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55–566 PDF 2008

COMMITTEE PRINTS ON ADMINISTRATION 

LEGISLATIVE PROPOSALS ON THE ANIMAL 

DRUG USER FEE ACT AMENDMENTS OF 2008 

AND THE ANIMAL GENERIC DRUG USER FEE 

ACT OF 2008 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

JUNE 5, 2008 

Serial No. 110–123 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan, Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff 

GREGG A. ROTHSCHILD, Chief Counsel 

SHARON E. DAVIS, Chief Clerk 

DAVID CAVICKE, Minority Staff Director 

(II)

(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

HENRY A. WAXMAN, California 

EDOLPHUS TOWNS, New York 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

GENE GREEN, Texas 

Vice Chairman 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

TOM ALLEN, Maine 

TAMMY BALDWIN, Wisconsin 

ELIOT L. ENGEL, New York 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JOHN D. DINGELL, Michigan (ex officio) 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 3 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 4 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 4 

Hon. Steve Buyer, a Representative in Congress from the State of Indiana, 

opening statement ................................................................................................ 5 

Hon. Jim Matheson, a Representative in Congress from the State of Utah, 

prepared statement .............................................................................................. 100 

WITNESSES

Bernadette Dunham, Ph.D., D.V.M., Director, Center for Veterinary Medicine, 

Food and Drug Administration; accompanied by Steven Vaughn, D.V.M., 

Director, Office of New Animal Drug Evaluation, CVM, FDA ......................... 6 

Prepared statement .......................................................................................... 9 

FDA response to submitted questions for the record .................................... 101 

Richard Carnevale, V.M.D., Vice President of Regulatory, Scientific and International Affairs, Animal Health Institute ......................................................... 33 

Prepared statement .......................................................................................... 35 

Stephanie Batliner, Chairperson, Generic Animal Drug Alliance; Director, 

Pre-Market Regulatory Affairs, IVX Animal Health Inc. ................................. 38 

Prepared statement .......................................................................................... 40 

Robert Martin, Executive Director, Pew Commission on Industrial Farm Animal Production ..................................................................................................... 46 

Prepared statement .......................................................................................... 48 

SUBMITTED MATERIAL

Committee print on the ‘‘Animal Drug User Fee Act Amendments of 2008’’ ..... 68 

Committee print on the ‘‘Animal Generic Drug User Fee Act of 2008’’ .............. 76 

(1) 

COMMITTEE PRINTS ON ADMINISTRATION 

LEGISLATIVE PROPOSALS ON THE ANIMAL 

DRUG USER FEE ACT AMENDMENTS OF 

2008 AND THE ANIMAL GENERIC DRUG 

USER FEE ACT OF 2008 

THURSDAY, JUNE 5, 2008 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:13 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Frank Pallone, 

Jr. (chairman) presiding. 

Members present: Representatives Pallone, Waxman, Towns, 

Green, Schakowsky, Matheson, Deal, Buyer, and Murphy. 

Staff present: William Garner, Jessica McNiece, Melissa Sidman, 

Ryan Long, Lance Kotschner, Chad Grant, Jodi Seth, Lauren 

Bloomberg, and Bobby Clark. 

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

Mr. PALLONE. The meeting of the subcommittee is called to 

order. 

Today we are going to have a hearing on two committee prints 

of the Administration’s legislative proposals on first, the Animal 

Drug User Fee Act amendments of 2008, and second, the Animal 

Generic User Fee Act of 2008, and I am going to recognize myself 

initially for an opening statement. 

Prior to 2003, the FDA’s review of animal drug submissions was 

taking over a year and a half to be completed. This obviously led 

to serious concerns that new and innovative pharmaceutical products were not making their way into the marketplace in order to 

treat our Nation’s pets as well as food animals that help sustain 

the Nation’s food supply. Accordingly, in 2003, Congress enacted 

the Animal Drug User Fee Act, ADUFA, which was modeled after 

the successful user fee programs for the review of human drug and 

medical device submissions. Like the user fee programs that preceded it, ADUFA authorized the FDA to collect fees to help ensure 

that the agency had the resources it needed to provide a timely review of animal drug applications. ADUFA also set new performance goals for FDA to review and act upon submissions within a 

stated timeframe. By the fifth year of the authorization period, 

2 

FDA was supposed to review 90 percent of submissions within the 

statutorily required time frame of 180 days. According to the required annual performance reports for the most recent fiscal years, 

FDA says that the agency has been meeting or exceeding the timeliness goals established under the program, and I am looking forward to hearing more from FDA about how this program has been 

working over the past 5 years and how it can be improved upon. 

Now, under the Administration’s legislative proposal to reauthorize ADUFA, the review times would remain the same as the existing performance goals for fiscal year 2008. The proposal would increase the amount of fees collected from $15 million to $24 million 

over 5 years for a total of $98 million. Revenues would be derived 

from a mix of application product, establishment, and sponsor fees. 

Other important provisions of the Administration’s proposal include a new end-review amendment process and improved communications between FDA and the regulated industries. Absent from 

the Administration’s proposal, however, is any provision relating to 

the issue of antimicrobial resistance. I recognize that there is a 

growing concern among stakeholders and members of this subcommittee about the use of antibiotics in food animals for prophylactic and/or growth purposes. As these practices become more commonplace, bacteria that are resistant to antibiotics begin to proliferate and this poses a significant threat to humans who may 

come into contact with antibiotic-resistant bacteria through eating 

contaminated or undercooked meat, by caring for livestock, or 

through polluted waterways. 

So clearly we face significant challenges when it comes to maintaining the effective use of antibiotics with fewer and fewer innovative antibiotic products coming down from the pharmaceutical pipeline. It is even more important that we keep the antibiotics that 

are currently on the market working, and I am anxious to hear testimony both from the FDA and the witnesses on our second panel 

about the problem of antibiotic resistance and what, if any, consideration should be made regarding this issue as we move forward 

with reauthorizing ADUFA. 

In addition to the reauthorization of ADUFA, the Administration 

has offered a proposal to establish a new animal generic drug user 

fee. According to FDA, the average review time of an animal generic drug submission was 570 days in fiscal year 2007 in spite of 

a 180-day statutory requirement. At the end of last year, there was 

a recorded backlog of 446 submissions waiting for review and agency action. As more and more brand pharmaceuticals come off patent over the next 5 years, we need to make sure that FDA has the 

resources it needs to effectively review generic animal drug submissions in a timely manner. Accordingly, the agreement between the 

FDA and the industry would provide for the collection of user fees 

increasing annually from $4.8 million to $6 million over 5 years for 

a total of $27 million, including the yearly cost of inflation. These 

additional revenues are designed to help speed up the review process, and by year 5 of the authorization period, most reviews of generic animal drug submissions would occur in 270 days or less, a 

substantial improvement over the time it now takes FDA to conduct such reviews. I am pleased that the industry and the FDA 

have been able to work out this agreement. I am looking forward 

3 

to hearing more about it today. If implemented, AGDUFA, we are 

calling it, will speed lower cost animal drugs to the marketplace 

and bring significant savings to ranchers, farmers, and pet owners. 

While this is an important and noteworthy goal, I also think it is 

equally, if not more important, to ensure the timely review of generic human drug applications. 

Over the past few years, I have tried to work to improve the 

speed in which the agency works to review generic applications for 

human drugs. We have lobbied appropriators for additional monies 

for the Office of Generic Drugs. Additionally, last year we included 

a provision in the FDA Amendments Act of 2007 to reform the citizen petition process, which has been abused in an effort to delay 

agency approval of generic applications. While steps have been 

taken to improve the efficiency in which the agency is reviewing 

generic human drug applications, more can and should be done to 

help ensure patients have access to cheaper and safer medications, 

and I see that Mr. Waxman is here and I know that he has always 

been a champion of trying to improve generics, get them on the 

market and try to bring costs down. I just mention the human because I do think we have to keep that in mind even as we are talking about the animal drugs today. 

Mr. PALLONE. Mr. Waxman is recognized for an opening statement. 

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

Mr. WAXMAN. Thank you very much, Mr. Chairman. I appreciate 

your holding this hearing. 

