision and evolving practice with regard to 
personalized medicine is to study genetic, molecular, and patient-
specific factors that can affect an individual's response to drugs or 
medical devices. Our efforts will continue to span the continuum of a 
medical product's lifecycle, which includes discovery, development, and 
use by the public with a focus on both safety and efficacy.
    In the pre-approval setting, we will continue to work with industry 
to use pharmacogenetic principles to identify optimal doses for 
patients, specific patient characteristics that would confer a better 
chance of taking a medical product that works and populations with 
unmet medical needs. These efforts help the industry bring products to 
market and help large segments of the public.
    For drugs to be targeted to the right patients, it is usually 
necessary to have a diagnostic test that can accurately identify just 
who the right patients are. We have discovered through ongoing 
interactions in this area with industry that upfront guidance and 
advice is needed, and close cooperation between FDA and industry, as 
well as between FDA's product centers is essential. For these reasons, 
we have established groups within the Center for Drug Evaluation and 
Research and the Center for Devices and Radiological Health that have 
specific expertise to focus on personalized medicine issues and work to 
make sure that the personalized medicine vision moves as quickly and as 
smoothly as possible within the confines of our regulations. We expect 
that as new drugs are developed and are beginning clinical trials, we 
will be able to provide timely advice to the drug and device 
manufacturers to assure that the test and the drug are ready for 
patient use at the same time, and that the combination is really 
working as we expect it to.
    We also have begun working with sponsors of drugs that are already 
on the market to implement tests that can make the drug work better, by 
determining postmarket whether there are certain identifiable 
populations that can gain benefit more than others, or populations that 
would be harmed by exposure to the drug. After a drug is approved, we 
continue to protect the public health by including important 
pharmacogenetic information in drug package inserts. Some notable 
examples include drugs used by millions of people worldwide such as the 
blood thinner warfarin, marketed as Coumadin, the anti-platelet drug 
clopidogrel, marketed as Plavix, the HIV medication abacavir, marketed 
as Ziagen, and the seizure medication carbamazepine, marketed as 
Tegretol. These efforts give clinicians a better understanding of why 
patients respond to medications so differently, and in some cases 
prevent life-threatening events such as serious bleeding, ineffective 
treatment, and fatal allergic reactions.
    In addition to drug development initiatives and labeling updates, 
we will continue to build our research infrastructure. We have 
established relationships with universities, pharmacy benefits 
managers, healthcare systems, personalized medicine coalitions, and 
sister HHS agencies, AHRQ and NIH, to answer questions related to drug 
response variability, and to create dialogue among many constituents to 
advance the public health mission of FDA. In summary, our vision is one 
where information on a drug's benefits and risks can be applied to 
individual patients using new knowledge and interventions developed 
through our involvement both before and after a drug are approved.

                     HUMAN RESOURCES/HIRING ISSUES

    Question. In 2004, The Department of Health and Human Services--
HHS--consolidated all human resource functions into 5 servicing 
centers. FDA, along with several other agencies, is serviced by the 
Rockville Human Resources Center.
    It has recently come to my attention that an internal audit 
conducted by HHS found that the Rockville HR Center, which services 
FDA, was failing in many areas. As a result, this center lost its 
authority to hire individuals from outside the government. HHS has 
implemented a process to work around this situation. However, this 
process has added time to FDA's service agreement, and FDA has had to 
independently contract with the Office of Personnel Management--OPM--
for some personnel actions. It may be more than a year before the 
Rockville HR Center gets all of its authority back.
    Given that the subcommittee has invested significantly in FDA by 
increasing the agency's budget by more than 39 percent since 2006 and 
that FDA is in a hiring surge right now, I take this situation very 
seriously. Currently, FDA is paying HHS for a service that is not being 
provided as contractually agreed, and is also outsourcing additional 
human resource activities to OPM in order to fill the gap left by the 
Rockville HR Center.
    Can you update us on this situation? How does this affect FDA's 
ability to bring qualified employees onboard?
    Answer. The significant budget increases resulting in a surge of 
hiring at FDA coupled with the Rockville HR Center's loss of outside 
hiring authority have strained the capacity of the FDA to effectively 
bring on the best qualified individuals. FDA can lose highly qualified 
candidates because of a new quality review process that has increased 
the time it takes before vacancies are advertised, certificates are 
issued and job offers are made.
    FDA is working closely with HHS to address this situation.
    Question. Since FDA is independently contracting with OPM for 
certain services, essentially paying two organizations for one job, 
would allowing FDA to send all personnel actions through OPM or 
allowing FDA to conduct human resource actions ``in house'' be a more 
preferable arrangement for the agency?
    Answer. Allowing the FDA to send all personnel actions through OPM 
is not an idea that has been fully researched. FDA would need to 
consult with OPM on its ability to provide such extensive staffing 
services for the Agency as we are not aware that OPM has the capacity 
to serve a large agency.
    Ideally, in order for FDA to be successful and effectively manage 
its human capital, FDA is in need of a HR solution that provides more a 
strategic concentration and alignment with its human capital goals with 
business needs, that is customer focused, that ensures effective policy 
and practices are in place, that is appropriately structured, resourced 
and supported and that has staff with an extensive understanding of the 
client and its mission. FDA is working closely with HHS to develop such 
a solution.

