[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]



       REAUTHORIZATION OF ANIMAL DRUG USER FEES: ADUFA AND AGDUFA

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             APRIL 9, 2013

                               __________

                           Serial No. 113-25






[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]




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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania        FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska                  ANNA G. ESHOO, California
MIKE ROGERS, Michigan                ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania             GENE GREEN, Texas
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee          LOIS CAPPS, California
  Vice Chairman                      MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia                JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             JIM MATHESON, Utah
ROBERT E. LATTA, Ohio                G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington   JOHN BARROW, Georgia
GREGG HARPER, Mississippi            DORIS O. MATSUI, California
LEONARD LANCE, New Jersey            DONNA M. CHRISTENSEN, Virgin 
BILL CASSIDY, Louisiana                  Islands
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
CORY GARDNER, Colorado               BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas                  PETER WELCH, Vermont
ADAM KINZINGER, Illinois             BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
                         Subcommittee on Health

                     JOSEPH R. PITTS, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan                LOIS CAPPS, California
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          JIM MATHESON, Utah
PHIL GINGREY, Georgia                GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            JOHN BARROW, Georgia
BILL CASSIDY, Louisiana              DONNA M. CHRISTENSEN, Virgin 
BRETT GUTHRIE, Kentucky                  Islands
H. MORGAN GRIFFITH, Virginia         KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida            JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina     HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)

















                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    67
    Prepared statement...........................................    68
Hon. Cory Gardner, a Representative in Congress from the State of 
  Colorado, opening statement....................................    68
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................    69
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, opening statement....................................    70
    Prepared statement...........................................    71
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................    71
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................    72

                               Witnesses

Bernadette Dunham, Director, Center for Veterinary Medicine, U.S. 
  Food and Drug Administration...................................    74
    Prepared statement...........................................    77
Richard A. Carnevale, Vice President, Regulatory, Scientific and 
  International Affairs, Animal Health Institute.................   103
    Prepared statement...........................................   106
Mike Apley, Professor and Section Head, Production Medicine and 
  Clinical Pharmacology, College of Veterinary Medicine, Kansas 
  State University...............................................   111
    Prepared statement...........................................   113
Lance B. Price, Professor, Department of Occupational and 
  Environmental Health, George Washington University.............   123
    Prepared statement...........................................   125

                           Submitted Material

Discussion drafts
    ADUFA........................................................     2
    AGDUFA.......................................................    38
Letter of April 5, 2013, from medical coalition to the Committee, 
  submitted by Mr. Waxman........................................   142
Letter of April 5, 2013, from medical and scientific 
  organizations to the Committee, submitted by Mr. Waxman........   145
Letter of April 2, 2013, from the Patient, Consumer, and Public 
  Health Coalition to the Committee, submitted by Mr. Waxman.....   148
Letter of April 24, 2013, from the the Food and Drug 
  Administration to the subcommittee, submitted by Mr. Pitts.....   150

 
       REAUTHORIZATION OF ANIMAL DRUG USER FEES: ADUFA AND AGDUFA

                              ----------                              


                         TUESDAY, APRIL 9, 2013

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 4 p.m., in room 
2123, Rayburn House Office Building, Hon. Joseph R. Pitts 
(chairman of the subcommittee) presiding.
    Present: Representatives Pitts, Burgess, Shimkus, Gingrey, 
Lance, Guthrie, Griffith, Ellmers, Upton (ex officio), Pallone, 
Capps, Green, Barrow, Christensen, Waxman (ex officio).
    Also present: Representative Gardner.
    Staff Present: Clay Alspach, Chief Counsel, Health; Gary 
Andres, Staff Director; Matt Bravo, Professional Staff Member; 
Sydne Harwick, Legislative Clerk; Robert Horne, Professional 
Staff Member, Health; Carly McWilliams, Professional Staff 
Member, Health; John O'Shea, Professional Staff Member, Health; 
Andrew Powaleny, Deputy Press Secretary; Chris Sarley, Policy 
Coordinator, Environment and Economy; Heidi Stirrup, Health 
Policy Coordinator; Tom Wilbur, Digital Media Advisor; Alli 
Corr, Minority Policy Analyst; Eric Flamm, Minority FDA 
Detailee; Karen Lightfoot, Minority Communications Director and 
Senior Policy Advisor; Karen Nelson, Minority Deputy Committee 
Staff Director for Health; and Rachel Sher, Minority Senior 
Counsel.
    Mr. Pitts. Time of 4 o'clock having arrived, this 
subcommittee will come to order. The chair will recognize 
himself for an opening statement.
    Today's hearing focuses on the reauthorization of two 
successful programs, the Animal Drug User Fee Act, ADUFA, and 
the Animal Generic Drug User Fee Act, AGDUFA.
    [The bills follow:]


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OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Pitts. In 2003, ADUFA I was authorized to help the Food 
and Drug Administration review of animal drugs. Similar to the 
prescription drug user fee for human drugs, under ADUFA, FDA 
collected funds to expedite the new animal drug approval 
process, reduce the application backlog and improve 
communications with drug sponsors. The program was authorized 
for 5 years, and Congress renewed the program for an additional 
5 years in ADUFA II in 2008.
    In fiscal year 2012, FDA completed 747 ADUFA reviews. And 
according to FDA, the agency has exceeded all performance goals 
outlined in ADUFA I and II. However, absent congressional 
action, FDA's ability to collect these user fees will expire 
September 30, 2013.
    FDA and industry have negotiated an agreement regarding the 
size and scope of ADUFA III, which would extend the program 
through fiscal year 2018, and these recommendations were 
delivered to the committee in February. Under the negotiated 
proposal industry would pay approximately $23.6 million in 
fiscal year 2014 and similar amounts adjusted for inflation for 
fiscal years 2015 to 2018. Twenty percent of this total would 
come from application fees, 27 percent from product fees, 27 
percent from sponsor fees, and 26 percent from establishment 
fees. The ADUFA III proposal also includes an annual offset 
adjustment based on any collection shortfall in previous years.
    AGDUFA I, ADUFA's generic cousin, was first authorized in 
2008 for 5 years in order to improve the review of abbreviated 
new animal drug applications, eliminate application backlogs 
and reduce review times. To date, according to the FDA, the 
agency has exceeded all performance goals but one from AGDUFA 
I. This program also expires September 30, 2013, unless it is 
reauthorized, and FDA and industry have negotiated an agreement 
for AGDUFA II.
    Under the proposed AGDUFA II agreement, industry would pay 
$7.3 million in fiscal year 2014, which allows for hiring of 22 
FTEs and includes a one-time cost of $850,000 for information 
technology; $6.9 million for fiscal year 2015; $7.4 million for 
fiscal year 2016; $7.9 million for fiscal year 2017; and $8.4 
million for fiscal year 2018. These fees would be paid through 
application fees, 25 percent of the total; product fees, 37\1/
2\ percent; and sponsor fees, also 37\1/2\ percent of the 
total.
    The legislation to reauthorize ADUFA III was introduced 
today by Congressman John Shimkus, and the AGDUFA II 
reauthorization sponsored by Representative Cory Gardner was 
also introduced today.
    I want to welcome all of our witnesses, thank them for 
being here today, look forward to your testimony. We have a new 
set of lights, and so green is go with your statement, a 5-
minute statement. Yellow I think there is 30 seconds left. Red 
is you are over time. So thank you.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    The Subcommittee will come to order.
    The Chair will recognize himself for an opening statement.
    Today's hearing focuses on the reauthorization of two 
successful programs--the Animal Drug User Fee Act (ADUFA) and 
the Animal Generic Drug User Fee Act (AGDUFA).
    In 2003, ADUFA I was authorized to help the Food and Drug 
Administration's (FDA) review of animal drugs.
    Similar to the Prescription Drug User Fee for human drugs, 
under ADUFA, FDA collected funds to help expedite the new 
animal drug approval process, reduce the application backlog 
and improve communications with drug sponsors.
    The program was authorized for 5 years, and Congress 
renewed the program for an additional 5 years in ADUFA II in 
2008.
    In FY2012, FDA completed 747 ADUFA reviews, and, according 
to FDA, the agency has exceeded all performance goals outlined 
in ADUFA I and II.
    However, absent Congressional action, FDA's ability to 
collect these user fees will expire September 30, 2013.
    FDA and industry have negotiated an agreement regarding the 
size and scope of ADUFA III, which would extend the program 
through FY2018, and these recommendations were delivered to the 
Committee in February.
    Under the negotiated proposal, industry would pay 
approximately $23.6 million in FY2014, and similar amounts, 
adjusted for inflation, for FYs 2015-2018.
    Twenty percent of this total would come from application 
fees, 27% from product fees, 27% from sponsor fees, and 26% 
from establishment fees.
    The ADUFA III proposal also includes an annual offset 
adjustment based on any collection shortfall in previous years.
    AGDUFA I, ADUFA's generic cousin, was first authorized in 
2008 for 5 years, in order to improve the review of abbreviated 
new animal drug applications (ANADAS), eliminate application 
backlogs, and reduce review times.
    To date, according to FDA, the agency has exceeded all 
performance goals but one from AGDUFA I.
    This program also expires September 30, 2013 unless it is 
reauthorized, and FDA and industry have negotiated an agreement 
for AGDUFA II.
    Under the proposed AGDUFA II agreement, industry would pay:
     $7,328,000 in FY2014 (which allows for the hiring 
of 22 FTEs and includes a one-time cost of $850,000 for 
information technology);
     $6,944,000 in FY2015;
     $7,429,000 in FY2016;
     $7,936,000 in FY2017; and
     $8,467,000 in FY2018.
    These fees would be paid through application fees (25% of 
the total), product fees (37.5%), and sponsor fees (also 37.5% 
of the total).
    The legislation to reauthorize ADUFA III was introduced 
today by Rep. John Shimkus, and the AGDUFA II reauthorization, 
sponsored by Rep. Cory Gardner, also was introduced today.
    I want to welcome all of our witnesses and thank them for 
being here today. I look forward to your testimony.
    Thank you. At this time, I would like to request unanimous 
consent for Congressman Gardner to participate in the 
subcommittee hearing. Without objection so ordered. I now yield 
the remainder of my time to Rep. Gardner.

    Mr. Pitts. At this time I would like to request unanimous 
consent for Congressman Gardner to participate in the 
subcommittee hearing. Without objection, so ordered.
    I now yield the remainder of my time to Representative 
Gardner.

  OPENING STATEMENT OF HON. CORY GARDNER, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Mr. Gardner. Thank you, Mr. Chairman, and I thank you for 
allowing me to be here today; Ranking Member Pallone and other 
colleagues on the subcommittee for the opportunity to 
participate today. And I would also like to congratulate 
Congressman Shimkus for his introduction of the Animal Drug 
User Fee Amendments Act of 2013.
    My congressional district is home to over 2.8 million head 
of cows, 450,000 hogs and pigs, and close to 160,000 sheep and 
goats. There is far more livestock in my district than there 
are people. At least that is what they tell me in Colorado. 
But, in fact, the State of Colorado is the fifth largest State 
in the Nation when it comes to cattle on feed.
    The ADUFA and AGDUFA programs have been a success at FDA, 
and the continuation of these important programs will ensure 
that livestock producers in Colorado and indeed throughout the 
country will continue to have access to safe and effective 
animal drugs to treat their herds.
    In particular, the Animal Generic and Drug User Fee Program 
at FDA has achieved noteworthy success since first being 
authorized in 2008. FDA decreased a significant backlog of 
applications and reduced the review time for new animal drug 
applications. The reauthorization of AGDUFA will continue this 
progress at FDA and other--and our producers with cost-
effective generic products that are available to the market on 
the market faster.
    It is an honor to have the opportunity to lead the 
reauthorization of AGDUFA through this committee, and I look 
forward to working with my colleagues to ensure its passage and 
to hearing from the witnesses today. And with that, Mr. 
Chairman, thank you, and I yield back the balance of my time.
    Mr. Pitts. The chair thanks the gentlemen, and now 
recognizes the ranking member of the subcommittee Mr. Pallone 
for 5 minutes for his opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE JR, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman.
    I am pleased that the committee is having a hearing on two 
important bills today, the Animal Drug User Fee amendments and 
the Animal Generic Drug User Fee amendments, both of which I 
have cosponsored. Without congressional action the current 
agreements will expire at the end of this fiscal year, which 
would have a serious and harmful impact on the ability of FDA's 
Center for Veterinary Medicine to review new and generic drug 
applications in a timely manner.
    Prior to 2003, FDA's review of animal drug submissions was 
taking over a year and a half to be completed, and this 
obviously led to serious concerns that new and innovative 
pharmaceutical products were not making their way on to the 
marketplace in order to treat our Nation's pets, as well as 
food animals that help sustain the Nation's food supply. 
Accordingly in 2003, Congress first enacted ADUFA to help 
improve the FDA review of new animal drugs.
    Like other user fee programs for human drugs, ADUFA 
authorized the FDA to collect fees to help ensure that the 
agency had the resources it needed to help expedite the new 
animal drug approval process, reduce the application backlog 
and improve communications with drug sponsors.
    In 2008, because of the success of this program, Congress 
reauthorized ADUFA for 5 years--that is ADUFA II--and so here 
we are again 5 years later. In order for the FDA to continue 
the success of this program, Congress must act to reauthorize 
these user fees.
    Under the proposed ADUFA III agreement, the industry would 
pay approximately $23.6 million in fiscal year 2014 and similar 
amounts in the remaining 4 years based on inflation adjusters. 
This includes some resources for technology infrastructure in 
the first year. These fees will continue to allow the agency to 
more efficiently and effectively review an animal drug 
applications and provide industry with predictability and 
speedier reviews.
    In 2008, Congress authorized the AGDUFA program for 5 years 
in order to improve the review of abbreviated new animal drug 
applications or generic versions of animal drugs. AGDUFA 
enabled the agency to eliminate its application backlog and 
reduce review times. Similar to ADUFA, FDA and industry 
negotiated an agreement regarding the size and scope of an 
agreement for generic animal drugs, or AGDUFA.
    Under the new proposal before us today, the industry would 
pay $7.3 million in fiscal year 2014, which includes technology 
funding; 6.944 million in fiscal years 2015; 7.429 million in 
fiscal year 2016; 7.936 million in fiscal year 2017; and, 
finally, 8.467 million in fiscal year 2018. Once implemented, 
AGDUFA will continue to speed lower-cost animal drugs to the 
marketplace and bring significant savings to ranchers, farmers, 
and pet owners.
    I think we can all agree that these programs have been 
particularly effective. This project should not be interrupted, 
and so, Mr. Chairman, I stand ready to work with you so that 
this process will be expeditious, and we can pass these 
agreements into law as soon as possible.
    Let me close by saying that I recognize that there is a 
growing concern among stakeholders and some members of the 
subcommittee about the use of antibiotics in food animals. 
Clearly we face significant challenges when it comes to 
maintaining the effective use of antibiotics. With fewer and 
fewer innovative antibiotic products coming down the 
pharmaceutical pipeline, it is even more important that we keep 
antibiotics that are currently on the market working. So I look 
forward to hearing from our second panel about how bacteria 
that are resistant to antibiotics begin to proliferate, and 
what type of threat this poses to humans.
    So thank you again for all the witnesses for being with us, 
and we are looking forward to your testimony.
    Nobody wants my time, right? No. I yield back.
    Mr. Pitts. The chair thanks the gentlemen.
    I now recognize the chairman of the full committee Mr. 
Upton for 5 minutes for an opening statement.

   OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Upton. Well, thank you, Mr. Chairman. I appreciate 
today's hearing on the reauthorization of the Animal Drug User 
Fee Act, as well as the Animal Generic Drug User Fee Act.
    You know, Congress first created ADUFA back in 2003 and 
AGDUFA back in 2008, and together these programs have yielded 
many benefits for the American people, and they have ensured 
that veterinarians, livestock producers, poultry producers, pet 
owners have access to new and affordable animal drugs to keep 
their animals healthy. They have assisted animal drug producers 
by fostering a stable and predictable FDA review process. And 
finally, they have helped American consumers by keeping that 
food supply safe. For companies like Zoetis, which employs over 
700 people in my district, these programs are essential for 
them to keep producing top-of-the-line drugs for pets and 
livestock.
    I was fortunate enough to be the lead House sponsor of the 
original ADUFA bill back in 2003, and it is great to see how 
successful it has been and how many Americans it has, in fact, 
helped. I believe that there is a bipartisan, bicameral 
interest in getting these user fees reauthorized well before 
they expire at the end of September of this year, and I intend 
to do all that I can to make sure that that effort happens. So 
I look forward to working with all of our colleagues on those 
bills. I want to particularly thank Mr. Gardner and Mr. Shimkus 
for their leadership on both of these pieces of legislation 
respectively, and I yield the balance of my time to John 
Shimkus.
    [The prepared statement of Mr. Upton follows:]

                 Prepared statement of Hon. Fred Upton

    Thank you for holding today's hearing on the 
reauthorization of the Animal Drug User Fee Act (ADUFA) and the 
Animal Generic Drug User Fee Act (AGDUFA).
    Congress first created ADUFA back in 2003 and AGDUFA in 
2008. Together, these programs have yielded many benefits for 
the American people. They have ensured that veterinarians, 
livestock producers, poultry producers and pet owners have 
access to new and affordable animal drugs to keep their animals 
healthy. They have assisted animal drug producers by fostering 
a stable and predictable FDA review process. Finally, they have 
helped American consumers by keeping the food supply safe.
    For companies like Zoetis, which employs over 700 folks in 
my district, these programs are essential for them to keep 
producing top of the line drugs for pets and livestock.
    I was fortunate enough to be the lead House sponsor of the 
original ADUFA legislation in 2003, and it is great to see how 
successful it has been and how many Americans it has helped.
    I believe there is bipartisan, bicameral interest in 
getting these user fees reauthorized well before they expire at 
the end of September. I intend to do all I can to make this 
reauthorization effort bipartisan, and I look forward to 
working with my Democratic colleagues on these bills.
    I thank John Shimkus and Cory Gardner for their leadership 
on ADUFA and AGDUFA, respectively.

  OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Mr. Shimkus. Thank you, Mr. Chairman. Thank you also, 
Chairman Pitts, and I appreciate holding this hearing on the 
user fee reauthorization bills that are important to our 
agriculture community and the consumers they serve.
    Today I am pleased to introduce legislation reauthorizing 
the Animal Drug User Fee Act, along with companion legislation 
to reauthorize generic drug user fees, introduced by my 
colleague from Colorado Cory Gardner. Together these bills will 
provide the FDA with critical resources to improve the animal 
drug approval process and allow drug manufacturers to bring 
innovative products to the market, improving food safety and 
animal health. These are the same tools the FDA has 
successfully utilized to reduce application backlogs and 
provide a more predictable process since ADUFA was first signed 
into law over 10 years ago.
    ADUFA is important to many of my constituents in southern 
Illinois as well as rural and agricultural communities across 
the country. It is a fact of life that animals get sick, and it 
is important for veterinarians to have the ability to provide 
the best drugs and treatment available. H.R. 1407 and 1408 
provide veterinarians access to products to prevent, control 
and treat animal diseases in our pets and livestock.
    Livestock producers benefit as well. Last week when I 
announced the introduction of ADUFA reauthorization, I stood 
with beef and pork producers from my district who spoke on the 
importance of this legislation to their businesses and 
livelihoods. They rely on the timely availability of these 
drugs to provide a safe food product to maintain the health of 
their herds.
    At the end of the day, all American consumers benefit from 
the availability of safe and affordable food. This will have 
positive impact on everyone in our district, from producers on 
family farms to pet owners and consumers in major urban cities 
and suburbs around the country.
    I want to thank Chairmen Upton and Pitts, along with 
Ranking Member Waxman and Pallone for becoming original 
cosponsors of these reauthorizations, and I look forward to 
working with them to move these bills through the committee. I 
believe the hearing today will be a productive next step for us 
to move forward on swift bipartisan passage of H.R. 1407 and 
1408 through the House.
    Thank you to our witnesses from the FDA and the animal 
health community for being here today. I look forward to 
hearing your input on the importance of a clean reauthorization 
process.
    With that, Mr. Chairman, I yield back the balance of my 
time.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the ranking member of the full committee Mr. Waxman, 
5 minutes for an opening statement.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Mr. Chairman.
    Our hearing today is going to examine FDA's animal drug 
user fee programs, which have been successful at speeding both 
brand and generic drugs for animals to the market, and that is 
very important. But the reauthorization of these user fee 
programs also gives us an opportunity to look at providing FDA 
with new tools to address a glaring public health crisis, the 
problem of antibiotic resistance.
    Antibiotics are truly a lifesaving gift. Unfortunately the 
more they are used, the less they work. Untold numbers of 
Americans die or are infected each year by antibiotic-resistant 
bugs. To remain effective, antibiotics must be used 
judiciously. To be sure, antibiotics are overprescribed for use 
in humans. That is a real and difficult problem and one that 
requires our attention. But we have to look at all areas in 
which antibiotics are used and reduce all unnecessary uses.
    We know that most antibiotic use occurs on the farm, and 
much of this use is not to treat sick animals, which everyone 
agrees is important, but for disease prevention or growth 
promotion. Unfortunately we don't know exactly how much because 
it isn't reported anywhere.
    We now have an overwhelming body of evidence showing that 
the overuse of antibiotics in industrial meat production is 
threatening to destroy the effectiveness of our most important 
antibiotics for human use. In recent years reports from the 
Institute of Medicine, GAO and the World Health Organization 
all describe the global public health threat generated by 
bacteria that had become resistant as a result of antibiotic 
use on the farms.
    There is a bill that would take steps to curtail the 
inappropriate use of important human antibiotics. 
Representative Slaughter's Preservation of Antibiotics for 
Medical Treatment Act, or PAMTA. We always take these things 
and put them down as acronyms. This bill has a long history. 
Congressman Dingell and I introduced the very first version 
back in 1980 as The Antibiotics Preservation Act.
    I think this legislation makes good sense, but it has, 
unfortunately, never moved very far. At least part of the 
reason it has failed to move is that industry claims there is 
not enough data to show a link between the use of antibiotics 
on the farm and the development of resistant bugs that harm 
people. That is why we need to ask industry to give us more 
data on how these drugs are being used. Industry should provide 
evidence to document its assertion that there is no link. 
Industry should not be able to have it both ways. We know a lot 
about how antibiotics are being used in humans thanks to our 
healthcare system infrastructure. We know very little about the 
use of antibiotics on farms and ranches.
    In the 2008 reauthorization of the animal drug user fee 
legislation, we took a sensible step by requiring drug 
companies to make certain limited reports to FDA on their 
animal antibiotics sales data, but we need to go further. 
Earlier this year I introduced the Delivering Antibiotic 
Transparency in Animals Act, or DATA. The DATA Act would 
enhance the information FDA gets about how these drugs are used 
by putting modest requirements on the drug companies and the 
major industrial meat product companies like Tyson or 
Smithfield Farms.
    This is a commonsense bill. There is no prohibition on the 
use of these drugs. We are simply asking that industry tell us 
more about the way these drugs are used so that we can learn 
more about how resistant bugs which are harming Americans every 
day are bred.
    The issue of antibiotic resistance is not new to this 
committee. In the 111th and 112th Congresses, we held several 
hearings on this issue. Now is the time for the next step by 
moving the DATA Act as we work to combat the public health 
crisis.
    I understand the argument for keeping the Animal Drug User 
Fee Acts free of controversy, but I do think we need to find a 
way to address this issue soon. We need to ensure that FDA has 
not only the resources and procedures for speeding safe and 
effective animal drugs to market, but also the information to 
ensure that they are being used judiciously.
    I thank you, Mr. Chairman, for holding this hearing today. 
I look forward to the hearing, hearing from our witnesses, and 
I yield back a second, the 3, 4 seconds I don't have any 
longer.
    Mr. Pitts. The chair thanks the gentlemen.
    That concludes the opening statements by the Members. We 
have two panels today. I will ask the first panelist to please 
come forward to the witness table and introduce her at this 
time.
    Dr. Bernadette Dunham, Director of the Center for 
Veterinary Medicine, U.S. Food and Drug Administration, is our 
first witness. Thank you for coming. You will have 5 minutes to 
summarize your written testimony. Your written testimony will 
be made part of the record. And so at this time, Dr. Dunham, 
you are recognized for 5 minutes.