As we consider FDA’s animal user fee program, we have to recognize it has been successful in speeding new medicines for animals 

to the market and that is important and that is why we have this 

user fee program for animals and that is why, quite frankly, we 

have the user fee program for FDA to approve human drugs as 

well. This reauthorization of the Animal Drug User Fee Act, or 

ADUFA, also gives us an opportunity to look at providing FDA 

with new tools to address what has become a glaring public health 

crisis. We now have an overwhelming body of evidence showing 

that the overuse of antibiotics in industrial farm production is 

threatening to destroy the effectiveness of many of our most important antibiotics for human use. Most recently, the Pew Commission 

on Industrial Farm Animal Production issued a report concluding 

that our current system of producing food animals and its reliance 

on the indiscriminate use of antibiotics poses an unacceptable level 

of risk to public health. I am glad that the executive director, Robert Martin, will be here today to walk us through some of the Commission’s findings. 

We also have reports from the Institute of Medicine, GAO, and 

the World Health Organization, all of which describe the very serious and growing threat to global public health generated by antibiotic resistance. Americans have experienced firsthand the importance of ensuring that we preserve our arsenal to fight the new and 

emerging superbugs like MRSA. We know that the overuse of antibiotics hampers our ability to do that. So we clearly need to look 

4 

at ways to reduce the overuse in animals of these antibiotics that 

are so vitally important for preventing and curing diseases in humans. 

This legislation deals with one critical issue related to animal 

drugs but clearly there are others. It is our responsibility as a subcommittee concerned with the health of the American public to examine those issues, and I hope in the course of this hearing we 

might consider evaluating the possibility of adding additional legislation to the reauthorization bill to deal with animal drug antibiotic use that is leading to human resistance to the antibiotics 

itself. 

I yield back the balance of my time, Mr. Chairman. Thank you. 

Mr. PALLONE. Thank you, Mr. Waxman, and I would ask unanimous consent to include in the record the statement of Chairman 

Dingell. Without objection, so ordered. 

[The prepared statement of Mr. Dingell follows:] 

STATEMENT OF HON. JOHN D. DINGELL

Mr. Chairman, thank you for beginning the consideration of two legislative proposals recently sent up by the Administration, and for your leadership on these important public health matters. Today’s hearing is the first step in crafting legislation 

that will provide the necessary resources for the Food and Drug Administration 

(FDA) to safely and efficiently review animal drug applications. 

The Animal Drug User Fee Act (ADUFA) expires on October 1, 2008, less than 

4 months from now. It is the responsibility of this Committee and the Congress to 

ensure that this program is reauthorized in a timely manner to avoid any personnel 

disruptions at the FDA. Hardworking, skilled employees at FDA are depending on 

us to do our job, so they can continue to do their job. 

An important component of the Administration’s proposals focuses on the need for 

greater resources at FDA. We have heard from a wide range of stakeholders on this 

point and I agree. This legislation must provide FDA with the necessary user fee 

structure to provide resources for the timely and thorough review of new animal 

drug applications. Equally important, we must ensure that Congress appropriates 

the requisite funds that have been authorized for FDA. 

As we begin this process of reauthorizing ADUFA and considering the proposed 

legislation to establish an animal generic drug user fee, we must diligently work towards strengthening the safety and effectiveness of the Nation’s supply of animal 

drugs. I thank the Chairman for holding this hearing on the proposals before us 

today and I look forward to the testimony of the witnesses. 

Mr. PALLONE. Next is our vice chair, Mr. Green of Texas. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Mr. Chairman, thank you for holding the hearing on 

today’s Animal Drug User Fee Act and the Animal Generic Drug 

User Fee Act. The Animal Drug User Fee Act was first signed into 

law in 2003 and allowed the FDA to collect user fees from brandname drug companies to reduce the backlog of the FDA’s review 

system for brand-name drugs. The Animal Drug User Fee Act and 

the Animal Generic Drug User Fee Act will provide the FDA with 

additional funds to supplement their appropriations funding from 

Congress and for expediting animal drug applications from Congress. These additional resources support FDA’s responsibility 

under the Food, Drug, and Cosmetic Act to ensure that new animal 

drug products are safe and effective for animals as well as for the 

public with respect to animals intended for food consumption. The 

5 

legislation allows the FDA to expedite and improve its review of 

the application for new drugs so that safe and effective new drugs 

will be available more quickly. 

The current ADUFA law will expire October 1 and generic drug 

companies would like a swift review process as well, which is why 

we are having the hearing today on these bills. I support both the 

bills and I thank the committee for having the hearing and look 

forward to the testimony of our witnesses, and I yield back my 

time. 

Mr. PALLONE. Thank you, Mr. Green. 

Mr. Towns. 

Mr. TOWNS. Thank you very much, Mr. Chairman, for holding 

this hearing. 

The reauthorization of the ADUFA is essential in providing safety measures directed towards animal health and disease prevention. Requiring animal health companies to provide additional 

funding to the FDA’s Center for Veterinary Medicine will enable 

the Center to meet its performance goals and expectations. 

The proposed AGDUFA bill is also a step toward meeting future 

standards of growth and performance. The AGDUFA bill has potential to provide essential resources to reduce the amount of time to 

review generic animal drug applications, which is very, very important. This initiative also helps support important health priorities. 

It supports a priority to transform health through an improved 

process that makes new drugs available in less time. 

In general, it has been proven that companies that research and 

develop animal drugs have been successful at reducing the review 

backlog while also increasing the FDA’s accountability of the standards it utilizes for its applicants. The reauthorization will also support FDA staff and reviews in place to continue uninterrupted. 

Again, let me thank you, Chairman Pallone, of course for having 

this hearing and I look forward to working with the committee to 

move these two ideas forward. 

On that note, I yield back. 

Mr. PALLONE. Thank you, Mr. Towns. 

I recognize the gentleman from Indiana, Mr. Buyer, for an opening. 

OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF INDIANA 

Mr. BUYER. Thank you, Mr. Chairman. 

I am glad we are holding the hearing today and I am hopeful 

that the process of reauthorizing the Animal Drug User Fee Act 

will be quick and smooth. It is vital to the business and agriculture 

in my home State of Indiana that this program is reauthorized 

quickly. This program is critical to providing for innovative medications for companion and food animals. I strongly support the proposal before us today and commend the animal drug community for 

the work they did to develop it. I urge the subcommittee to preserve this well-vetted proposal and to restrain from attaching 

measures that compromise a quick passage. 

The Animal Drug User Fee Act has been very successful in 

speeding the process of getting innovative drugs to our Nation’s 

market. Since its initial authorization in 2003, FDA’s review procVerDate Nov 24 2008 12:45 Apr 08, 2010 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-123 SCOM1 PsN: JIMC
6 

ess for new animal drugs has decreased significantly from an average of 295 days to 180 days. I look forward to authorizing a process 

to speed the development of generic animal drugs as well. Currently, FDA’s review process for generic animal drugs lasts on average 4 to 5 years. This year we have a new proposal for a generic 

drug user fee program which will decrease this review time to an 

average of 270 days. 

Again, I strongly support the two proposals before us today. They 

have been well vetted by the business and regulatory communities 

and it is critical to our companion and food animal communities 

that these measures move forward quickly without delay, and I 

thank the chairman for his good work along with the ranking member. 

Mr. PALLONE. Thank you. 

The gentleman from Pennsylvania, Mr. Murphy, is recognized for 

an opening. 

Mr. MURPHY. I waive opening, Mr. Chairman. 

Mr. PALLONE. The gentleman waives. OK. So I think we are done 

with the opening statements. We have two panels today. Welcome. 

The first panel consists of Dr. Bernadette Dunham, who is director 

of the Center for Veterinary Medicine at the FDA. She is the 

speaker, and she is accompanied by Dr. Steven Vaughn, who is director of the Office of New Animal Drug Evaluation, and David 

Wardrop, Jr., who is director of the Office of Management, but I 

understand you are going to speak and they are going to accompany you for questions. You know the drill, 5-minute opening. We 

may subsequently send you some written questions at the discretion of the committee. 

I now recognize Dr. Dunham. Thank you for being here. 