                            FOREIGN OFFICES

    Question. In fiscal year 2008, the subcommittee provided funding 
for FDA to begin the process of opening offices in foreign countries. 
For the first time, FDA employees are permanently stationed in 
countries like China and India that export a lot of FDA-regulated 
products. Can you update us on the status of the foreign offices? Where 
are they located and are they fully staffed?
    Answer. I am happy to provide the status of FDA foreign offices. 
The location of FDA's foreign offices and their status are listed 
below. The persons who have been hired but have not yet reported to 
their duty posts are training for their assignments as well as 
undergoing the various Department of State clearances required of them 
and their families. They are also performing various assignments 
pertaining to their future deployment from their current duty stations 
in the United States and through temporary duty assignments in-country.
    China.--A total of 8 FDA staff will be posted in three locations, 
Beijing--4, Shanghai--2 and Guangzhou--2. The locations were opened in 
November 2008. At this time, only the Country Director is posted in-
country. By June 1, 2009, four additional FDA staff will be posted in-
country and the remaining three by the end of July.
    India.--A total of 12 FDA staff will be posted in two locations, 
New Delhi and Mumbai. The New Delhi office opened in January 2009. At 
this time, only the Acting Country Director is posted in-country. By 
July 1, 2009, five additional FDA staff will be posted in-country, one 
by July 30, 2009, and another by November 1, 2009. Four additional 
hires will be made and deployed in-country early in CY 2010.
    Latin America.--A total of 7 staff will be posted in three 
locations, Costa Rica, Chile and Mexico. The San Jose, Costa Rica 
office opened in January 2009. At this time, only the Regional Director 
is posted in-country, in Costa Rica. By August 15, 2009, 4 additional 
FDA staff will be posted in-country. Two additional hires will be made 
and deployed in country early in CY 2010.
    Europe.--A total of 3 staff will be posted in three locations: 
Brussels, Belgium; London, England--the European Medicines Agency; and 
Parma, Italy--the European Food Safety Agency. The Brussels location 
opened in December 2008. At this time, only the Regional Director in 
Brussels is posted in-country. The staffer for the London location will 
be posted in-country on June 22, 2009. The staffer for Parma will be 
hired and posted in-country in early CY 2010.
    Question. Do you have any specific examples of how staff located in 
foreign countries has made FDA-regulated products exported to the 
United States safer?
    Answer. The primary purpose of posting FDA scientists and 
inspectors overseas is to engage more proactively and consistently with 
various communities--regulatory, industry, and third parties--in 
strategic regions abroad to help FDA better accomplish its domestic 
mission to promote and protect the public health of the USA. FDA staff 
in foreign countries do this by helping FDA acquire more robust 
information based on which the Centers and ORA can make the necessary 
decisions to help assure the safety, efficacy--as appropriate--quality, 
and availability of FDA-regulated products. To this end, FDA officials 
abroad are involved in the activities described below.
    FDA is working with counterpart agencies in countries where we have 
foreign offices, gathering better knowledge about the production of 
FDA-regulated products and their transport to U.S. ports. FDA is also 
working with trusted counterpart agencies to leverage scientific, 
inspectional, and other resources. When requested, FDA is engaging with 
developing counterpart agencies to help build their regulatory 
capacity. In addition, FDA is working with private and public sector 
trusted third parties, and we are providing helpful information about 
industry compliance with FDA regulatory standards. FDA is also working 
with regulated industry to provide greater information about the 
applicable standards for their products to be admitted to the USA. FDA 
is engaging with U.S. agencies that are already present in foreign 
countries]that have complementary missions to FDA.
    An example of how FDA staff located in foreign countries has helped 
make FDA-regulated products safer is the situation with contamination 
of various dairy and dairy-containing products from China that were 
found to contain melamine or its analogs. FDA issued an Import Alert 
just prior to the FDA office's opening in Beijing. The FDA Country 
Director facilitated collaboration with the Chinese Government to 
address the problem in an expedited manner.