STATEMENT OF BERNADETTE DUNHAM, DIRECTOR, CENTER FOR VETERINARY 
          MEDICINE, U.S. FOOD AND DRUG ADMINISTRATION

    Dr. Dunham. Thank you very much.
    Good afternoon, Chairman Pitts, Ranking Member Pallone and 
members of the subcommittee. I am Dr. Bernadette Dunham, 
Director of the Center for Veterinary Medicine at the Food and 
Drug Administration. Thank you for this opportunity to discuss 
FDA's proposals for reauthorization of the Animal Drug User Fee 
Act and the Animal Generic Drug User Fee Act.
    As you know, these fee programs are designed to expedite 
access to new therapies for food-producing animals and 
companion animals, and foster innovation in drug development by 
enabling FDA to maintain a stable workforce to provide a 
predictable and timely review process.
    These programs have been highly successful and have enabled 
FDA to eliminate a backlog in application, dramatically reduce 
the time needed to review animal drug applications and other 
submissions, improve timely communications with drug sponsors, 
and achieve other efficiencies in the drug approval process, 
while still ensuring the drugs are safe and effective.
    In my testimony today I will provide the status of FDA's 
reauthorization activities. I will also provide some 
information about each program, our achievements to date, and 
our proposed changes.
    The user fee provisions of ADUFA II and AGDUFA I will 
sunset on October 1st, 2013, if not reauthorized. Timely 
reauthorization is needed to ensure there is it no disruption 
to these important programs.
    FDA began the reauthorization process with the public 
meeting held November 7th, 2011, and began discussions with 
stakeholders in February 2012. FDA published the negotiated 
recommendations in the Federal Register on December 5th, 2012, 
and solicited public comment. Another public meeting to get 
input on the recommendations was held December 18th, 2012. The 
final recommendations transmitted to Congress include for each 
program the goals letter outlining the performance metrics, the 
proposed legislative language, and a summary of public 
comments.
    FDA considers the timely review of the safety and 
effectiveness of new animal drug applications to be central to 
the agency's mission to protect and promote public health. 
Under the original Animal Drug User Fee Act enacted in 2003, 
the agency agreed to meet a comprehensive set of performance 
goals established to show significant improvement in the 
timeliness and predictability of new animal drug review 
process. The additional funding enabled FDA to increase the 
number of review staff by approximately 30 percent.
    In 2008, before ADUFA I expired, Congress passed ADUFA II, 
which included an extension of the program for an additional 5 
years. And I am pleased to report that FDA has exceeded all of 
the performance goals established under ADUFA for each year of 
this critical program.
    During the first 5 years of the program, the agency was 
able to dramatically reduce review times from 500 days to 180 
days and completely eliminate the backlog of 833 submissions 
within the first year.
    Due to the current success of the program, FDA and industry 
agree that only minor refinements to the performance goals that 
ADUFA II established were necessary. Our recommendations 
relating to the financial enhancements of this program include 
a new statutory inflation adjuster, a new provision for 
recovering collection shortfalls, and a modification of the 
workload adjuster.
    To increase revenue stream stability, reduce application 
fee costs and minimize the potential for collection shortfalls, 
the recommendations also modify the fee revenue distribution. 
FDA's recommendation to Congress after consultation with the 
regulated industry is that the total fee revenue estimate for 
fiscal year 2014 will be $23.6 million, which includes a one-
time information technology funding in the amount of $2 
million.
    AGDUFA I authorized FDA's first-ever generic animal drug 
user fee program, and the additional funding enabled FDA to 
increase the number of review staff by approximately 45 
percent. Furthermore, the authorization of AGDUFA I enabled 
FDA's continued assurance that generic animal drug products are 
safe and effective, and provided pet owners, ranchers and 
farmers with greater access to lower-cost therapeutic drugs. 
FDA agreed to meet performance goals to expedite the review of 
generic applications and submissions without compromising the 
quality of the agency's review.
    During the 4 years of AGDUFA I, FDA has exceeded every goal 
every year, with one minor exception. We missed a performance 
goal by 1 day for one submission of an investigational generic 
new animal drug in 2009.
    The additional resources provided under AGDUFA I enabled 
FDA to completely eliminate a backlog of 680 submissions in 22 
months. In addition, the agency has been able to dramatically 
reduce review times from 700 days to 270 days.
    FDA's goals for AGDUFA II are to sustain and enhance the 
core program's operation and performance, while providing 
predictable review times and resources sufficient to keep pace 
with actual costs. FDA and industry agreed to shorter review 
times for certain reactivations and resubmissions and to 
implement a process for timely foreign inspections.
    Our recommendations for financial enhancements for AGDUFA 
II include a fixed inflation adjuster of 4 percent each year to 
achieve the proposed revenue levels, and modification of the 
workload adjuster to ensure that it adequately captures FDA's 
workload. We also recommend modifying the fee revenue 
distribution to increase the stability of the revenue stream 
and reduce application fee costs.
    The total 5-year revenue for AGDUFA I was $27.1 million. 
The proposed total 5-year revenue for AGDUFA II will be $38.1 
million, which includes a one-time IT funding for $850,000 for 
fiscal year 2014 for the first year planned of a total of 
$7.328 million.
    FDA's ADUFA and AGDUFA legislative proposals represent 
considerable input from and agreement of stakeholders, the 
public, and the agency. ADUFA and AGDUFA are widely regarded as 
extremely successful programs. The recommendations we have 
submitted for reauthorization of these programs will ensure FDA 
has a stable workforce to provide the predictable and timely 
review process the drug sponsors need in order to foster 
innovation. They will also provide for expedited access to new 
therapies for food-producing animals and companion animals, 
while ensuring the drugs are safe and effective.
    Thank you for the opportunity to discuss ADUFA and AGDUFA 
programs, and I am happy to answer any questions.
    Mr. Pitts. Thank you, Dr. Dunham, for your opening 
statement.
    [The prepared statement of Dr. Dunham follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Pitts. I will begin the questioning and recognize 
myself 5 minutes for that purpose.
    Dr. Dunham, Congress first enacted ADUFA in 2003 and AGDUFA 
in 2008. Would you explain how ADUFA and AGDUFA improved FDA 
regulations of new animal drug, generic animal drugs as far as 
benefit to public health is concerned? And then tell us what 
the new improvements, the improvements in the new proposed 
ADUFA and AGDUFA agreements, how they would improve that.
    Dr. Dunham. Yes, sir. These programs have enabled us to 
adequately have the scientific staff that we need to do our 
reviews and to afford us the opportunity to bring innovative 
products to our review process, thereby enhancing and 
protecting both the health of the animals and from that, very 
specifically looking at food-producing animals, to ensuring 
their health is sustained, and therefore any product that you 
are going to consume should be safe. And the extensive review 
we have to assure that is something that we have benefited from 
with this program.
    And continuing along that line, that also applies then to 
the AGDUFA, or generic animal drugs, where, again, the safety, 
effectiveness and availability of these products which are 
needed because of the diversity of the species that we have, 
these programs have both been successful.
    And the public health side is both sides, companion animal 
medicine to ensure they are safe and effective and keeping 
animals healthy, because, as you know, even with zoonotic 
medicine, there is an opportunity for problems there. So this 
is one thing we value very much when we cross over the lines of 
public health in everything we do for our review process.
    The changes that we will be looking at are to further 
enhance our interaction with our sponsors in working with them 
earlier as they come forward with innovative products. The more 
that we can partner with them in regards to reviewing the 
science behind their innovation, we can address issues of 
concerns and help them work through this and provide data that 
can hopefully bring us to a single review. This will allow the 
expedition of an approved product that is meeting all of our 
standards for safety and effectiveness, and get those drugs to 
the veterinarians for them to be able to take care of all the 
species. And I think the diversity of the species that we deal 
with is challenging, and for that reason these programs have 
helped us tremendously.
    Mr. Pitts. Thank you.
    Why are the ADUFA and AGDUFA agreements so important to 
livestock, and poultry producers, and veterinarians, and pet 
owners and consumers? And what are the consequences of the not 
reauthorizing the animal drug user fee programs?
    Dr. Dunham. Again, with the success that we have had and 
the capability of bringing forth more safe and effective 
products to address the plethora of diseases that we have 
because we have so many species that we need to look at, this 
program has led to that success. And there are still many, many 
more diseases that we need to address with our sponsors.
    The program, if we were not to continue this, would, in 
fact, set us back. The way in which we have been able to have 
expedited reviews, i.e., work with our companies to address and 
review the science, if we don't have the staff to complete 
that, we are going to be turning back and having slower 
reviews, and that is going to, I think, lead to harm because we 
are not going to have the needed products that we want out 
there to address the concerns of the health of the animals that 
we take care of every day.
    And I do believe that with the programs sustaining us, 
there is a lot of new science coming forward, and the 
challenges for having these review processes will bring the 
best of the best together and, I think, open more venues that 
we see information that we gather on the animal side many times 
transmits over for information on the human side.
    And so I think together we can be a force to reckon with, 
because this is what we need in this day and age. And more 
importantly, I think it is something that we understand these 
drugs that we develop, although we need many of them, there is 
innovative science coming onboard, and we have to be very 
judicious in how we use the products, as you mentioned earlier 
in the testimony coming forth with the Members. And I think the 
more that we are aware of the complexity of the challenging 
reviews that we have, the more we can work together to ensure 
public health.
    Mr. Pitts. All right. How do ADUFA and AGDUFA take small 
businesses into account? What accommodations do these programs 
make for them? And then finally I want to ask how does ADUFA 
foster innovation in drug development?
    Dr. Dunham. With the opportunity to give waivers for 
sponsors where they are small businesses, we can work with 
them. And many times on the first round through, we will work 
very closely with them to help minimize the cost factor the 
first time around.
    We are also able to give waivers, as we have always done, 
for anything from minor species. And at the same time that we 
do this, we work very closely with the sponsors to bring them 
in earlier, as I said, to be able to address what they propose 
to do and understand the procedures they have to go through in 
order to get there.
    For generic drugs, where they will copy your pioneer, we 
have an opportunity there on the fee system that we can address 
the small businesses so that if it is the first time in and 
they haven't had any approvals, it is a much lower fee, and 
once they get above six applications approved, it will be an 
increase in the fee on that one, and when they have had more 
than that. So we give a break on the finances in order to help 
them, and all of our sponsors have benefited from that.
    When the sponsors are able to have recovery of not only the 
efficacy and the speed with which drugs are approved, then when 
you get it to market, the benefit comes back always for 
research. When we can do that, they are able to break ground 
with innovation. And what we do now is we try to meet with them 
very, very early on, even before they are coming with the 
application, so that we can understand where they are going to 
be going. And with these opportunities we can then fine-tune 
issues or be able to flag something that is going to be very 
challenging, and work with them to review sooner, and be able 
then to hopefully have all of these various technical sections 
that they have to meet be met thoroughly and effectively, and 
hopefully with one cycle review.
    So having our staff be able to engage in interaction with 
them has been a real success rate. I think the sponsors have 
also improved, because the more that they can understand what 
it takes to have a really good application coming in the front 
door, the quicker we are going to have a single review, and 
that is the goal, and that is the time saving across the board.
    Mr. Pitts. The chair thanks the gentlelady, and my time is 
expired. I now recognize the ranking member of the subcommittee 
Mr. Pallone, 5 minutes for questions.
    Mr. Pallone. Thank you, Mr. Chairman, and thank you, Dr. 
Dunham, for being here today.
    I know you are not likely to answer the question, but I 
have to ask you really just to alert the FDA to an issue that I 
am concerned about, and that is implementation of an e-labeling 
or a paperless labeling system for drug products. And I would 
like to quickly use this opportunity to go on record with a 
question and look forward to hearing back from the FDA in a 
timely manner.
    Three successive FDA unified agendas starting in the spring 
of 2009 have contained notice of a proposed rule signaling to 
me that electronic distribution of required drug product 
prescribing information is an FDA priority. E-labeling would 
ensure that most up-to-date prescription drug product, safety 
and efficacy information is available to healthcare providers, 
something I think we all agree is critical. In addition, it 
would also provide significant gains to patients, manufacturers 
and dispensers. In today's world current technology makes e-
labeling a viable alternative that has tremendous value and 
could hopefully also lower costs.
    So my two questions are given the need for e-labeling, is 
there a date that the agency can commit in regards to 
completing the rulemaking process in implementing e-labeling? 
And second, is there any update on your process moving forward 
that you can share? And I don't expect you to answer this, but 
if you want to; if not, through the chairman, you know, have 
the FDA get back to us.
    Dr. Dunham. I would be delighted to pass that question over 
to the key members in the agency that can address that and have 
them get back to you as soon as possible.
    Mr. Pallone. Thank you.
    Thank you, Mr. Chairman.
    Now, getting back to the Animal Drug User Fee legislation, 
Dr. Dunham, I want to thank you for your testimony about these 
important programs. It is clear they have been every bit the 
success that the other user fee programs at FDA have been. They 
have allowed the agency to move efficiently and effectively to 
review animal drug applications, and have provided industry 
with predictability and, of course, speedier reviews. And I am 
glad to be a cosponsor of the legislation. We will work to see 
that it moves through this committee in a timely way.
    Another topic at today's hearing which has come up is 
antibiotic resistance and its relationship to the use of these 
important lifesaving drugs in food-producing animals. As this 
committee well knows, antibiotic resistance is a grave public 
health threat. I recognize that there is a growing concern 
among stakeholders and some members of the subcommittee about 
the use of antibiotics in food animals. Specifically they say 
that there is a lack of data on how antibiotics are used and in 
what quantities. But in the 2008 ADUFA reauthorization 
legislation, we did include some provisions to address this 
knowledge gap.
    So my first question is can you tell us about what those 
provisions did? Then what kind of information did you get as a 
result? And do you think it has been successful overall? In 2 
minutes.
    Dr. Dunham. Actually, in fact, it was very successful. I 
think section 105 allowed us to be able to report out what the 
sponsors did with regards to sales of their drugs and 
distribution. And when we did this, it was really good because 
we had a lot of comments coming back, and, in fact, the 
comments have said, can we do more, and can we make this even 
more useful?
    And I think always we would appreciate the opportunity in 
ways to work with everybody to get the best data. And what we 
have done is we have now also put out an advanced notice of 
proposed rulemaking just to do that, to gather information from 
many stakeholders as to additional ideas for how to improve, 
what this data would look like. There are areas that we would 
like to refine, and we hope with the 2012 report we are going 
to see the format change.
    And further, based upon receiving some additional input, 
one of the areas that you know is important is how do we gather 
information on use data, and this is something that extends way 
beyond. And we do want to be able to work with our other 
agencies, such as USDA and CDC, and academia to figure out some 
ways to do this. And we have also been looking at different 
programs internationally. People are embracing how to do this.
    So I think this is a very good way for us to reach out and 
improve this, and we look forward to reviewing the comments and 
coming back with some proposals. But I think this is something 
that we all want to work together on.
    Mr. Pallone. Well, you still have 30, 40 seconds here. What 
kind of information did you actually get, though?
    Dr. Dunham. We are talking fast.
    We were able to put out exactly what--the actual indication 
for the groups of animals. We do it in aggregate, and they will 
be able to say what the dosage is, what the form of 
administration is, their sales distribution.