STATEMENT OF BERNADETTE DUNHAM, PH.D., D.V.M., DIRECTOR, CENTER FOR VETERINARY MEDICINE, FOOD AND 

DRUG ADMINISTRATION; ACCOMPANIED BY STEVEN 

VAUGHN, D.V.M., DIRECTOR, OFFICE OF NEW ANIMAL DRUG 

EVALUATION, CVM, FDA 

Dr. DUNHAM. Thank you very much. Good morning, Chairman 

Pallone and members of the subcommittee. I am Dr. Bernadette 

Dunham, director of the Center for Veterinary Medicine, referred 

to as CVM, at the U.S. Food and Drug Administration, which is 

part of the Department of Health and Human Services. I am accompanied today by Dr. Steven Vaughn, to my right, director of the 

Center for Veterinary Medicine’s Office of New Animal Drug Evaluation, and to my left, Mr. David Wardrop, Jr., executive officer 

and director of CVM’s Office of Management. 

FDA appreciates the opportunity to testify on the reauthorization 

of the Animal Drug User Fee Act and the proposed Animal Generic 

Drug User Fee Act. This morning I will be presenting an abbreviated oral testimony, if acceptable to the Committee. FDA has 

submitted a detailed written statement for the record. Thank you. 

FDA is the federal agency that regulates almost everything we 

eat except for meat, poultry and processed egg products, which are 

regulated by our partners at USDA. FDA’s responsibility extends 

to live food animals and animal feed. The Animal Drug User Fee 

Act, referred to as ADUFA, enacted in 2003, authorizes FDA to colVerDate Nov 24 2008 12:45 Apr 08, 2010 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-123 SCOM1 PsN: JIMC
7 

lect user fees from the animal drug industry to enhance the process 

for the review of animal drug applications. Fees collected under 

ADUFA are in addition to the base appropriations and they enable 

FDA to pursue a comprehensive set of review performance goals 

and commitments designed to improve the timeliness and predictability of the review of new animal drug applications, supplemental 

NADAs and investigational new animal drug submissions 

I am here today to share some very good news with you. Since 

ADUFA’s enactment, FDA has exceeded all the program’s review 

performance goals. Review times for original NADAs have decreased from 295 days to 180 days. Resources provided by ADUFA 

have allowed CVM’s scientists to keep pace with the rapid advances in science and medicine that drive the quality of healthcare 

and as a part of their work in review the animal drug applications. 

User fee funding has enabled the agency to hire and retain highly 

qualified scientific staff to address critical public health issues such 

as antimicrobial resistance that play a role in the review of new 

animal drug applications. This legislation has been extremely valuable to FDA to help us fulfill our commitment to promote and protect public and animal health. 

The user fee provisions of ADUFA will sunset on October 1, 

2008, if not reauthorized. Recognizing that timely reauthorization 

is needed to ensure there is no disruption to the program, FDA 

held public meetings, negotiated with the Animal Health Institute, 

which represents the majority of animal drug industry for pioneer 

drugs, published negotiated recommendations in the Federal Register, and accepted comments on those recommendations. FDA’s 

proposal to Congress includes input from stakeholders. Our goals 

for the legislative proposal to reauthorize ADUFA are to sustain 

and enhance the core program’s operation and performance while 

providing predictable review times and resources sufficient to keep 

pace with actual costs. Performance improvement enhancements 

are aimed at reducing costs for some submissions, providing for improved handling of inspections, improving communication between 

sponsors and the agency, and increasing the flexibility of the application process. FDA’s proposal also includes technical changes to 

increase the administrative efficiency of the user fee program. 

Because user fees have not kept up with the increasing costs of 

the program, FDA is proposing to change the financial provision of 

ADUFA to place the program on sound financial ground. At the 

proposed funding level of $98 million over 5 years, FDA has confidence that it will have a stable review workforce over the 5 years 

covered by ADUFA II. This will enable FDA to commit to a continuation of the fiscal year 2008 performance goals throughout the 

period covered by ADUFA II as well as to additional performance 

enhancements. 

Now I would like to address the Animal Generic Drug User Fee 

Act, AGDUFA. Currently, FDA’s review of generic animal drugs is 

funded entirely through appropriations. Under FDA’s generic animal drug user fee proposal, the generic animal drug industry would 

pay user fees that would be available to FDA in addition to the appropriated funds to spend on the process for the review of generic 

animal drug submissions. The proposed legislation will generate an 

estimated $27 million in user fees over 5 years. Fees dedicated to 

8 

the review process of applications will provide essential resources 

to improve generic animal drug review times. Review times for generic animal drug submissions have increased significantly in recent years, and at the end of fiscal year 2007, there was a backlog 

of 446 submissions for generic animal drugs, an increase of 93 percent over fiscal year 2000. The statutory review time is 180 days, 

but in fiscal year 2007, the actual review time was 570 days. With 

49 pioneer animal drugs to come off of patent between 2009 and 

2011, review times will increase unless improvements are made. 

This legislation is critical to FDA to improve its approval process 

for generic animal drugs. By passing AGDUFA, Congress will provide significant savings to ranchers, farmers, rural communities, 

and pet owners who struggle to pay the high price of pioneer drugs 

for their animals. In preparing its AGDUFA proposal for Congress, 

FDA negotiated with the Generic Animal Drug Alliance, which represents the majority of the animal generic drug industry. FDA’S 

AGDUFA recommendations ensure that generic animal drug user 

fee program will have a sound financial footing and strong performance goals. Resources generated through user fees will be sufficient 

to cover the actual cost of meeting specified performance goals. 

AGDUFA’s performance goals mirror those of ADUFA. The first 

goal is to reduce specific review times for sentinel submissions. It 

is estimated the review of an original generic animal drug application takes approximately 700 days in fiscal year 2009. It will take 

270 days by 2013. For generic investigational new animal drug protocols, the 400 days needed to review in 2009 will be reduced to 

100 days by 2013. These significant process improvements will help 

bolster a struggling generic animal drug industry. The AGDUFA 

proposal includes an amendment process to reduce the time and review cycles associated with similar submissions from a single sponsor and it incorporates several changes aimed at improved communication between sponsors and the agency. Resources generated by 

AGDUFA will be used to increase review staff, refine FDA’s business process for review of generic animal drug submissions, provide 

training and development for program staff and develop policies 

targeted at more efficient review. This proposal benefits from 

FDA’s ADUFA experience and will allow FDA to continue to maintain the high standards of safety and effectiveness for animals. 

In conclusion, FDA’s ADUFA and AGDUFA legislative proposals 

represent considerable input from and agreement of stakeholders 

and the agency. FDA urges passage of these proposals and we will 

work with Congress in any way we can to assist with that effort. 

Thank you for the opportunity to present testimony before the 

subcommittee, and we welcome any questions. 

[The prepared statement of Dr. Dunham follows:] 

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Mr. PALLONE. Thank you, Doctor. We are going to have some 

questions now from members of the subcommittee. 

You know there is great concern about antimicrobial resistance. 

While the overuse of antibiotics is certainly a factor, many researchers believe that the use of antibiotics in food animals also 

poses a great risk. In 2004, the GAO issued a report assessing Federal agencies’ efforts to address the risk to humans from the use 

of antibiotics in animals and the GAO found that while FDA had 

begun conducting risk assessments, most of these assessments 

were for drugs other than those that were critically important for 

human health. Can you tell how much progress the FDA has made 

in conducting risk assessments on existing approvals that are critically important to human health versus risk assessments at the 

time of initial review? I am making that distinction between existing approvals and risk assessments at the time of initial review for 

the drug. 

Dr. DUNHAM. The concerns for antimicrobial resistance have 

been and continue to be a top priority for the agency. Concerns 

arising from antimicrobials in animal feed was identified more 

than 30 years ago, and in regard to those responses, FDA has 

taken into account antimicrobial resistance as part of the animal 

drug review process, and we do look at all the data on the potential 

resistance to be selected to the animal and also to be transferred 

to bacteria that could contaminate food products. 

Mr. PALLONE. But do you have any—can you make a distinction 

in terms of your progress on the existing approvals, you know, the 

currently approved drugs as opposed to those assessments that are 

done when you are initially reviewing the drug that haven’t been 

approved yet? 

Dr. DUNHAM. Assessment on drugs that have not been approved? 

