[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                        HOUSE OF REPRESENTATIVES


                             SECOND SESSION


                             JULY 14, 2010


                           Serial No. 111-144

      Printed for the use of the Committee on Energy and Commerce






                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                        HOUSE OF REPRESENTATIVES


                             SECOND SESSION


                             JULY 14, 2010


                           Serial No. 111-144

      Printed for the use of the Committee on Energy and Commerce


                         U.S. GOVERNMENT PRINTING OFFICE 

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                 HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
BARON P. HILL, Indiana
DORIS O. MATSUI, California
JERRY McNERNEY, California
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
JANE HARMAN, California              TIM MURPHY, Pennsylvania

                            C O N T E N T S

Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     1
    Prepared statement...........................................     3
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     7
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     8
    Prepared statement...........................................    10
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    16
Hon. Janice D. Schakowsky, a Representative in Congress from the 
  State of Illinois, opening statement...........................    17
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    18
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................    19
Hon. Donna M. Christensen, a Representative in Congress from the 
  Virgin Islands, opening statement..............................    20
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................    21
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    22
Hon. Zachary T. Space, a Representative in Congress from the 
  State of Ohio, opening statement...............................    23
Hon. Bruce L. Braley, a Representative in Congress from the State 
  of Iowa, opening statement.....................................    24
    Prepared statement...........................................    26
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, prepared statement....................................   230
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................   232
Hon. Roy Blunt, a Representative in Congress from the State of 
  Missouri, prepared statement...................................   237
Hon. John Sullivan, a Representative in Congress from the State 
  of Oklahoma, prepared statement................................   239


Joshua Sharfstein, M.D., Principal Deputy Commissioner, Food and 
  Drug Administration, U.S. Department of Health and Human 
  Services.......................................................    28
    Prepared statement...........................................    31
    Answers to submitted questions...............................   316
John Clifford, D.V.M., Deputy Administrator, Veterinary Services, 
  Animal and Plant Health Inspection Service, U.S. Department of 
  Agriculture....................................................    42
    Prepared statement...........................................    44
    Answers to submitted questions...............................   322
Rear Admiral Ali S. Khan, M.D., M.P.H., Assistant Surgeon 
  General, Acting Deputy Director, National Center for Emerging 
  and Zoonotic Infectious Diseases, Centers for Disease Control 
  and Prevention, U.S. Department of Health and Human Services...    49
    Prepared statement...........................................    51
    Answers to submitted questions...............................   324
Per Henriksen, D.V.M., Ph.D., Head of Division, Division for 
  Chemical Food Safety, Animal Welfare and Veterinary Medicinal 
  Products, Danish Veterinary and Food Administration............    77
    Prepared statement...........................................    80
    Answers to submitted questions...............................   327
James R. Johnson, M.D., F.I.D.S.A., F.A.C.P., Professor of 
  Medicine, University of Minnesota, and Fellow, Infectious 
  Diseases Society of America....................................   104
    Prepared statement...........................................   107
    Answers to submitted questions...............................   332
Gail R. Hansen, D.V.M., M.P.H., Senior Officer, Human Health and 
  Industrial Farming Group, Pew Charitable Trusts................   123
    Prepared statement...........................................   125
Christine Hoang, D.V.M., M.P.H., C.P.H., Assistant Director, 
  Scientific Activities Division, American Veterinary Medical 
  Association....................................................   163
    Prepared statement...........................................   165
    Answers to submitted questions...............................   334
Randall Singer, D.V.M., M.P.V.M., Ph.D., Associate Professor of 
  Epidemiology, Department of Veterinary and Biomedical Sciences, 
  College of Veterinary Medicine, Division of Epidemiology, 
  School of Public Health, University of Minnesota...............   183
    Prepared statement...........................................   185
Richard Carnevale, D.V.M., Vice President, Regulatory, Scientific 
  and International Affairs, Animal Health Institute.............   204
    Prepared statement...........................................   206
    Answers to submitted questions...............................   341
Stuart Levy, M.D., Professor of Molecular and Biology, Professor 
  of Medicine, Tufts University..................................   216
    Prepared statement...........................................   218

                           Submitted Material

Letter of July 13, 2010, from Centers for Disease Control to Mr. 
  Pallone, submitted by Mr. Waxman...............................   241
Statement of San Francisco Medical Society, submitted by Mr. 
  Waxman.........................................................   257
Statement of Physicians for Social Responsibility in Los Angeles, 
  submitted by Mr. Waxman........................................   258
Documents for the record submitted by Ms. Schakowsky.............   259
Statement of Hon. Leonard L. Boswell, submitted by Mr. Waxman....   313



                        WEDNESDAY, JULY 14, 2010

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 2:12 p.m., in 
Room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone, Jr. [Chairman of the Subcommittee] presiding.
    Members present: Representatives Pallone, Dingell, 
Schakowsky, Baldwin, Barrow, Christensen, Murphy of 
Connecticut, Space, Braley, Waxman (ex officio), Shimkus, 
Buyer, Pitts, Sullivan, Murphy of Pennsylvania, Blackburn and 
    Staff present: Ruth Katz, Chief Public Health Counsel; 
Sarah Despres, Counsel; Rachel Sher, Counsel; Stephen Cha, 
Professional Staff Member; Emily Gibbons, Professional Staff 
Member; Virgil Miler, Professional Staff Member; Alvin Banks, 
Special Assistant; Allison Corr, Special Assistant; Eric Flamm, 
FDA Detailee; Karen Lightfoot, Communications Director, Senior 
Policy Advisor; Elizabeth Letter, Special Assistant; Lindsay 
Vidal, Special Assistant; Mitchell Smiley, Special Assistant; 
Clay Alspach, Minority Counsel, Health; and Ryan Long, Minority 
Chief Counsel, Health.


    Mr. Pallone. The meeting of the Health Subcommittee is 
called to order, and the subcommittee is convening today for 
its third hearing to discuss antibiotic resistance and its 
threat to public health. Today we will examine the use of 
antibiotics in food-producing animals and the impact of this 
use on human health.
    Antibiotics, as you all know, are among the most 
significant medical innovations of the 20th century. The CDC 
lists control over infectious disease as one of its top 10 
great public health achievements of the last century, and 
antimicrobials are crucial to that accomplishment. And yet we 
must collectively be alarmed that we are undermining the power 
of antibiotics by failing to use them judiciously. In past 
hearings, we have heard testimony about physicians that are 
prescribed antibiotics just in case their patients have 
bacterial infections, and we all know patients that have 
stopped taking their antibiotics once they felt better, even if 
they didn't finish the treatment. It is clear that the 
consequences of such actions are severe. Manmade antimicrobial 
resistance weakens our options to treat pneumonia, food-related 
diseases including E. coli and Salmonella, and hospital-
acquired infections, commonly known as MRSA.
    Our examination of antibiotic resistance would not be 
complete without a discussion of the use of antimicrobials in 
animals. It is very timely that we are having this hearing 
today. Last month the FDA issued draft guidance detailing its 
position that using medically important antimicrobial drugs for 
food production purposes threatens the protection and promotion 
of the public health. FDA will state today that antibiotics 
should only be given to animals under supervision of a 
veterinarian and should only be used to assure animal health 
and not to promote growth. We will have the opportunity today 
to hear from the major experts and stakeholders in the field 
about reactions to FDA's draft guidance and the overall debate 
on how animal use of antibiotics impacts human health.
    As we consider future action to limit antibiotic 
resistance, it would be helpful to hear about the Danish 
experience. Starting in 1995, the Danish government implemented 
aggressive steps to limit the use of antibiotics in food-
producing animals and collected extensive data that they and 
the World Health Organization used to evaluate the effects of 
these actions. Clearly, any future action to limit antibiotic 
resistance must be carefully considered and guided by science.
    We have two great panels today of government and private 
witnesses with 10 people total testifying who will contribute 
to this discussion, and I know that many of the witnesses 
rearranged their schedules today to be here including Dr. Josh 
Sharfstein at the FDA. We greatly appreciate your ability. 
However, I am going to have to say one thing you are not going 
to like, and that is that unfortunately as too many times has 
been the case here, we did not get the testimony within 48 
hours before the hearing. I know that the hearing was changed, 
I guess, from tomorrow to today but we notified everybody 3 
weeks ago of that, and the FDA testimony arrived at about 6 
p.m. Tuesday, which was last night, and the CDC testimony also 
arrived late in the day on Tuesday, which obviously doesn't 
make the 48 hours, so please in the future, it is really 
important that we get the testimony 48 hours before the 
hearing. Otherwise we really can't adequately prepare for the 
hearing, so I just want to mention that, and I don't want to be 
difficult but it really is important.
    [The prepared statement of Mr. Pallone follows:]

    Mr. Pallone. With that, I will yield to our ranking member, 
the gentleman from Illinois, Mr. Shimkus.


    Mr. Shimkus. Thank you, Mr. Chairman, and thank you for 
obviously the admonition about getting testimony in, and I 
appreciate that. I know it is not easy.
    Thank you all for coming. The debate centers around whether 
antibiotic use in animals presents a safety risk for humans. 
Rather than focus on theory, we must really rely on the science 
behind the issue. So far there is nothing that links use in 
animals to a build-up of human resistance, and so I will be 
focusing on, I know it sounds crazy, but real science, real 
peer-reviewed science and testing, which in previous testimony, 
and I have the record from the previous hearings that we have 
done none in this country. There has been no testing in this 
country on this connection. So the challenge will be to not 
move in public policy until we have verifiable peer-reviewed 
science to address this issue.
    We do know through the hearings that people are overusing 
and misusing antibiotics and that leads to faster development 
of resistance of drugs in the body, and when it comes to people 
getting sick from foodborne antibiotic-resistant strains, 
evidence shows it is again from humans through handling food, 
not animals. Even then because of our rigorous oversight, 
foodborne illnesses in the United States have continued to 
decline over the past decade. Nevertheless, as science develops 
and we learn more, we can always work to improve risk-based 
approach to making people and the foot they eat safer. We 
should explore ways to strengthen our hazardous analysis and 
critical control points, plans across the spectrum from farm to 
    At the same time, FDA should continue its strict approval 
path of antibiotics for animal use. The FDA process is 
resulting in increasing amounts of approved antibiotics that 
are not used in human medicine at all. As a result, those 
classes of antibiotics have no potential impact on human 
resistance while yielding benefits on the farm. Still, there 
are some who would ban use of antibiotics in animals similar to 
what occurred in Denmark in the late 1990s, and I know the 
chairman mentioned that, and I will be talking about that 
research too. Since the ban, Danish animals' death and diseases 
have increased. To control these increases, therapeutic use of 
antibiotics to treat sick animals more than doubled to a level 
greater than all antibiotic use combined prior to the year of 
the ban. So they banned it and we use more. Animals are not 
healthier; they are sicker. So that is why we do appreciate 
this hearing, and this question, we did make humans safer? No. 
Only did humans not become any less resistant, they became more 
resistant to antibiotics in Denmark. Resistance increased in 
Salmonella, penicillin, tetracycline. At the same time those 
resistances in the United States have decreased to about half 
the level of Denmark. Before we go down a path that will have a 
devastating economic impact on our agriculture industry, we 
must ensure science drives this debate.
    So again, I want to thank you, Mr. Chairman, for holding 
this hearing.
    The last thing I do want to mention is that we have 10 
witnesses today. This is our third or fourth hearing on 
antibiotics. We have not had a single hearing on the new health 
care law passed. We have asked for the CMS actuary. We have 
asked for Secretary Sebelius. Now we have a recess appointment, 
Dr. Berwick, who we like to see, who said some interesting 
things about rationing care and that we would do it with our 
eyes open, but I guess what is as telling as anything else why 
we need to have a hearing is, it seems that in the $160 million 
that we provided to Pennsylvania for the high-risk pool, 
abortion and abortion services are being expanded at taxpayers' 
expense. I thought this was a promise made to the pro-life 
Democrats in voting for the bill through the Executive Order. 
Obviously that was not the case and that is why we should have 
a hearing, and I yield back my time.
    Mr. Pallone. Thank you, Mr. Shimkus.
    The chairman of our full committee, the gentleman from 
California, Mr. Waxman.


    Mr. Waxman. Thank you very much, Mr. Chairman. I am pleased 
you are holding this third of a series of hearings on 
antibiotic resistance. This is a serious public health problem.
    Our first hearing provided the context for understanding 
the nature of the problem, the scope, the statistics and the 
science that make up this emerging public health crisis. The 
focus of today's hearing, the use of antibiotics in animals, is 
an issue that has been raised by numerous members of this 
subcommittee as well many of our previous witnesses, 
representing both the public and private sectors, and I think 
we would all agree that the topic is complicated and 
    I believe we would also all agree on this point: By 
definition, antibiotic resistance is bred by the very use of 
antibiotics, be it by humans or by animals. To remain 
effective, then, antibiotics need to be used judiciously.
    As we learned at our last hearing, antibiotics are being 
overprescribed in humans. That is a very real and difficult 
problem and one that requires our full and immediate attention.
    But the issue with animals is something else. For animals, 
we use antibiotics for purposes other than treating illnesses 
in the animal. As we will hear today, animals raised for food 
production are routinely provided antibiotics to prevent 
infections. In stark contrast to animals, we would be shocked 
if a pediatrician ever ordered antibiotics for an entire 
nursery school class to keep the children from being infected 
with strep throat. But in this country, that is standard 
practice for a barnyard full of pigs or cows or chickens. In 
addition, animals regularly are fed these drugs not to treat 
any illness at all but simply to promote growth. In both 
situations, this is an overprescribing of a very different 
    There appears to be universal agreement on yet another 
point: The key to reducing antibiotic resistance is to reduce 
the use of antibiotics. The Food and Drug Administration 
recently announced one approach for achieving this goal with 
respect to animals. In June, the agency issued draft guidance 
which recommends that antibiotics not be given to animals to 
promote growth and that when these drugs are used, they should 
be administered only under the supervision of a veterinarian. 
This sounds to me like a very good first step.
    But we must do more to tackle this piece of the antibiotic 
resistance puzzle and we must do so as part of a comprehensive 
strategy designed to safeguard the vitally important public 
health tool that is our antibiotics. I would like to put into 
the record a letter from Dr. Frieden, the director of the 
Centers for Disease Control to Chairman Pallone, and according 
to Dr. Frieden, ``The Centers for Disease Control and 
Prevention finds there is a compelling body of evidence to 
demonstrate this link between antibiotic use in animals and the 
resistance from the antibiotics.''
    [The information appears at the conclusion of the hearing.]
    Mr. Pallone. Without objection, so ordered.
    Mr. Waxman. It is critical we encourage the development of 
new drugs. It's also essential to preserve the antibiotics we 
already have. That means we must move expeditiously to slow the 
advancement of antibiotic resistance in both humans and 
animals. In each instance, our strategy must be based on 
science. I agree with that statement. But science, not just the 
science that may fit our constituency but real science and the 
scientific evidence is now strong enough to create a consensus 
among major public health groups and experts around the world 
that the time has come to reduce the use of antibiotics in 
animals. Organizations as diverse as the American Medical 
Association, the Institute of Medicine, the World Health 
Organization, and as we will hear from both CDC and the FDA, 
they all agree: We must take action now.
    This brings us to today's hearing. It is an important 
hearing. Mr. Chairman, I want to thank Dr. Sharfstein. He has 
been very accommodating to be here today. He accommodated us by 
rearranging his schedule. I happen to know that by watching 
television he has been very busy. I didn't see him out in Los 
Angeles at any of the beaches, so I think he has been working 
pretty hard and I have noticed he has been involved in Avandia. 
We would like those statements in earlier, but I think they 
ought to cut you a little slack. At least I am going to make 
that comment. And the same is true for others but we do need 
these statements as early as possible.
    I thank all the witnesses who are here. I particularly 
thank you, Mr. Chairman, for this hearing. I think this is 
going to be an interesting one. Let us follow the science. 
Thank you. Yield back.
    [The prepared statement of Mr. Waxman follows:]

    Mr. Waxman. Can I ask, Mr. Chairman, two statements by 
unanimous consent be added to the record, one from two 
California-based groups, the San Francisco Medical Society and 
Physicians for Social Responsibility in L.A. regarding the use 
of antibiotics for animals?
    Mr. Pallone. Mr. Chairman, the----
    Mr. Waxman. I ask unanimous consent their statements be 
added to the record.
    Mr. Pallone. The Republicans just want to look at it.
    Mr. Waxman. I certainly want them to look at it. Whether 
they agree with the statements or not, I think that the 
    Mr. Shimkus. Reserving the right to object. We don't want 
to get into----
    Mr. Waxman. I will pull back and have you look at it, and 
then we will ask unanimous consent at a later time.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Mr. Pallone. OK. So we are going to proceed without at this 
point. I don't know, you took me back when you talked about 
seeing him on the beaches. I didn't realize you traveled from 
beach to beach.
    Mr. Waxman. I was in L.A. My district has a lot of beaches 
and I didn't see him at any of them.
    Mr. Pallone. Next is the gentleman from Indiana. Oh you 
want to reserve your time. OK.
    Then we go to the gentleman from Pennsylvania, Mr. Pitts.