    The issue there has been could we have more, can we refine 
this, and I think that there are areas that we can, and this is 
what we do with working with our stakeholders to be able to 
fine-tune this so we can have a little bit more information.
    I think what is really critical is we are also very nicely 
at the same time doing two other things. We have a proposal out 
there right now, which is Guidance 209, which we did finalize 
to say we do want to phase out growth promotion and feed 
efficiency use of medically important antibiotics and bring 
back in oversight by veterinarians. And Guidance 213 is how we 
work with our pharmaceutical companies to make the label 
changes appropriate to do just that and to change that 
authorization on the labeling as well. And the veterinary feed 
directive is one of the key tools that will come back in with 
the hands of a veterinarian to do all of that. That is 
happening simultaneously.
    What would be really good now is as we fine-tune all of 
this, what does that look like when you really do see these 
strengths occurring and you are getting feedback from what the 
distributions are, and how we can further enhance this 
reporting schedule. And I do think everything is coming 
together in a way that I really appreciate with collaboration 
in addressing the very important issue, because, as you said 
earlier, it is a very important issue internationally. 
Everybody is involved. Judicious use is critical no matter what 
the antimicrobial. And I think together now you are finding 
everybody rallying, and I think in the spirit of collaboration, 
this is the best I could ever have. I am very grateful to work 
with so many fabulous folks coming up with new ways of 
addressing this very important issue.
    Mr. Pallone. All right. Thank you. Thanks very much.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentleman from Illinois Mr. Shimkus, 5 minutes 
for questions.
    Mr. Shimkus. Thank you, Mr. Chairman. I think I am going to 
be following up on my friend Mr. Pallone's question. But before 
I do that, Dr. Dunham, I see you got your Ph.D. In 
cardiovascular physiology from Boston University; is that 
correct?
    Dr. Dunham. Yes, sir.
    Mr. Shimkus. Is that animal cardiovascular physiology, or 
is it one and the same or----
    Dr. Dunham. Believe it or not, it was actually in a medical 
program that I was doing with my basic science Ph.D. So it was 
done at Boston University and Harvard Medical School. So we 
were dealing with patients, and we had then some opportunity 
for live-animal medicine.
    Mr. Shimkus. Obviously with the University of Illinois 
close to my district and knowing folks who have gone into 
veterinarian medicine, it is a pretty stringent, obviously, 
path to get there and sometimes more difficult, some would 
say----
    Dr. Dunham. Yes, it is.
    Mr. Shimkus [continuing]. Than some other aspects. So I 
just noticed that on your bio and wanted to ask about that.
    And you have been with the FDA for a long time.
    Dr. Dunham. Yes, since 2002.
    Mr. Shimkus. And the other point is that in this day and 
age, when we question role of government, I think the FDA and 
really the history with this program, it really does talk about 
the benefits of some government activity involved in protecting 
the safety and advocacy of our food supply for our public. So 
it is--I mean, even conservative Republicans have to talk to 
some of our friends in the district and say, yes, there is a 
role for government, and this is one, and this has been 
helpful, and why.
    But can you walk us through what you have done and the FDA 
actions have been over the past few years when it comes to this 
whole debate on the animal use--antibiotic use in animals?
    Dr. Dunham. What we have done is we have always had a very 
detailed review requirement on safety and effectiveness for 
drugs being used in food animals, and we have developed one 
important document, Guidance 152, which really did take a look 
at the very important drugs and to put those into a category of 
those that are very critical and most important. And with that 
the majority of all our antimicrobials are, in fact, under 
prescription. It is the very old drugs that you know have these 
particular labels on them that were not as specific as we would 
like them.
    Anymore now it is really important that we understand what 
the pathogen is, what the disease is that it caused, how do you 
have the correct label, and then working with the veterinarian 
and the producers together, because everybody is engaged in 
this to make sure we have a very healthy animal and, from that, 
a safe food product. Working together they are able then to 
assimilate exactly what would be the requirement for a drug to 
be used and to follow through.
    And now anymore we are able to fine-tune, working with 
laboratories and also our national antimicrobial resistance 
monitoring system, to really be able to understand what these 
pathogens are doing and where is the resistance occurring.
    Number one, I don't want the drug to develop resistance in 
the animal, and I certainly don't want to have a problem with 
resistance in people, and that is why everybody has a role to 
play in judicious use of these very important drugs. And these 
programs now bring us together so that we can track and follow 
through to see what is happening. And the more that we have the 
veterinarian back overseeing and working closely, this will be 
another way of enhancing that judicious use, which is really 
important.
    And in combination, that data comes back that we are 
looking at for our review process so that we can be able to see 
what is happening with resistance and follow that across the 
board. And I think this way, if there are three or four drugs, 
it will be a veterinarian to work at that program, understand 
that particular production site, and be able to select the best 
antimicrobial, and be able to follow that.
    Mr. Shimkus. My time is running short. And you were talking 
about older drugs and stuff. What authority currently does the 
FDA have to restrict the use of any antibiotic that my have 
adverse impact on human health?
    Dr. Dunham. I am sorry, could you repeat that one more 
time?
    Mr. Shimkus. What authority does FDA have today on--you 
know, if there was an old antibiotic that they might suggest 
might have an adverse impact on human health, what can FDA do 
today?
    Dr. Dunham. Right now, as I mentioned, we have taken a very 
active approach to be able to work a collaborative procedure to 
be able to phase those out. We have identified them. We have 
said these older drugs that are medically important will be 
phased out. We have 213, which is the guidance we would like to 
see finalized and approved this year. Within the first 3 months 
the sponsors will let us know their intention, and we have 
given them 3 years to make those changes, and this allows us to 
then go to a mandatory process if they don't.
    Mr. Shimkus. So this all debate occurred in your 
discussions with the, obviously, stakeholders in the industry 
and yourself.
    Dr. Dunham. Yes. This is one thing that I am very proud of 
to think that we have reached out and said, you know, we have a 
problem, we all know this. How can we all work together through 
this? And I think when everybody rolls up their sleeves and 
comes to the table and addresses this issue, you bring the best 
of the best out of everybody and many solutions. And not one 
size fits all, so how do we do this? And doing it together I 
think is a real success. So I am looking forward to that.
    Mr. Shimkus. Thank you very much.
    I yield back, Chairman.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentlelady from California Mrs. Capps for 5 
minutes for questions.
    Mrs. Capps. Thank you, Mr. Chairman, for holding this 
hearing.
    I know my colleagues have heard me talk a great deal about 
the beauty of an innovation that takes place in my district. 
One of our biggest agricultural sectors is cattle production, 
so having a working Center for Veterinary Medicine at the FDA 
is very important to the central coast of California as well.
    I want to thank the agency and industry partners for 
working together to come up with their agreement. I am pleased 
that we are here working on this topic today, and thank you, 
Dr. Dunham, for your testimony.
    It seems clear that over the years FDA has recognized that 
the use of antibiotics in food-producing animals can lead to 
the development of drug-resistant infections in humans. In 
1999, FDA released a framework to evaluate the potential impact 
antibiotic use in food-producing animals could have on the 
development of antibiotic resistance in humans. 2005, FDA 
withdrew the approval of one such antibiotic, fluoroquinolone, 
for use in poultry because a significant increase in resistance 
to that drug was observed in humans after it became widely used 
in chickens.
    More recently FDA has announced that it is unwise and 
irresponsible to use important human antibiotics for growth 
promotion in animals, and the agency has taken a number of 
steps to encourage the industry to voluntarily stop such uses.
    Dr. Dunham, can you and will you now tell us a bit more 
about what went into the withdrawal of fluoroquinolone and the 
human health concerns that led FDA to take this extraordinary 
step?
    Dr. Dunham. Thank you, Representative Capps--we had an 
opportunity to, again, bring the best science forward and to 
follow this along. And with the data that we had at that time, 
one of the problems that we have seen is Campylobacter is a 
problem within poultry. And when we had an opportunity to watch 
what was happening, when exposed then to the drug, at that time 
the data was being collected so that we could see there really 
was not only the hazard, but then once there was further 
exposure, then we had a problem that we were able to identify. 
And upon doing so and collecting the best science and review, 
then we were able to take action.
    And I think once we know the risk, the hazard, the 
exposure, that is the time when you have all the science that 
can be behind you when you make a decision like that. And then 
we went forth with that proposal at that time, and a few years 
later it was taken off the market.
    Mrs. Capps. I appreciate your response and this example, 
which I was hoping that would be addressed in this way, because 
it really highlights a troubling glimpse, I believe, into the 
dangers to human health from the overuse of important 
antibiotics on farms. And I am glad that we can see as a 
committee that you are in your Department attempting to build 
cooperation from industry in eliminating unnecessary uses of 
these drugs through a voluntary approach. But I do hope, and I 
guess this is the cautionary note, that if the voluntary 
approach fails, that FDA will either take a leadership role 
with regulatory action, or come back to us to let us know that 
you need new authority.
    I believe we really--this is scratching the surface here 
with this one example. Antibiotic overuse does pose a harmful 
public health threat, and we need our preeminent public health 
regulatory agency to do all it can to protect American people 
and preserve the effective of these lifesaving drugs by 
overuse, and they become less effective when they are really 
needed for something else that is serious.
    Last Congress we had numerous debates right here in this 
room about the shortages in the antibiotic pipeline and about 
the numerous potential superbugs that are resistant to our 
current antibiotic arsenal. These are human causes like 
overprescription and improper use. There are--one of things 
contributing to this is overprescription and improper use that 
contribute to the resistance for sure. But as FDA's actions now 
have shown, animal uses also contribute, and I wanted to get 
that on the record so that we could highlight the importance. 
These issues are related, and I urge this committee and my 
colleagues to work together on this aspect of this issue so 
that we can address the full causes of antibiotic resistance. I 
appreciate your testimony and your being here today.
    I yield back the balance of my time.
    Mr. Pitts. The chair thanks the gentlelady and now 
recognizes the gentleman from Virginia Mr. Griffith, 5 minutes 
for questions.
    Mr. Griffith. Thank you so much for being here today; do 
appreciate it very, very much.
    You know, we look at these issues, and I am very concerned 
about the ag issues in my district, and it is one of largest 
industries in my district. I have been looking for ways to 
promote it and ways to expand it, and, of course, these issues 
that you bring up today are very important.
    According to the National Cattlemen's Beef Association, 
there are approximately 7,600 beef farmers and 220,000 head of 
cattle in the Ninth District, and that is not counting our 
lambs and our goats and everything else that we have. For this 
reason development and approval of new animal drugs and generic 
drugs, including antibiotics, are very important to the farmers 
that I represent.
    I do appreciate your being here and the positive 
relationship that I am told exists between your office and the 
stakeholders in the ag and pharmaceutical industry. So I do 
appreciate that.
    I am concerned about large-animal vets and the shortage we 
have of those. I understand that there is a big concern about 
that shortage, and I am just wondering if the FDA is taking 
those concerns into consideration when proposing new guidance 
documents.
    Dr. Dunham. Thank you very much. And, yes, we are. We have 
been meeting with the American Veterinary Medical Association 
because this issue of do we have sufficient food-animal 
veterinarians available has been an issue for a number of 
years.
    And the other thing that is happening while we address 
those issues is to understand the plethora of veterinarians and 
where they are located versus where they are not, and how 
things have changed with regard to the practice of veterinary 
medicine as we have seen even with human medicine, and the 
technologies are enabling a tremendous amount of change that we 
want to embrace.
    Just for example, we have the capability of smartphones. We 
have the capability of labs talking to each other much better 
and correlating and very quickly turning things around. So you 
think about all of that, and you say, well, how can I do this 
even more effectively? We need to hear from the producers and 
the veterinarians as to how we can coordinate this. The 
opportunity for veterinary technicians has been looked at. The 
universities are all embracing where advancements in medicine 
have taken us and how then are we using those in practice.
    The coordination with some of our producers are state-of-
the-art with how, as you know, they are set up, their track 
record, their records of medical references, their access to 
laboratories, and, again, a veterinarian to be there, which is 
so important, to oversee and work through this and be able to 
prescribe and know what is happening with those herds to ensure 
their health is there, again, to make sure we are protecting 
public health and any food item.
    And I think as we talk through them, there is a variety of 
different ways of addressing concerns as we work through these, 
where I said, again, not one-size-fits-all and we learn from 
each other, and certain things that work in one State can work 
in another State.
    The opportunity, again, for communication is going to be 
critical as we establish the veterinary-patient relationship in 
a way that embraces today's technology, where we are located 
and how we interact. And I have been very, very pleased. We had 
a committee that was brought together through the American 
Veterinary Medical Association for just that purpose, how do we 
work through these challenging issues right now. And, in fact, 
there are a number of students that I am very pleased are 
continuing to seek their careers in the food-animal production 
side of veterinary medicine.
    Mr. Griffith. Well, I have got two questions arising out of 
your answer. One, do you think that we should be working to see 
that we get either larger enrollment in our existing schools, 
or should we be looking to maybe expand and have some new 
veterinary medicine schools open up in the country?
    Dr. Dunham. Well, actually there are a few more schools 
that I think will be opening up. I think the most important 
thing is for us, when we are talking to the next generation, is 
to encourage them, I think, to a stellar occupation in 
veterinary medicine. I can't be prouder to be a veterinarian 
because of the plethora of issues that we get to be challenged 
with. It is fantastic, and it is so rewarding to encourage them 
and let them know there are careers in the field. That is one 
thing I would love to see us do more of.
    The schools themselves are actually top notch. And you 
mentioned a minute ago that it is oftentimes more challenging, 
Representative Shimkus, to get into veterinary medicine. That 
is true. But I think the rewards that you get afterwards in the 
public health mission that we accomplish every day is 
outstanding. So that would be part and parcel of what I would 
encourage.
    Mr. Griffith. And then the other question I would have, we 
had some hearings about medical devices before we left, and 
there were some interesting cheap fixes that we saw, and there 
were other issues involved that wouldn't affect the veterinary 
side. But I am just wondering if FDA is prepared to move a lot 
of those things forward fairly quickly, because we learned 
about a device that was being used for children in the African 
Continent, but it was an $8 hack onto a smartphone. And it 
would seem to me, you know, as the FDA prepared--I know you 
can't answer for people--but on the animal side, are we 
prepared to get that stuff out into the field as fast a 
possible when it is something as simple as an $8 hack on a 
smartphone?
    Dr. Dunham. As long as we can keep things and make sure it 
doesn't impinge on safety and effectiveness, we are going to 
work through a number of these opportunities to be able to 
further enhance how we can share information that is so rapid 
and moving so quickly, and also tracking. And I think with that 
there is that capability of, you can pull up an X-ray or lab 
report.
    You could have our veterinarians, which are first 
responders, getting back to us very, very quickly right now, 
and I think that alone says so much when you realize how 
quickly everything moves in this day and age. Internationally 
we travel, animals travel, microbes travel. It is incredible. 
Food is already across countries before you can blink your eye. 
The more that we need to embrace technology for all the 
benefits, it is also quintessential in protecting animal health 
and public health to be able to enhance those communications.