Mr. PALLONE. I think we are trying to make a distinction between those drugs that have been on the market and have been approved for some time as opposed to those that are going through 

the process now. 

Dr. DUNHAM. I understand. We have a review process that is 

going right now to take a look at some classes of antimicrobials 

that have been approved for a very long time. Those are classes, 

not individual drugs, and we are going through and pulling and 

looking at each one of those. So there is a tremendous amount of 

work that is being done right now to take a look at those as well 

as the literature review available for all of those classes of 

antimicrobials that very, very early on were approved compared 

to— 

Mr. PALLONE. Do you have—and you don’t have to give it to me 

today, you can get back to me but— 

Dr. DUNHAM. Oh, I would be happy to get back to you. 

Mr. PALLONE. But is there a schedule for conducting these risk 

assessments for those drugs that have been approved for some time 

that you can get back to us, you know, more information about how 

you are going about that and how long it is going to take? I will 

say a schedule. 

Dr. DUNHAM. All right. We would be happy to get that information. 

22 

Mr. PALLONE. OK. And my impression is, the FDA has not been 

able to conduct a lot of risk assessments on those currently approved drugs. I mean, would you want to comment on that? I 

mean, do you think there is enough? Do you think there should be 

more? 

Dr. DUNHAM. At the moment we are currently going back, as you 

mentioned, and reviewing that, and we will be glad to give you a 

further update on that information. 

Mr. PALLONE. In getting back to me, if you could indicate the average length of time to conduct a risk assessment on those products 

that are currently approved and whether you think that length of 

time is acceptable. I guess that is all I wanted. Just get back to 

us on that. 

Let me get to a second set of questions here. Again, it goes back 

to antibiotics. We have heard from various stakeholders about 

FDA’s authority to act when they think that the use of an antibiotic in a food-producing animal is harmful to human health. 

Take, for example, the case of Baytril, manufactured by Bayer. It 

is my understanding that FDA found that the use of the product 

in poultry posed a threat to human health and sought to withdraw 

its approval. After 5 years of appeals and administrative proceedings, the approval was finally withdrawn. So the question is, 

does the FDA have any concerns about the process which you have 

to undergo to withdraw a product’s approval if you think it poses 

a threat? Do you think that 5 years that I mentioned in the case 

of Baytril is an excessive amount before the approval can be withdrawn? Do you think this process deters the agency from conducting risk assessments on products with existing approvals? So 

essentially this would be the opportunity to change that process 

and to change the law if you thought that we should, so I just 

wanted you to comment on it. 

Dr. DUNHAM. Thank you very much. As you know right now, our 

authority does allow us to go through that review process to determine if there is a serious health threat and, if so, we would be addressing that, and as you mentioned with the Baytril procedure, we 

have to make sure there is reasonable certainty of no harm, and 

if so, we do investigate and an opportunity to have a notice of hearing at which time we take a look at the information that is there 

and the safety of that drug, and during that procedure, if we have 

decided that, then the sponsor has the burden to come back and 

show us information. In the case of Baytril, as you pointed out, this 

was withdrawn. 

Mr. PALLONE. But it took 5 years. So my question is, do you 

think that we should do—well, first, do you think that is excessive? 

And obviously if you think it is a problem, what would you want 

us to do in reauthorizing the law to correct it? 

Dr. DUNHAM. Well, at the moment, that authorization has been 

working but we would be very happy to work with you if you have 

anything alternative that we would like to consider. At the moment 

we follow that procedure and, as you well know, the product would 

remain on the market during the time that we go— 

Mr. PALLONE. So you do feel it is too long and that we should 

try to address it? I am not trying to catch you in being evil or anything. I am just trying to find honestly if you think that that is 

23 

something we should try to correct because you think it is too long 

a process. 

Dr. DUNHAM. Well, as I said, at the moment right now, with our 

process and what we have a chance to do and how we do it, it has 

been working and that is the caveat that we undergo the approval 

process and then the withdrawal process. 

Mr. PALLONE. So you are open to a change. OK. 

Mr. Deal. 

Mr. DEAL. Thank you, Mr. Chairman. 

I suppose we ought to ask, in light of the reauthorization issue 

before us, what would happen if Congress fails to enact the 

ADUFA reauthorization by September 30, and would there be layoff notices sent to employees, and how many employees would be 

affected and when would these notices have to go out? 

Dr. DUNHAM. Yes, sir. This would be critical if we do not get this 

reauthorization to the program and all that we have accomplished. 

We do have to apply notice 60 days in advance of the reenactment 

time to our employees and we would possibly be impacting 58 employees that we currently have under the ADUFA procedure. So we 

would lose the talent that we have right now and the impact would 

really step us back with the whole program that has been incredibly well performing. It has been a successful program and we really would be hurt if we couldn’t get this reinstituted. 

Mr. DEAL. So time is of the essence, in other words? 

Dr. DUNHAM. Yes, sir, it is. Thank you. 

Mr. DEAL. Let me ask this question. Does the CVM believe it has 

enough authority to protect the effectiveness of antibiotics used to 

treat human illness, especially those that are considered by FDA 

as critically important to human health, and if not, then what further authorities would you feel like you need from Congress? 

Dr. DUNHAM. As you know, we do have the authorities to go 

through and review, because that is our goal, to approve safe and 

effective products, and we do look at public health, and if there 

were indications that any drug on the market was impacting 

human health, then we can conduct a thorough review and take action, as we mentioned a minute ago, on that. 

Mr. DEAL. So you feel like you do have adequate authority in 

that regard? 

Dr. DUNHAM. Yes, sir. 

Mr. DEAL. This agreement calls for an end-review amendment of 

deficiencies in a sponsor’s application, and also the creation of electronic submission too. How do you anticipate that these will affect 

approval times? 

Dr. DUNHAM. Oh, it is going to be well welcomed. If we can move 

into the electronic age, for example, the ease with which the sponsors can provide us that and the ease with which our reviewers can 

access and modify as well as storage of all the data that comes 

from the electronic submission will be a great improvement as we 

move forward in the 21st century. So that would be great. Thank 

you. 

Mr. DEAL. I think that answers my questions. Thank you very 

much. 

I yield back, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Deal. 

24 

The gentlewoman from Illinois, Ms. Schakowsky. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. I wanted to get 

back to that issue that you had raised, Mr. Chairman, about the 

potential overuse of antibiotics and the effect that it can have on 

humans, and maybe you answered this question but I am wondering if you could explain the 2003 FDA guidance for industry 

that laid out the agency’s requirements for evaluating antimicrobial drugs that may pose a risk to public health. Is that what 

you were referring to in the answer to the chairman’s question? 

Dr. DUNHAM. Yes, it was part of our procedure. Whenever we do 

a review, if there was a concern to public health of a specific product, then we can take a very detailed approach and look through 

that, take a look at the science, and if there is indication of harm, 

then we will follow through and take that information, review it, 

and if we have determined that is the case, as was the example 

with Baytril, then we can put out a notice of opportunity for hearing at which time then the sponsor would have an opportunity to 

push back and give us information to say whether or not that 

project is safe or not. The review goes through and a decision 

would be made at the end of that notice of opportunity for hearing. 

Ms. SCHAKOWSKY. And what was the conclusion of that investigation? 

Dr. DUNHAM. In the case of Baytril, it was removed and we no 

longer use that for treatment in poultry. 

Ms. SCHAKOWSKY. Is it a matter of a particular drug or is a matter of the quantity of antibiotic present in the animal products that 

we eat? 

Dr. DUNHAM. In the case of the drug, you are looking at the drug 

itself, and when you take a look at, for example, a residue, as we 

would follow through in an animal of that drug product, there are 

limits that we establish courtesy of the review process. In the case 

of the drug, if, as you mentioned a minute ago, there was an impact to public health, then we take a look at that drug and its impact specifically and how it is being used. 

Ms. SCHAKOWSKY. And do we have good scientific data on just 

what the impact is, the cumulative effect of eating animal products 

that are treated with antibiotics? Is this an area where we are still 

doing research and studying this? 

Dr. DUNHAM. This area is in fact very complicated. It is not black 

and white. There are so many venues that impact this and we, yes, 

are along with many other scientists heavily involved with current 

studies and review to assess all of this and understand this very 

complicated procedure. 