    Mr. Pitts. Thank you, Mr. Chairman.
    This is now the third hearing this subcommittee has held on 
antibiotic resistance. First was on April 28th of this year and 
second was held on June 9th. There is no doubt that over the 
last 50 years antibiotics have saved countless lives worldwide. 
There is also no doubt that we are experiencing a growing 
amount of bacterial resistance to antibiotics, and many 
infectious diseases are becoming increasingly difficult to 
treat as a result.
    For the purposes of this hearing, however, the key question 
is this: Does the use of antibiotics in feed-producing animals 
cause antibiotic resistance in humans? An exchange between 
Chairman Emeritus Dingell and Dr. Thomas Frieden, director of 
the Centers for Disease Control and Prevention, during the 
April 28th subcommittee hearing is instructive, and I will 
briefly quote. Mr. Dingell asked, ``There appears to be much 
debate over whether the practice of adding antibiotics to 
agricultural feed is thought to promote drug resistance. What 
does current science and surveillance tell us on this point?'' 
Dr. Frieden answered, ``I am not aware of evidence in this 
country that has documented the spread from animals to humans, 
feed animals to humans.'' Mr. Dingell then replied, ``I am 
getting the impression from what you are telling us here is 
that we really don't know what the nexus between the feed with 
antibiotics is and when there is a point of danger and what is 
the level of danger and what research is going on.'' Mr. 
Dingell was right. There is much that we don't know about how 
the use of antibiotics in animals causes or does not cause 
antibiotic resistance in humans.
    Clearly, more study must be done. However, until we have 
definitive scientific evidence, it seems to me that legislation 
like H.R. 1549, the Preservation of Antibiotics for Medical 
Treatment Act, or PAMTA, as they are calling it, which seeks to 
eliminate the use of antibiotics in animals except for 
treatment purposes, is premature and potentially dangerous. I 
am pleased that it appears that the FDA is working with the 
scientific and medical community in its new guidance, and I am 
interested to see what the comment period produces. As I have 
said before, we should study and explore every possible cause 
of antibiotic resistance but we should let the scientific 
evidence guide us.
    I look forward to hearing from our distinguished panel of 
witnesses today. Thank you, Mr. Chairman. I yield back.
    Mr. Pallone. Thank you.
    The gentlewoman from Illinois, Ms. Schakowsky.


    Ms. Schakowsky. Thank you, Mr. Chairman, for your 
leadership on this issue.
    The CDC has described antibiotic resistance as one of the 
world's most pressing health problems and overwhelming data 
proves that antibiotic resistance is increasing in this 
country. This is a safety issue, a public health issue and 
quite frankly an issue of national security.
    Mr. Chairman, I would like to submit for the record 
statements regarding the need for legislative action to protect 
the effectiveness of antibiotics, legislation like the 
Preservation of Antibiotics for Medical Treatment Act. These 
letters are from organizations including the American Medical 
Association, the American Academy of Pediatrics, Consumers 
Union, Union of Concerned Scientists, and over 1,000 individual 
physicians from across the country who have concluded that the 
non-judicious use of antibiotics in livestock is a problem of 
public health. So if I could submit these for the record?
    Mr. Shimkus. Reserving the right to object, Mr. Chairman, 
just so we get a chance to look at them.
    Ms. Schakowsky. On June 28th, the FDA released draft 
guidance on this issue. The report states that ``The overall 
weight of evidence supports the conclusion that using medically 
important antimicrobial drugs for production or growth-
enhancing purposes in food-producing animals is not in the 
interests of protecting and promoting the public health.'' In 
other words, pumping animals full of non-medically necessary 
antibiotics is not good for public safety. I want to point out 
that this guidance carries no enforcement mechanism but rather 
asks the industry to voluntarily follow these suggestions.
    It is obvious to me that legislation is needed. Eighty 
percent of the meet randomly tested by the National 
Antimicrobial Resistance Monitoring System shows traces of 
antibiotic-resistant bacteria. Antibiotic resistance is not a 
victimless phenomenon. Seventy percent of the 98,000 people a 
year who die from hospital-related infections had a microbe 
resistance to one or more antibiotics.
    Mr. Chairman, I have looked forward to this hearing for 
quite some time because it provides an opportunity to get the 
facts straight. I want to leave today knowing who has clear 
jurisdiction over the use of antibiotics in feed. If it is more 
than one agency, I want to know what the agencies are doing to 
work together and who is in the lead, and I want to feel 
confident that the agencies do not forget about this issue once 
this hearing is gaveled to a close, and I yield back.
    Mr. Pallone. Thank you.
    Next is the gentlewoman from Tennessee, Ms. Blackburn.


    Mrs. Blackburn. Thank you, Mr. Chairman, and thank you to 
those of you who prepared testimony and are here before us 
today. Certainly this is a topic that all of us are concerned 
about. Whether or not it should be the topic that is taking the 
time that we have today and the taxpayers' money, I will add, 
is a subject of another debate.
    And Mr. Chairman, I will have to tell you, as we look at 
what is rolling out with this new health care law, I think it 
is very evident to us that that is where our time needs to be 
spent. When my children were little, and there was an issue in 
front of them that needed to be addressed, I would always 
remind them that avoiding the issue did not make it easier to 
handle the issue in the long term. If you want to address the 
problem, it is important that you hit it head on, and we are 
hearing from people of the numerous problems that exist with 
this health care bill that has been passed by this Congress and 
signed into law. There is a lot of concern over there over the 
expansion of agencies. There is tremendous confusion over the 
implementation or the expected implementation of that bill. 
There is surprise by taxpayers that benefits are going to be W-
2'd back to them on their health insurance. We are hearing from 
employers all during the July 4th break as we talked about 
freedom and the imperative of preserving freedom. We heard from 
employers who were saying we are so concerned about the cost. 
Look at what it is going to cost us to provide insurance under 
this new list of mandates with all of these new agencies, with 
all of these new directives. That, believe it or not, 
translates into jobs lost, and the employers are concerned 
about that. Now, maybe my colleagues across the aisle are not 
that concerned but I can tell you losing the number of jobs 
that have been lost in the past 15 months is a tremendous 
concern. There is talk about rationing. There was a recess 
appointment. Talk about national security. How about securing 
the border? That is something that needs attention from this 
Congress. Definitely that is an issue that is of great 
importance to the American people.
    Now, while the use of antibiotics in animals and the 
transference of that to humans is important and we are 
concerned, we know that there is a lack of large amounts of 
data on this issue. Does it need our attention? Yes. Do we need 
to keep a focus on this as we go forward? Yes. But what is an 
imperative right now is that we look at what the people of this 
country are saying they want us to address, an ill-conceived 
health care bill that was passed that is a government takeover 
of health care and they want to make certain that we tend to 
getting that off the books. I yield back.
    Mr. Pallone. Next is the gentleman from Connecticut, Mr. 
    Mr. Murphy of Connecticut. Thank you, Mr. Chairman. I am 
eager to hear more about the subject that we are convened to 
learn about today, so I will waive my opening statement.
    Mr. Pallone. The gentleman from Georgia, Mr. Gingrey.


    Mr. Gingrey. Mr. Chairman, thank you.
    As past hearings have highlighted, we have a potential 
antibiotic crisis on the horizon. Simply put, we do not have 
enough new antibiotics in the development pipeline to meet the 
health care needs of the 21st century. Therefore, I believe it 
is important for this committee to review the current 
regulatory structure and promote incentives that will encourage 
greater antibiotic production. To that end, I look forward to 
working with my colleagues on both sides of the aisle to 
achieve this worthy goal and to look forward to the testimony, 
of course, from our witnesses today.
    Mr. Chairman, on another note, following up a little bit 
from the opening statement of Ms. Blackburn, I am appalled that 
President Obama used the July 4th recess to appoint Dr. Donald 
Berwick as the new CMS administrator without allowing a single 
public hearing. During the health reform debate, this 
Administration promised the American people that reform would 
not ration health care. In fact, the White House's own Web site 
under the heading ``health insurance reform reality check'' 
claims to debunk, and I quote, ``the myth that reform will mean 
a government takeover of health care or lead to rationing.'' 
According to Dr. Berwick, however, the question, and this is 
his quote, ``is not whether or not we will ration care but 
whether we will do so with our eyes open.'' To be frank, Dr. 
Berwick's outspoken support of health care rationing is 
completely at odds with the Obama Administration's statements 
on whether rationing is good for our country.
    In his inaugural address, President Obama said that, and I 
quote, ``On this day, we gather because we have chosen hope 
over fear, unity of purpose over conflict and discord.'' In the 
July 26, 2008, edition of the British Medical Journal, Dr. 
Berwick chose hope when describing his support for the British 
health care rationing system and this is another quote from Dr. 
Berwick: ``The only sentiment I feel for the NHS [National 
Health Service] that exceeds my admiration is my hope. I hope 
you will never, ever give up on what you have begun.'' Mr. 
Chairman, my hope is that we have some clarity on this issue. 
Either the President and his Administration support or they are 
opposed to health care rationing. The American people deserve 
answers, and unfortunately, this recess appointment has stolen 
those answers from them.
    Mr. Chairman, I urge this committee to schedule a public 
hearing on Dr. Berwick and his plans for our seniors' health 
care program. Further, given past statements and opposition to 
rationing, I believe that the Administration owes us answers to 
very, very simple questions. Number one: Does President Obama 
support Dr. Berwick's philosophy on health care rationing, and 
number two, does President Obama agree with Dr. Berwick's 
statement that any humane civilization must, again, Dr. Berwick 
``redistribute wealth from the richer among us to the poor and 
the less fortunate.'' Given that Dr. Berwick now runs our 
seniors' health care program, I sincerely believe the American 
people deserve a public hearing so we can get answers to these 
questions, and with that, Mr. Chairman, I will yield back.
    Mr. Pallone. The gentlewoman from the Virgin Islands, Ms. 


    Mrs. Christensen. Thank you, Mr. Chairman.
    For decades, the scientific literature worldwide has shown 
that non-therapeutic low-dose antibiotic use in farm animals 
has caused increased resistance in humans yet I understand that 
in 1977 when FDA attempted to take steps to curtail such use, 
Congress ignored the research and the effort was lost. So thank 
you, Chairman Pallone and Ranking Member Shimkus for your 
attention to this important issue. Under your leadership, I am 
sure that we are not going to repeat that unfortunate 
interception, which is resulting in what is now termed a crisis 
in antibiotic resistance.
    I commend the FDA for the draft guidance they have issued 
this year, and while I think it is a good first step, I think 
it is up to the Congress to go further and pass H.R. 1449, the 
Preservation of Antibiotics for Medical Treatment Act. Led by 
Denmark and Europe, it has been proven that good animal 
husbandry and judicious use of antibiotics has successfully 
reduced resistance without adversely affecting industry or 
profits. This is yet another area where our country is 
threatening to fall behind, and this is unacceptable, not only 
in terms of our leadership but because it places Americans at 
undue and unnecessary risk. It also has the potential to put 
our meat and poultry industry at risk. There can be no denying 
that swift and definitive action must be taken to protect the 
health of current and future generations as well as to protect 
the health of our future economy.
    I welcome the witnesses and look forward to their 
    Mr. Pallone. Thank you, Ms. Christensen.
    I have two statements that Mr. Waxman put forward for the 
record, one from the San Francisco Medical Society and 
Physicians for Social Responsibility in--well, one from the San 
Francisco Medical Society, the other from the Physicians for 
Social Responsibility in Los Angeles regarding the use of 
antibiotics, and I would ask unanimous consent that these 
statements be entered into the record. Without objection, so 
    [The information appears at the conclusion of the hearing.]
    Mr. Pallone. And then we had another statement from Ms. 
Schakowsky. There were one or two letters from Ms. Schakowsky 
that she asked to be entered into the record, and I would ask 
unanimous consent that those also be entered into the record. 
Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pallone. And next is the gentleman from Michigan, our 
chairman emeritus, Mr. Dingell.


    Mr. Dingell. Mr. Chairman, I thank you for your courtesy 
and I commend you for the hearing.
    Today's hearing is the third in a series of hearings on the 
emerging public health threat posed by antibiotic resistance. 
The specific focus of this hearing has proven to be the more 
controversial aspect of the concern raised by public health 
experts. Its controversy spends decades and very frankly some 
very serious and important answers are required.
    I introduced legislation on this topic in 1980, the 
Antibiotics Preservation Act. That bill would have directed the 
Secretary to designate antibiotic drugs which may or may not be 
used in subtherapeutic doses in animal feed or ingredients of 
animal feed unless such use is required to meet a compelling 
need. Interested parties expressed very passionate opinion on 
the legislation during hearings that year. I remember being 
troubled by the efforts of FDA Commissioner von Eschenbach in 
2007 to approve use of certain antibiotics of last resort in 
food-producing animals. While there is substantial disagreement 
between major parties on the magnitude of the problem and the 
proper approach, I believe all sides would generally agree on 
two things. One, antibiotic resistance is a growing public 
health threat. According to the Infectious Diseases Society of 
America, about 2 million people across bacterial infections in 
U.S. hospitals each year. Ninety thousand people die as a 
result. About 70 percent of these infections are resistant to 
at least one drug.
    It appears the injudicious use of medically important 
antimicrobial drugs in animal agriculture increases the level 
of antimicrobial resistance in animals and humans. A variety of 
scientific committees, task forces and organizations including 
a number of government organizations have studied the issue. 
The general conclusion drawn from these studies is that the 
injudicious use of antimicrobial drugs is not in the interest 
of protecting and promoting human health, and while that 
includes many different things, it is a warning to us.
     While we can agree on these two points, there is a great 
deal of uncertainty as to how to address this critical issue 
and getting proper information on this matter is necessary to 
properly address it. We must not take for granted the current 
authority that rests in the Food and Drug Administration to 
responsively address this matter. I was encouraged by recent 
actions in that agency, specifically the issuance of a draft 
guidance, and look forward to updated programs in their work in 
other areas including the development of new antimicrobials.
    I hope today's hearing will provide some interest on a few 
critical questions that come to my mind. First, is the problem 
best solved by a one-size-fits-all approach or should the 
impact of each drug be separately considered? Two, are 
additional authorities and resources justifiably needed to 
fully address the problem? I might just observe, I think so. 
Three, do the benefits of curbing the use of antimicrobial 
drugs outweigh the risk of doing so? Four, what data should be 
reasonably required of regulators to justify future action on 
the use of antimicrobials in animal feed? And lastly, how do we 
define judicious use in a way that removes all ambiguity and 
helps us attain our public health goals while not impairing our 
other concerns about animal health and about the business of 
agriculture? I believe the answers to these questions will 
guide us as we seek ways to address the problem we have before 
us. Our attempt to address the problem should not be rushed. It 
must be based on sound science and good information. It must be 
done in a way that protects both human and animal health, and 
it should not unnecessarily disrupt the animal agricultural 
    I look forward to hearing the views and thoughts of our 
witnesses this afternoon. I am especially interested in hearing 
the views of our agency experts on this matter.
    Again, Mr. Chairman, I thank you for this and I commend you 
for your leadership. I yield back the balance of my time.
    Mr. Pallone. Thank you, Chairman Dingell.
    Next for an opening statement, the gentleman from 
Pennsylvania, Mr. Murphy.


    Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman, for 
holding this hearing.
    For decades, doctors have known that the widespread use of 
antibiotics is going to speed the development of bacterial 
mutation in antimicrobial resistance but what we don't do is 
give antibiotics to every schoolchild just to prevent 
    Today, 70 percent of all health care-associated infections 
in the United States are resistant to at least one antibiotic. 
These infections cost some $50 billion a year. One antibiotic-
resistant infection, MRSA, kills more people in the United 
States every year than HIV/AIDS. But what would happen if it 
finally becomes resistant to the few remaining effective 
    Of course, this resistance is not limited to human health. 
The vast majority of evidence for the last three decades points 
to linkage between routine low-level antibiotic use in food 
animals and the transfer of antibiotic-resistant bacteria to 
people, often through the food supply. The American Medical 
Association, the American Academy of Pediatrics, the American 
Public Health Association and the American College of 
Preventive Medicine have all called for a significant reduction 
in the amount of antibiotics we use in food animal production. 
Antibiotics have four purposes: to treat disease, control the 
spread of disease once an infection has occurred, prevent 
disease from occurring and promote the growth in animals.
    Last month, the FDA issued guidance to drug makers, animal 
farmers, veterinarians that represents a step toward ending 
antibiotic use for growth promotion and increasing veterinary 
oversight of animal antimicrobial drugs that are available over 
the counter at feed mills. Some drug makers are already moving 
in this direction, and I encourage pharmaceutical companies, 
farmers and the FDA to keep working together to limit any 
unnecessary use of antibiotics.
    I look forward to hearing from the FDA and other witnesses 
of how they intend to ensure that disease prevention does not 
become growth promotion by another name. There are other 
solutions out there that will keep our food supply safe, our 
society healthy and our antibiotics effective, and I hope this 
hearing today will awaken our colleagues to the very real 
threat to public health posed by the declining effectiveness of 
antibiotics. Any use of antibiotics anywhere can cause bacteria 
to select for resistance but overuse and misuse of antibiotics 
simply gives bacteria an environment-rich situation to develop 
resistance and multiply.
    To really cut health care costs, save lives and preserve 
the effectiveness of these vital drugs, we have to eliminate 
unnecessary antibiotic use everywhere we find it, in hospitals, 
nursing homes, the general community and sometimes even on the 
    With that, I yield back.
    Mr. Pallone. Thank you, Mr. Murphy.
    The gentleman from Ohio, Mr. Space.