    Mr. Griffith. Thank you so much, and I yield back, Mr. 
Chairman.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentlelady from Virgin Islands Dr. Christensen 
for 5 minutes for questions.
    Mrs. Christensen. Thank you, Mr. Chairman, and thank you 
for your answers as well and your testimony.
    I also want to follow up on the resistance issue, and I 
think just to step back for a moment and make sure that we all 
understand what we are talking about. And for the record, could 
you give us a brief overview of how antibiotic resistance 
developed, and why it is a particular problem with continual 
long-term administration of antibiotics in feed or water as is 
done for growth-promotion purposes?
    Dr. Dunham. I think the question of antimicrobial 
resistance is challenging. It is incredibly complex, and I 
don't have the answer. But I do know that there are incredible 
minds internationally working on this, as we all need to, every 
day, because it touches all of us, not just humans and not just 
animals; everything, plants as well. So the more that we are 
able to understand the complexity of this, we have the 
opportunity to intervene.
    No matter what, judicious use of any antimicrobial, 
anywhere, from a dentist, physician or veterinarian, is 
quintessential. That being said, then that is why it is so 
important that we have the veterinarians overseeing and using 
these drugs with their medical training, and working closely 
with the producers who absolutely then know their animals and 
how we can coordinate this and track it.
    I think that part is happening more and more, and the 
recognition that if you use an antimicrobial, you are putting 
pressure back on that pathogen. You want to make sure you have 
eliminated that pathogen. So knowing the right antimicrobial to 
choose based upon what the pathogen is and the disease that it 
has caused, and to follow that through or to work up your lab 
to be able to decide that, that is the kind of stuff that we 
all have to embrace, and that is what we are seeing.
    So one thing we have chosen, as I mentioned, was to 
recognize that I think growth promotion and feed efficiency 
were very, very older claims on antimicrobials way back, and 
what was missing was exactly the pathogen, and the disease and 
the dosage. Now we want to come fast forward, and all of these 
very important drugs need to have that, and they need to be 
under veterinary oversight. So where they would have been in 
the past, we are now looking to do that; phase out, labels will 
be changed, identification is on the label. So now when a 
physician or a veterinarian is looking at this label, it will 
identify that, and then they can do the proper workup. That 
brings us back again to developing judicious use across the 
board.
    Mrs. Christensen. As a physician, you know, we are always 
pressured to give antibiotics for viruses, for flus and so 
forth. Sometimes that is quite unpopular because you just don't 
do that unless you have a pathogen. So it is important, as you 
said, in human health as well as in animal.
    But when we held a hearing on antibiotic use on animals 
back in 2010, one thing we heard from some animal producers was 
that growth promotion was actually a manifestation of disease 
prevention; and that is, the reason why antibiotics could make 
animals grow faster and use feed more efficiently was that the 
low chronic doses of antibiotics actually were preventing 
disease. The question that raises, of course, is whether when 
the industry says it phasing out growth-promotion uses of 
medically important antibiotics, maybe it simply intends to 
change the label, but not its practices.
    So could you help address this question for us: How does 
FDA define disease ``prevention''? And is it possible for 
industry to essentially switch a growth-promotion claim to a 
disease-prevention claim with just some data showing that the 
same dose of a drug that promotes growth will also prevent a 
disease?
    Dr. Dunham. That is why with Guidance 213, which we 
certainly hope will be finalized this year, it will have us 
work very closely with the pharmaceutical company, because now 
they really do have to come back. And if there is going to be a 
prevention claim, it has to be able to identify everything we 
just talked about very clearly, because that is what was 
missing before.
    Mrs. Christensen. So you don't have a definition for 
``disease prevention'' in this instance?
    Dr. Dunham. You will see that in 213. But basically if you 
want to control something, that means you already have a 
problem. You can see within a herd there is a group of animals 
that have a problem, and you want to see to be able to prevent 
and control that from further expanding.
    If you want to prevent, you would need to have, again, an 
awareness of the history of the animal, the herd, and whether 
or not as a veterinarian everything you have seen indicates 
that you can be expecting something to happen. But you would 
still have to now very much understand what that pathogen is to 
be able to make that call. And only the veterinarian, in 
pulling everything together in their medical history, would 
make that decision, and it would have to be then, as far as the 
drug sponsor coming in and have a label, that if they are going 
to put that claim on, what are they preventing, and what is the 
surrounding circumstances that a veterinarian would need to 
make it happen.
    So you would have treatment, control and prevention in each 
one to be fine-tuned and explained, and now those labels would 
have to meet this new criteria before they could have that on 
them.
    Mrs. Christensen. Thank you.
    Thank you, Mr. Chairman.
    Mr. Pitts. The chair thanks the gentlelady. And now 
recognize the gentlelady from North Carolina, Ms. Ellmers, for 
5 minutes for questions.
    Mrs. Ellmers. Thank you, Mr. Chairman.
    And thank you, Dr. Dunham. And a moment ago you were 
speaking with my colleague, Mr. Griffith, about the excellent 
veterinarian schools in the country. And being a member 
representing District 2, North Carolina, I have to speak up for 
the NC State School of Veterinary Medicine; excellent school. 
And I will just have to add, as I have told everyone that I 
have come in contact with over the last 2 weeks, that my son 
has been accepted to NC State in the agriculture business 
school.
    Dr. Dunham. Fantastic.
    Mrs. Ellmers. So I am very excited about that.
    I am concerned. You know, in North Carolina, agriculture is 
the number one industry, and, you know, ag and our farmers, so 
important. Some of the larger farms, entities, you know, doing 
great and certainly have their issues to deal with. Some of the 
smaller farm entities, obviously any of these, you know, any 
more regulation or any more burden we put on them just makes it 
harder for them do what they need do. And, you know, I am 
particularly concerned about those farmers in the 
administration of any of these, you know, any of the jeopardy 
that we put them in.
    You know, how would you explain to them that they can use 
the FDA? And I will just talk about the veterinary feed 
directive. How can we speak to them and know that this is 
something that is going to be feasible for them, something that 
is going to be workable, that they will be able to take 
advantage of, but at the same time be able to afford cost-wise?
    Dr. Dunham. That is a great question. And I am actually 
able to tell you right now we are very pleased because we have 
just teamed up with the USDA. We are having five very special 
outreach listening sessions to address and listen from folks 
that are in either very remote locations or their concerns as 
to what this will do and mean for them. So right now we have 
our first one, which actually took place in Bowling Green, 
Kentucky today.
    Mrs. Ellmers. Great.
    Dr. Dunham. And then we will be doing Olympia, Washington, 
Fort Collins, Colorado, Pierre, South Dakota, and College 
Station, Texas. And it is for that whole purpose, both 
listening to veterinarians as we have been doing, but also the 
producers, what are some of the hurdles they think they will be 
facing and how will we help them move through this, because it 
is not one size fits all. And you are absolutely correct, a 
smaller group versus a big producer that has everything they 
need, how do we help them understand those issues and how can 
we work with them.
    The aspect of the veterinarian and how can they establish 
their veterinary patient-client relationship, they can set that 
up, and they have now a lot more latitude of what does that 
look like. And how you and I can set it up would be different 
to how I would set it up with somebody else. That is going to 
help. And the more that we dialogue them, that is going to 
bring us together to address their concerns so that we are not 
going to be adding further to their challenging days, because 
we need them, be they small or large, they are all a part of 
what we want with agriculture. And I am very pleased to know 
that we have been having some good feedback with them.
    And they share their concerns already. We have had a lot of 
meetings with different producers. They have come in or they 
have actually come into D.C. and they have come from different 
States, and we have had a chance to meet with them, explain 
what this all looks like, what will the veterinary feed 
directive be, and how a veterinarian now has the opportunity to 
fine-tune and be responsive for this and to work with them. And 
I have been really, really impressed with the willingness to 
say, well, I have this issue, maybe we could do this, what 
about this. That brings out the best, and the solutions are 
going to be terrific coming forward.
    Mrs. Ellmers. Great. Well, thank you. And, you know, I am 
glad you mentioned coupling with the USDA, because my next 
question has to do with, you know, the veterinary shortages 
that of course across the country we are faced with. And, you 
know, one of the things that we are looking at here in Congress 
are the possibility of, you know, basically veterinarian 
medicine loan repayment programs. And, you know, from your 
perspective, I don't want to put you on the spot, you know, but 
there is a high basically tax that is associated with that, as 
high as 39 percent of repayment. In your opinion, coming from 
the FDA and having to do with our farmers and agriculture 
across this country, to me, I mean, that is pretty 
straightforward. That is a pretty negative effect, especially 
when you are talking about trying to serve underserved areas. 
What is your opinion on that? And I mean, just in the 40 
seconds you have left, if you can just give me a little idea of 
what you think.
    Dr. Dunham. That is definitely a challenge. I think all of 
our students, no matter where they are, are facing tremendous, 
tremendous burdens with the student loans. Any possible way we 
can assist is going to be welcomed, and they appreciate that. 
And yet when I meet with the students, they are absolutely 
dedicated and thrilled to be doing what they want to do, and 
yet they are willing to take on these loans. So anything we can 
do to help is what we have to do, and to show them that there 
is still a way to have a career that is incredibly rewarding 
while, as you said, paying off these loans.
    So I do welcome that. I know all of the associations are 
trying to do something. We would like very much to even have a 
student loan repayment program ourselves. Haven't quite got all 
the money for that, but I would love to do that. But anything 
that we can do and encourage would be a real positive, because 
we need them, it is a career that we have to have and sustain. 
Veterinary medicine is so important. I know many times we look 
at those as just being the ones that take care of the animals, 
but veterinary medicine crosses so many areas.
    Mrs. Ellmers. Absolutely.
    Dr. Dunham. And they come with the most incredible 
dedication. And then their experience, maybe they will be 
members of Congress. It will be fantastic what they can 
continue to do.
    Mrs. Ellmers. Great. I truly appreciate your testimony. 
Thank you.
    Dr. Dunham. Thank you.
    Mr. Pitts. The chair thanks the gentlelady. I know the 
gentleman just walked in. We are about to wrap up questions.
    Dr. Gingrey, do you have any questions you would like to 
ask?
    Dr. Gingrey. Mr. Chairman, I think I will just pass at this 
time. Thanks.
    Mr. Pitts. All right.
    All right, at this time, then, with unanimous consent, we 
will recognize Representative Gardner, 5 minutes for questions.
    Mr. Gardner. Thank you, Mr. Chairman. And thank you, 
members of the committee.
    Dr. Dunham, thank you for your testimony today. And just a 
couple of quick questions for you. Everybody has bragged about 
their vet school, so I will throw in a word for Colorado State 
University and the aforementioned Fort Collins, Colorado, where 
you will be having a clinic here, at least a forum, very soon. 
So thank you for your participation in that.
    In your testimony you described the significant backlog on 
generic applications prior to the authorization of AGDUFA. What 
caused that backlog in the first place? And if you don't mind 
maybe talking a little bit about the causes. Was it simply a 
matter of resources? Go into that a little bit.
    Dr. Dunham. It was actually resources and just not having 
the resources to have the dedicated people we need to do that 
review. And I can't echo enough how appreciative we are of this 
program, because once you get a chance to fill the resources 
and have staff that can do the review, it is incredible what 
you can accomplish. And to have that sustained reliability, 
then, on not only keeping our FTEs, but you are able to then 
give back to the companies to know exactly what these 
performances are. And together we can enhance and get those 
drugs reviewed. And so that is why this program and its 
reauthorization is critical, because we have established so 
much, and I would hate to see us go back. And the success story 
exemplifies that.
    Mr. Gardner. I think in your testimony, I believe you were 
talking about, was it was AGDUFA or ADUFA? I think you talked 
about hitting every single performance goal except for the 
one----
    Dr. Dunham. That was on AGDUFA.
    Mr. Gardner [continuing]. By one day. And that was AGDUFA, 
correct, as a result of this?
    Dr. Dunham. Yes.
    Mr. Gardner. And in your discussions with farmers and 
ranchers, I know you spoke with my colleague a little bit about 
this, can you describe the importance of having generic drugs 
on the market?
    Dr. Dunham. I think it is really important. As we all know, 
we always value what the cost factors are. And just like on the 
human side, it is an opportunity to have a safe and effective 
drug that would be able to give you some cost savings. And I 
think, as you said earlier, with the plethora of animals and 
species we have, you can see how much more diversity we are 
going to have to deal with all of that.
    So the more that we can have generic drugs come through and 
have their approval, it is going be helping everybody. We need 
so many drugs approved for so many different diseases in so 
many species, it is constantly challenging us. So this is 
another plus, and I have been very impressed with what they 
have done.
    Mr. Gardner. About 2 months ago, Jennifer Johansson, who is 
the vice chair of the Generic Animal Drug Alliance, testified 
before the Senate HELP Committee stating that the number of 
generic new animal drug applications decreased after the 
implementation of AGDUFA. Are you aware of a reason for this? 
Do you feel at the present time that the submissions are 
adequate to provide available generics to producers?
    Dr. Dunham. I think we are seeing that. I think at the time 
we were also going through some economic turmoil and I think 
there was a little bit of hesitancy, we even saw that, as to 
how many applications were actually coming in, and that is 
something that goes along with what happens in the market. But 
that seems to have leveled out right now, and I would have to 
say that I think we are going to continue to see more coming 
forward.
    Mr. Gardner. You mentioned some of the feedback, the forum, 
the information you are getting from stakeholders. We have 
talked about what you are getting from veterinarians, what you 
are talking about getting from people in the livestock 
industry. Could you describe the stakeholder process with other 
people who may be outside of the industry itself but who are 
interested in the pharmaceutical issues as it pertains to the 
animal side?
    Dr. Dunham. Yes. And we have a number of stakeholders, many 
of them are here actually today in the audience. We have a 
number of other activist groups, i.e., that are helping us 
across the board with anything on medicine, consumers, 
academics, association groups that you will see here trying 
again to see how can we work together to address whatever these 
challenging issues are. Working with other agencies as well 
brings us forward. The public at large. We often have calls, 
letters from the public with their issues and their concerns 
all the way from whatever it is with companion animal medicine 
to the issues du jour of how we can be more judicious in the 
use and protection of antimicrobials. I know we don't do the 
biologics, that is done with USDA, but together those will help 
address the health concerns that we face and the venues of how 
we can all come together.
    And what that also does is it brings some of the best 
scientists and the issues du jour and how fast science is 
advancing. And so there have been opportunities to further 
collaborate with groups. They have come in and suggested 
different things that we can do with them. The sharing of 
information has been absolutely fabulous on that end.
    Mr. Gardner. Thank you, Dr. Dunham. I yield back my time.
    Mr. Pitts. The chair thanks the gentleman. That concludes 
our first panel.
    Thank you very much, Dr. Dunham, for coming, for all the 
good information and testimony you presented. The members may 
have additional questions. They will forward those to you if 
they do.
    We will now call the second panel to the witness stand and 
I will introduce them as they come. Dr. Richard Carnevale, Vice 
President of Regulatory, Scientific and International Affairs, 
Animal Health Institute. Secondly, we have Dr. Mike Apley, 
Professor and Section Head of Production Medicine and Clinical 
Pharmacology, College of Veterinary Medicine, Kansas State 
University. Thirdly, Dr. Lance Price, Professor in the 
Department of Occupational and Environmental Health, George 
Washington University. And that concludes the second panel.
    Thank you all for coming. You will each have 5 minutes to 
summarize your testimony. Your written testimony will be placed 
in the record.
    Dr. Carnevale, we will start with you. You are recognized 
for 5 minutes.