Ms. SCHAKOWSKY. Because it is very threatening, the fact that 

we have all these drug-resistant incidents where this could be a 

major threat to public health over time, and we want to be sure 

that the FDA is looking ahead. 

Dr. DUNHAM. Yes we are, and I think again, with the talent that 

we have, cutting-edge science to know what is happening, the 

traceability, surveillance programs, information internationally as 

well as domestically comes into play. Environmental issues, medicine in general, everything is very much in tune to understand all 

of this, and I think it is a very exciting area that we have for our 

scientists to be involved. 

25 

Ms. SCHAKOWSKY. And does the FDA have all the authority it 

needs to enforce its guidance and perhaps enforce new standards 

that could be set up? 

Dr. DUNHAM. Yes, we do. 

Ms. SCHAKOWSKY. Do you think there is enough evidence at this 

point to at least consider phasing out the use of antimicrobials for 

non-therapeutic use in food animals? 

Dr. DUNHAM. That is another area that we are looking at the information right now. It is under review. 

Ms. SCHAKOWSKY. And what is the timeline for that? 

Dr. DUNHAM. I am going to respond back to Mr. Pallone and you 

with the information that we will return to you in written documentation. 

Ms. SCHAKOWSKY. Yes, but you do have a protocol and a timeline 

and all that for completing this review or this study? 

Dr. DUNHAM. We have information that I will be able to provide 

to you that will give you an outline of everything we have, yes. 

Ms. SCHAKOWSKY. The Union of Concerned Scientists estimates 

that 70 percent of all antibiotics in the United States are used in 

healthy pigs, poultry, beef, and cattle. Is that the case? 

Dr. DUNHAM. I would have to get back to you to confirm any documentation of that number. 

Ms. SCHAKOWSKY. The doubling of the user fee that is being proposed, and so this will mainly be used to shorten the review period? I know you went over it in your testimony, but if you could 

just summarize, though, how that money would be used? 

Dr. DUNHAM. Right now for ADUFA, we will continue with our 

review times that we have now reached at the end of ADUFA I. 

Ms. SCHAKOWSKY. Which is how many days? 

Dr. DUNHAM. One-hundred and eighty days without statutory 

time, which now under ADUFA II will allow us to further enhance 

working through communication with our sponsors. We will have 

10 public workshops over the 5-year period. We will be able to work 

with our sponsors now to have an understanding of any of the preapproval potentially foreign facility inspections, to work with them 

in advance to again keep the times down and to complete that information that is collected. We hope very much to move forward 

into the 21st century with electronic submissions and reviews 

which will help not only storage but access and free moving of the 

information that we receive for our reviewers, and we will have an 

opportunity to further enhance overall communication with sponsors. For example, sometimes they come in at the very, very end 

and there may be non-substantial information but something that 

needs to still be reviewed, and we can add that on with very little 

additional time instead of going back, as we used to under ADUFA 

I, and have to do another notice of a letter to come back and go 

through another review cycle. Keeping it down to one review cycle 

time is very, very critical. This will help get that product that is 

going through approval on the market without having further 

delay. 

Mr. PALLONE. The gentlewoman is a minute over. 

Ms. SCHAKOWSKY. Oh, I am sorry. If I could just ask one more 

thing about the pet food that we get? Can we be sure that it is safe 

now? 

26 

Dr. DUNHAM. We have our food protection plan and I think we 

have come a long way since the melamine incident, which has really been fantastic to open up the awareness to people not only for 

pet food but human food and feed in general. So yes, we have come 

a long way. 

Ms. SCHAKOWSKY. Thank you. 

Mr. PALLONE. The gentleman from Indiana, Mr. Buyer. 

Mr. BUYER. Thank you, Mr. Chairman. 

The FDA had given previous testimony and the Commissioner 

has also supported for us to give authority to the FDA to destroy 

counterfeit, adulterated, or misbranded drugs that may be found in 

any of our ports of entry, and that is with regard to human consumption. Do you not believe that it would make sense that we also 

extend that authority, that if you find a misbranded, adulterated 

or counterfeit drug that would be used for animals that you also 

be given the authority to destroy? 

Dr. DUNHAM. I don’t believe I have had an opportunity to really 

address this within our group for CVM. I know it is happening on 

the human side. We haven’t seen as much counterfeit opportunities 

for animal drugs the way I know you do see it on the human side, 

but we definitely would appreciate any opportunity to keep only 

our approved products on the market and be able to intervene 

whenever we do see adulterated products coming across. 

Mr. BUYER. So therefore, following the syllogism of logic, would 

it not make sense that FDA be given the authority to destroy if in 

fact you found a misbranded, adulterated, or counterfeit animal 

drug? If you want to do it for humans, you would think you would 

want to do it for an animal drug too, would you not? 

Dr. DUNHAM. And I would just need to confirm that we have 

gone through with our counsel on that to let you know that we 

have had a green light to look at animal drugs as well. 

Mr. BUYER. Let me ask about your personal opinion. Do you not 

in your personal opinion think that it is common sense, if we are 

going to protect humans, we ought to protect animals equally? 

Dr. DUNHAM. We do with our drugs to make sure they are safe 

and effective and approved. I do agree, yes. 

Mr. BUYER. All right. I don’t want to do the dance with you, OK? 

It is easy for me to pick up the phone and ask the Commissioner 

because the Commissioner is going to say absolutely. 

Dr. DUNHAM. Yes, we do. I do. 

Mr. BUYER. All right. Now let me ask you in your professional 

opinion, since we also know, now, would FDA support—if we were 

to put in language giving you the authority to destroy a counterfeit, 

adulterated, or misbranded drug, would you not welcome that authority? 

Dr. DUNHAM. Yes, I would. 

Mr. BUYER. All right. Thank you. 

Mr. Chairman, here is my question to you. I think we have an 

opportunity here. As Mr. Matheson and I are working with you and 

Chairman Dingell on the food and drug safety side of the bill, not 

only creating electronic pedigree, but one of the provisions for 

which you have also agreed is about giving the authority to FDA 

to destroy these misbranded, adulterated, or counterfeit drugs. It 

is easier for us to put that provision in this bill with regard to aniVerDate Nov 24 2008 12:45 Apr 08, 2010 Jkt 037690 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-123 SCOM1 PsN: JIMC
27 

mals rather than in the other drug and safety bill expanding that 

and say well, we want to include animals. See what I am saying? 

We have two different provisions, one dealing with human consumption on food and human use on drugs. Let us leave those provisions to apply to humans. This is our opportunity to take that 

provision and leave it in the animal bill. 

Mr. PALLONE. I think I followed you, and I think we will look 

into it. I don’t want to prejudge it in any way but we will certainly 

look into it. 

Mr. BUYER. I just think we have an opportunity. We have got 

something that is moving. Earlier when I had proposed this when 

we were doing the reauthorization of PDUFA, Chairman Dingell 

said whoa, Steve, hold off, we are going to do a food and drug safety bill, and that is when Mr. Matheson and I began to work together on building an electronic pedigree bill that incorporates 

what the Commissioner was asking for, and so as we are working 

cooperatively on that side of the bill to deal with human consumption and medications, I just once again think it makes a lot of 

sense that we work with you and I will work with Mr. Matheson, 

that this could be included perhaps in your own manager’s amendment that we take care of this issue. 

Now, as the lady from the FDA just testified, well, we are not 

seeing that as much, my sensing would be that if people are beginning to drive toward generics because of costs, it is only a matter 

of time before the criminal syndicates then move into this economic 

space because it is highly lucrative, and that is where they are 

moving. So let us give them the tools to be able to combat this before the syndicates can move into the space would be my argument, 

and I would like to work with the ranking member and the chairman to do just that. And Mr. Matheson, you and I have not had 

an opportunity to discuss this. This just came up, but I think this 

is one that only makes sense. Building a consensus on how to 

dance. I yield back. 

Mr. PALLONE. Let me just explain to you. I think you all understand what we have before us are two drafts based on what the Administration and the industry agreed to. Obviously the purpose of 

the hearing today is to entertain any other ideas either for or 

against that, so this is certainly something that we will look into 

without prejudging whether we would definitely do it. But the 

whole idea of today’s hearing is to get these kinds of ideas. So 

thank you. 