    Mr. Space. Thank you, Mr. Chairman.
    We have before us a public health issue of significant 
importance. Studies have indicated the antibiotics upon which 
our doctors and hospitals relied are losing their effectiveness 
in treating very serious illnesses. This resistance is a very 
real problem and indeed a very scary one. Our committee is 
right to investigate it and right to consider potential 
    I am, however, worried about some of the discussions 
relating to limiting the use of antibiotics in the agricultural 
setting. My Congressional district is home to a significant 
agricultural industry which directly employs over 17,000 people 
and countless more indirectly. It is the linchpin of our 
economy and an industry easily affected by regulation here in 
Washington, D.C. Many of the farmers in my district rely on the 
use of antibiotics to keep animal populations healthy and run 
productive businesses. And while we must be mindful of the 
importance of equipping farmers and veterinarians with the 
tools they need to treat animals when they are sick, obviously 
we all have to be mindful of the strategic necessary of 
preventing illnesses from spreading.
    Today's witnesses offer a variety of opinions on this 
issue, many of which take different approaches to the same 
issue. I look forward to the testimony and to learning more 
about their perspectives. I believe it is critical that we 
study the evidence further and take into account all options 
and all sides of the issue before deciding whether to move 
forward. If the committee does decide to move forward on this 
issue, it is my hope we will move in a moderate and bipartisan 
fashion while working with stakeholders in the agricultural 
industry. This issue is an important one and worthy of careful 
consideration, and we must be vigilant in ensuring that the 
policies we create are carefully thought out.
    And with that, Mr. Chairman, I yield back.
    Mr. Pallone. Thank you, Mr. Space.
    The gentleman from Iowa, Mr. Braley.


    Mr. Braley. Thank you, Chairman, for holding this important 
hearing on the use of antibiotics in animal agriculture, and I 
also want to thank all the witnesses who came here today, and I 
hope that we can have a meaningful conversation on this issue.
    Most Americans when they go into a supermarket and buy some 
pork or chicken or beef have no idea where that food came from 
how or how it wound up in the supermarket or in their kitchen. 
A lot of public health officials have never been to a farm and 
seen with their own eyes and talked to production people 
involved in agriculture about how that food is taken care of 
and how it is grown and how it is processed and how it is 
shipped off to the packing house where it is ultimately dealt 
with and sent to their table.
    A lot of parents take their kids into doctors' offices and 
demand the use of antibiotics for something that won't even 
respond because it is a viral infection. We are a culture that 
looks for simple, easy answers when oftentimes we are talking 
about complex tradeoffs, and it is no different here talking 
about the very real public health concerns about antibiotic 
resistance and very real production concerns about food safety 
and food supply.
    When I was a student at Iowa State University, it was a 
well-known accepted fact that it was more difficult to get into 
the Iowa State Veterinary Medicine College than the University 
of Iowa College of Medicine, and yet we seem to think that 
public health research is somehow in some way more superior 
than animal veterinary research even though oftentimes they 
come from the same raw data.
    So my hope for this hearing is that we can all agree on 
some fundamental things: A, that antibiotics are essential for 
fighting bacterial infections in humans, and yet there is still 
significant disagreement in some sectors about the specific 
relationship between the use of antibiotics in feed products as 
they relate to consumption of food and how that affects 
antibiotic resistance in humans. I have always been an advocate 
for science-based approach and I think this is an issue that 
demands careful, thoughtful consideration of all scientific 
points of view. Rather than come to conclusions based upon 
ideology, I think we need to look through the entire body of 
research available. There many well-intentioned people on both 
sides of this debate, and my hope is, we can continue to have 
meaningful discussions around tables like this, talk about the 
best forward to move forward to make sure we continue to have a 
safe, reliable food supply and are doing everything we can to 
protect human health. We need to continue to assess how 
antibiotics are being used in animals but also across the 
spectrum in ways that they are being abused and creating the 
type of antimicrobial resistance we are seeing today, and we 
also need to make sure that as we listen and learn from the 
witnesses who have come here today, we continue to fund the 
necessary research to get to the bottom of how these problems 
relate to one another and how we make the best informed 
decisions to protect the public health interest.
    So I want to thank you all for being here today. I look 
forward to your input, and I yield back.
    [The prepared statement of Mr. Braley follows:]

    Mr. Pallone. Thank you.
    And we also have the gentleman from Georgia, Mr. Barrow.
    Mr. Barrow. I thank the chairman.
    I can add nothing to the comprehensive statement of my 
colleague, Mr. Braley, so I will waive an opening.
    Mr. Pallone. I thank the gentlewoman.
    That concludes our opening statements so we will now turn 
to our first panel. I want to welcome you. Let me introduce 
each of you. First on my left is Dr. Joshua Sharfstein, who is 
the Principal Deputy Commissioner for the Food and Drug 
Administration. And then we have Dr. John Clifford, who is 
Deputy Administrator for Veterinary Services, Animal and Plant 
Health Inspection Service for the Department of Agriculture, 
and finally is Rear Admiral Ali Khan, who is Assistant Surgeon 
General, Acting Deputy Director of the National Center for 
Emerging and Zoonotic Infectious Disease with the Centers for 
Disease Control.
    I think you know the drill, 5-minute opening statements. 
And I should mention, I guess we are expecting votes, but I am 
going to proceed and then we will see. We may have to--well, we 
will have to interrupt at some point but I think we might as 
well start with Dr. Sharfstein.



    Dr. Sharfstein. Good afternoon, Chairman Pallone and 
Ranking Member Shimkus and members of the subcommittee. I am 
Dr. Joshua Sharfstein, Principal Deputy Commissioner of the 
Food and Drug Administration, an agency of the Department of 
Health and Human Services. Thank you for holding this hearing. 
Thank you for the opportunity to discuss FDA's role and work 
with respect to antimicrobial resistance, and we appreciate 
your leadership.
    In my testimony, I will describe FDA's actions to combat 
resistance and discuss the newly released draft guidance 
entitled ``The Judicious use of medically important 
antimicrobial drugs in food-producing animals.''
    As I will discuss in more detail later, in the draft 
guidance FDA concludes that the overall weight of evidence to 
date supports the conclusion that using medically important 
antimicrobial drugs for production purposes is not in the 
interest of protecting and promoting the public health. 
Developing strategies for reducing antimicrobial resistance is 
critically important for protecting both human and animal 
health, both of which are very important to scientists and 
regulators at the FDA.
    Antimicrobial resistance is being addressed on a number of 
fronts. Dr. Khan from CDC will talk about the data associated 
with human resistance as it relates to antimicrobial use, and 
his agency's leadership in efforts to fight resistance in human 
medicine, but I do want to make a comment as a pediatrician.
    I remember vividly in 1998 when I was a pediatric resident 
and the Centers for Disease Control and the American Academy of 
Pediatrics published principles for the judicious use of 
antibiotics in common pediatric infections including the common 
cold, ear infections, sinusitis and sore throat. I remember 
giving conferences on the basis of that and I remember the 
format of the papers and how they printed off the computer. 
Children have many infections, and as Congressman Braley 
mentioned, there was a big issue of parents coming and 
expecting antibiotics, and these were very strict guidelines 
for pediatrics on when to use antibiotics and when not to. 
There was a major effort in pediatrics starting around that 
time to reduce prescribing, to reduce antimicrobial resistance, 
and it had an impact. A recent study in the Journal of the 
American Medical Association showed that antibiotic 
prescription rates for children under 5 with respiratory 
infections decreased by 41 percent between 1995 and 2005. That 
study was published last year.
    Many centers at FDA are addressing the public health 
concern about antimicrobial resistance including the Device 
Center, which works on diagnostics, the Biologic Center, which 
works on vaccines, the Drug Center, which works on Drugs. 
Because today's hearing focuses on antimicrobials in 
agriculture, I want to talk about the efforts at the Center for 
Veterinary Medicine.
    Our efforts start with surveillance through the National 
Antimicrobial Resistance Monitoring System. CVM works with CDC 
and USDA in overseeing surveillance of resistance in multiple 
areas. In addition, CVM has an approach for assessing 
resistance associated with the use of drugs intended for food-
producing animals. There was a guidance issued, Guidance 152, 
which explains an approach when there is a new product coming 
onto the market, how we assess whether there is a risk from 
antimicrobial resistance and how that translates into our 
regulatory pathway.
    However, many antimicrobial drug products that were 
approved prior to the implementation of this guidance have not 
been evaluated, and a particular concern are those 
antimicrobials that are considered medically important drugs, 
meaning those that are important in human medicine and are 
approved in food-producing animals for production or growth-
enhancing purposes.
    To address this concern, the Center for Veterinary Medicine 
released a guidance, as you have heard, on June 28. This is 
intended to inform the public of FDA's thinking on this issue 
and to minimize resistance by outlining broad principles for 
assuring that medically important antimicrobial drugs are used 
judiciously in animal agriculture. The draft guidance reviews 
major public health reports on this topic including reports by 
the Institute of Medicine, the Government Accountability 
Office, the World Health Organization and its affiliated 
agencies. Those reports include multiple peer-reviewed studies 
conducted around the world including in the United States.
    Based on this evidence, in this draft guidance FDA 
recommends phasing-in measures that would, one, limit medically 
important antimicrobial drugs to uses in food-producing animals 
that are considered necessary for assuring animal health, and 
two, include veterinary oversight or consultation. These steps 
would help reduce overall use of medically important 
antimicrobial drugs and reduce the selection pressure that 
generates antimicrobial resistance.
    Prior to issuing the draft guidance, FDA consulted with a 
wide variety of stakeholders. We spoke with CDC and USDA and 
got their input on the recommendations. I visited a farm in 
southern Illinois, which was a very interesting experience, and 
we are committed to working with all stakeholders across the 
spectrum, our sister agencies as we get comments from the 
public on the right way to implement this policy. We are 
seeking comment through August 30, 2010, and we look forward to 
a very productive dialog to figure out a very sensible path 
through this issue that promotes both human and animal health. 
Thank you.
    [The prepared statement of Dr. Sharfstein follows:]

    Mr. Pallone. Thank you, Dr. Sharfstein.
    Dr. Clifford.


    Dr. Clifford. Good afternoon, Chairman Pallone and Ranking 
Member Shimkus and other members of the subcommittee. My name 
is Dr. John Clifford and I am the Deputy Administrator for 
Veterinary Services with the Department of Agriculture's Animal 
and Plant Health Inspection Service. In this position, I also 
serve as the U.S. Chief Veterinary Officer for animal health.
    Today the subcommittee is looking at an important issue 
that has far-reaching consequences for human and animal health. 
USDA believes that it is likely that the use of antimicrobials 
in animal agriculture does lead to some cases of antimicrobial 
resistance among humans and in animals themselves, and we 
believe that we must use medically important antimicrobials 
judiciously. USDA is committed to playing an active role in 
preserving the effectiveness of medically important 
    USDA believes that policy decisions must be science-based 
and will provide research to inform the debate. To do this, 
USDA will work with our federal partners including those at 
this table.
    What constitutes judicious use and how it applies is a 
central question to this debate. This must be answered with a 
sound scientific evaluation and with data-based decision-
making. USDA is working to conduct surveillance and research 
and a number of agencies within the Department are actively 
engaged on projects to better understand the issue. My written 
statement details many of these efforts.
    Beyond my department, FDA has an existing process for 
completing risk assessments concerning the use of 
antimicrobials. USDA believes that this process provides a 
rational, science- and data-based approach to making decisions 
about specific antimicrobial use. This is preferable to the 
approach that broadly eliminates antimicrobials for specific 
    As we move forward, we must carefully address what current 
research says and identify gaps in our scientific knowledge. We 
are committed to working with our federal partners as we have 
been on these important issues. We need more data so that the 
policy can properly balance risk between animal and human 
health needs.
    USDA is also looking to expand its existing partnership. 
For instance, USDA is interested in expanding our work with HHS 
to improve outreach with veterinarians in the animal 
agriculture community. We need to work together to conduct 
research and develop new therapies that protect and preserve 
animal health without increasing the risk of resistance to 
medically important antimicrobials.
    USDA is also interested in making our veterinary experts 
available to provide guidance and share information with 
veterinarians and producers. This Nation's farmers and ranchers 
want to do the right thing. If we provide them with the 
resources and information so they can make informed decisions, 
they will do the right thing.
    Mr. Chairman, I can assure you that USDA recognizes the 
challenges of antimicrobial resistance and that the entire 
Department is taking these challenges very seriously. We are 
committing to ensuring that medically important antimicrobials 
are used judiciously, which will preserve both human and animal 
    I will be happy to answer any questions that you or your 
members of the committee may have. Thank you.
    [The prepared statement of Dr. Clifford follows:]

    Mr. Pallone. Thank you, Dr. Clifford.
    Dr. Khan, or Admiral Khan, I guess.

                     STATEMENT OF ALI KHAN

    Admiral Khan. Good afternoon, Chairman Pallone, Ranking 
Member Shimkus and other members of the subcommittee. I am Ali 
Khan from CDC, and thank you for the invitation to address the 
subcommittee today.
    Antimicrobial agents are used to treat infection by 
different disease-causing microorganisms. Resistance occurs 
whenever and wherever antibiotics are used, in the community, 
on the farm or in health care settings. Antibiotics are a 
subset of antimicrobials used specifically to fight bacterial 
infections. Many of the bacteria in our food that cause human 
disease are also in food animals. These healthy food-producing 
animals commonly carry bacteria in their intestinal tract and 
they can cause disease in humans including Salmonella and 
Campylobacter are two examples. Today I will focus on the human 
health impact of antibiotic-resistance bacteria as they relate 
to food animals.
    There is unequivocal and compelling evidence that the use 
of antibiotics in animals leads to the development of drug-
resistant bacteria that have adverse impacts on human public 
health. This has been demonstrated for numerous production 
animals--pigs, cattle, poultry--for numerous pathogens--
Salmonella, E. coli, Campylobacter enterococcus--and in 
numerous countries--Denmark, England, Spain, Canada, and right 
here in the United States. Antibiotic-resistant pathogens move 
through the food supply, so use of antibiotics in animals 
results in resistant bacteria in food animals. These resistant 
bacteria then can be present in the food supply and be 
transmitted to humans. And finally, these resistant bacterial 
infections can result in adverse human health consequences such 
as increased hospitalizations or potentially death.
    Please allow me to describe some specific examples. Let us 
see if slide one works here. Can somebody bring up the first 
slide potentially?
    Mr. Pallone. Do we have technicians here? Oh, there you go.
    Admiral Khan. Let us go to the next one. Perfect.
    [Slide shown.]
    So Campylobacter is one of the leading causes of foodborne 
bacterial disease in the United States. It causes approximately 
2 million cases per year. And studies have unequivocally 
demonstrated movement of resistant pathogens through the food 
supply linked to antibiotic use in animals. So what you can see 
nicely in this slide to the far left is antibiotic--well, that 
depends on what side of the screen you are looking at, to the 
far left of the slide. There is probably less than 1 percent 
resistance in those bacteria, and then following the use of 
fluoroquinolones and the licensing for fluoroquinolones in 
poultry, what you can see is a dramatic increase starting 2 to 
3 years later that has persisted despite a decision by FDA a 
couple of years ago to stop the use of fluoroquinolones.
    Now, this failure to see a subsequent decline in resistance 
really is a cautionary tale for us and it suggests that the 
movement of resistance from animals to humans should be 
considered a sentinel event and demonstrates that resistance 
once it occurs may not be easily reversed and that prevention 
is a much better strategy that a control strategy.
    [Slide shown.]
    The next slide shows similar data in the United Kingdom. 
Again what you can see is introduction in the yellow box of a 
type of quinolone antibiotic in animals and then the increase 
shows, the increase in resistance, not just in a number of 
different animal species but in humans also.
    And then finally, the Canadian data, which is really quite 
dramatic, published this year from Quebec, and what this shows 
is changes in cephalosporins. This is a common antibiotic that 
we use, changes in cephalosporin resistance in chicken and 
human Salmonella and chicken E. coli strains that appear to be 
related to changes in the use of a type of similar antibiotic 
in animals, and what you see is a marked decline in those 
resistance in the E. coli and the Salmonella following a 
decision for voluntary reduction of the antibiotic in animals, 
and what is not on this slide is, if you follow out to 2, 3 
years, there was a limited reintroduction of that antibiotic 
for animals, and you see a little spike again as the antibiotic 
is reintroduced. So very nice, clean evidence of what happens. 
You introduce the animal. You reduce the antibiotic into the 
animal population and increase in resistance, and then some 
examples of a decrease in resistance associated with 
discontinuing the antibiotic in animals.
    Now, studies in Europe have also demonstrated the most 
compelling and direct links between non-therapeutic use, often 
referred as subtherapeutic use or use for growth promotion, et 
cetera, in food-producing animals and subsequent antimicrobial 
resistance in humans. So the ban of growth promoters in Denmark 
has prevented spread of vancomycin-resistant enterococcus in 
humans, reduced resistance in pathogens like Campylobacter and 
reduced serious human infections, for example, due to specific 
types of resistant Campylobacter, and this conclusion has been 
independently verified by the World Health Organization.
    Finally, antibiotics are a critical in our Nation's defense 
against infectious diseases and we need to take strong measures 
to make sure that we maintain their effectiveness. This 
subcommittee and my colleagues at HHS and USDA have focused on 
elements of a comprehensive strategy to protect public health 
by avoiding resistance that stems from the overuse of 
antibiotics in animals. Consistent with this one health 
approach to the prevention of infectious diseases, CDC supports 
these efforts to minimize non-judicious use of antibiotics in 
both animals and humans for better human health, animal health 
and environmental stewardship.
    Thank you again for the invitation to testify today and I 
will be happy to answer any questions.
    [The prepared statement of Admiral Khan follows:]