    STATEMENTS OF DR. RICHARD A. CARNEVALE, VICE PRESIDENT, 
REGULATORY, SCIENTIFIC AND INTERNATIONAL AFFAIRS, ANIMAL HEALTH 
    INSTITUTE; DR. MIKE APLEY, PROFESSOR AND SECTION HEAD, 
   PRODUCTION MEDICINE AND CLINICAL PHARMACOLOGY, COLLEGE OF 
VETERINARY MEDICINE, KANSAS STATE UNIVERSITY; AND DR. LANCE B. 
PRICE, PROFESSOR, DEPARTMENT OF OCCUPATIONAL AND ENVIRONMENTAL 
              HEALTH, GEORGE WASHINGTON UNIVERSITY

               STATEMENT OF RICHARD A. CARNEVALE

    Dr. Carnevale. Thank you, Mr. Chairman and members of the 
subcommittee. Thank you very much for holding this hearing on 
this important piece of legislation, as you have aptly 
described today, and for the opportunity to speak to you today 
about an important human and animal health benefit that results 
from using medicines to keep animals healthy.
    I am Dr. Richard Carnevale. I am a veterinarian by training 
with a degree from the University of Pennsylvania School of 
Veterinary Medicine, and I am here today on behalf of the 
Animal Health Institute, a trade association that represents 
companies that make medicines for animals.
    Our companies share a common mission. We contribute to 
public health by protecting animal health. Animal health 
products also give veterinarians and livestock and poultry 
producers the necessary tools to protect the health and well-
being of food-producing animals. Veterinarians work hard to 
prevent disease in animals, and it is important for them to 
have the medicines available when needed to treat a disease or 
disease threat.
    Mr. Chairman, the Center for Veterinary Medicine has a 
rigorous science-based approval process that provides to the 
American public the products necessary to protect public health 
by protecting animal health. Every year scientists uncover new 
diseases in animals, some of which pose a threat to human 
health. As more animals are raised to feed the planet and as 
animals are reared closer to people, we will continue to need 
new medicines to protect animal and human health.
    The reauthorization of ADUFA will continue to provide the 
agency the resources necessary to maintain and improve this 
approval process, provide new and innovative products to allow 
our pets to live longer and healthier lives, and contribute to 
food safety by keeping food animals healthy.
    The FDA animal drug approval process looks much like the 
human drug approval process. Animal drug companies submit data 
packages that demonstrate safety, efficacy, and the ability to 
meet the same stringent FDA manufacturing standards as human 
medicines. It is a costly process, requiring as much as $100 
million and 7 to 10 years to bring an animal drug to market.
    The market for animal drugs, however, is nothing like the 
market for human drugs. Our products are used to treat seven 
different major species of animals and many more minor species. 
A blockbuster animal drug will have sales of around $100 
million, but the vast majority of animal health products have 
market sizes of around $1 million or less. There is no Medicare 
or Medicaid--excuse me. I am missing a page. Sorry. I will move 
right on.
    The reauthorization of ADUFA will continue to provide the 
agency the resources necessary to maintain and improve this 
approval process, provide new and innovative products to allow 
our pets to live longer and healthier lives, and contribute to 
food safety. Passage of this important legislation will have 
several benefits. FDA/CVM benefits by having additional 
resources to meet its mission of protecting public health. 
Animal health sponsors benefit from a stable and predictable 
review process, allowing them to make informed decisions about 
the investment risks of research and development dollars. 
Veterinarians benefit from having new and innovative medical 
advances available to treat, control, and prevent diseases in 
their patients. Livestock and poultry producers and the 
veterinarians on whose advice they rely also have the tools to 
keep food animals healthy. Pet owners benefit by having their 
animals live longer and healthier lives, increasing their 
enjoyment of these companions. And consumers reap the food 
safety benefits that come as a result of the availability of 
additional tools to keep food animals healthy.
    AHI believes that the funding agreed to by the industry 
over the next 5 years is based on an objective assessment of 
agency resource needs and will allow the agency to maintain all 
current standards and also improve performance in key areas. 
The agreement calls for approximately $118 million in funding 
over the 5 years and uses a variable rather than fixed 
inflation factor, as was mentioned today. The financial 
agreement seeks to reduce the impact that fees may have on 
small businesses and small product markets by reducing the 
total percentage of fees coming from new animal drug 
applications and supplemental applications from 25 percent to 
20 percent. The agreement also includes a provision for FDA to 
make up potential fee shortfalls that may be experienced by 
allowing for adjustments to levied fees in the outyears of the 
program.
    FDA has consistently met timeframes for all sentinel 
submissions identified in the goals letter, as Dr. Dunham 
explained, and we are confident the agency will continue to do 
so over the next 5 fiscal years. The new agreement continues 
all current submission review timeframes mandated in ADUFA II; 
however, the new agreement adds important enhancements to the 
review process.
    Animal drugs generally go through a phased review process, 
whereas each specific area, called technical sections, of the 
new animal drug application is submitted and reviewed 
independently. Once the technical sections for safety, 
efficacy, manufacturing, and environmental impact are 
completed, an administrative NADA is filed referencing those 
sections, and approval of the product occurs within 60 days. If 
technical sections can be completed more rapidly, it will lead 
to earlier filing of the administrative NADA and, therefore, 
reduce overall time to market of safe and effective animal 
medicines.
    Mr. Pitts. Could you wrap up, please?
    Dr. Carnevale. Yes. And that will be accomplished by 
significantly shortening the review times of the second pass 
submissions.
    There are other agreements that we have talked about today, 
and I will sum by saying that the new agreement commits the 
agency to work with the industry to examine some longer-term 
goals. First, AHI will enter into discussions about how to 
extend conditional approval process and also will take a look 
at how current animal drug combinations are approved. This 
could have significant future import with the advent of the FDA 
proposal to move more antimicrobials used in feed to the 
veterinary feed directive program, as was discussed.
    Mr. Chairman, I ask you to pass this legislation in a 
timely manner and reject any changes that would jeopardize this 
bill so this program can continue without interruption. Thank 
you very much.
    Mr. Pitts. Thank the gentlemen.
    [The prepared statement of Mr. Carnevale follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Pitts. Recognize Dr. Apley, 5 minutes for opening 
statement.

                    STATEMENT OF MIKE APLEY

    Dr. Apley. Mr. Chairman and members of the committee, good 
afternoon, I am Mike Apley. I am a veterinarian----
    Mr. Pitts. Is your mike on? Yes.
    Dr. Apley. Got it. Thank you.
    I am Mike Apley. I am a veterinarian and a clinical 
pharmacologist at Kansas State University College of Veterinary 
Medicine, with friends at North Carolina and Colorado.
    Mr. Shimkus. What about Illinois?
    Dr. Apley. Some up there, too.
    My specialty areas are food animal production and the use 
of drugs in these animals. Today I wanted to share with you a 
little bit about how drugs are used in food animals.
    The first thing I wanted to emphasize is that this use 
revolves around the relationship of veterinarians to food 
animal producers. Veterinarians are a vital part of the drug 
use decisions by food animal producers, especially for 
antibiotics. This relationship is described and promoted in 
programs such as beef quality assurance and pork quality 
assurance. The combination of close monitoring and knowledge of 
the animals by the producer with the training and experience of 
the veterinarian is the best possible approach to animal 
health.
    Antibiotics may receive approval by the FDA Center for 
Veterinarian for five indications: treatment of disease, 
prevention of disease, control of disease, improved feed 
efficiency, and improved rate of gain. Those last two 
indications are production uses, which may also be referred to 
as growth promotion claims. These claims are specifically 
referred to in FDA Guidance for Industry 209, which Dr. Dunham 
referred to, in which FDA/CVM refers to these indications as 
injudicious uses and asks for voluntary withdrawal of these 
indications.
    While the FDA has not released official definitions for 
indications 2 and 3, which were prevention and control, that I 
am aware of as yet, as a clinical pharmacologist I wanted to 
share my working definitions of these applications. Prevention 
is the use of an antibiotic to prevent disease occurrence in a 
population of animals when experience suggests that this 
particular time in a production cycle is very likely to result 
in a disease outbreak in this population of animals. The need 
for prevention varies according to the current disease pressure 
and may change over time. Control, on the other hand, is use of 
an antibiotic to reduce the number of additional clinical cases 
in a population where clinical observation or recent stressors 
and exposure indicate that the disease process is clinically 
apparent or in development.
    The overarching goal of veterinarians and producers is to 
replace the need for prevention or control uses of antibiotics 
through practices such as biosecurity and vaccinations. The use 
of antibiotics for therapy and control are considered a 
therapeutic use by the American Veterinary Medical Association, 
the FDA Center for Veterinary Medicine, the World Organization 
for Animal Health, and Codex Alimentarius.
    In my submitted testimony, I have included tables of labels 
for cattle and swine. My first table summarizes uses that are 
labeled for improvement of rate of gain or feed efficiency, 
with the emphasis on ones that would be affected by Guidance 
209. For antibiotics in cattle with labels strictly for 
improvement of rate of gain or feed efficiency, there are four 
which are not classified as human medically important and five 
which are. There are some labels which have a rate of gain or 
feed efficiency claim and a prevention or control claim. In 
that category, there is one which is not medically important 
and three that are. These claims are examples of ones that 
would be affected by the removal of growth promotion claims. 
When we move to prevention or control of disease only, there 
are only three out of eight which are medically important.
    I would also like to emphasize the findings of a study in 
which I was lead author, which addressed the use of antibiotics 
in the feed for swine. In this study, it was found that 
approximately 15 percent of the medically important antibiotic 
use in feed for swine was for growth promotion. The greatest 
use on a kilogram basis of the medically important antibiotics 
in swine was attributable to the tetracyclines, which are 
chlortetracycline and oxytetracycline in these cases.
    As for cattle, there are other antibiotics, which have an 
injectable or in-water route of application on the label. These 
include ceftiofur, ampicillin trihydrate, tulathromycin, 
penicillin G. This illustrates the complexity of this issue and 
the need to evaluate our discussion based on these different 
antibiotics and pathogens of interest.
    Lastly, if they are to be used other than according to the 
label, there must be a veterinarian involved, and this would 
include any changes in dose, duration, or disease indications. 
Provisions are available to allow some extralabel use in feed 
and minor food animal species, but for major food animal 
species, any extralabel use in the feed is illegal.
    Thank you for the opportunity to be here today, and I will 
answer questions as they come.
    Mr. Pitts. The chair thanks the gentleman.
    [The prepared statement of Mr. Apley follows:]


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    Mr. Pitts. And now recognizes Dr. Price 5 minutes for an 
opening statement.

                  STATEMENT OF LANCE B. PRICE

    Dr. Price. Chairman Pitts, Ranking Member Pallone, and the 
members of the Health Committee, thank you for this 
opportunity. My name is Lance Price. I am a professor of 
occupational and environmental health at George Washington 
University here in D.C., where I study the connection between 
antibiotic use in food animal production and antibiotic-
resistant infections in people. As such, I am here to testify 
that we need to know more about the antibiotics that we are 
using in food animal production.
    First, let me thank you for giving us the 2008 ADUFA 
amendments that have shed some light on the gross quantity of 
antibiotics being sold through food animal producers. However, 
today's antibiotic resistance crisis forces me to ask you for 
even more detailed information in the 2013 reauthorization.
    Antibiotic resistance is one of the greatest threats that 
we face as a Nation. Tens of thousands of Americans' lives are 
lost each year due to antibiotic-resistant infections, and we 
have no choice but to act swiftly and aggressively to meet this 
enormous public health challenge. The victims of this crisis 
have names, like Carlos Don, a boy who died 2 weeks before his 
13th birthday of a drug-resistant infection. The victims are 
also the parents who pace helplessly in hospital rooms while 
doctors struggle and eventually fail to find an antibiotic to 
treat their sick children.
    Sadly, we fail these victims even now, because we know how 
to control resistance, but we have taken insufficient action to 
do so. We control resistance by reducing antibiotics in 
hospitals and in clinics, but also, and importantly, we control 
resistance by reducing antibiotic use on our industrial farms. 
For as long as we have known about antibiotics, we have known 
that the more we use them, the more likely we are to have 
resistance, but despite this knowledge, we continue to use 
antibiotics as cheap production tools on our industrial farms. 
And I would like to be clear: We do need antibiotics to treat 
sick animals, but using them routinely for nontherapeutic 
purposes threatens animal and human health alike.
    Our own FDA, the agency that is charged with protecting 
human health and charged with regulating antibiotics in food 
animals production, tells us that our food supply is riddled 
with antibiotic-resistant bacteria. Let me show you what the 
FDA tells us about drug-resistant bacteria in our food supply. 
These are the ADUFA reports since 2009. And what they tell us 
is that our food supply is full of drug-resistant bacteria. 
They show that half of the ground turkey products on our 
grocery store shelves are contaminated with multidrug-resistant 
E. coli, including some strains that are resistant to our most 
important antibiotics, such as cephalosporin. In the 2010 
report, they showed a strain of salmonella that was resistant 
to all the antibiotics that they tested.
    Now let me show you what we know about antibiotic use in 
food animal production. Here are the ADUFA reports. So here are 
the drug-resistant bacteria in our food supply, here are the 
ADUFA reports reporting on the drugs that are used in food 
animal production. The ADUFA reports tell us that 30 million 
pounds of antibiotics are being used in food animal production 
each year, but they tell us little else. They don't tell us how 
antibiotics are being divided up among the major animal 
species, whether they are sold over the counter or under 
veterinary order, or the proportion of antibiotics sold for 
nontherapeutic purposes. We need this information and we need 
our FDA to give us more.
    The FDA has offered only voluntary guidelines to eliminate 
the most egregious use of antibiotics: growth promotion in food 
animal production. In response to criticisms that these 
voluntary guidelines are weak, the FDA Deputy Commissioner, 
Mike Taylor, said that the FDA would trust, but verify 
compliance. Unfortunately, without more detailed data 
collection, the FDA will lack the information it needs to 
verify, leaving them only to trust. The time to verify is now 
and the time for more detailed data collection is now.
    ADUFA is the perfect bill for requiring additional data 
collection for three reasons: ADUFA is now, ADUFA is about 
drugs used in food animal production, and ADUFA already 
authorizes the FDA to collect some high level data via Section 
105. With these data, we can assess the impact of FDA's 
voluntary guidelines, we can identify places where improvements 
can be made, and hopefully we can confirm industry claims that 
antibiotics are being used more sparingly.
    This is an issue about transparency, it is about 
accountability, but most of all it is about public health. We 
need to act now to protect American lives. So as a public 
health researcher, a microbiologist, and a citizen of this 
country, I implore you to require more detailed data collection 
and reporting from the FDA, including how the antibiotics are 
being used divided up among those major animal species, whether 
they are sold over the counter or under veterinary control, and 
the proportion of antibiotics sold for growth promotion, 
disease prevention, control and treatment, such as the 
provisions included in the DATA Act, H.R. 820, sponsored by 
Ranking Member Waxman and Congresswoman Slaughter.
    In closing, I would like to thank you for your time and for 
giving me the opportunity to testify on such a critical issue.
    Mr. Pitts. The chair thanks the gentleman.
    [The prepared statement of Mr. Price follows:]