                 FISCAL YEAR 2009 SUPPLEMENTAL FUNDING

    Question. In fiscal year 2009, FDA received $150 million in 
supplemental funding to jump start activities that would be funded with 
the regular fiscal year 2009 appropriations bill. Nine months after 
this funding was provided, FDA has spent about $30 million. The agency 
only has only 4 months, until September 30, 2009, to spend the 
remaining $120 million. Does FDA have a plan to spend the remainder of 
this money or will it go back to the Treasury at the end of the fiscal 
year?
    Answer. FDA has a plan in place to spend the $150 million provided 
in the fiscal year 2008 Supplemental. FDA has designated $30 million of 
the Supplemental for Information Technology--IT--and FDA is at various 
stages of the procurement process to spend the unobligated balance of 
the $30 million so that the contract awards will be made by the end of 
this fiscal year. Further, FDA planned to add 324 staff with funds 
provided by the fiscal year 2008 Supplemental, and FDA has achieved 
approximately 83 percent of that staffing goal. The balance of the year 
will see a steep acceleration of spending of the fiscal year 2008 
Supplemental funds for payroll and related operational costs, and the 
obligation of contracts for IT projects and purchase of equipment.

          CRITICAL PATH INITIATIVE/MODERNIZE DRUG DEVELOPMENT

    Question. In March of 2004, former Commissioner McClellan 
referenced a need to modernize development paths and processes back in 
FDA's ``Innovation or Stagnation'' document which led to the Critical 
Path initiative. It's been more than 5 years now. Over the past 2 years 
the subcommittee has provided more than $23 million for the critical 
path initiative. Do you think that initiative has been a success and 
why/why not?
    Answer. The Critical Path Initiative--CPI--is an unequivocal 
success. CPI is leading the Sentinel Initiative, working to develop and 
implement America's first active system to enable FDA to query large 
health information databases and monitor, in real time, medical product 
safety and efficacy. CPI is modernizing the electronic portal 
MedWatchPlus, enabling better and more complete adverse events reports.
    In an FDA collaboration with the Serious Adverse Events Consortium, 
a genetic link has been identified associated with acute liver injury 
in some people who take the antibiotic Flucloxacillin. SAEC is making 
publicly available to researchers pooled data on genetics associated 
with drug-induced skin rashes like Stevens-Johnson syndrome. In 2007, 
FDA approved a new genetic test to help physicians assess whether a 
patient is especially sensitive to the blood-thinner warfarin and 
updated the label. In 2006 and 2007, FDA's CPI launched more than 40 
research projects. In 2008, CPI researchers collaborated with 84 
government agencies, universities, industry leaders and patient groups 
from 28 States and 5 countries on 60 research projects that are 
speeding the development of innovative therapies and safety monitoring 
systems to treat killers like tuberculosis, cancer, and Alzheimer's.
    CPI is modernizing the clinical trials enterprise to increase the 
quality and efficiency of clinical trials and ensure trial participant 
safety. As part of a personalized medicine initiative, CPI research has 
identified genetic biomarkers that are being explored for their value 
in making medicines safer and more effective. CPI is supporting and 
leading innovations needed to transform FDA into a robust, 21st-century 
regulatory agency. CPI is implementing cutting-edge information systems 
vital to supporting medical innovation and public health safety, like 
e-management of clinical study information and an e-platform to move 
FDA's largely paper-based infrastructure to a fully automated system.