    Mr. Pallone. Thank you very much. I thank all of you.
    We have three votes, the last votes of the day, about half 
an hour or so, and so we are going to stand in recess.
    Mr. Shimkus. Mr. Chairman, will you yield for a minute? 
During the break, could we ask the majority since those slides 
weren't provided as far as I know in the testimony, that we get 
copies of those slides?
    Mr. Pallone. Yes, we will get copies for you.
    Mr. Shimkus. Thank you.
    Mr. Pallone. So we will stand in recess.
    Mr. Waxman. Mr. Chairman, before we break, may we renew our 
unanimous consent request to put the----
    Mr. Pallone. I am sorry, Mr. Chairman.
    Mr. Waxman. Oh, we did it already?
    Mr. Pallone. They have all been entered including Ms. 
Schakowsky's. They have all been entered.
    Mr. Shimkus. I was all over it for you.
    Mr. Pallone. The subcommittee stands in recess.
    Mr. Pallone. The subcommittee hearing will reconvene. We 
are going to have questions now, and I will start with myself 
for 5 minutes.
    This is sort of--I am going to cover all three of you with 
this. I will start with Dr. Sharfstein.
    At the end of last month, as you mentioned, the FDA 
released a draft guidance on the judicious use of medically 
important antimicrobial drugs in food-producing animals, and as 
I understand it, the guidance essentially says that antibiotics 
that are important for treating human disease should not be 
used in animals except as needed to assure their health, and it 
also says that veterinarians should be involved when the 
antibiotics are used for that purpose. So I guess my point is 
to note that today medically important antibiotics, whether 
important for treating people or treating animals, are used for 
non-therapeutic purposes, and so many of the people who use 
them for those purposes, Dr. Sharfstein, haven't necessarily 
reacted to your guidance in a positive way.
    So my questions are about the scientific basis for the 
guidance. What led you to develop the guidance? Did you meet 
with stakeholders such as industry that would be affected by 
the policies? What has been the general reaction to the 
guidance? Who supported it? Who has opposed it? I mean, we know 
that the producers aren't happy about it. On the day your 
guidance was released, the president of the National Pork 
Producers Council said FDA didn't present any science on which 
to base this. So that is my question, really, is it 
scientifically based? What is your response to the naysayers?
    Dr. Sharfstein. Well, we look forward to the comment period 
and we will review everything that we get from different groups 
officially. I actually have been impressed at the interest 
across many different areas of the animal agriculture in 
working with FDA and I will note that the Animal Health 
Institute, that they welcome the guidance, and the AVMA said 
that they were pleased that we are committed to working with 
the veterinary profession to address antimicrobial resistance 
    So I think it may be--you know, I wouldn't necessarily buy 
into us versus them on this. I think that is a very sensible 
path. It really rests on a mountain of strong science, and one 
of the documents we cite, I think is really excellent. It is 
the WHO 2003 report which walks through six lines of evidence 
that exists, citing multiple studies including a number done in 
the United States, and the six are outbreak investigations 
which trace Salmonella infections to farms, epidemiological 
investigations which demonstrate that people are more likely to 
have visited or lived on a farm prior to illness, that they 
have antimicrobial-resistant infections, field studies 
including some I think you will hear about on the next panel 
where they actually prospectively demonstrate how antimicrobial 
use in food animals selects for the emergence of resistance, 
case reports including children who have been sick, spatial and 
temporal associations where countries where they use less 
antimicrobial agents you see less antimicrobial resistance in 
bacteria, and finally, molecular subtyping, so this is the 
sixth type of evidence, and I will be happy to submit this to 
the record--it is cited in our report--where you actually can 
trace the specific bacteria around, and they find--and one of 
the studies I found most interesting, I think it was from 
Minnesota, is that the resistant strains of the bugs in humans 
match the resistant strains in the animals and those match the 
sensitive strains in the animals except for the resistance 
genes, but the sensitive strains in humans don't match those. 
So you think it basically looks like the resistance is coming 
from the animals and the animal resistance is developing in the 
animals, and they do that by molecular analysis of the actual 
    So I really do think there is a very strong foundation of 
evidence. I think Dr. Khan----
    Mr. Pallone. Well, let me ask the other two guys.
    Dr. Khan, do you agree with Dr. Sharfstein on this, and Dr. 
Clifford, do you believe that growth promotion is an 
injudicious use of antibiotics? Basically if you would comment.
    Admiral Khan. CDC supports the FDA position. The position 
is consistent with the one health approach and essentially how 
we use antibiotics for human use, and a number of members of 
the committee have pointed that tout. So we use antibiotics in 
humans specifically for treatment, for prophylaxis when it is a 
specific targeted individual or targeted drug for targeted 
indication, and those are the three uses in antibiotics. So, 
you know, I have kids in daycare, and lots of them are infected 
with all sorts of things. Nobody would ever propose that all 
children in daycare, for example, should be on antibiotics 
through that whole time frame. So this is very consistent with 
the one health approach and how we deal with antibiotics in 
    Mr. Pallone. Dr. Clifford?
    Dr. Clifford. We work very closely with FDA in consultation 
with this document and provided feedback to them. We think this 
is a good first step, and we welcome seeing the comments as 
well that FDA receives on this particular document.
    As far as whether growth promotion or judicious use of 
antibiotics, our position is that with regards to judicious use 
of medically important antibiotics, we are talking about 
treatment, control and prevention of animal health issues and 
disease. So there are antibiotics, though, that are used, or 
antimicrobials that are used in animals that have no analog 
being used in human medicine and should not be of concern 
unless there is proven evidence to the human side.
    Mr. Pallone. OK. Thank you all.
    Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Dr. Clifford, is there science to support the removal of 
antibiotic use for growth promotion?
    Dr. Clifford. I am sorry?
    Mr. Shimkus. Is there science to support the removal of 
antibiotic use for growth promotion?
    Dr. Clifford. You mean as far as the cause and effect?
    Mr. Shimkus. Right.
    Dr. Clifford. There is some cases.
    Mr. Shimkus. Well, can you cite them?
    Dr. Clifford. Well, obviously you can cite the Danish 
    Mr. Shimkus. No, I am talking about United States.
    Dr. Clifford. Not right offhand, no, I cannot.
    Mr. Shimkus. Do you know of any U.S.-supported research 
peer review?
    Dr. Clifford. I cannot cite any.
    Mr. Shimkus. You are similar to other testimony we received 
in April where Dr. Fauci and also quoted Dr. Frieden, and this 
is the hearing record. ``To my knowledge and to Dr. Frieden's 
knowledge, I don't think any of those studies have been done in 
the United States.''
    I mean, I saw Dr. Sharfstein give you a note. The question 
is for you, not for Dr. Sharfstein. Dr. Sharfstein, I will ask 
you questions if you have--with my time available.
    Equating animals to people is like equating an apple to an 
orange. I am just--that is why we have vets and that is why we 
have doctors. That is why vets are not qualified to work on 
human beings or medical doctors qualified for animals unless I 
am sure in parts of southern Illinois years ago but--let me ask 
Dr. Sharfstein. What decreases in the level of human antibiotic 
resistance will we see if FDA proceeds with this Guidance 209 
document as currently proposed?
    Dr. Sharfstein. I expect that if we go forward with 
Guidance 209 as currently proposed that this will reduce 
antibiotic resistance pressure. We will have less antibiotic 
resistance in animals and less antibiotic resistance in humans, 
and it will promote both human and animal health.
    Mr. Shimkus. And by what percent?
    Dr. Sharfstein. I don't think I can answer the exact 
    Mr. Shimkus. And can you cite me a study, a U.S. study that 
verifies that analysis and that answer?
    Dr. Sharfstein. Yes, I can. The Institute of Medicine's 
2003 report was very clear that this would be the right 
approach to take for this reason.
    Mr. Shimkus. Is that a study and is it peer-reviewed 
    Dr. Sharfstein. It is a study, and they do have a peer-
review process at the Institute of Medicine. The Institute of 
Medicine is considered our Nation's leading scientific expert, 
you know, group. They looked at this issue. They said to do 
nothing is in effect to allow the continued evolution of 
antimicrobial-resistant microbes which poses serious and long-
    Mr. Shimkus. And let me--and what do we see as a national 
government? Have we done any additional research to verify 
their findings?
    Dr. Sharfstein. There has also been research in King County 
related to Campylobacter that is very compelling. There is a 
New England Journal study from Minnesota that is very 
compelling. I would be happy to submit all these studies for 
the record.
    Mr. Shimkus. We would like them all, please.
    Dr. Sharfstein. Dr. Frieden mentioned in his letter to the 
committee that there is extensive data from the United States.
    Mr. Shimkus. Yes, correcting the record by which he was 
quoted in April, and we find that curious and also timely that 
that occurred.
    Dr. Khan, I want to go to your slides that you had 
presented to us, and if the staff could pull up slide number 1 
for me from Dr. Khan's. I am sorry. We should have given you a 
heads-up, but if we didn't, we apologize. That is the right 
    The antibiotics on chart 1 are mostly used for therapeutic 
use, not subtherapeutic use. Is that correct?
    Admiral Khan. Yes.
    Mr. Shimkus. I see that there was no reduction in the 
little arrow there for those who have it. That is when it has 
been removed. There was no--in fact, there is an increase after 
it was removed. What does that say?
    Admiral Khan. That says prevention is really a lot more 
important than control, so these may represent sentinel events. 
The moment you get a resistant bacteria from animals that makes 
it way into the human population, there is a different set of 
drivers for maintaining it in humans that makes it impossible 
to shut it down.
    Mr. Shimkus. Could it be that there is another cause for 
the resistance other than for which we are speaking of today?
    Admiral Khan. I think the data is pretty unequivocal. 
Before the use of fluoroquinolone----
    Mr. Shimkus. Well, let us go to the second slide. Let us 
talk about this unequivocal data here. This is the, I can't 
pronounce it, quinolone resistance, Salmonella and typhimurium. 
First question. I was elected to Congress in November of 1996, 
took office in 1997. This chart ends in 1997, 14 years ago. Is 
there no data after that?
    Admiral Khan. There is data after that.
    Mr. Shimkus. And what does that data show?
    Admiral Khan. The data shows continued resistance. The 
purpose of this specific slide was to show that the 
introduction of this antibiotic into animals led to an increase 
in resistant bacteria in not just----
    Mr. Shimkus. I think if you would add data, I think what we 
can find, and maybe this is why it was not submitted is that 
you are going to see a decrease, and if that is the case, I 
find it very perplexing and very troubling that we use data 
from 1997 and we don't go to 14 years later to show the path.
    Mr. Chairman, I know my time is expired, but the last 
thing, I also have problems with the third slide. That is the 
importance of getting data and information here in a timely 
manner so we can check sources, and to use World Health 
Organization data, to have dumbed down from the Danish study 
which will make the Danish products competitive because it is 
going to make us more difficult to compete. We are dumbing down 
our ability, is very problematic and I would agree with some of 
my colleagues, even on the other side, we better go very, very 
carefully and use real science in this antibiotics use of 
animals, and I yield back my time.
    Mr. Pallone. Chairman Waxman.
    Mr. Waxman. Dr. Khan, just on that last question you were 
asked, if you had more data, you say it would show the same 
results as what you saw in 1997?
    Admiral Khan. It depends on the country, sir. So in the 
U.K. there is continued persistence. In the United States, 
using National Antibiotic Resistance Monitoring System, NARMS, 
which is a system we use with FDA, that FDA, USDA and CDC 
sponsors, there is variable data for different pathogens that 
shows either continued increase or for some select Salmonellas 
decreases in resistance. The reason I used--so the first slide 
is actually U.S. data, fluoroquinolones in the United States, 
unequivocal that the moment you use the fluoroquinolones, 
within 2 to 3 years from less than 1 percent you went up to 20 
percent resistance. That has remained----
    Mr. Shimkus. Mr. Chairman, I don't want to be 
disrespectful, but the point is, that is for therapeutic----
    Mr. Waxman. Just a minute. You are disrespectful.
    Mr. Pallone. Chairman Waxman has the time.
    Mr. Shimkus. Well, I was hoping you yield, but I apologize.
    Mr. Pallone. No, he is not yielding at this time.
    Mr. Waxman. Go ahead. He doesn't like the answer you are 
giving but let us hear what it is.
    Admiral Khan. So that initial data, sir, the 
fluoroquinolone data is U.S. data. We also have abundant 
additional U.S. studies showing this. So if we look at 
Salmonella typhimurium DT-104, multi-resistant outbreak amongst 
people, that was due to ground beef. If we look at Salmonella 
Newport, this is a multi-resistant strain----
    Mr. Waxman. Well, let me ask you this because in USA Today 
on Monday, the director of the National Pork Producers Council 
said that, ``According to top scientists with the Centers for 
Disease Control and Prevention and the National Institutes of 
Health, there are no scientific studies linking antibiotic use 
in livestock production with antibiotic resistance in people.'' 
Is this an accurate reflection of CDC's views?
    Admiral Khan. Sir, Director Frieden has submitted a letter 
to the committee that specifically states that there is a 
compelling body of evidence to demonstrate this link that is 
summarized above, so there is multiple North American studies 
that describe how use of antibiotics in animals results in 
resistant bacteria in food animals. These resistant bacteria 
then are present in the food supply and transmitted to humans. 
And finally, these resistant bacteria can result in adverse 
human health consequences such as increased hospitalization, 
and there is good scientific evidence for each one of those 
three assertions.
    Mr. Waxman. Well, a large part of the confusion seemed to 
stem from the question about the adequacy of the peer-reviewed 
literature showing a link between antibiotics use in animals 
and resistant infections in humans. Do you think there is 
substantial scientific evidence demonstrating a link between 
antibiotic use in animals and infections in humans, and can you 
discuss the implications of European versus USA data?
    Admiral Khan. So there is an unequivocal evidence and 
relationship between use of antibiotics in animals and 
transmission of antibiotic-resistant bacteria causing adverse 
effects in humans following that pathway that I have outlined. 
The Danish data is also very clear on the use of subtherapeutic 
use of antibiotics for animals and what the consequences on 
resistance in humans.
    Mr. Waxman. Dr. Sharfstein, do you think there is 
substantial scientific evidence demonstrating a link between 
antibiotic use in animals and infections in humans?
    Dr. Sharfstein. Yes, I do think that.
    Mr. Waxman. And is this scientifically controversial?
    Dr. Sharfstein. I don't believe so, no.
    Mr. Waxman. I wanted to ask a different line of questions, 
and that is regarding, as we consider antibiotic use in 
animals, we have heard concerns from some of the producers that 
reducing the routine use of antibiotics in animals could result 
in increased risk of foodborne illnesses. Since we have 
representatives of two of the country's leading public health 
agencies, I would like to ask you about your assessment of the 
risks and benefits of reducing the use of antibiotic use in 
animals. I think it is important to understand that no one here 
is proposing to ban the use of antibiotics for animals. The 
goal here is to reduce the use of antibiotics that are 
important to human health and animals, particularly when that 
use provides little or no benefit to those animals.
    Dr. Sharfstein, as you know, it is the mandate of the Food 
and Drug Administration to ensure that the food supply is as 
safe as it can be, so would you be concerned if you believed 
that reducing the use of important human antibiotics in animals 
could result in increased risk to the food supply?
    Dr. Sharfstein. Let me make sure I understand your 
question. Am I concerned or would it be concerned?
    Mr. Waxman. Are you concerned if you reduce the use of 
antibiotics in animals that affect humans that this could 
result in increased risk to the food supply?
    Dr. Sharfstein. I think with our guidance, we are talking 
about the use for not-health purposes, so we don't believe if 
we are eliminating the use for not-health purposes we are going 
to have adverse health consequences.
    Mr. Waxman. Is there evidence to support the claim that 
phasing out certain uses of antibiotics could increase risks to 
the food supply?
    Dr. Sharfstein. I think if by certain uses you mean the 
uses we are proposing phasing out, you know, for growth 
promotion, feed efficiency, I would say no, there is not 
    Mr. Waxman. Dr. Khan, you are the Nation's leading 
epidemiologist at CDC as well as the agency tasked with 
conducting outbreak investigations foodborne illness. Would CDC 
be concerned if it believed that phasing out certain use of 
antibiotics in animals would increase the risk of illness in 
    Admiral Khan. No, sir, there is no scientific evidence 
suggesting a negative impact on human health for limiting the 
non-judicious use of antibiotics in animals.
    Mr. Waxman. Thank you.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    Next is the gentleman from Indiana, who has 8 minutes. Mr. 
    Mr. Buyer. Thank you very much.
    Dr. Clifford, I have a question that deals with 
adulterated, counterfeit, knockoff drugs. We have a problem in 
our country, and countries around the world are challenged by 
this. Do you see any escalation or any evidence of adulterated 
counterfeit drugs in animal health?
    Dr. Clifford. Congressman, since this really falls under 
FDA's jurisdiction, I would have to turn to them to answer that 
    Dr. Sharfstein. In the United States----
    Mr. Buyer. Hold on a second.
    Dr. Sharfstein. Oh, I am sorry.
    Mr. Buyer. Hold on. Go ahead. Thanks. For animal health.
    Dr. Sharfstein. For animal health, I think we are going to 
have to get back to you. I am not prepared to answer that. I 
have not heard of a significant counterfeit problem in the 
United States but I want to make sure and get back to you.
    Mr. Buyer. You know, as our problem is growing, it is only 
time before it migrates. It is going to follow the money, 
right? Bad guys follow the money. And that is why I asked the 
    I want to thank the FDA for continuing the blitzes that you 
are doing at international mail facilities, so thank you for 
doing that. You are trying to ``get the word out'' to Americans 
that if you go on the Internet and you think that that is an 
approved Web site to order your pharmaceutical products, that 
you are really playing Russian roulette with your life, and so 
thank you for keeping these blitzes going and trying to get the 
word out. I noted in your testimony when you were with us in 
March, you had in your testimony, ``Protecting Americans from 
unsafe or contaminated drugs is not just an important 
responsibility of the FDA, it is our core charge.'' Do you 
agree with that today?
    Dr. Sharfstein. I do believe that. I think it is one of the 
reasons that FDA----
    Mr. Buyer. So----
    Dr. Sharfstein [continuing]. Was established.
    Mr. Buyer. I am sorry?
    Dr. Sharfstein. I was saying, it is one of the reasons FDA 
was established.
    Mr. Buyer. You also then in your testimony talked about FDA 
must adopt a new approach. Now, I think when you talked about 
your new approach, also you were concerned about the 
production, i.e., raw ingredients, that are used within our 
supply chain for which people are buying at retail outlets 
within the gold standard of our own country. So ensuring that 
we maintain that gold standard, you are putting your eyes on 
that supply chain and production. I don't have any problems 
with that. I think that is wonderful. I think the 
Administration is doing what it is supposed to do. I applaud 
you with regard to your striking the agreements with other 
countries, putting more inspections on other soils. That is 
    With regard to your--it is twofold. Not only do you have 
that to do but we also have the mail facilities. Now, as we are 
doing this, we have got both of these going on at the same 
time, is we are trying to then do our electronic pedigree, and 
Mr. Dingell has a bill, and we are going to do work and do this 
electronic pedigree, but let me tell you what I was bothered 
about what I read in the Miami Dade about your last blitz. I 
think it is great. Like I said, you are doing the blitz. You 
did a 3-day blitz. You did everything you were supposed to do, 
your coordination with Customs, Border Protection, thousands of 
pieces of foreign mail. You X-rayed them. You separated them. 
You identified them, the suspicious pharmaceutical products. 
You ID'd them. You showed how many of them were counterfeit and 
knocked off, and then you sent them back. America has to be 
shocked, and the counterfeiters have to be excited that America 
is a place where you can counterfeit your drugs, send them to 
America, steal people's money, and the American government will 
send the counterfeit drugs back to you so you can then send 