The gentleman from Utah. 

Mr. MATHESON. Thank you, Mr. Chairman, and thank you, Mr. 

Buyer, for raising that issue, by the way. 

Dr. Dunham, I wanted to ask you a couple of questions about 

antibiotics, if I could. The World Health Organization has established a measurement for antibiotic usage data collection called Defined Daily Doses, and Europe has mandatory reporting of the consumption data collection using this measure and it is my understanding that it has enabled comparisons that we are unable to 

perform right now in the United States. Does the FDA require 

manufacturers to submit data in this format or some other comparable format using a uniform measurement? 

28 

Dr. DUNHAM. At the moment, we do receive the quantity that 

they produce on anniversary of the approval. We receive that information from them. 

Mr. MATHESON. Does the information you receive help you in 

terms of having a way to better understand patient safety, in this 

case, animal safety? I mean, is the data you are getting comparable 

to what the Europeans ask for as mandatory reporting data? I 

didn’t think it was. That is why I am asking. 

Dr. DUNHAM. Well, we have adverse drug reporting that we will 

look at on any individual drug that has been approved. We have 

that system that is all part of our Federal Food, Drug, and Cosmetic Act. 

Mr. MATHESON. Can you tell me the percentage of antibiotic 

drugs sales that are for humans versus animals? 

Dr. DUNHAM. I cannot but I could certainly look into that and get 

you some information, sir. 

Mr. MATHESON. Do you know whether the antibiotics that are 

used to treat sick animals or animals exposed to disease or—let me 

rephrase this. Are antibiotics used to treat sick animals or animals 

exposed to disease or for other purposes such as growth promotion 

and/or disease prevention? 

Dr. DUNHAM. There are products on the market that are approved for growth promotion and feed efficiency and then they are 

also there to treat disease. 

Mr. MATHESON. Does FDA maintain a database of animal antibiotic use data? 

Dr. DUNHAM. We again would receive the information as far as 

quantities and any adverse reaction to those drugs. 

Mr. MATHESON. OK. Mr. Chairman, that is all I have to ask. I 

will yield back. 

Mr. PALLONE. The gentleman from Pennsylvania, Mr. Murphy. 

Mr. MURPHY. Thank you, Mr. Chairman. 

Just a couple quick questions on some issues. I am concerned 

about the timing of this bill. Before, you were asked about some 

impacts it would have in terms of layoff notices, you commented on 

that. I am concerned about the clinical impact of any delays here. 

Does current status of this or in any additions that would be coming up in this changed legislation impact you? So for example, 

would the delays hold up any ability to handle any improvements 

or modernizations in what you do now? 

Dr. DUNHAM. Yes, it would, because of the advances we have 

been looking for, and a specific example would be if we wanted to 

move forward with the electronic era, it would be impacted by this 

as well. But more importantly, the biggest impact by far is going 

to be the lack of the scientific technical expertise and talent that 

we need to continue to do the reviews and that is going to stall and 

we are going to have a delay again on having the review to enable 

safe products to be approved and be used to help both protect companion animals and food animals. 

Mr. MURPHY. Would it then negatively impact on your ability to 

enforce new regulations or, more specifically and more concerning, 

to respond to any emergencies? 

Dr. DUNHAM. Overall, whenever we do receive anything like an 

emergency reaction, we would have the staff to respond to that. 

29 

The biggest impact is going to be again the review of any new products coming through that we would like very much to have come 

through for approval and be on the market. That would be delayed. 

Mr. MURPHY. I see. And just another question I thought of while 

Mr. Buyer was raising his questions too. With regard to drugs that 

are used both for animals and for humans, so similar ones or identical ones, and what Mr. Buyer was raising about counterfeit or 

other drugs coming over on black markets, and it is an issue we 

have discussed a number of times in this committee, is there jurisdiction now if it is the same drug for both animals and human use 

that if it came through labeled as an animal drug but was identical 

to human, would you have the power at this point to take action 

that he is referring to? 

Dr. DUNHAM. If we haven’t gone through the approval process of 

that drug and it is coming from outside the United States, then it 

is not approved. It has to come through our review process. So 

many times you will have a drug approved in another country but 

you wouldn’t be able to import it and use it if it hasn’t gone 

through our review process. 

Mr. MURPHY. What action would you take if you found it at a 

port? 

Dr. DUNHAM. Then you would be able to prevent entry coming 

into the port. 

Mr. MURPHY. If that drug was approved for human use but not 

animal drug, I mean, does it go— 

Dr. DUNHAM. Well, once again, if it is not approved, the only way 

that you would be able to possibly have a veterinarian use that is 

if it is an approved drug through FDA. So a human approved drug 

through the FDA procedure, not outside of the United States, and 

only then would a veterinarian be able to use that. So even if it 

is approved in another country, a human drug, still coming over 

here it hasn’t gone through our review process even on the human 

side. 

Mr. MURPHY. I raise the issue because we hear some people trying to use animal drugs because they are less expensive than 

human drugs, but that is a discussion for another hearing another 

day. Thank you very much. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Murphy. 

I am going to have a second round because I for one have some 

questions I wanted to ask Dr. Dunham, and this is an area that, 

as I said, we basically took the Administration’s proposal so we do 

have some questions. 

Another issue that has been brought to my attention regarding 

antimicrobial resistance is the lack of data that exists on how antibiotics are sold and used by ranchers, meat producers, farmers, et 

cetera. As I understand it, currently there are no data sources that 

FDA can draw upon that show the total quantity of antibiotics used 

in animals, the species they are used in, the purpose of the use, 

therapeutic versus prophylactic or growth promotion purposes, or 

the method used to deliver the antibiotic. Is that correct, in your 

opinion? 

Dr. DUNHAM. We do not have the individual use. We have the 

drug and what it is approved for and only information on quantity 

30 

marketed at the end of the anniversary do we have information 

coming back unless there were some adverse events, and then we 

would have data from that. 

Mr. PALLONE. OK. Do you think that it is important for FDA in 

its mission to have access to that additional data, and how would 

that data enable FDA to better track antimicrobial resistance or 

determine any threats to the public health? 

Dr. DUNHAM. As I said, for that opportunity at the moment, what 

we have, it comes in strictly as quantity marketed, and we have 

been complying with that and using that information but we don’t 

have access to anything further. 

Mr. PALLONE. Well, do you think it would be burdensome to collect this additional data from manufacturers and those delivering 

the antibiotics, what I am suggesting? 

Dr. DUNHAM. I probably would have to make some inquiries and 

get back to you. 

Mr. PALLONE. You can get back to us. Sure. Get back to me in 

writing. I would be very happy with that. 

Dr. DUNHAM. Thank you. 

Mr. PALLONE. I understand that at some point, if Congress does 

not act to reauthorize ADUFA, you would have to issue the RIF notices. We dealt with this possibility before, when we were dealing 

with PDUFA and MDUFA. Can you tell me how many employees 

at FDA might be subject to those RIFs, and what is the agency’s 

deadline for issuing those notices and whether you have any flexibility in determining when the notices will be sent out? Because 

when the agency was able to hold off sending out RIF notices when 

we dealt with PDUFA and MDUFA last year, I think what they did 

is, because they knew the Congress was moving to reauthorize in 

a timely fashion, they had the flexibility not to send out the notices. Is that true? 

Dr. DUNHAM. I would need myself to personally confirm that. 

Otherwise I do know we are required 60 days before that date to 

let the employees know they could undergo a RIF, and that is why 

is so critical that we move this piece of legislation forward. 

Mr. PALLONE. Do you know how many employees would be subject to those notices? 

Dr. DUNHAM. Approximately 58. 

Mr. PALLONE. Fifty-eight. All right. Well, again, get back to us 

on that issue of flexibility, because I know that there was some 

flexibility used with regard to PDUFA and MDUFA because they 

knew that we were moving, and I commit to you that obviously the 

reason we are having this hearing today is because we do want to 

move forward with passing a bill and getting it signed into law in 

a timely fashion. 