                        OFFICE OF GENERIC DRUGS

    Question. Dr. Sharfstein, last year the Committee expressed 
interest in adequate funding for the Office of Generic Drugs--OGD--an 
interest which still remains. As FDA has noted, almost 70 percent of 
prescriptions are now filled with generics; it is obvious that in an 
environment emphasizing greater need for cost control, one key area 
that has been successful in achieving savings has been greater reliance 
on quality generic drugs.
    Last year, FDA advised the Committee that OGD's target was 1,900 
actions for fiscal year 2009, including approvals, tentative approvals, 
not approvable and approval actions on applications. FDA stated that 
the agency was on track to achieve that goal and to exceed the fiscal 
year 2008 number of 1,780 actions. Could you update us on the actual 
progress made in each of these categories? Please outline the reasons 
why you believe FDA has either been exceeding or failing to meet those 
goals.
    Answer. The Office of Generic Drugs--OGD--had 1,779 total actions 
in fiscal year 2007 and in fiscal year 2008, a total of 1,933 actions. 
The Office is expecting to meet the fiscal year 2009 goal of 2,033 
actions. As of the end of May 2009, OGD had taken 399 approval or 
tentative approval actions and 941 not approval actions for a total 
1,340 actions. The average for the 8 months is 167. To meet the goal, 
the average for the remaining months must be 173 actions per month. OGD 
believes it will achieve that average because there has been an upward 
trend of actions per month related to newer reviewers becoming more 
productive.
    Question. Last year, FDA stated that the fiscal year 2003-2005 
cohort approval time was 16.6 months and that the yearly median time to 
approval increased due to the escalating workload. Please update those 
numbers for us. We are interested in seeing recent numbers relating to 
how long oldest ANDAs which are still under review have been pending 
before the FDA. In July, 2008, the agency advised the Committee that 
there was one ANDA pending for 11 years, 9 pending over 9 years, and 
about 100 pending for more than 4 years. Could you provide us with an 
updated status report on those numbers? What emphasis is being placed 
on clearing this backlog? What are the reasons for these delays?
    Answer. The median time to approval currently stands at 21.6 
months. This includes both the time with the Office of Generic Drugs--
OGD--and the time with the applicants as they prepare responses to 
deficiencies that FDA identifies.
    Approval time has been increasing due to the number of pending 
applications. There are currently 137 applications that have been 
pending longer than 4 years. There are a variety of reasons for certain 
applications remaining as pending for a long time. Some are pending 
because of the need to achieve a satisfactory inspection result. Others 
are pending because the sponsor firms are subject to the application 
integrity policy that precludes FDA approval. Others may be held up 
because of patents, 180-day exclusivity, or other legal matters. Others 
have complicated scientific matters that require additional review time 
and subsequent additional review cycles. While OGD tries to be as 
efficient as possible in the review process, OGD officials want to be 
certain that all deficiencies and scientific issues are addressed 
before approval.
    The number of pending applications remains at around 1,600 
applications. OGD is concerned about the number of pending applications 
and the office would like to clear the backlog. However, the OGD 
continues to receive more applications than it can act on each month. 
Within the group of pending applications, there are applications that 
cannot be approved because of patents or exclusivity on the reference 
drug, and there are applications that have had at least one review 
cycle. In addition to the workload of original abbreviated new drug 
applications--ANDAs--OGD receives around 350 supplements per month for 
post-approval manufacturing changes that also require review and 
action.
    Question. FDA also advised the Committee in 2008 that many of the 
old, pending ANDAs ``have challenging scientific issues with respect to 
determination of bioequivalence resulting in extended review periods.'' 
This acknowledgement of potential scientific inadequacies at OGD is of 
concern. In February, OGD Director Gary Buehler stated his goal of 
fully staffing two bioequivalence divisions and adding a third 
division. He also indicated his priority in securing additional 
microbiologists and recruiting a pharmacologist/toxicologist to enhance 
the Office. What actions does OGD take to address these challenging 
scientific issues? What progress has been made toward reaching Mr. 
Buehler's goals? To what extent is OGD using, or could it be placing 
more emphasis on using, the scientific capabilities of other offices 
within CDER for the more complicated scientific reviews? We are 
interested in learning whether, then, the backlogs at OGD are strictly 
a matter of resources, a question of where the resources are being 
placed, or a lack of collaboration within FDA agency-wide?
    Answer. The Office of Generic Drugs--OGD--continues to work under a 
structure of two Divisions of Bioequivalence and three functioning 
Divisions of Chemistry. The addition of another division in both the 
chemistry and bioequivalence review areas would enhance review 
efficiency. During 2008, OGD hired 10 microbiologists, and the office 