them to someone else that you can steal more money from. This 
is like one of the dumbest policies I think we have in this 
    Now, last year I sent questions on this, and the answer 
from FDA is that FDA currently has authority to seek through 
the judicial process the destruction of any drug and other FDA-
related products that relates to the Federal Food, Drug and 
Cosmetic Act. Now, the person right next to your inspectors, 
Customs, I mean, there is no wall. You have been there, right? 
There is no wall between these guys. That customs person, when 
they see it identified prima facie as knockoff, they destroy 
it. But if they hand off and give to the FDA person, the FDA 
says we can't destroy it, put a label on it and they send it 
back. I know you have got to be uncomfortable with that as a 
policy. Are you?
    Dr. Sharfstein. Yes. I mean, I have spoken to some of the 
inspectors who are, you know, as frustrated as you are.
    Mr. Buyer. All right. Now, if you are willing to step into 
a new--and that was your testimony that you gave to us in 
March, that you embrace and wanted to adopt a new approach with 
regard to the raw ingredients, through production and 
distribution always to U.S. consumers, I think I have an 
opportunity. I think, Mr. Dingell, we have an opportunity to 
help protect America, and that is embrace what the FDA is 
saying here, Mr. Dingell, and let us figure out how we can 
destroy these when they are identified, when your inspectors 
identify them. Let us not send them back to the counterfeiters 
so they can continue to rip off people. You know, Doc, come on, 
they are preying upon the most vulnerable of our population, 
which is awful. Would you be willing to work with Mr. Dingell 
and I to come up with a policy here that can give your 
inspectors the ability to destroy these counterfeit, knockoff, 
adulterated drugs?
    Dr. Sharfstein. Yes, and I believe we have been already 
starting that process by working with your staff and 
Congressman Dingell's staff on this issue.
    Mr. Buyer. All right. Well, I want to be as proactive as we 
possibly can. John Dingell, to his credit, started this a long 
time ago with his paper pedigree, and he has always had a great 
interest. It goes all the way back many years into the 1970s, 
and I applaud what he has done. I think he has got to be pretty 
shocked on where America is today compared to where we were in 
the 1970s, and as a policy and I know you adopted this, I was 
just as frustrated with the last Administration but I am 
embracing your spirit, and if we are able to move ahead, Mr. 
Dingell, I want to join with you today and I want to work with 
the FDA and I want to resolve this matter.
    I want to yield to the chairman for a second.
    Mr. Dingell. I thank the gentleman. He is most kind to me, 
and I want to thank him for the kind comments he has made about 
me. I want to assure him that my assurances of the last 
Congress, I would be happy to work with him, and I happen to 
agree with the gentleman about the problem of imports, about 
tracing pharmaceuticals and other drugs, and I am pleased to 
report to the gentleman that very shortly we will be 
circulating a draft for comments about pharmaceutical safety, 
and I hope that the gentleman when that occurrence happens that 
he will look at it with sympathy and I look forward to working 
with him because he is a valuable member of the committee, and 
I thank him.
    Mr. Buyer. I thank the gentleman.
    The last, can I do this piece of math? Thirteen----
    Mr. Pallone. The gentleman's time has expired, but all the 
    Mr. Buyer. I ask unanimous consent for 30 seconds.
    Mr. Pallone. Yes, with all the love and bipartisan here----
    Mr. Buyer. God bless you.
    Mr. Pallone. I certainly don't want to stop the gentleman.
    Mr. Buyer. Thirteen international mail facilities, on 
average 35,000 are pharmaceutical packages, times 365 days, 
that is 1,666,075 packages a year. If 80 percent are 
counterfeit, adulterated or knocked off, that means there are 
132,860 pharmaceutical packages that are coming into the 
country that are either adulterated, counterfeit or knockoff, 
and people are taking these and they are not metabolizing in 
the body in ways in which as doctors you intend.
    With that, I yield back. Thank you.
    Mr. Pallone. Thank you.
    The gentlewoman from--I am sorry. Chairman Dingell is next.
    Mr. Dingell. I thank you, Mr. Chairman.
    These questions are for all three witnesses. The first is 
yes or no. Is there a definitive link between antimicrobial use 
in animal feed and antibiotic resistance in humans? Starting 
with Dr. Sharfstein.
    Dr. Sharfstein. Yes.
    Mr. Dingell. Our next witness, Doctor.
    Dr. Clifford. Yes, some.
    Mr. Dingell. Some?
    And you, Dr. Khan.
    Admiral Khan. Yes, sir.
    Mr. Dingell. Now, Dr. Sharfstein, please tell us what 
scientific studies support your claim.
    Dr. Sharfstein. I think the best document that begins to 
summarize those is this 2003 study from the World Health 
Organization and it goes through outbreak investigations, 
epidemiological investigations, field studies, case reports, 
spatial and temporal associations and molecular subtyping. In 
each of those areas of research there are studies that support 
that statement.
    Mr. Dingell. Now, Doctor, if you would like, I would be 
pleased to have you make other submissions supporting the 
statement which you just made.
    So next question to all three of our panel members. Are 
these studies based--rather is to Dr. Sharfstein. Are these 
studies based entirely on the European experience or do we have 
some that reflect experience in the United States?
    Dr. Sharfstein. They are both based on European experience 
and some that are in the United States including one by someone 
I went to medical school with.
    Mr. Dingell. Now, again, Dr. Sharfstein, it is my 
understanding that FDA currently has authority to withhold 
approval for certain animal drugs if they are use poses a risk 
to the public health. Is that correct?
    Dr. Sharfstein. That is correct.
    Mr. Dingell. OK. Now, does the likelihood that an 
antimicrobial drug used to treat a food-producing animal may 
cause antibiotic resistance to a problem in humans to pose a 
risk, and I put the risk to public health in quotes. What is 
the answer to that? Do you want me to repeat the question?
    Dr. Sharfstein. Yes.
    Mr. Dingell. Does the likelihood that an antimicrobial drug 
used to treat a food-producing animal may cause an antibiotic 
resistance problem in humans pose a ``risk to public health''?
    Dr. Sharfstein. I think that the likelihood that that would 
happen does factor into the regulatory process as we approve 
new antimicrobials, so yes.
    Mr. Dingell. And our other two witnesses, Dr. Clifford and 
Dr. Khan, what is you view on that question?
    Dr. Clifford. Could you repeat that question again, please?
    Mr. Dingell. It is a difficult question. All right. Does 
the likelihood that an antimicrobial drug used to treat a food-
producing animal may cause an antibiotic resistance problem in 
humans pose a ``risk to the public health''?
    Dr. Clifford. I still--yes, I mean, it is possible for 
    Mr. Dingell. Dr. Khan.
    Admiral Khan. Yes, sir, and there is currently ample 
evidence that use of antibiotics in animals results in 
resistant bacteria in food animals, resistance is present in 
the food supply and transmitted to humans and that resistant 
bacteria result in adverse human health effects. So that data 
already exists and is summarized in various documents.
    Mr. Dingell. Now, gentlemen, again, based on this 
interpretation, and this is to Dr. Sharfstein, based on this 
interpretation, since 2003 FDA has considered the likelihood 
for antimicrobial resistance in the drug approval process. Is 
that correct?
    Dr. Sharfstein. Yes.
    Mr. Dingell. Now, has the interpretation been applied to 
all drugs currently on the market as well as new applications 
for drugs where the manufacturer is seeking access to the 
    Dr. Sharfstein. No, it has just been applied to new drugs 
coming on, and that is the reasons we would like to do this 
guidance is addresses some of the issues with the drugs that 
were already on the market.
    Mr. Dingell. But you are not dealing with those which are 
already on the market. All right.
    Now, why has this interpretation not been used more widely 
for those drugs that were on the market prior to 2003? Is it 
for want of authority by Food and Drug?
    Dr. Sharfstein. I don't believe it is for want of 
authority, no.
    Mr. Dingell. Now, Doctor, what are some of the barriers to 
new antibacterial drug development and what is FDA doing to 
help spur innovation in this area?
    Dr. Sharfstein. I think there are two main barriers to 
antimicrobial drug development. One of them is the need for 
clear approval pathways so that companies can design studies 
that can reach the right endpoints and be approved, and FDA is 
working very hard to get the science right so we can have those 
clear approval pathways. There is a meeting by the end of July 
that will be the next step in that process.
    The second major issue is the issue of incentives for 
antibiotic development because it is expensive to bring drugs 
to market, and for antibiotics we don't want them to be used 
that much when they are there so the market isn't that great, 
so we believe there is a market issue as well as a pathway 
issue. FDA is supportive of discussions around the market 
incentive issue but it is a little bit outside of our sphere to 
really solve that problem.
    Mr. Dingell. Thank you.
    Mr. Chairman, I have used more than my time. Thank you.
    Mr. Pallone. Thank you, Mr. Chairman.
    Next is the gentlewoman from Illinois, Ms. Schakowsky.
    Ms. Schakowsky. Dr. Sharfstein, I am trying to understand 
then what the guidance says. Does it say it will only apply to 
new drugs?
    Dr. Sharfstein. No, no. I am sorry. I must have been 
    Ms. Schakowsky. Oh, OK.
    Dr. Sharfstein. There is a Guidance 152 that only applies 
to new drugs. I was referring to a guidance that was issued in 
2003. I think that was what Chairman Dingell was referring to. 
This new guidance--one of the reasons that we are issuing this 
new draft guidance is because the old one doesn't apply to 
existing drugs. This deals with some of the issues with 
existing drugs.
    Ms. Schakowsky. This would apply to all antibiotics?
    Dr. Sharfstein. All medically important antibiotics.
    Ms. Schakowsky. Right. OK. So we have the FDA, the USDA, 
the CDC here today. Which agency has lead jurisdiction to 
ensure then that the public is not at risk from overuse of 
antibiotics in livestock feed?
    Dr. Sharfstein. I think FDA has regulatory authority over 
the use of antimicrobials in animals, but we work very closely 
with our----
    Ms. Schakowsky. That was my next question. So how do you 
coordinate? Is there some sort of a----
    Dr. Sharfstein. Yes, the President's Food Safety Working 
Group is one of the places that we have had very good 
discussions. This issue has been presented in a lot of 
discussions, and then separate from the big group, we have also 
worked individually. I think Dr. Clifford and the team at FDA 
were on the phone multiple times, and certainly CDC was within 
HHS, we are constantly talking to CDC at FDA.
    Ms. Schakowsky. The FDA voluntary guidelines address non-
therapeutic use, right?
    Dr. Sharfstein. It addresses what we call production uses, 
growth promotion, feed efficiency.
    Ms. Schakowsky. But I heard that poultry farmers have 
recently stated that from egg to slaughter, chickens and 
turkeys always need antibiotics to prevent disease. Now, here 
is my concern. If you are only talking about non-therapeutic 
use, what is to prevent farms from re-categorizing the purpose 
of the antibiotics they give to animals instead of actually 
ending the overuse?
    Dr. Sharfstein. Well, I think you are getting to the 
concept of prevention, how we would approach preventive uses, 
and what the guidance, the draft guidance states is that it is 
not enough for someone to say I think this prevents disease, 
that is not enough, that our approach to prevention has to be 
based on evidence, and factors to consider include the evidence 
of effectiveness, the evidence that such a preventive use is 
consistent with accepted veterinary practice, evidence that the 
use is linked to a specific microbial agent, evidence that the 
use if appropriately targeted and evidence that no reasonable 
alternatives for intervention exist. So if we were going to 
look at prevention uses, which we do believe are important, can 
be important for animal health, we would apply kind of a 
scientific evidence-based set of criteria to that scenario.
    Ms. Schakowsky. Dr. Khan, are you comfortable with that as 
well? Because you talked about prevention being the best thing.
    Admiral Khan. Very much, ma'am, and this is also consistent 
with how we use antibiotics in humans for prevention purposes, 
so a good example is meningococcus. It is a meningitis, 
inflammation of the brain. We do use it for prevention, a 
specific drug for prevention purposes, but it is specific to 
targeted people who get it. You get the drug twice a day for 
two days for targeted infection. You don't get it forever, and 
everybody in the emergency room, for example, doesn't get it.
    Ms. Schakowsky. Let me ask you this. To what extent would 
it be true to say that the use of antibiotics can be effective 
in masking unsanitary conditions where livestock is raised? In 
other words, if you use antibiotics, then you don't have to be 
quite as precise about the level of cleanliness at places. Is 
this ever an issue?
    Dr. Clifford. Production management with regards to farms 
and location of animals, that type of thing could be possible 
but that is not a good management use of animals and it is not 
going to lead to their bottom line economically. If they run 
poor sanitation on a farm and have to use antibiotics to offset 
that, they are taking away cost and dollars from their 
operation, and the bottom line with production agriculture, it 
is economics. I mean, they are raising food and----
    Ms. Schakowsky. But let me--can I ask one quick question?
    Dr. Sharfstein, the guidance has no enforcement component. 
How can we be sure that it will have any effectiveness at all?
    Dr. Sharfstein. Well, the way we think of this is not much 
as a guidance or regulatory document, this we kind of put out 
as a white paper. This is sort of the foundation for how FDA 
intends to move in this area, and then it is basically like a 
foundation for us to build on. We have had some productive 
discussions with the various components of the animal 
agriculture industry and we expect that we will be seeing 
movement in this direction by their good efforts and I think 
their comments in response to the guidance indicate that, but I 
also think that as we move forward under this kind of 
framework, we will be open to the idea that we will then have 
to, you know, consider regulatory options. So this was not 
intended as a regulatory document. It was really intended as a 
here is what the science says, here is the right direction to 
move in, and really let us get comments on how to do this as 
well as possible with the minimal impact on agriculture and let 
us do it effectively, but we are going to see what we can get 
from setting this vision and then we are going to consider 
other things.
    Ms. Schakowsky. This is really a health hazard. It all 
sounds real slow but I hope that we will have a progress report 
that will show some movement before too long. Thank you.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    The gentlewoman from the Virgin Islands, Ms. Christensen.
    Mrs. Christensen. Thank you, Mr. Chairman, and thank the 
panelists. I really thought I had missed this first round of 
questioning with the panel but I am glad I didn't.
    Just maybe three questions. Dr. Sharfstein, welcome back.
    Dr. Sharfstein. Thank you.
    Mrs. Christensen. The FDA should now be implementing and 
receiving--I apologize if this question was asked--and 
receiving more detailed animal drug sales data under the Animal 
Drug User Fee Act Amendments that was signed into law in 2008. 
Has any data started coming in?
    Dr. Sharfstein. Yes, we have started to get data.
    Mrs. Christensen. I am concerned that we don't seem to have 
a method in this country to track actual usage of these drugs 
in animals that become food. Is that concern warranted, and if 
so, when would be able to review an analysis of this new data 
to see whether additional reporting requirements might be 
    Dr. Sharfstein. Well, first, we are starting to pull 
together the data. We are just getting--I don't think we have a 
complete set yet. I am not 100 percent sure about that, but I 
know that we are just sort of pulling it together, and I don't 
think it will be too long before we will be able to share some 
of that information. But I think to your point, I think you are 
exactly right. The data under ADUFA is just part of it. It is 
overall sales and a little bit by particular use, but it 
doesn't really tell you how the antimicrobials are being used. 
It is not the kind of data, for example, that we might get 
about pediatric practice and pediatricians' use of 
antimicrobials, and so I think that one of the things that we 
have been talking about, and there is a meeting very shortly in 
NARMS coming up is that there is a need for a better 
surveillance system and that is something where we hope to work 
very closely with USDA on.
    Mrs. Christensen. Thank you.
    Dr. Khan, we talked a lot about the antibiotic resistance 
in animals and the fact that it creates resistance in humans 
but how do people become exposed to antibiotic-resistant 
bacteria through the food supply? Is it by eating contaminated 
meat and poultry or can cross-contamination become a problem? 
And does cooking resolve the problem? Could you just clarify 
for us how that happens?
    Admiral Khan. Yes, ma'am, I would be glad to. There are 
multiple mechanisms by which resistant bacteria in animals can 
make their way into humans. The first is the most obvious. That 
would be the direct transmission or the direct route, and that 
would be directly from animals to humans, and we see that----
    Mrs. Christensen. Just from contact working with animals?
    Admiral Khan. Direct contact, and we see that reported all 
the time. The second mechanism within that direct route is from 
food, so contamination of food that subsequently you are 
handling and you become infected. So we see that route as the 
direct route. There is also the indirect route of transmission, 
and this is where specific genetic material within a bacteria 
of animals can move into bacteria of humans and that 
resistance, so although the bacteria in animals doesn't move to 
humans, the resistant pattern moves into humans and then can 
cause human resistant bacteria.
    Mrs. Christensen. Thank you for that clarification.
    And Dr. Clifford, if funds were available, would the USDA 
be willing to initiate a pilot program where producers could 
receive assistance for transitioning to antibiotic-free methods 
and where results could be collected and reported?
    Dr. Clifford. I think one of the issues that is out there 
is the lack of evidence of cause and effect when you remove 
these things, so I think it would be important to look at some 
of these types of things from the standpoint of a pilot project 
but also from the standpoint of the development of other 
methods and working with industry and such as vaccine 
development and other technologies to be able to better address 
this issue.
    Mrs. Christensen. So do you have other priorities such as 
vaccines? New vaccines would be a higher priority than----
    Dr. Clifford. I am not saying which one would be the 
highest priority but I think all those things need to be looked 
at, and I think we as a body within the federal agencies need 
to be identifying, sitting down and working with the industry 
and others to identify the highest priorities and identify the 
way that we can best use our resources to address those.
    Mrs. Christensen. In your testimony, you say that animal 
impacts must be considered in the context of the decision-
making process. Does that mean that there is some tension 
between USDA and FDA over the approach or are you all on the 
same page?
    Dr. Clifford. Well, I think in general concept, we are on 
the same page. I mean, it is not that FDA and USDA are going to 
agree on every particular issue. I think it is important to 
note that as we all know, this is an extremely complex issue. 
My role as chief veterinary officer is the protection of animal 
health. Obviously I care very much about public health as well. 
So I think we have got to look at all of these things and 
balance these things, and this is a very complex issue and we 
don't believe that one size fits all.
    Mrs. Christensen. Thank you for your answers.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Ms. Christensen.
    Thanks a lot. Unfortunately, we are interrupted with two 
sets of votes today but I appreciate your bearing with us and 
also changing the date which we did on you a few weeks ago, so 
this is very helpful. Now, we will likely send additional 
questions in writing within the next 10 days or so, but I 
appreciate your being here today. Thanks so much.
    Marathon panel coming up here. Let me welcome the second 
panel. I hope you have enough room there kind of squeezed in. 
Let me introduce each of you. Starting on my left is Dr. Per 
Henriksen, who is Head of the Division for Chemical Food 
Safety, Animal Welfare and Veterinary Medicinal Products from 
the Danish Veterinary and Food Administration. And then we have 
Dr. James R. Johnson, Director of Infectious Disease Fellowship 
Program and Professor of Medicine at the University of 
Minnesota; Dr. Gail R. Hansen, who is Senior Officer for the 
Human Health and Industrial Farming Group of the Pew Charitable 
Trust; Dr. Christine Hoang, who is Assistant Director, 
Scientific Activities Division for the American Veterinary 
Medical Association; Dr. Randall Singer, Associate Professor of 
Epidemiology, Department of Veterinary and Biomedical Sciences, 
also from the University of Minnesota; Dr. Richard Carnevale, 
Vice President, Regulatory, Scientific and International 
Affairs from the Animal Health Institute; and Dr. Stuart Levy, 
who is Professor of Molecular and Microbiology and Professor of 
Medicine at Tufts University.
    As you know, we ask each of you to limit your comments to 5 
minutes, and then of course you can submit additional written 
comments as well, and we will start with Dr. Henriksen.