And then lastly, in your testimony you note that FDA worked 

and negotiated with industry, both the Animal Health Institute 

and the Generic Animal Drug Alliance, in putting forward the 

ADUFA II and the AGDUFA proposals. Did you also meet with 

consumer groups and incorporate concerns raised by those groups? 

And if so, what changes did you make to incorporate consumer concerns? 

Dr. DUNHAM. With the submitted comments to our documents, 

the majority of the views were supported of the ADUFA and 

31 

AGDUFA proposal, and there were a few that would like us to do 

a little more, like you mentioned, which is to look at aspects of do 

we do enough on antimicrobial resistance, and as we have explained to you today, our procedures of the review do incorporate 

looking at issues of antimicrobial resistance during the review process. So if anything, it would be a chance of where do we do more, 

and I think we have the capability of doing that and incorporating 

that into our review right now. 

Mr. PALLONE. OK. Thank you. 

Any other member want to ask additional questions? Mr. Deal. 

Mr. DEAL. Thank you. Can you tell us what is the FDA approval 

process if we compare the approval process of antibiotics for animals versus the approval process of antibiotics for humans? Is it 

more or less stringent in the animal environment? 

Dr. DUNHAM. If I may, I am going to have Dr. Vaughn go 

through that review process difference between human and animal. 

Mr. DEAL. My understanding is that there may be a benefit analysis in one area versus benefit analysis in the other, but I will let 

you answer. 

Dr. VAUGHN. Thank you, Mr. Deal. On the animal drug side, our 

evaluations are for primarily human food safety for the products 

that are derived from those animals and the potential transference 

of any adverse effects either through chemical residues or antimicrobial resistance or impact of the drugs on human gastrointestinal flora. And so to that end, we are looking strictly from a 

safety standpoint and it is not offset by the potential benefit that 

may be derived from that drug in animals. 

Mr. DEAL. OK. A related question deals with the definition I 

guess of a term that we often hear used and that is the term 

‘therapeutic use’ of a drug. Some of these areas I am going to list 

maybe seem simplistic to ask you the question, but do you feel that 

it is appropriate to use antibiotics in animals for the following purposes, first of all, disease treatment? 

Dr. VAUGHN. For disease treatment, yes, sir. 

Mr. DEAL. All right. What about for disease prevention? 

Dr. VAUGHN. Disease prevention, if I can explain a little bit, the 

way we go about establishing indications on our labels for those 

products that do get approved, we do look at them as therapeutic 

and non-therapeutic, and for the non-therapeutic, we would include 

things for growth promotion, average daily gain, feed efficiency, 

those types of claims, and in those cases, for antimicrobials, we 

have not approved a single product for quite a few years. Those applications just are not coming to us. And on the therapeutic side, 

we consider claims such as prevention, control, and treatment, and 

as a veterinarian, I can tell you that it is important, depending on 

the disease process, to intervene at the appropriate time to have 

the best effect for that drug, and in some cases, if we wait until 

we actually have clinical signs of disease, that we will not be able 

to get the clinical effect that we need to be able to get from these 

therapeutic products. 

Mr. DEAL. So treatment, prevention, and control would all be 

considered appropriate therapeutic usage for antibiotics in animals? 

Dr. VAUGHN. Yes, sir. 

32 

Mr. DEAL. OK. I think that is all. Thank you very much. 

Mr. PALLONE. Does any other—yes, Ms. Schakowsky. 

Ms. SCHAKOWSKY. I just want to clarify something. You said that 

the FDA, that you have adequate authority to take action if you 

conclude there is a problem with antibiotic resistance, but yet in 

response to the chairman’s questions about Baytril, you said that 

it took 5 years to remove that drug and that is just one drug. So 

to me, that doesn’t seem—either it doesn’t seem like adequate authority or that the process is awfully slow. So if the FDA knows 

that a drug is generating antibiotic resistance, don’t you think 5 

years is too long to deal with that and that the American people 

could be at risk for too long? 

Dr. DUNHAM. As I mentioned, the procedure that we use in having to go through in this case the review and the court hearing, 

took that long, and we would be happy to work with you if you 

have any additional suggestions or ideas you would like to modify 

to that procedure that currently our jurisdiction allows us to go 

that way. We had that review, and you are right, it took 5 years 

before completion. During that entire time, the product would stay 

on the market. That is currently the system that we operate under. 

So we would be happy to work with you. 

Ms. SCHAKOWSKY. Well, I would appreciate that because in your 

mind, isn’t 5 years an awfully long time if this is something that 

should be off the market? 

Dr. DUNHAM. And it takes a scientific review and the back-andforth before a decision was made. 

Ms. SCHAKOWSKY. But don’t you think that is an awfully long 

time to—obviously the conclusion was that there is some kind of 

risk. Isn’t 5 years too long? Don’t we need to work on that, in your 

view, to figure out how to shorten the process? 

Dr. DUNHAM. We would be very happy to work with you on anything that you have that you are willing to provide. 

Ms. SCHAKOWSKY. Thank you. 

Mr. PALLONE. Mr. Matheson, did you want to ask additional 

questions? OK. 

Thank you, Dr. Dunham and the two that accompany you. I 

think this was very helpful. And as I said, we basically put these 

proposals together based on the Administration’s agreement and 

we are just going to follow up after the hearing and try to see if 

we have any additions or suggestions to change it, but we do intend to move this in a timely fashion, I want to assure you. 

Dr. DUNHAM. I appreciate that very much. Thank you for the opportunity. 

Mr. PALLONE. And I will ask the second panel to come forward 

now. Welcome. Let me introduce our second panel. To my left is Dr. 

Richard Carnevale—I don’t know if I am pronouncing that correctly—who is Vice President of Regulatory, Scientific, and International affairs for the Animal Health Institute, and next is Ms. 

Stephanie Batliner, who is Chairperson of the Generic Animal 

Drug Alliance and also Director of Pre-market Regulatory Affairs 

for IVX Animal Health Inc. from St. Joseph, Missouri, and then is 

Robert Martin, who is Executive Director of the Pew Commission 

on Industrial Farm Animal Production. We have 5-minute opening 

statements become part of the record, and the Committee may subVerDate Nov 24 2008 12:45 Apr 08, 2010 Jkt 037690 PO 00000 Frm 00038 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-123 SCOM1 PsN: JIMC
33 

mit additional questions in writing for you to answer very quickly 

after the hearing. And so we will start with Dr. Carnevale. 

STATEMENT OF RICHARD CARNEVALE, V.M.D., VICE PRESIDENT OF REGULATORY, SCIENTIFIC AND INTERNATIONAL 

AFFAIRS, ANIMAL HEALTH INSTITUTE 

Dr. CARNEVALE. Good morning, Mr. Chairman and members of 

the subcommittee. Thank you very much for holding this hearing 

on this important piece of legislation and for the opportunity to 

speak to you today about the benefits to human and animal health 

from FDA-approved animal medicines. 

I am Dr. Richard Carnevale. I am a veterinarian and a vice 

president with the Animal Health Institute, a trade association in 

Washington that represents companies that make medicines for 

animals. Our companies share a common mission: we contribute to 

public health by protecting animal health. As companion animals 

have become a more important part of our everyday lives, they 

have moved from the backyard into our living rooms and bedrooms, 

increasing their importance to humans and requiring attention to 

their health needs. As medical breakthroughs from human medicine are adapted to animal medicine, our pets are living longer and 

healthier lives. 

Animal health products also give veterinarians and livestock and 

poultry producers the necessary tools to protect the health and 

well-being of food-producing animals. A vital first step in producing 

safe meat, milk, and eggs is keeping animals healthy. Veterinarians work hard to prevent disease in animals. However, it is important for them to have medicines available when they are needed to 

treat a disease they cannot prevent. 

The statutory standard for FDA approval of animal drugs under 

the Federal Food, Drug, and Cosmetic Act is the same as that for 

human drugs: they must be proven safe and effective. As a result, 

the animal drug review process looks much like the human drug 

review process. Animal drug companies submit data from scientific 

studies to demonstrate safety, efficacy, and the ability to meet the 

same stringent manufacturing standards. It is a costly process, requiring as much as $100 million and 7 to 10 years to bring an animal drug to market. In the case of food animals, the standard to 

ensure that meat, milk, and eggs are safe for human consumption 

adds an additional set of requirements that increases the costs and 

time to market. 