now has 17 on staff. That business unit is steadily increasing review 
output as new microbiology reviewers become more productive. OGD has 
developed the position description for a pharmacologist/toxicologist, 
and the office will advertise that position soon.
    In addition, OGD has increased its science staff over the past 
year. OGD scientists assist the review divisions by addressing 
challenging scientific and review issues. The Science Staff in OGD 
oversees contracts for studies with outside groups.
    OGD uses the scientific capabilities of other offices and 
collaborates with scientists Agency-wide by routinely consulting 
experts in other components of the Center for Drug Evaluation and 
Research, seeking opinions on clinical matters from physicians in 
specialty areas, seeking concurrence on bioequivalence assessments from 
the Office of Clinical Pharmacology, using statisticians from the 
Office of Translational Sciences, assessing potential safety matters 
through consults to the Office of Surveillance and Epidemiology, 
requesting input on questions of immunogenicity from the Office of 
Biotechnology Products, requesting certain laboratory research from the 
Office of Testing and Research, and using the services of the Advisory 
Committee for Pharmaceutical Science.
    Managing and reducing the backlog of applications requires ensuring 
OGD has the right number of staff are on board, has the right skill 
sets to address the various scientific issues, and continues 
coordination and collaboration with the right staff within FDA. OGD 
continues to manage and reduce the backlog using this three-pronged 
strategy.
    Question. The President's budget relies on substantial resources 
for OGD and its field activities through a new Generic Drug User Fee. 
As you know, this fee has been proposed in the past and was not 
implemented. How optimistic are you that such a user fee can be enacted 
this year, and what activities have you undertaken to develop a 
specific proposal and when might the Committee learn more about this?
    Answer. Although generic drug user fees have been proposed in 
previous budgets, FDA plans to reengage the generic drug industry in 
user fee discussions this year to make progress on this important 
proposal. Our aim will be to develop a user fee program that provides 
the FDA generic drug program with the resources needed to modernize and 
enhance the capacity of the generic drug review process and to ensure 
timely patient access to safe and effective new generic drugs. FDA 
believes that the resources in the fiscal year 2010 proposed generic 
drug user fee program are necessary to reduce the review backlog and 
ensure patient access. Although there are uncertainties associated with 
any new user fee discussions, FDA believes that successfully concluding 
discussions with stakeholders will promote the important goals of 
timely patient access to safe and effective generic drugs.
    Question. The Food and Drug Administration Amendments Act of 2007--
Public Law 110-85--contained a new provision intended to speed the 
agency's review of Citizen Petitions. Could you provide the Committee 
with estimates of how many petitions you have reviewed under this new 
authority and the timeframe for that review? How many petitions were 
pending before enactment of Public Law 110-85 and what is their status?
    Answer. Section 914 of the Food and Drug Administration Amendments 
Act of 2007--FDAAA--added section 505(q) to the Federal Food, Drug, and 
Cosmetic Act--the Act. This amendment requires that FDA respond to 
certain petitions regarding the approvability of certain applications 
within 180 days. Specifically, new section 505(q) applied the 180 day 
timeframe to citizen petitions and petitions for stay of agency action 
that pertain to the approvability of a pending application submitted 
under section 505(b)(2) or (j) of the act--generic drug applications. 
This complex provision of FDAAA took effect upon enactment--September 
27, 2007. Therefore, FDA has had to interpret the new provision and 
develop implementing procedures while simultaneously addressing citizen 
petitions and petitions for stay that are subject to the new 
requirements.
    FDA has received 40 citizen petitions as of May 20, 2009 that is 
subject to section 505(q) and has responded to 29 of those petitions as 
of May 20, 2009. Of the 29 responses, 28 were answered in 180 days or 
less. The remaining 505(q) petitions have been pending with the agency 
fewer than 180 days.
    Prior to enactment of FDAAA, there were approximately 216 citizen 
petitions pending, of which approximately 73 raised issues about the 
approval standards for generic applications, patents or exclusivity, or 
other issue that could delay approval of generic applications. Not all 
of the 73 pending petitions would have been subject to section 505(q) 
even if they had been submitted after it passed. We have completed 
approximately 21 of these 73 petitions, and 29 of the other backlogged 
petitions, since the passage of FDAAA.

                          SUBCOMMITTEE RECESS

    Senator Kohl. At this time, we will bring this hearing to a 
close, and the subcommittee will stand in recess until June 4 
when we'll be talking about the USDA budget request.
    Thank you very much.
    Dr. Sharfstein. Thank you.
    [Whereupon, at 3:02 p.m., Tuesday, May 19, the subcommittee 
was recessed, to reconvene subject to the call of the Chair.]
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