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    Mr. Pitts. That concludes the opening statements of the 
panelists. I will begin the questioning and recognize myself 5 
minutes for that purpose.
    Dr. Carnevale, what are some of the benefits of ADUFA and 
AGDUFA to livestock, poultry producers, veterinarians, pet 
owners, consumers? And why have ADUFA and AGDUFA been so 
successful?
    Dr. Carnevale. Well, as you heard today, there is a really 
great need for new products for both livestock and pets and 
horses and other species as well. Getting a drug approved is a 
very expensive process, as I mentioned in my testimony. What 
ADUFA and AGDUFA does is allows the company to have more 
certainty with the agency about how the product will be 
reviewed and the timeframes for that approval.
    It doesn't give any certainty that the product will be 
approved. All the standards for safety and efficacy are still 
maintained. It simply gives the manufacturer a better idea of, 
if they invest the amount of money it takes to get a product 
approved, they will have the FDA do an efficient job of 
reviewing that product, and if the data supports it, it will be 
approved.
    So it helps to have these drugs out there faster for the 
livestock owner that needs those treatments. ADUFA will help 
get those products to market faster. It will help the pet owner 
as well to get products in the hands of his small animal 
veterinarian faster so that these products can be used. And it 
just enhances the whole efficiency of getting these products on 
the market.
    Mr. Pitts. What are, in your opinion, the most important 
improvements in the user fee agreements that we are talking 
about today?
    Dr. Carnevale. I think the important improvement is that we 
have maintained a reasonable cost basis. I think one of the 
things that we were concerned about going into ADUFA III was 
the cost of the program, the escalating cost of the user fee 
program, in addition to the cost of development.
    We were able to do a very good objective assessment of what 
the costs should be, and I think we are compensating FDA for 
the needed costs that they have in running the program, but not 
overpaying. So I think that is one of the benefits that came 
out of the negotiation.
    Also, we were able to get them to enhance the process. I 
mentioned second pass reviews. It will allow those second pass, 
the second time the submission comes into the agency to maybe 
have a shorter timeframe, to speed that administrative approval 
process. So there are some significant benefits. We also got 
the agency to agree to look at some long-term changes in the 
process that might help to get products to the market sooner.
    Mr. Pitts. Do you feel, in light of the testimony we have 
heard today, that the FDA review process as it exists today 
protects animal and public health?
    Dr. Carnevale. There is no question it does. It is a very 
rigorous process. I used to work at the agency a number of 
years ago. I know how rigorous the process is that takes place 
at the Food and Drug Administration. As I mentioned, the data 
requirements are as great, if not more, for animal drugs, 
particularly food animal drugs, than they are for human 
medicine. FDA protects animal health to the utmost extent.
    Mr. Pitts. Thank you.
    Doctor----
    Dr. Carnevale. Human health as well.
    Mr. Pitts. Dr. Apley, can you please elaborate on the role 
of veterinarians in animal drug development and drug use 
decisions?
    Dr. Apley. In animal drug development, as a practicing 
veterinarian, previously I had the opportunity to interact with 
companies and interact on needs that drove research and 
development, which was very valuable for all of us.
    As a veterinarian that guides use, one of our most 
important things we do is work with producers to develop 
protocols and establish those protocols. And to show you how 
far that goes, in my days as a feedlot consulting veterinarian, 
we actually had computerized records, and each animal that was 
treated was individually identified. And one of the first 
things I did each time I visited, twice a month, to train and 
monitor records was to go through the individual animal 
treatment records and determine what our treatment response 
was, if we were doing things appropriately. And we had a 
protocol that could change, but the only way it could change 
was if we all agreed on it.
    Mr. Pitts. In your opinion, does the FDA have the authority 
to appropriately address antibiotic issues?
    Dr. Apley. In my opinion, they do. I have worked with them 
as a veterinarian and as a member of both producer and 
veterinary organizations. They are very good, in my opinion, 
about seeking our input and also evaluating what is going on 
out in the field.
    Mr. Pitts. And do you think the reauthorization of these 
user fee programs will foster animal drug development?
    Dr. Apley. I do, yes.
    Mr. Pitts. My time has expired. Thank you very much. 
Recognize the ranking member of the subcommittee, Mr. Pallone, 
5 minutes for questions.
    Mr. Pallone. Thank you, Mr. Chairman.
    I wanted to ask Dr. Price about your testimony regarding 
antibiotic resistance. Although this committee has looked at 
this issue repeatedly in the past, we do have some new members 
who did not get to participate in our prior hearings, and for 
those of us who were around, it might help to get a refresher. 
First of all, can you describe how resistance develops for us?
    Dr. Price. Sure. So what we are talking about are bacteria 
that are resistant to the effects of antibiotics, right, and 
those bacteria can cause infections in people and those 
infections are harder to treat.
    The way bacteria become resistant to antibiotics are 
through mutations in the DNA, but also by picking up genes from 
other bacteria. And these things are promiscuous, you know, the 
Berlusconis of the biological world, and they pass these genes 
around. And when you use an antibiotic, you select for those 
resistant ones, those that have picked up these resistance 
genes, to proliferate, and they grow and they multiply.
    And bacteria multiply. I mean, you can go from, seriously, 
one bacterium to billions in 24 hours. These are fast growing 
bacteria. And so wherever you are using antibiotics, you are 
selecting for these drug-resistant bacteria, whether it be in a 
hospital or on a farm where you have thousands of animals 
crammed together and, you know, among each others' feces and 
sharing bacteria constantly. And so when you add in these 
antibiotics, that is the magic ingredient for creating drug-
resistant pathogens.
    And then when you butcher those animals, you almost 
inevitably contaminate the carcass with the bacteria from those 
animals, and now you have meat products that are contaminated 
with drug-resistant bacteria that then are distributed to every 
grocery store in the country. And the NARMS reports tell us 
that the drug-resistant bacteria are there, that our food 
supply is riddled with drug-resistant bacteria.
    And then there are the food animal producers, the people 
working in the industry that can pick up these resistant 
bacteria, bring them to their homes, bring them into our 
hospitals.
    Mr. Pallone. And then what is the harm to humans at that 
point? Because now they become resistant as well? What is the 
harm to humans?
    Dr. Price. So the harm to humans is that we get infected 
with these drug-resistant bacteria, and the best defense 
against a bacterial infection is an antibiotic. So if you go 
into a doctor with a bacterial infection, they are going to try 
to treat you with an antibiotic, but if that bacteria is 
resistant to antibiotics, you could die of that infection, that 
treatment is going to fail.
    And so every time we use antibiotics, every drug that we 
waste for nontherapeutic purposes in food animal production is 
creating resistance to those drugs, so those are taken off the 
shelf for therapy. So the physician has to reach higher and 
higher on that shelf for those last drugs.
    Mr. Pallone. And what you are saying is that the very 
nature of farm production with this bacteria causes that 
environment where the resistant bacteria thrive, essentially?
    Dr. Price. Exactly. So when I look at a modern food animal 
production setting, I see the perfect setting for disease 
proliferation, for bacteria to spread among animal hosts, 
right. So we know if we cram people together in unsanitary 
conditions, they are going to spread bacteria among one 
another. And then we add the magic ingredient, which is 
antibiotics, which is going to force those bacteria to become 
resistant to those antibiotics. You know, people call these 
factory farms, but I don't see factories making meat, I see 
factories making drug-resistant bacteria.
    Mr. Pallone. All right. Thank you very much.
    Mr. Pitts. The chair thanks the gentlemen. Now recognize 
the gentleman from Illinois, Mr. Shimkus, 5 minutes for 
questions.
    Mr. Shimkus. Thank you, Mr. Chairman.
    And, Dr. Carnevale, you have heard Dr. Price and some of 
his answers. Can you explain to us why there are logistical 
difficulties and expenses for your members in reporting sales 
by animal species, dose, intent of use, and for the growth 
promotion, disease control, or treatment?
    Dr. Carnevale. Yes. Well, as you know, since 2008, our 
companies have been providing sales data. Sales data is not an 
indicator of use. The problem with our companies trying to 
refine exactly how those products are being used in the field 
is because when our companies sell their product, particularly 
feed use products, they will sell them to a distributor, to a 
veterinarian, to other sources. They may get used at that level 
or they may be sold to other distributors.
    So once the product is out in the field and being used our 
companies don't know what the product was sold for, because 
many of these products have multiple species on the label and 
multiple indications. So they are frequently fairly long labels 
for many of these products. And once the product is sold in the 
marketplace our companies simply don't know exactly what 
species it has been used in or what is the purpose it was used 
for.
    Mr. Shimkus. Thank you.
    Dr. Apley, what is the relationship, if any, between the 
most serious human antibiotic-resistant concerns and antibiotic 
use and resistance in food animals?
    Dr. Apley. I think that relationship is discussed on the 
basis of specific organisms of concern. One of the things I 
want to make clear is that I think engaging in this 
conversation is critical and support that. I think if we start 
to assume that all resistance is due to this, we go down a road 
where we are going to end up with consequences that aren't 
appropriate. If you look at organisms such as salmonella, it is 
quite appropriate to have these discussions. There are others 
for which I think the evidence is much less apparent, at least 
in my evaluation of it.
    Mr. Shimkus. So, I mean, you mean consequences that are not 
appropriate. What do you mean by that statement?
    Dr. Apley. We do good in animals with antibiotics when we 
apply them judiciously. We can have benefits for their health. 
And, you know, we talk about in the environments they are in. 
Well, if you take modern swine production, you know, you shower 
in, you shower out. They take a group of animals completely 
out, it is steam cleaned, it is sanitized, they come back in, 
and still----
    Mr. Shimkus. So versus this walking around in each others' 
feces and----
    Dr. Apley. At times during the production period, like with 
a slatted floor, they will have some there, they track it 
through, so there is some present, but it isn't like they are 
wallowing in a cesspool. It is designed so that it is tracked 
through, goes into a pit and then is removed.
    Mr. Shimkus. And you have operated major feed operations, 
or you have observed all this process----
    Dr. Apley. Yes.
    Mr. Shimkus [continuing]. In the field?
    Dr. Apley. Yes. But we do have beneficial effects on 
creating healthy animals. And I am a believer that healthy 
animals create healthy food.
    Mr. Shimkus. And that was my follow-up, too. It would be 
better to have a healthy animal that goes through the food 
process than an unhealthy animal for human consumption?
    Dr. Apley. Correct. And I want to emphasize that our goal 
in the food animal industries is to prevent disease. Sometimes 
we get the impression that we are throwing these things around 
and just flying them in. They are an expense to us, and when we 
have to use them, we have an animal that is ill or on the verge 
of being ill, and it is in everyone's best interest, the 
animal, the producer, the consumer, that we do everything we 
can, vaccines, animal flow, to produce that. So it is important 
we realize that we don't use antibiotics because we are lazy 
and don't want to try to prevent disease, we use them as a 
tool.
    Mr. Shimkus. Let's follow up on the collection of data and 
the responses that you have heard here. Will use data provide 
us the information we need to understand the epidemiology or 
the risk of antibiotic resistance? It is hard for me to say; 
easy for you all.
    Dr. Apley. I think we have to carefully define between use 
date and sales data. There is a recent paper by Jensen that was 
conducted in Denmark, in the Netherlands, that showed very 
clearly that sales data does not correlate well with use data.
    And then the other important thing we ask is how are we 
going to use these data. It is very important that when we have 
these data we actually apply them to something that is related. 
If we collect use data over here and have resistance data over 
here and marry them together, we will get lines on a graph 
which we may try to interpret, but they may be, in fact, not be 
related.
    I am not saying we shouldn't look, but we need to put very 
careful thought into how we are going to collect and interpret 
the data first.
    Mr. Shimkus. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Pitts. The chair thanks the gentlemen. And now 
recognize the ranking member of the full committee, Mr. Waxman, 
5 minutes for questions.
    Mr. Waxman. Thank you very much, Mr. Chairman.
    Dr. Price, thank you very much for being here today. Some 
in the animal production industry have recognized the 
overwhelming scientific evidence and acknowledge that routinely 
giving antibiotics to animals in their feed or water can lead 
to the growth of resistant bugs. However, they claim there are 
too many steps between raising those animals on the farm and 
buying their meat at the grocery store, and that the risks of a 
consumer contracting an antibiotic-resistant pathogen from that 
meat is remote.
    Could you describe the steps by which the uses of 
antibiotics on the farm lead to these human illnesses?
    Dr. Price. Well, I think it is very clear with the classic 
food-borne pathogens, like salmonella, for instance, that when 
we use antibiotics in food animal production, there is a direct 
line. We create the drug-resistant strains of salmonella in 
food animals that then make a direct line to humans through the 
food supply.
    But the research that we have been doing in my lab and 
around the world now is looking beyond those classic food-borne 
pathogens, and now we are looking at the two biggest killers: 
we are looking at staph aureus and we are looking at E. coli. 
And every time we look now we are seeing more and more evidence 
that those bacteria, some burden of those--let me give you a 
case of the burden.
    Mr. Waxman. Well, let me interrupt you, because I only have 
5 minutes. In other words, isn't it a mistake to say that you 
give an antibiotic to an animal for whatever reason and the 
consumer that eats the meat from that animal is not exposed? 
Isn't it that by using antibiotics for whatever purpose we are 
engendering the development of bacteria that are resistant to 
the antibiotics that we have now available?
    Dr. Price. Exactly. Whenever we use antibiotics on the 
farm, we are creating drug-resistant bacteria that could 
possibly cause----
    Mr. Waxman. And obviously antibiotics are appropriate under 
some circumstances, but there is such a large use of 
antibiotics for animals that we don't know if they are being 
used for therapeutic purposes or just being used to generally 
keep the animal healthy and in better commercial shape. Isn't 
that what the problem is?
    Dr. Price. It is.
    Mr. Waxman. Now, Dr. Apley seemed to talk about healthy 
animals are better, so that means we want to keep animals 
healthy. But is there a problem in trying to keep animals 
healthy if they don't have a disease, if we are just giving 
them antibiotics as a preventative for a disease?
    Dr. Price. I see a major problem with using antibiotics to 
try to keep animals healthy as a preventative tool. If we have 
created a food animal system that makes animals sick routinely, 
then we have created a faulty system, we need to change the 
system. We need to prevent infections other ways than using 
antibiotics. That only invites resistance. And so I will say 
again, I think we should treat sick animals, but if we see that 
animals are getting sick all the time, we should change the way 
we are doing it.
    Mr. Waxman. Now, we don't have the data, and I have 
introduced a bill called the DATA Act to require industries to 
provide FDA with more detailed information on which drugs are 
sold and in what quantities for which animals and report to FDA 
to provide more detailed public reports on that information.
    Now, Dr. Carnevale said they don't keep track of this 
information. Of course they can make some estimates about it. 
They can know details. But they certainly have a lot more 
information than anybody else about the use of their 
antibiotics.
    How would public health researchers such as yourself make 
use of this information and why is getting this information so 
important?
    Dr. Price. Well, we need to look at the relationship 