                        TUFTS UNIVERSITY


    Dr. Henriksen. Thank you, Mr. Chairman, Mr. Ranking Member 
and members of the subcommittee for inviting me to testify. 
First I can say I am a veterinarian by training, got my degrees 
from Royal Veterinary and Agriculture University of Copenhagen, 
Denmark. I have been working as a scientist for more than 10 
years. I have been working in the farmers' organization as a 
health consultant for more than 5 years and working for the 
Danish government for more than 10 years.
    As a representative of the Danish government, I am aware 
that the use of antibiotic growth promoters is a contentious 
issue in the United States and that Denmark is often mentioned 
in the debate. Against this background, I wish to emphasize 
that the Danish government is not represented here today to 
advocate for or against any specific legislative proposals. 
However, we are a nation willing to share our experiences when 
requested and therefore we have accepted your kind invitation.
    I submitted five fact sheets for the record, and with the 
subcommittee's indulgence, I will therefore shorten my remarks 
to allow for your questions.
    Mr. Pallone. I want to interrupt and say that I understand 
you obviously came from Denmark here today to participate in 
this hearing, and we really appreciate your coming so far to be 
with us today. Thank you.
    Dr. Henriksen. Thank you.
    Denmark is a major livestock producer in Europe and the 
world's largest exporter of pork. Danish livestock production 
is highly industrialized, intensive and supplies modern 
management principles. Due to the significance for the Danish 
economy, the Danish government takes the competitiveness of the 
Danish farmers seriously.
    Treatment with antibiotics is in many cases essential for 
human and animal health and an uncritical use of antibiotics 
can lead to several antibiotics becoming ineffective. Because 
antimicrobial resistance can be transferred between bacteria, 
regardless of whether the bacteria are pathogenic or not, the 
development of antimicrobial resistance in any kind of bacteria 
can constitute a problem.
    It is a fact that antimicrobial resistance can be 
transferred from animals to humans by consumption of meat, and 
every year also Denmark experience human outbreaks caused by 
consumption of meat contaminated with resistant bacteria.
    A ban on antimicrobial growth promoters was considered 
necessary for several reasons in Denmark. There was science-
based evidence that the use of antibiotics in animal feed could 
create resistance in pathogenic bacteria to medically important 
antibiotics, and there was a real concern that doctors would 
run out of options for treating life-threatening infections in 
humans. Given the fact that very recently, a Danish Ph.D. 
project concluded that production animals and meat might be a 
source of human E. coli urinary tract infections, the Danish 
ban seemed to be an example of due diligence.
    Among the initiatives that are all mandated by the Danish 
government, I would like to mention the following: No 
prophylactic use of antimicrobials and mandatory low fixation 
of the veterinarians' profit from sales of medicine. This 
fixation of low profit was an initiative of the Danish 
Veterinary Medical Association. The critically important 
antibiotics call fluoroquinolones can only be used in Denmark 
if a laboratory test shows that no other antibiotics can be 
used. Treatment guidelines for swine and cattle veterinary 
practitioners have been issued by the government. Continuous 
monitoring and research in antimicrobial resistance in animals, 
humans and food. Monitoring of foodborne pathogens in Danish as 
well as imported meat. Antimicrobial resistance is one of the 
parameters used to determine whether a shipment of imported 
food is dangerous or not. Control and action plans to combat 
Salmonella bacteria in poultry and pork and Campylobacter in 
poultry are implemented. And the most recent development 
includes mandatory action plans in swineherds above a certain 
threshold value for antibiotic use, the so called ``yellow 
    It is important to note that, according to our experience, 
a ban on antibiotic growth promoters can immediately and 
dramatically reduce the amount of antibiotics used. In Denmark 
the decrease was 40 percent. Such a ban should not stand alone 
in the long run. This explains the fact that we have 
implemented this range of follow-up measures and we can expect 
also to have to take additional steps in the future.
    The ban of growth promoters has resulted in a marked 
reduction in antimicrobial resistance as measured among several 
different bacterial species in food animals. The percentage of 
macrolide resistance in porcine Campylobacter has decreased 
from 80 percent before the ban to less than 20 percent in 2006. 
A similar reduction from more than 75 percent vancomycin 
resistance in enterococci isolated from broilers before the ban 
to less than 5 percent.
    Additionally, Denmark has a markedly lower level of 
resistant bacteria in meat compared to meat imported from other 
EU member states. I can mention as an example, that the 
percentage of cephalosporin resistance in E. coli isolated from 
Danish broilers' meat is less than 5 percent, while more than 
35 percent of E. coli isolated from broiler meat from other EU 
member states reveals cephalosporin resistance. This marked 
difference in resistance can be ascribed to our ban of growth 
promoters and low usage of antimicrobials compared to other EU 
    The Danish swine industry has been producing pigs without 
the use of growth promoters for many years now and has 
increased both the production and the productivity. The same 
picture applies in the broiler chicken and cattle industries. 
In the last few years, and particularly in 2009, we have noted 
an increase of usage of antimicrobials above the concurrent 
increase in pig production. However, as this increase appears 
more than 10 years after the ban, we do not relate this to the 
ban. Nevertheless, we take this recent increase in usage 
seriously and have imposed several initiatives.
    When presenting the Danish experience here in the United 
States, it is important to stress that Denmark is favored by a 
range of institutional characteristics which helped 
implementing the ban and the following steps. In Denmark, we 
can identify every herd, farmer and veterinarian and we are 
able to pinpoint the antimicrobial usage right down to the 
individual cow and to an age group of swine. This is due to our 
many databases on husbandry and medicine usage. And we have 
also monitored and researched in resistance for the past 15 
years in a program called DANMAP. Our farming industry is 
highly organized in a cooperative structure with one common 
organization for farmers and food companies. We have a 
longstanding tradition for working towards a consensus between 
government, industry and the Danish Veterinary Medical 
Association. I would like to mention that the Danish Veterinary 
Medical Association along with the Danish Medical Association 
has supported a ban from the beginning.
    Working as an entity, the Danish swine industry has 
therefore played an important role and voluntarily stopped all 
non-therapeutic use of antibiotics starting in 1998, with a 
total state ban in place by January 2000. Only 2 weeks ago the 
Danish swine industry again issued a voluntary ban, this time 
against therapeutic treatment with the critically important 
antibiotic cephalosporin. Danish farmers are well educated and 
have easily learned to produce pigs without growth promoters. 
Instead, they use good management, weaning at 28 days instead 
of 21 days, initiatives concerning food and proper care of sick 
animals. These institutional advantages have enabled Denmark to 
take ambitious risk-mitigating strategies in order to combat 
antimicrobial uses and resistance and without endangering the 
economic sustainability of the swine industry.
    If you have any questions, I will gladly answer them, and I 
will also your attention to the fact sheet handed out. Thank 
you for your attention.
    [The prepared statement of Dr. Henriksen follows:]

    Mr. Pallone. Thank you, Dr. Henriksen.
    Dr. Johnson.


    Dr. Johnson. Chairman Pallone----
    Mr. Pallone. Could you maybe bring that mic a little 
closer? I always gave Dr. Henriksen a lot of leeway, since he 
came from Denmark. The rest of you should try to stick to the 5 
minutes. I think you have to either turn it on or move it 
    Dr. Johnson. It was the turning it on. Thank you.
    Chairman Pallone, Ranking Member Shimkus and members of the 
subcommittee, on behalf of the 9,000-plus members of the 
Infectious Diseases Society of America, or IDSA, I appreciate 
this opportunity to speak in support of the Health 
Subcommittee's efforts to promote judicious use of medically 
important antibiotics in animal agriculture. I am James 
Johnson, an infectious diseases physician, a Professor of 
Medicine at the University of Member, and a member of IDSA's 
antimicrobial resistance work group.
    I applaud the emphasis that Ranking Member Shimkus and 
Congressman Pitts as well as other speakers today have put on 
science as a foundation and guide for decision-making in this 
area. I would point out that IDSA is made up of research 
scientists, infectious disease commissions and public health 
epidemiologists who value and rely on the scientific method. 
IDSA supports rigorous science and critical impartial 
evaluation of the scientific evidence base. IDSA also publishes 
two of the premier peer-reviewed scientific medical journals in 
infectious diseases, Journal of Infectious Disease and Clinical 
Infectious Disease. These two journals have published dozens, 
if not hundreds, of peer-reviewed scientific studies on this 
    IDSA supports efforts to eliminate all non-judicious uses 
of antibiotics in human medicine and agriculture such as the 
Preservation of Antibiotics for Medical Treatment Act, or 
PAMTA, and the FDA's recently announced public health approach 
toward antibiotic use in food animals. The elimination of non-
judicious will mean the end of antibiotics for growth 
promotion, feed and efficiency and routine disease prevention 
in food animals. The United States also must strengthen efforts 
to ensure that all other food animal antibiotic use is 
supervised by a veterinarian within the boundaries of a valid 
veterinarian-client-patient relationship.
    Now, IDSA regards the development of antibiotics to treat 
life-threatening infections as one of the most notable medical 
achievements of the past century. Unfortunately, these wonder 
drugs' ability to cure is being increasingly compromised by 
emerging antibiotic-resistant pathogen, and there are few new 
antibiotics in development that will come to our rescue any 
time soon. As a result, infectious disease physicians and 
public health experts believe that we must do everything in our 
power to preserve existing antibiotics to protect both human 
and animal health.
    As noted in opening statements by several committee member 
including Congressman Murphy and the Administration witnesses, 
an extensive body of scientific evidence demonstrates that 
antibiotic use in food animals does contribute to the spread of 
resistant bacteria to humans, leading to drug-resistant 
infections with their many adverse consequences. Our written 
testimony cites science-based studies and reports from 
authoritative panels over the past 40 years that support this 
position including studies supported by USDA and CDC. 
Eliminating non-judicious antibiotic uses in food animals would 
help protect the American people against drug-resistant 
infections and extend the utility of existing antibiotics. This 
concludes reflects a broad consensus within the medical, 
scientific and public health communities. Such measures have 
been advocated repeatedly by the World Health Organization and 
the National Academy of Sciences, and as you have heard here 
today, have already been implemented across Europe.
    IDSA is very encouraged by FDA's new draft guidance to 
industry which establishes a policy framework for judicious 
food animal antibiotic use. We view this new guidance as an 
important first step. Both FDA's guidance and PAMTA provide 
elements of the overall policy framework that Congress should 
consider as it moves forward to develop and enact legislation.
    We are concerned, however, by FDA's apparent decision to 
rely on drug companies to voluntarily remove growth promotion 
and feed efficiency claims from their drugs' labels. Past 
experience suggests that this will take years or decades and 
many companies will not comply. Therefore, we urge Congress to 
expedite the process through legislation.
    We also are concerned that FDA does not specify its plans 
for eliminating those uses of antibiotic in food animals for 
prevention, control and treatment that likewise may be non-
judicious. These also must be addressed.
    U.S. experts also require access to reliable and 
standardized data regarding the scope of antibiotic consumption 
in humans and animals. The lack of data in both the human 
health and agricultural settings impedes our ability to respond 
effectively to the antibiotic resistance problem. Although the 
U.S. Animal Drug User Fee Amendments, or ADUFA, legislation of 
2008, as mentioned earlier, strengthened FDA's ability to 
collect animal antibiotic sales and distribution data. This was 
only for national-level data. What we need are local-level data 
reported by animal species. Of importance, also pharmacists do 
not control antibiotic distribution in the agricultural sector. 
Instead, feed mill operators are responsible for mixing animals 
into antibiotic feed and they control antibiotic distribution 
from the drug manufacturers to our Nation's farmers. Given feed 
mills' key role in distributing these lifesaving drugs, they 
must become better integrated into the infrastructure for 
protecting antibiotic by tracing and regularly reporting to the 
FDA the amount of antibiotics being consumed by each animal 
    In conclusion, the Subcommittee on Health has a long 
history of leadership in addressing our Nation's most pressing 
public health issues. Today, IDSA calls upon you to help 
protect our patients and the health of every American by 
adopting strong measures including PAMTA to end non-judicious 
antibiotic use in food animals and to require that other food 
animal uses of these precious drugs be supervised by a 
veterinarian within a valid veterinarian-client-patient 
relationship. We also urge the committee to move with haste to 
enact the Strategies to Address Antimicrobial Resistance, or 
STAR Act, which will significantly strengthen U.S. antibiotic 
resistance efforts. Finally, we urge you to enact statutory 
incentives to spur new antibiotic development.
    Thank you, and I will be happy to answer questions.
    [The prepared statement of Dr. Johnson follows:]

    Mr. Pallone. Thank you, Dr. Johnson.
    Dr. Hansen.