between antibiotic use and antibiotic resistance, especially 
for the newer drugs. You know, the emergence of cephalosporin-
resistant E. colis. You know, ask an infectious disease doc 
what they would use if they got a cephalosporin-resistant E. 
coli, and many would probably tell you they would use a 
carbapenem. And carbapenem-resistant E. colis are the CREs, the 
nightmare super bugs that the CDC hasbeen talking about.
    So we need to understand how these antibiotics are being 
used, but also, as I said before, I think we need to be able to 
celebrate the food animal producers who are using them less.
    Mr. Waxman. If we don't have every bit of information to 
show the link between the sale of an antibiotic and the use of 
the antibiotics, aren't estimates important rather than just 
say, we don't know, and therefore we don't want to know? I 
mean, if we recognize, for example, that drug companies don't 
have firsthand knowledge of how the drugs are actually used, if 
we ask them to give an estimate of which animals they are sold 
for, if they have good sales departments, they should have at 
least a basis for these estimates. Isn't that important and 
helpful information?
    Dr. Price. It is certainly important. And I hear people say 
that it is hard to get those data, it is so hard, it is going 
to be hard to do this. But I say what is hard is trying to 
treat a kid with a multidrug-resistant infection, watching them 
die of these drug-resistant infections, or trying to find new 
antibiotics to replace the ones that we have blown out through 
growth promotion and routine disease prevention.
    Mr. Waxman. And if you will permit, Mr. Chairman. And the 
bill does ask for requirements by people who use the 
antibiotics, so we can get a pretty good picture overall even 
if the drug companies don't have detailed information about how 
their drug is being used after they sold it. But they don't 
know who the customers are and what it is used for. Thank you.
    Dr. Price. That is why I am supportive of your bill.
    Mr. Waxman. Thank you.
    Mr. Pitts. The chair thanks the gentleman. And now 
recognize the gentlelady from North Carolina, Ms. Ellmers, 5 
minutes for questions.
    Mrs. Ellmers. Thank you, Mr. Chairman.
    And thank you to our panelists for being here today.
    Dr. Apley, we are talking about tools and we are talking 
about antibiotics being used by veterinarians and farmers for 
their livestock to keep animals healthy. What other tools are 
there besides antibiotics that can be used if we are trying to 
get away from the use of antibiotics?
    Dr. Apley. Sure. And I mentioned pig flow strategies, for 
example, for the swine industry, which involves very precise 
control of where the pig is produced, where they move next, and 
monitoring disease upstream, if you will, say, in the actual 
pig production facility or in the farrowing facilities so that 
they can nip it in the bud before it goes further. An example 
in cattle is preconditioning, where instead of shipping them 
straight to the feedlot, as in the past, we give them an 
intermediate stage maybe closer to where they originally were, 
of altering weaning ages. One of the things we have discovered 
in cattle is called the Sandhills calving system, where we move 
them to fresh pastures; fence line weaning of calves, genetic 
selection. The list goes on and on, and there is a real, real 
huge focus on that type of disease prevention.
    Mrs. Ellmers. So it is more the process of the livestock 
farmer really taking care of the animals and making changes 
necessary.
    I also want to ask you, and just in some of the other 
testimony and questioning that you had, to my understanding 
just listening to you, you feel that the data collection as far 
as antibiotic usage is adequate? Is that a correct assumption 
on my part?
    Dr. Apley. If I could really know a few more things, I 
would like to know out of interest. I think the question 
becomes, how would we work it so that it is practical and 
doable? And then as a scientist, I always want to know that the 
data I have collected here, how it is confounded, what differs 
in how it was collected to something I am going to compare it 
to.
    So data estimates are good, but if we are going to make 
real conclusions as X is causing Y----
    Mrs. Ellmers. Right.
    Dr. Apley [continuing]. Then we have to be incredibly 
careful on how we interpret that. What I am waiting to hear is, 
as we move forward on methods for collecting the data, is how 
do we anticipate interpreting it and then moving from 
interpretation to regulatory or other uses.
    Mrs. Ellmers. Perfect. Thank you. I appreciate your 
approach. I think that is very effective.
    Dr. Price, I have got some questions. I was just going over 
some of your testimony here. You are critical, I think that is 
an accurate assessment, of the FDA on the use of antibiotics 
and the treatment of use of antibiotics. And one of the quotes 
that I am just going to point out here, it says, the FDA, I am 
paraphrasing there, negotiated an agreement to collect fees 
from drug makers in exchange for expediting drug approval, 
while missing a prime opportunity to seek some commonsense 
provisions to simply measure, not restrict, just measure the 
use of antibiotics.
    But in all honesty, isn't that really what you are looking 
for? I mean, you really are looking to restrict. And you have 
pointed out a number of situations. And, look, I am a nurse, I 
totally understand the idea and concept, and I think we are all 
well aware of overuse of antibiotics, but I am not necessarily 
sure that the farming community is where we need be focusing 
and not on just the over-prescription made on antibiotics, you 
know, out there in the medical world.
    You named a few forms of bacteria--staph aureus, MRSA--you 
also mentioned cephalosporin-resistant E. coli. Now, E. coli I 
know are being found on farms, obviously. But are those found 
on farms? Are these particular bacteria strains there and 
something that we should be issuing?
    And I would further that, and we have only got 30 seconds, 
so I apologize, my time will be running out, but we do cook 
food, I mean, and so the assumption that food is being eaten 
that is, you know, filled with bacteria, it does get cooked. So 
I would like you to comment on that as well.
    Dr. Price. OK. I will go quickly. We see the same E. coli 
that cause urinary tract infections, kidney infections, blood 
infections on the farm, we see them in the animals, we see them 
in the meat. We see staph aureus, we see multidrug-resistant 
staph aureus, and we see MRSA on the farms. And there is a 
difference on the farms that use antibiotics and those that 
don't. We see more antibiotics on the conventional farms than 
those antibiotic-free farms. That is very clear.
    You said we should cook the meat. It is true. We should 
cook the meat. I don't want anybody to think we shouldn't. But 
do you cook chicken? When you open that package, you know that 
liquid that is in there? Think about drug-resistant bacteria on 
your hands. So you open that up. Now your hands are 
contaminated. But we have spoken, so you are going to be really 
careful. And you are going to put that chicken right in the hot 
frying oil, right? And then you are going to take that package 
and you are going to open up the cabinet and you are going to 
throw it away. You have just contaminated your cabinet. You are 
going to go wash your hands. You are going to contaminate your 
faucet, you are going to pump the soap and contaminate that. 
And you are going wash your hands and you are going to sing 
``happy birthday'' and get them really clean, and you are going 
to rinse them off and you are going to recontaminate and you 
are going to make a salad, and that salad can get drug-
resistant bacteria in it. And that is how those things can 
spread. And you still have them on your cutting board, on your 
countertop. These things spread around. We don't think it is 
that people are eating chicken sushi. That is gross, right? It 
is cross-contamination and that happens.
    Mrs. Ellmers. OK. And I appreciate that. And I realize I 
have run out of time, so I appreciate the indulgence. But I 
would say there again, it is an issue of process and 
efficiency. So thank you.
    Mr. Pitts. The chair thanks the gentlelady. And now 
recognize the gentlelady from Virgin Islands, Dr. Christensen, 
5 minutes for questions.
    Mrs. Christensen. Thank you, Mr. Chairman. And good 
afternoon to the panel.
    Dr. Price, it is nice to welcome a fellow Colonial here 
today. And my first question, you may have already answered, 
because the first question I had was, is there more that the 
FDA and industry should be doing to address the problem of 
antibiotic resistance stemming from the use of these drugs on 
the farm? And you have about four or five recommendations 
regarding reporting and data. Is there anything further that 
you would add?
    Dr. Price. Well, I just want to emphasize that prudent use 
goes beyond just growth promotion. So that is, as I said, the 
most egregious use. But I think routine disease prevention. So 
I am not talking about, you know, for a short period of time 
you see that there is a problem and you have to use 
preventative antibiotics, but I am saying when you time it for 
a flock cycle or a herd cycle and you are going to say every 
time we are going to give antibiotics at this time, that is a 
problem and that is going to select for drug-resistant 
bacteria, and it does select for drug-resistant bacteria, and 
we have to get past that. You know, control I am OK with, 
therapy I am definitely OK with, but this routine disease 
prevention is, I think, insane.
    Mrs. Christensen. I am sure you are just passionate about 
the overuse of antibiotics in human beings.
    Dr. Price. I am. I am. And they work hand in hand, and I 
wanted to say that earlier. It is not just antibiotic use in 
food animal production. I don't want anybody to walk away from 
here thinking that. You know, we have abused antibiotics in the 
hospitals and we have abused them on the farms. And the thing 
is, as I think about this environmental health paradigm where 
they say, with cancer, they say, you know, the genes load the 
gun and the environment pulls the trigger. So you are born with 
this propensity for cancer and then you get exposed to a 
carcinogen, and that can pull the trigger. But I think about 
the food loading the gun. So you are ingesting drug-resistant 
bacteria that is loading your system.
    Most of us probably have some of these drug-resistant 
bacteria in our guts. Most of the time it is no problem. But 
then we get sick, we go into the hospital, we get treated with 
antibiotics, and then those bacteria have a selective 
advantage, and they proliferate and they get disseminated, and 
then they get disseminated into the hospital.
    Mrs. Christensen. Thank you. And I had asked Dr. Dunham a 
question I wanted to ask you also. As we finalize the guidance 
that recommends the phasing out of animal production uses like 
growth promotion and feed efficiency, do you think it is 
possible for industry to essentially switch a growth promotion 
claim to a disease prevention claim with just some data showing 
that the same dose of a drug that promotes growth would also 
prevent disease?
    Dr. Price. I am very concerned about this. I am very 
concerned that if we don't collect very detailed data, that if 
we don't get the data that I am asking for, that Congressman 
Waxman's bill would collect, that people are just going to 
change what they are doing. We need to be collecting data on 
how much are being used so we can see hopefully that they come 
down. But if they just switch the names of it, the bacteria 
don't care. The bacteria don't think about names of antibiotic 
use.
    Mrs. Christensen. Thank you. I yield back the balance of my 
time. Thank you.
    Mr. Pitts. The chair thanks the gentlelady. And now 
recognize the gentlemen from Colorado, Mr. Gardner, 5 minutes 
for questions.
    Mr. Gardner. Thank you, Mr. Chairman. And thank you to the 
witnesses today for joining this hearing.
    And, Dr. Price, you mentioned factory farmers earlier. What 
is your definition of a factory farm?
    Dr. Price. Well, as I said, other people use this term. I 
rarely use that term. I think when I see these farms, I see 
factories making drug-resistant bacteria. I see an industry----
    Mr. Gardner. Just to be clear----
    Mr. Price [continuing]. That is breaking all the rules.
    Mr. Gardner. Just to be clear, you are not talking about a 
feedlot in and of itself being a factory farm?
    Dr. Price. No. I am talking about any kind of CAFO where 
you have animals packed together that are part of an industrial 
system where you are bringing the animals all in, you are 
cramming them together, and you are feeding them feed that is 
laced with antibiotics.
    Mr. Gardner. And I want to be very clear here. I am not 
trying to put words in your mouth.
    Dr. Price. Please.
    Mr. Gardner. You don't like feedlots?
    Dr. Price. I don't like putting thousands of animals 
together under unsanitary conditions and giving them 
antibiotics. I do not like this.
    Mr. Gardner. OK. So just the way we keep feedlots, you 
don't like that?
    Dr. Price. I do not like situations where we feed animals 
crammed together antibiotics, because I know what it does. It 
creates antibiotic-resistant bacteria.
    Mr. Gardner. Right.
    Dr. Price. My family owns a cattle ranch in Texas. I was 
raised working work on a cattle ranch. I am not against meat 
production. There is not a person in this room that loves a 
hamburger more than me, I can tell you that.
    Mr. Gardner. Thank you.
    Dr. Apley, it is not often that I get somebody from Kansas 
before this committee, so I thought we would spend the rest of 
the time talking about water. Just kidding, just kidding.
    Dr. Apley, as a veterinarian you are obviously trained in a 
different way than a doctor is in how to assess--than an M.D., 
a medical doctor that treats humans, is trained to communicate 
with something that can't talk back to you to tell you where it 
hurts, to tell you what is wrong. And because of that you have 
a different relationship with the people that you see, the herd 
that you oversee, your--the people, the ranchers that you are 
dealing with.
    Can you tell me a little bit about how you interact with 
the people who are managing a herd, because you have a 
relationship with them, right? It is not just, you know, 
distributing a drug, here it is, and you don't see them again, 
and they walk away, and they are gone.
    Dr. Apley. Well, probably the best way to describe a day, 
show up, look at the records, see the manager, and then the 
rest of my day was spent with the people that took care of the 
animals. The hardest thing as a veterinarian is to just stand 
back and not do, but to watch and observe. So we observed what 
they were doing, and we used protocols and standard operating 
procedures as the basis for our training.
    Mr. Gardner. And what would happen--if we talked about some 
of the preventative efforts to make sure that our herds are 
healthy, what would happen? What would the economic impact be 
on our food supply if we did not prevent disease in our herds?
    Dr. Apley. Well, it would be dramatic and catastrophic if 
we weren't able to prevent disease, and that goes back to all 
the different ways we are summing together to try to prevent 
that disease.
    Mr. Gardner. Would it impact the supply available to 
consumers around the world?
    Dr. Apley. It would definitely have a negative impact on 
what we are able to produce, yes.
    Mr. Gardner. Could you talk a little bit about some of 
the--and you mentioned it before, but go over again some of the 
key points of public and animal health safeguards that are in 
place from a regulatory standpoint and industry standpoint.
    Dr. Apley. Well, for example, in feed use we are not able 
to use that off label at all. That is strictly by the label. 
For injectable uses, uses we can use on individual animals like 
that, there is the ability to use that off label, but only 
under very strict Animal Medicinal Drug Use Clarification Act 
regulations, which require veterinarians involved, has a valid 
rationale, assigns an extended withdrawal period to make sure 
the animals are properly identified.
    Mr. Gardner. And is there anything the FDA could be doing 
more to establish appropriate guidelines, regulations regarding 
the administration of animal drugs?
    Dr. Apley. I think one of the biggest things, and Dr. 
Dunham mentioned this, is there are listening sessions out 
there as we look at moving towards all of the feed and water 
uses being under veterinary control, that we come up with a 
system with limited veterinary availability in some areas that 
makes that workable for all parties. We appreciate them have 
those listening sessions, and I think right now that is one our 
biggest goals to get that done correctly.
    Mr. Gardner. Thank you. And just appreciate your work with 
us today and look forward to working with you through the 
process.
    Yield back my time.
    Mr. Pitts. The chair thanks the gentlemen.
    We have a UC request.
    Mr. Pallone. Mr. Chairman, I would ask on behalf of Mr. 
Waxman unanimous consent to enter into the record some letters 
that were sent to him and you with regard to the DATA Act.
    Mr. Pitts. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. I want to thank the witnesses for your 
testimony. It has been a very important hearing; excellent, 
excellent testimony. Members may have questions that they will 
send to you. I remind Members they have 10 business days to 
submit additional questions for the record, and I ask the 
witnesses to respond to the questions promptly. And Members 
should submit their questions by the close of business on 
Tuesday, April 23rd.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 6:05 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]


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