                  STATEMENT OF GAIL R. HANSEN

    Dr. Hansen. Chairman Pallone and Ranking Member Shimkus and 
members of the subcommittee, good afternoon, late afternoon, 
and thank you for inviting me. I am Gail Hansen. I am a 
veterinarian. I am a member of the AVMA, the American 
Veterinary Medical Association, and I also a Senior Officer 
with the Pew Charitable Trust.
    Obviously, I care very deeply about this issue and I have 
worked on antimicrobial resistance from a lot of different 
angles. I was a State public health veterinarian for the Kansas 
Department of Health and Environment in Kansas, obviously, in 
working with both human and animal diseases. I was also a 
veterinarian in private practice for several years in 
Washington, New York City, North Carolina, and before I even 
got into veterinary school I was interested in this topic 
because I worked for the Food and Drug Administration, what was 
then the Bureau of Veterinary Medicine, in 1978. That was the 
year that FDA first proposed eliminating some drugs as growth 
promoters in animal feeds based on the science, and we are 
still here today.
    I want to pick out one experience with a bacteria called 
Campylobacter that you have heard about to illustrate the real 
problem of antibiotic resistance, and let me give you a quick 
background on Campylobacter. It is a real common foodborne 
disease similar to Salmonella and E. coli, which you may be 
familiar with. You get the same sort of symptoms. You have 
diarrhea, you have vomiting. It is pretty unpleasant. There can 
be some nasty complications that can occur with Campylobacter. 
I guess the good news about that is that we can treat it with 
antibiotic. The bad news is that the bacteria is becoming 
resistant to antibiotics. We also that this is a bacteria that 
is found in poultry and cattle. People get it from eating 
contaminated poultry or meat, as we have heard before.
    So let me talk to you about the Campylobacter outbreak that 
I dealt with in Kansas in 1998 in Salina, Kansas. We had a 
middle school where we had over 100 people that got sick with 
Campylobacter. The physicians were using Cipro and tetracycline 
to treat people because those are the drugs that all the books 
said you should use, but then we found out that Campylobacter, 
that Campylobacter was resistant to both of those drugs so the 
physicians couldn't use those drugs. There was unequivocal 
evidence that the resistance came from antibiotic that were 
given to animals. Tetracycline was used and still is used in 
cattle and poultry, and at that time Cipro was used in poultry 
and it is still used in cattle today.
    So antibiotic resistance from feeding low levels of 
antibiotics to animals is real. It is here. We have got 40 
years of science-based evidence and it is very clear. I have a 
book here which I have given you an annotated version of the 
bibliography of this that has some of the peer-reviewed studies 
that we have over the last 40 years, so there is plenty of 
    Antibiotics are overused in farm animals, in industry 
farming to the detriment of human health. Animals are fed low 
levels of antibiotics for growth promotion in the absence of 
disease, and especially when bacteria come in contact with low 
levels of antibiotics, it makes it much easier for them to 
become resistant to antibiotic. That whole thing of what 
doesn't kill you makes you stronger works for the bacteria as 
well. And then that resistance gets transferred to people and 
ultimately the antibiotics that we use for people don't work 
anymore for people and they don't work for animals either, and 
that is pretty scary.
    But there are some effective alternatives to low-level 
antibiotic use available to farmers and ranchers. Just this 
last Saturday, I got back from a trip to Denmark looking at 
what Dr. Henriksen talked about, and how their industrial 
farmers are able to efficiently raise pork without the use of 
non-therapeutic antibiotics. Farmers only give antibiotics, as 
he said, when they are prescribed by a veterinarian for a 
specific disease. The farmers at that point worked with 
veterinarians and with others to find effective management 
strategies that work.
    So the American public really needs Congress to pass PAMTA. 
The FDA guidance document is not likely to fix the problem by 
itself. We need your help, and that is what PAMTA does. PAMTA 
disallows the use of seven classes of antibiotics that are 
critically important for human health to be used for non-
therapeutic purposes unless it can be shown that the use 
doesn't contribute to antibiotic resistance in people. It still 
allows antibiotics to be used to treat sick animals. We 
absolutely have to have that. But we want to make sure that we 
protect antibiotics for people and animals. We can help the 
farmers and ranchers get past this outdated and very dangerous 
practice of feeding antibiotics to healthy animals.
    Unfortunately, the American Veterinary Medical 
Association's position on PAMTA is different from mine and from 
many other veterinarians. I am disappointed, I guess is the 
best word, that the AVMA has not yet come to the same 
conclusions that the American Medical Association and the 
American Nurses Association, the American Academy of Pediatrics 
has come to on the importance of this bill.
    Thank you for the opportunity to testify. I would be happy 
to answer any questions.
    [The prepared statement of Dr. Hansen follows:]

    Ms. Schakowsky. [Presiding] Thank you.
    Dr. Hoang.


    Dr. Hoang. Thank you for the opportunity to speak about 
antimicrobial resistance and the use of antimicrobials in 
animal agriculture. My name is Dr. Christine Hoang and I 
represent the American Veterinary Medical Association.
    As a veterinarian with a dual degree in veterinary medicine 
and public health, and additionally certified in public health, 
my work is largely focused on scientific evaluations to inform 
the decision-making process both domestically and abroad 
through the AVMA, the Codex Alimentarius Commission and prior 
to that the Food and Agricultural Organization of the United 
    The AVMA's 80,000 members are engaged in every aspect of 
veterinary medicine and public health. As veterinarians, our 
oath ethically charges us with promoting public health and 
protecting animal health and welfare. With that also comes the 
responsibility to be cognizant of the potential health impacts 
in humans that may occur as a result of any decision that we 
make. The veterinarian must always the consider individual 
animal, other animals and humans in contact with that animal, 
and if it is a food animal, we must ultimately consider the 
people who consume the end product. The decisions of the 
veterinarian go far beyond a single animal or person and an 
entire herd or flock and potentially hundreds of thousands of 
people that are affected by the many foods that are produced by 
a single animal. Therefore, as veterinarians, we carry a heavy 
burden but we do willingly with the knowledge, education and 
ability to make the right decision and to use the tools that 
are available to us appropriately and judiciously. Our members 
share the same concerns as our human health counterparts but 
yet we have additional concerns that must be considered: 
impacts on animal health and welfare and even negative impacts 
on human health that are often unrealized.
    Two decades ago, a study concluded that human health 
hazards from growth-promoting uses could not be proven nor 
disproven. The debate continues today for that very same 
reason. A direct epidemiologic investigation still cannot be 
completed. Furthermore, there are divergent opinions due to 
differing levels of acceptable risk. For example, a person 
might find risk associate with food unacceptable, any risk 
would be unacceptable, but risks associated with high-speed 
driving perfectly permissible.
    As veterinarians, we must consider many risks, risk to the 
animal, risk to ourselves, risk to our clients, risk to public 
health, risk of action and risk of inaction, and the accepting 
of some of those risks in order to minimize others. Whenever 
antibiotics are used, there is some risk of resistance 
developing. That risk resistance can be transmitted to humans 
yet systems are in place that can trigger further investigation 
to determine the level of those associated risks. Risk analyses 
that evaluate only risk report adverse effects ranging anywhere 
from one in 32,000 to seven in 100 million. Risk analyses that 
also consider benefits indicate an increase in thousands of 
sensitive strained human cases for a reduction of a fraction of 
a single resistant case. Therefore, the greater risk of 
foodborne illness must be weighed against the many other 
    We caution against preemptive bans based on the following 
observations in other countries: significant increases in 
therapeutic use as a substitution for growth promoters. The 
need for increased therapeutic uses are indicative of a decline 
in animal health and welfare associated with disease and no 
clear evidence of a significant human health benefit. 
Veterinarians are trained medical professionals with the 
ability to predict disease conditions and recommend appropriate 
therapy. Those uses should not be considered injudicious nor 
banned as routine use. If a disease is predictable and can be 
prevented, it is incumbent upon the veterinarian to initiate 
appropriate therapy to prevent animal pain and suffering. 
Although over-the-counter antibiotic are available for such 
therapies, they are not unregulated. If a drug is not used 
according to the approved label indications for the dose, 
duration, disease or species or within extra-label drug use 
regulations, it is illegal.
    The AVMA's antimicrobial use task force recently concluded 
that veterinarians should be involved in the decision-making 
process for the use of all antimicrobials in animals regardless 
of the distribution channel through which it was obtained. This 
would encompass prescription products, veterinary feed 
directives and over-the-counter antibiotics. Without exception, 
the AVMA is supportive of measures to mitigate risk to human 
health. To avoid potential diversion of resources away from 
more appropriate disease control measures, we encourage a 
regulatory strategy that is based on science, risk and benefit 
analysis, risk management that is commensurate with the level 
of risk, and cooperation with all relevant stakeholders. The 
AVMA is committed to providing consumers with the safest food 
possible and to protect human health against the current risk 
without compromising the health of food animals.
    Thank you for the opportunity to appear before you today.
    [The prepared statement of Dr. Hoang follows:]

    Ms. Schakowsky. Thank you, Dr. Hoang.
    Dr. Singer.


    Dr. Singer. Mr. Chairman and members of the subcommittee, I 
would like to thank you for giving me the opportunity to 
discuss the role of antibiotics in animal agriculture. My name 
is Dr. Randall Singer. I am an Associate Professor or 
epidemiology at the University of Minnesota, both in the 
College of Veterinary Medicine and in the School of Public 
    Antibiotic resistance continues to be a critical issue that 
affects human health, animal health and environmental health. 
All uses of antibiotics have the potential to select for 
resistant bacteria. What we are discussing here today, though, 
is risk and specifically the potential that the use of 
antibiotics in animal agriculture might result in more 
antibiotic-resistant bacteria that then lead to increased human 
health harm.
    One of the antibiotic uses that is of particular concern is 
the approved label claim of growth promotion. The fact is that 
this label claim is almost 50 years old. It is an unfortunate 
label whose name has never been changed. Unfortunate why? 
Because we now know that the reason these antibiotics help 
animals grow faster is because these antibiotics help animals 
maintain their health status. They prevent disease as well. And 
for evidence of this, we need to look no further than the 
Danish experience. It is a fact that following the removal of 
growth-promoting antibiotics in Denmark, the animals got 
sicker. Animal diseases that had been kept under control now 
appeared as a quote from their papers, epidemics, as stated by 
the Danish themselves. The unfortunate truth is that more than 
15,000 swine producers in Denmark, over 60 percent of the total 
that existed before the ban, went out of business, most of 
these being the small and mid-sized farms.
    But let us not focus on productivity. When it comes to 
antibiotics, we should be thinking about impacts on health. The 
only documented health benefit of the ban in Denmark was a 
decrease in some resistance in some bacteria on farms and in 
the community. There was no real human health benefit related 
to fewer resistant infections, at least that I have seen 
reported from the Danish experience.
    Regardless, perhaps it is time to retire the outdated label 
claim of growth promotion. After all, its name implies a 
strictly production use of antibiotic. But let me ask you this. 
Since when it has become better to treat the sick than to 
prevent the disease in the first place? If we can give a lower 
dose of a second-tier antibiotic to animals to prevent a 
disease from occurring by, for instance, improving the gut 
health of that animal, isn't this better than having to treat 
an entire population of sick animals with a high dose of a 
critically important antibiotic? The growth promotion doses 
give us that option.
    We need to take a holistic view of health that seeks to 
maintain the healthiest animal population possible. Healthier 
animals lead directly to a safer food supply. Nobody in the 
animal industry wants to continue, though, with the status quo. 
Changes in production are happening. Companies are voluntary 
reducing their uses of antibiotics. But we still need options 
for preventing and treating disease and these are disappearing 
as can be seen in the poultry industry. The only animal 
agricultural antibiotic banned from use in the United States 
remains the fluoroquinolones in poultry production. There is 
another antibiotic. It has no human counterpart and it still 
has not been approved for treating disease in poultry in the 
United States. Both of these antibiotics are available as 
treatment options in Europe. I will stress that again. 
Fluoroquinolones are available in Europe as a treatment option.
    In the absence of efficacious treatment options, the 
poultry industry at least needs the option of using antibiotics 
to prevent disease in the first place. What we should be doing 
is determining what antibiotic uses minimize risks to human 
health while maximizing animal health. How do we begin to 
quantify those risks and determine the antibiotic uses that 
pose the least risk? FDA's Center for Veterinary Medicine has 
an approved risk assessment approach as described in Guidance 
for Industry Document number 152. I was part of a team that 
used this approach to examine a specific antibiotic class, and 
we found that under the FDA's own definition, there was 
reasonable certainty of no harm to human health associated with 
this use. That is a peer-reviewed publication.
    I am in full agreement with the many international reports 
and FDA statements that we need to continue to assess these 
risks but they need to be done a drug-by-drug basis in each 
animal species. All antibiotics that fall under the same usage 
category are not equal in terms of their impacts on resistance 
or their impacts on human and animal health.
    In conclusion, Mr. Chairman and members of the 
subcommittee, I thank you for the opportunity to speak today. 
Antibiotics are an integral component of animal health and 
healthier animals lead to healthier people. I would hope that 
decisions regarding antibiotics, their approval and removal 
from use will continue to rest with the FDA's Center for 
Veterinary Medicine, who has in place a system for assessing 
the risks to human health associated with animal antibiotic 
use. I hope that those who make the final decisions about 
antibiotic use are truly interested in all health, human, 
animal and environment, and agree that preventing disease is 
always preferable to having to treat the sick. The best way to 
manage antibiotic uses in animal agriculture is through sound, 
rational, science-based policy that evaluates the risks and 
benefits of all antibiotic uses. Thank you.
    [The prepared statement of Dr. Singer follows:]

    Ms. Schakowsky. Thank you.
    Dr. Carnevale.


    Dr. Carnevale. Chairman Pallone, Ms. Schakowsky and Ranking 
Member Shimkus and members of the subcommittee, thank you for 
the opportunity to appear before you today. I appeared before 
this committee some time back during the Animal Drug User Fee 
hearings, and I want to thank the committee for moving that 
piece of legislation through. We greatly appreciate it.
    My name is Dr. Richard Carnevale. I am a veterinarian and 
Vice President at the Animal Health Institute. AHI is an 
industry trade association representing companies that make 
medicines for animals. Before AHI, I spent nearly 20 years at 
the FDA and USDA working on animal drugs and food supply.
    While I submitted more thorough comments for the record, I 
would like to talk to you today about one simple truth: animals 
need medicines including antimicrobials. Without safe and 
effective medications to treat, control and prevent diseases, 
animal welfare would suffer and deaths would increase. 
Additionally, as Dr. Singer pointed out, healthy farm animals 
are critical to safe food. Animal health companies invest in 
the development of new medicines to provide veterinarians and 
producers the tools to keep food animals healthy and must be 
able to rely on a predictable science-based regulatory process.
    There has been much debate, as we all know, over the 
contribution of animal antimicrobial use to resistant bacterial 
infections in humans. Antimicrobial resistance is a serious 
public health threat but resistance is not a single problem. It 
is a problem comprised of several different bacteria/drug 
combinations that must be examined individually to ascertain 
risks. For example, some of the most widely recognized 
resistance problems in humans are in respiratory tract 
infections and venereal diseases like gonorrhea. In neither of 
these cases is there any evidence that antimicrobial use in 
animals is associated with these problems.
    Both antimicrobial-resistant and susceptible bacteria can 
contaminate foods, our food safety system is comprised of 
multiple layers of protection to reduce their presence. The 
first layer of protection is a stringent regulatory review 
process at FDA. Animal antimicrobials must meet all the same 
requirements as antimicrobials used in humans with two 
additional requirements. First, sponsors must show that drug 
residues left in foods are safe for human consumption. Second, 
the FDA Guidance for Industry 152, which Dr. Sharfstein spoke 
of, outlines a qualitative risk assessment process for new 
antimicrobials. This process is designed to estimate and manage 
the risk of antimicrobial-resistant bacteria that could be 
transferred from animals to humans.
    Quantitative risk assessments have also been conducted and 
published on key antimicrobials, particularly those used in 
animal feed. A quantitative assessment is a more detailed 
review of each step along the food production continuum from 
farm to table that could contribute to or reduce the presence 
of foodborne bacteria. These studies have routinely reported 
extremely low levels of risk.
    As Dr. Sharfstein discussed, FDA has announced two new 
initiatives relative to antibiotics used in food animals. These 
actions illustrate that the agency has broad authority to take 
actions it deems necessary to protect public health. AHI 
welcomes these initiatives and understands the reasons for 
their concerns. We will, of course, comment in detail to both 
    A second layer of protection and one of the most important, 
in my opinion, is reducing bacterial contamination in slaughter 
and processing plants. Improved hygienic and pathogen-reduction 
measure in meat and poultry plants under the USDA HACCP 
pathogenic reduction regulation has significantly reduced 
bacterial contamination and therefore antimicrobial-resistant 
bacteria as well.
    A third layer is in the multi-agency National Residue 
Program and National Antimicrobial Resistance Monitoring System 
to assure antimicrobials are being used properly and according 
to labels. Judicious-use guidelines which the AVMA 
representative has spoken about help to ensure that 
antimicrobials are being used responsibly in food and companion 
    Finally, USDA has mandated safe food handling labels, and 
there are extensive food safety education programs that 
instruct consumers how to properly handle and cook foods to 
avoid foodborne illness.
    Before I close, I want to note that Congress in the last 2 
years passed legislation dealing with the use of antimicrobials 
in animals. The 2008 Farm Bill included a mandate for 
additional research on antibiotic resistance in food animals 
and the 2008 Animal Drug User Fee Amendments required FDA to 
collect antibiotic use data from sponsors by March of 2010. We 
expect the report from the agency later this year.
    Mr. Chairman and members of the subcommittee, there are 
clear benefits to using antimicrobials to keep animals healthy 
including attending to animal welfare and assuring food safety. 
FDA has a stringent review process to ensure that 
antimicrobials are safe and effective. Monitoring data from the 
NARMS program as well as public and private risk assessments 
have shown the process is working. With that said, FDA has 
recently articulated concerns with the way certain antibiotics 
are currently labeled and used. The animal health industry is 
committed to working collaboratively with the agency to address 
those issues while assuring that important animal health 
products continue to be available to prevent, control and treat 
animal disease.
    Thank you for the opportunity to appear today and I welcome 
any questions.
    [The prepared statement of Dr. Carnevale follows:]

    Ms. Schakowsky. Thank you.
    Dr. Levy.

                    STATEMENT OF STUART LEVY

    Dr. Levy. Thank you. Mr. Chairman and members of the 
subcommittee, thank you for inviting me to testify on this 
crucial subject of antibiotic use in animal husbandry. I am 
Stuart Levy, a physician, research scientist and Professor of 
Molecular Biology, Microbiology and of Medicine at Tufts 
University School of Medicine in Boston. I also serve as 
President of the Alliance for Prudent Use of Antibiotics.
    For more than 3 decades, I have been studying antibiotic 
use in animal husbandry and its effect on bacteria associated 
with animals, farm workers and their families and the 
environment in general. Throughout my career, I have noted the 
paradoxical nature of human engagement with antibiotics, hence 
the title of my book, the Antibiotic Paradox. On one hand, 
antibiotics cure disease, are miraculous. On the other hand, 
they select among their targets those which are resistant and 
make these drugs not effective.
    My own research stretching back to the early 1970s has 
confirmed the broad environmental impact of antibiotic use, and 
I stress that. We performed the first and only prospective 
study of the effect of introducing antibiotic-, in this case, 
tetracycline-laced feed for chickens on a farm. By one week, 
almost all E. coli bacteria in the intestinal tracts of 
chickens were tetracycline resistant. By 3 months, the chickens 
and most of the farm dwellers were excreting E. coli not only 
resistant to tetracycline but to other antibiotics as well. We 
also demonstrated that low-dose non-therapeutic amounts of 
tetracyclines can in fact propagate bacteria resistant to the 
drug and other antibiotics at high levels. Resistant bacteria 
were found to move among animals and from animals to people.
    Antibiotics are unique. They are societal and ecological 
drugs. Each individual taking an antibiotic whether animal or 
person becomes a factory producing antibiotic-resistant 
bacteria. Thus, there is a difference in the environmental 
impact when the same amount of antibiotic is given to one as 
opposed to a number of animals sharing that particular 
environment. In principle, fewer animals will be given 
antibiotics and for less time when antibiotics are used 
prophylactically as compared to growth promotion.
    Mr. Chairman, we are not gaining ground in the struggle 
against antibiotic resistance. Antibiotics are continually 
misused and overused in both human medicine and animal medicine 
at great cost to our society in terms of human health and cost 
of health care. It is estimated that antibiotic resistance 
leads to more than $20 billion in hospital costs and up to $35 
billion when society costs are included. Some progress has been 
made in encouraging more judicious use of antibiotics in human 
medicine but there has been precious little progress with 
respect to stemming the spigot of antibiotics flowing into 
animal agriculture.
    In contrast, other industrialized nations have come to the 
same conclusion that many public health organizations around 
the world have, and that is that the use of antibiotics for 
growth promotion and feed efficiency must be curtailed. We can 
take some encouragement in the FDA's recent release of a draft 
guidance. We need to move with greater urgency to stem the use 
of antibiotics in industrial animal production. Because most 
antibiotics currently approved for growth promotion are also 
approved for routine disease prevention, I have great concern 
that feeding large quantities of antibiotics non-
therapeutically will continue, rendering meaningless any FDA 
guidance on eliminating antibiotic use for growth promotion.
    Mr. Chairman and committee members, in view of the 
certainty in my opinion of the public health threat, the 
history of regulatory inaction and unyielding nature of the 
relevant industry, it is now clear that even a well-intentioned 
FDA is unable to overcome the influence of agribusiness. We 
have given moral persuasion, medical urgency, scientific study 
and voluntary guidance a chance and the situation has not 
changed. We can't wait any longer.
    Legislation pending in this session of Congress, the 
Preservation of Antibiotics for Medical Treatment Act, would 
withdraw the use of seven classes of antibiotics vitally 
important in human health from food production unless animals 
are sick with disease or the use is needed for disease 
prevention without threat to human health. I urge this 
committee to move expeditiously to consider and approve this 
important legislation.
    Thank you for giving me the opportunity to testify, and I 
will answer any questions.
    [The prepared statement of Dr. Levy follows:]

    Ms. Schakowsky. I want to thank all of our witnesses. As is 
obvious, I guess, Mr. Pallone had to go to yet another 
committee that he is on where they are voting and so he won't 
be able to return.
    I have some questions that I want to ask but I also want to 
let you know that we have a whole bunch of questions that I 
fear will not be asked and therefore we will get them to all of 
you and would appreciate very much your answers in writing 
    Mr. Shimkus. Madam Chairman, can we also ask, it wasn't 
done, I think, a UC that all members' statements can be 
submitted for the record?
    Ms. Schakowsky. That all members' statements can be 
submitted for the record, without objection so ordered.
    Mr. Shimkus. Thank you.
    Ms. Schakowsky. I want to give a special thank you to Dr. 
Henriksen for coming from Denmark, and I wanted to give him the 
opportunity at this hearing to answer some questions, because 
there has been a lot of discussion about the Danish experience. 
We have seen articles and heard testimony claiming that even 
though you eliminated the use of antibiotics for growth 
promotion, you ended up using more antibiotic than you had 
before because all the animals got sick. That is what we are 
hearing. And in fact, in the testimony of the American 
Veterinary Medicine Association, Dr. Hoang states and Dr. 
Singer as well that antibiotic use went up between 1998 and 
2008. So can you clarify for us exactly what the situation has 
been with regard to antibiotic use in Denmark? And as part of 
that, can you tell us what steps you took to reduce antibiotic 
use and what impact each step has had on the use of 
    Dr. Henriksen. Yes, I will try to answer your questions, 
all your questions. It is correct that after the ban the 
consumption of therapeutic antibiotics has been increased but 
in the same period the pig production has been increased too, 
and if you see my fact sheets on page 10, you can see figure 1 
which both has the antibiotic usage in all types of animals and 
the number of pigs produced, and in that period from 1998 to 
2008, you can see an increase in the therapeutic use of 
antibiotics but an almost similar increase in the number of 
pigs produced in Denmark. You can put it another way, that is 
to calculate how many milligrams per kilo pig produced in 
Denmark, and you can have the data before the ban. Before the 
ban in 1994, the total use of antibiotic growth promoters and 
for therapeutics were 99 milligrams per kilogram of pig 
produced, and even in 2008 the total consumption was 49 
milligrams per kilogram pig produced. That is, we have reduced 
the total usage of antibiotic per kilogram pig produced from 99 
to 49 milligrams. That is a 50 percent reduction.
    It is correct as stated by many U.S. observers that the 
disease situation has changed in Denmark. Diseases come and go 
in humans and animals, but if you look at the fact sheet on 
page 14, you can see the mortality in weaners, the mortality 
since 1993 to 2003, 2004 has been increasing from about 2 
percent to almost 5 percent, but since 2004 the mortality in 
weaners has decreased almost to the level from 1992-1993. So in 
that respect to mortality in weaners, the more focus of disease 
in Danish pig production cannot be released by the mortality 
figures. If you compare to the mortality in finishers in figure 
7 on page 14, you can see that the mortality has been varying 
little during the 1992 to 1997, 1992 to 2007, but the mortality 
is between 3 and 4 percent. So there has not been any 
significant impacts on mortality neither in weaners nor in 
    I would like to add on the previous page on the fact sheet, 
page 13, figure 4, this is the productivity as we express it in 
Denmark, number of pigs produced per sow per year, and you can 
see from 1992 to 2006, 2007, the number of pigs per sow per 
year has been increasing from 20 to more than 22 pigs per sow 
per year. That means that during this phasing out of growth 
promoters has been increasing production, but I would of course 
admit in some farms you see severe disease problems, and this 
is the task for a trained veterinarian to deal with the 
specific problem in specific farms whether it should be a 
vaccination schedule, prophylactic changes in the environment, 
new ventilation system, better feed quality and so on, maybe 
prolonged weaning age from 3 weeks to 4 weeks, or treatment 
with antibiotic. So that I think most of the questions I 
    Ms. Schakowsky. Let me just then underscore and make sure 
that this is correct, that the total antibiotic consumption in 
food-producing animals has been reduced by about 40 percent 
from the mid 1990s until today. So we are talking about total 
consumption is just almost in half or about 40 percent. Is that 
    Dr. Henriksen. That is correct when you compare the total 
use of antibiotic growth promoters and therapeutic use in the 
end of 1997-98 to 2008, yes, that's correct.
    Ms. Schakowsky. Thank you. I appreciate your being here and 
I appreciate your testimony.
    Mr. Shimkus.
    Mr. Shimkus. Thank you, Madam Chairman.
    But I will say from ban until now, therapeutic use has gone 
up, and that--and you are shaking your head, which I think that 
means yes. We do appreciate you coming a long way.
    Madam Chairman, and this has been addressed with the staff 
for submission to the record a statement from the pork 
producer, if you would----
    Ms. Schakowsky. Without objection, so ordered.
    [The information was unavailable at the time of printing.]
    Mr. Shimkus. Thank you, Madam Chairman.
    The other thing I want to--I need to highlight some stuff 
going back to the previous panel and the third chart I didn't 
get a chance to talk about. I think the issue--I just want to 
get it on the record that the United States and Canada had 
pathogen reduction regulations during this time and the issues 
of voluntary withdrawal too. So there is more to be said by 
charts that unfortunately we didn't have time to pursue that 
with the previous panel because of time.
    Another thing I want to make sure to put on the record, and 
this is from the D.C. area, that there is a huge price 
discrepancy between food products that are antibiotic-free and 
conventional price, and there is a list of 10 products here and 
it goes from anything from 141 percent to 20 percent change in 
retail prices. So another thing to place on the table is the 
cost of basic food products from beef to eggs to you name some 
of the issues.
    Also, the reduction in Danish swine farms from the passage 
of legislation from 12,500 to 3,500, and for my friend from 
Denmark, the United States is the number 1 pork-producing 
country in the world. He knows that. I think it is a percentage 
of what is exported based upon what is consumed. But I would 
say second is the EU followed by, I don't know if it is Canada 
or Brazil, but this is a major industry in the United States. 
It is a major industry in my Congressional district, and that 
is why we want to make sure that science is addressed because 
we are concerned about antibiotic issues. We have had hearings. 
But we want to make sure that again that we don't do more harm 
than good. And I appreciate the various opinions and the issues 
on risk because healthy animals should grow bigger. I mean, if 
you are sick, you are not going to grow. If you are healthy, 
you do grow.
    We just passed a health care bill that said preventative--
let us make sure we keep Americans healthy because of the high 
cost in taking care of sick people, but here we are going to 
flip the charts. We are going to turn it upside down. We are 
going to say let us don't keep the animals healthy, let us do 
therapeutic antibiotics when they are sick.
    Dr. Carnevale, I have two questions, because we heard from 
a lot of the panelists both here and then also on the first 
panel that there is unequivocal evidence, and it reminds me of 
the climate change debate, that the science is settled. Well, I 
think the American public understands that the science is not 
settled. Is there unequivocal evidence that there is a 
connection between the use of antibiotics in animals and 
connect them to human health?
    Dr. Carnevale. Well, as many have said today, this is a 
very complicated issue. I would say there is not unequivocal 
evidence that the use of antibiotics in animals, particularly 
those used in animal feed, are directly responsible for human 
health impacts, and human health impacts has been kind of 
loosely defined here, but I would certainly think that the most 
key human health impact would be failure of the treatment of a 
    Mr. Shimkus. Yes, and let me--my time is very limited and I 
want to be respectful of my colleagues. And the animal feed 
issue is different than what the Danish experience was in the 
use of antibiotics. I don't want you to elaborate.
    I want to follow up. My second question is, the FDA role. 
The FDA role is to make sure they approve drugs for animals and 
for humans. Now, when they say this antibiotic is good for use 
in animals, do they also look at its possible risk for human 
consumption through the process? Do they have to consider the 
effect on human health?
    Dr. Carnevale. Yes.
    Mr. Shimkus. So when the FDA says it is OK, it is not only 
saying it for the animal, it is saying it for human health and 
    Dr. Carnevale. Absolutely. They have a mandate to approve 
drugs safe and effective, which means safe to the animal, safe 
to humans and safe to the environment.
    Mr. Shimkus. My time is expired. Thank you, Madam Chairman.
    Ms. Schakowsky. Thank you.
    I wonder if you would mind if I just follow up with Dr. 
Henriksen, just find out what the Danish experience was on the 
cost of production after the ban. I don't know if----
    Mr. Shimkus. No, we talked and I will be happy as long as 
our colleague down there is fine.
    Ms. Schakowsky. Just a quick question. Was there any impact 
on the cost of production after the ban or the cost to the 
consumer after the ban?
    Dr. Henriksen. The prices in the shops have not been 
increased due to this ban. I don't have any data available with 
me about the production costs for the farmer.
    Ms. Schakowsky. Thank you.
    Dr. Henriksen. I can present it to you if you want.
    Ms. Schakowsky. Thank you.
    Congresswoman Christensen.
    Mrs. Christensen. Thank you, Madam Chair, just a few 
    Dr. Hoang, the AVMA, I understand, suggests that the 
current FDA approval process for antibiotic use in food animals 
is sufficiently strict to protect human health but the FDA 
doesn't apply a standard regarding antibiotic resistance 
retroactively to drugs that were approved maybe decades ago. So 
what is the AVMA's position? Should we reevaluate the safety or 
not of already approved drugs?
    Dr. Hoang. The AVMA is supportive of reevaluation of the 
drugs that have been previously approved, but I might also add 
that the FDA does have the authority to withdraw a drug if they 
find that there is an imminent human health hazard, which they 
have not done so.
    Mrs. Christensen. Thank you.
    Dr. Levy, why do you think the United States has yet to 
follow the example of other industrialized nations in limiting 
antibiotic use in meat production? Is it because the scientific 
basis for action is questionable? It seems to me there is a lot 
of evidence. I don't think the bacteria behave much differently 
here than in Europe, so what do you think the reason is?
    Dr. Levy. That is exactly what I was thinking. It has 
bothered me a lot as I go out to teach about how to use 
antibiotics that Europe, I think, is ahead of us by eliminating 
this major source of resistant emergence. Why? It is much more 
difficult in this country to get this ban. I had preferred all 
along in my career that it would be more voluntary and that you 
wouldn't need a legislative ban, but I have been disappointed.
    But anyway, all that being said, as we know, the Europeans 
looked at the data and with one fell swoop they said 
precautionary principle, we eliminate this use. I think the 
scientific data is clear, and I am a scientist and I have 
looked at the data, and the APUA has actually put out a few 
years ago an evaluation of this whole prospect with 
stakeholders and all agreed that this is no longer needed. 
First of all, we don't even know if growth promotion is really 
working. If it is prophylactic, let us call it prophylactic. 
And as I said in my statement, there is a big difference in 
terms of the selection of the numbers of animals that we get 
for growth promotion, which is everyone, whether healthy or 
not, versus prophylaxis, which in human medicine, look at what 
we do with surgery. We eliminated all that extra antibiotic and 
we gave a dose before and a dose or two after. Why aren't we 
doing that with animals? Where are the studies? If we call it 
prophylaxis, show me that it is prophylaxis. Show me what--I 
mean, a spade a spade. What is it? And so I think it is a 
different, should I say culture, but I don't think that 
anyone--there are plenty of us in the United States that agree 
with the European decision.
    Mrs. Christensen. And I noted Dr. Hansen in her statement--
I don't have a question for you but I know that you said that 
even in 1977, that is where I got the point I made in my 
opening statement, that the evidence was significant but we did 
not allow FDA to apply a ban. Is that correct?
    Dr. Hansen. Yes, ma'am. I would certainly agree with that. 
I think that we certainly don't lack the science at all. We 
certainly have--this is just a representative portion of the 
science that we have. We may lack or we may have at least up 
until this point with all these hearings may have lacked some 
of the political will.
    Mrs. Christensen. Thank you.
    Dr. Carnevale, how does AHI justify opposing significant 
reductions in antibiotic use in food animals when such overuse 
ultimately helps to contribute to the demise in your products' 
ability to treat both human and animal disease? Aren't you 
sacrificing long-term financial well-being, not to mention 
public health, in favor of short-term profit in this case?
    Dr. Carnevale. If I understand the question, you are saying 
why do we oppose reducing antimicrobial use. I don't think AHI 
has ever said that. I think what our position is is that these 
products have been approved as safe and effective by the FDA
    Mrs. Christensen. Safe and effective for treatment.
    Dr. Carnevale. Safe and effective for all the claims on the 
    Mrs. Christensen. From growth----
    Dr. Carnevale. They have been approved as safe and 
effective for growth promotion, disease prevention, disease 
treatment and disease control, whatever is on the label.
    Mrs. Christensen. Well, FDA has issued some guidelines now 
    Dr. Carnevale. Yes.
    Mrs. Christensen. Does AHI support the guidelines that 
    Dr. Carnevale. We welcome the opportunity to work with the 
agency on their concerns about it. We clearly understand that 
they do have a concern about the way these products have been 
marketed for many years over the counter. We do understand they 
have a concern for the growth promotion claims. I don't want to 
prejudge the situation. I simply want to say that our companies 
are committed to working with the agency to try to address 
those concerns, and if there are alternatives that we can come 
up with for growth promotion claims, I am sure our companies 
will be more than happy to pursue that track.
    Mrs. Christensen. And are your companies----
    Dr. Carnevale. Yes, we really want to work with the agency 
on this.
    Mrs. Christensen. Are your companies willing to report on 
the sale of medicines, drugs for animal use?
    Dr. Carnevale. In fact, they are required to now under the 
Animal Drug User Fee Act. In fact, our companies have all 
submitted those reports to the FDA as of the end of March 2010. 
So yes.
    Mrs. Christensen. Thank you, Madam Chair.
    Ms. Schakowsky. Well, that concludes all the questioning. I 
really thank you for your patience today, for staying with us 
all afternoon. In closing, I want to remind members that you 
may submit additional questions for the record to be answered 
by the relevant witnesses. The questions should be submitted to 
the committee clerk within the next 10 days. The clerk will 
notify your offices of the procedures.
    And without objection, this meeting of the Subcommittee is 
adjourned. Thank you.
    [Whereupon, at 5:55 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]