Animal health companies rely on a rigorous, efficient, predictable, and science-based review process at the Food and Drug Administration’s Center for Veterinary Medicine to provide these 

products to society. That is why our companies supported the first 

authorization of the Animal Drug User Fee Act more than 5 years 

ago. ADUFA I made it possible for our companies to bolster funding at CVM so that they could meet performance standards to improve the efficiency and predictability of the animal drug review 

process. 

We believe ADUFA I has been successful. The backlog of overdue 

pioneer animal drug submissions that existed at the beginning of 

the program is gone. FDA CVM has successfully met the performance timelines established by the legislation. As a testament to this 

34 

progress, 2007 was a banner year for approval of new and innovative products with CVM approving nine new chemical entities, giving veterinarians new medicines to fight diseases and other conditions in animals. 

The legislation before you to reauthorize this successful program 

builds upon this record of achievement. Whereas the total cost of 

ADUFA I came to around $43 million over 5 years, sponsors will 

contribute $98 million to this process over the life of the next legislation. 

Many will benefit should Congress approve this bill. FDA CVM 

of course benefits by having additional resources to meet its mission of protecting public health. Animal health company sponsors 

benefit from a stable and predictable review process, allowing them 

to make informed decisions about the investment risks of research 

and development dollars. Veterinarians and animal owners benefit 

from having new and innovative medical advances to treat, control, 

and prevent diseases in their patients. And finally, consumers benefit from a safer food supply as a result of the availability of additional tools to keep food animals healthy because healthy animals 

means healthful and safe food. These widespread benefits are why 

a broad coalition of companion animal interests and animal agriculture interests support this legislation. Attached to my testimony, Mr. Chairman, is a copy of the coalition letter sent to you 

earlier this year from a broad mix of groups asking for congressional action on this bill. 

The regulatory process this bill will support is one of the most 

protective of human health in the world. The bill does not in any 

way alter or change the rigorous pre- and post-approval animal 

safety and food safety standards. FDA CVM has a rigorous and robust process that takes into account animal and human safety 

throughout the life cycle of the product. We strongly believe this 

bill intensifies CVM’s public health focus by increasing the resources used to meet that mission. The timely availability of animal medicines approved by FDA protects public health. A process 

that is cumbersome and inefficient delays those products that are 

safe and effective and encourages the use of untested and illegally 

compounded products in an attempt to address unmet animal 

health needs. The rigorous review process and monitoring systems 

in place are at the heart of a broad system of protections that ensure that all medicines including antibiotics are safe for animals 

and humans. 

Mr. Chairman, I have attached more information in my written 

statement on the review process related to antimicrobials. 

In summary, Mr. Chairman, CVM has a rigorous science-based 

review process that provides to society the products necessary to 

protect public health by protecting animal health. The reauthorization of ADUFA will continue to provide the Agency the resources 

necessary to maintain and improve this process, provide new and 

innovative products to allow our pets to live longer and healthier 

lives, and contribute to food safety and food security by keeping 

food animals healthy. I urge you to move a clean ADUFA II bill in 

a timely manner so this program can continue without interruption. Thank you. 

[The prepared statement of Dr. Carnevale follows:] 

35 

STATEMENT OF RICHARD CARNEVALE

Mr. Chairman and members of the Subcommittee: 

Thank you for holding this hearing on this important piece of legislation, and for 

the opportunity to speak to you today about the important human and animal 

health benefits that result from using medicines to keep animals healthy. 

I am Dr. Richard Carnevale. I am a veterinarian by training with a degree from 

the University of Pennsylvania and I am here today on behalf of the Animal Health 

Institute, a trade association that represents companies that make medicines for 

animals. Our companies share a common mission: we contribute to public health by 

protecting animal health. With food animals in more demand from our growing global population, the importance of the nexus between animal health and human 

health has never been greater, and is one of the driving forces behind the Center 

for Disease Control’s ‘‘One Health’’ initiative. Recent highly-publicized threats like 

avian influenza highlight this nexus. As companion animals have become a more 

important part of our everyday lives they have moved from the backyard into our 

living rooms and bedrooms, increasing their importance to humans and requiring 

greater attention to their health needs. As medical breakthroughs from human medicine are adapted to animal medicine, our pets are living longer and healthier lives. 

Animal health products also give veterinarians, and livestock and poultry producers, the necessary tools to protect the health and well-being of food producing 

animals. More and more evidence demonstrates that a vital first step in producing 

safe meat, milk, and eggs is keeping animals healthy. Veterinarians work hard to 

prevent disease in animals, but it is important for them to have medicines available 

when needed to treat a disease. 

The statutory standard for FDA approval of animal drugs under the Federal Food, 

Drug, and Cosmetic Act is the same as that for human drugs: they must be proven 

to be safe and effective. As a result, the animal drug approval process looks much 

like the human drug approval process: animal drug companies submit data packages to demonstrate safety, efficacy, and the ability to meet the same stringent FDA 

manufacturing standards. It is a costly process, requiring as much as $100 million 

and 7–10 years to bring an animal drug to market. In the case of food animals, the 

standard to ensure that meat, milk, and eggs are safe for human consumption adds 

an additional set of requirements that increases the cost and time to market. 

The market for animal drugs, however, is nothing like the market for human 

drugs. Our products are used to treat seven different major species of animals and 

many more minor species. A blockbuster animal drug will have sales of $100 million, and the vast majority of animal health products have a market size of around 

$1 million. There is no Medicare or Medicaid and, except in rare cases, no employer 

supported health insurance—the cost of animal drugs is borne in full by the animal 

owner. Animal health companies rely on a rigorous, efficient, predictable, and sciencebased review process at the Food and Drug Administration’s Center for Veterinary 

Medicine (CVM) to provide these products. That’s why our companies supported the 

first authorization of the Animal Drug User Fee Act more than 5 years ago. The 

Animal Drug User Fee Act of 2003 (ADUFA I) made it possible for our companies 

to bolster funding at CVM so that they could meet performance standards to improve the efficiency and predictability of the animal drug approval process. 

As a result of an efficient and predictable regulatory process, animal health companies can be more confident investing research dollars in the United States. According to data AHI collects, in 2006 pioneer animal health companies invested $663 

million in research and development of new and innovative products, a seven percent (7%) increase over the preceding year. 

We believe ADUFA I has been successful. The backlog of overdue pioneer animal 

drug submissions that existed at the beginning of the program is gone. FDA/CVM 

has successfully met the performance goals established by the legislation. Timeframes have been uniformly met, restoring predictability to the review process. As 

a testament to this progress, 2007 was a banner year for approval of new and innovative products with CVM approving nine new chemical entities, giving veterinarians new medicines to fight diseases and other conditions in animals. Examples include medicine to treat heart failure in dogs, control pain and inflammation from 

osteoarthritis, and to treat and prevent motion sickness. 

The legislation before you to reauthorize this successful program builds upon this 

record of achievement. Animal health companies approached ADUFA II with the 

goal of reducing overall review times. CVM came to the table with a need for additional resources to compensate for the gap between the increased employee cost and 

Congressional appropriations. The end-review amendment process established in 

this agreement will help reduce the overall review time by reducing the number of 

36 

submission cycles. The ten agreed upon workshops will help CVM and sponsors deal 

with the complex scientific questions that often surround the review of these products. 

Whereas the total cost of ADUFA I came to around $43 million over 5 years, spon- sors will contribute $98 million to this process over the life of this legislation. The 

only change in the financial structure is the inflation factor calculated annually during the life of ADUFA I has been agreed to and built into the annual costs of 

ADUFA II, giving both sponsors and CVM more predictability regarding the program’s revenue. Many will benefit should Congress approve this legislation: 

1. FDA/CVM benefits by having additional resources to meet its mission of protecting public health. 

2. Animal health sponsors benefit from a stable and predictable review process, 

allowing them to make informed decisions about the investment risks of research 

and development dollars. 

3. Veterinarians benefit from having new and innovative medical advances available to treat, control, and prevent diseases in their patients. 

4. Livestock and poultry producers, and the veterinarians on whose advice they 

rely, also have the tools needed to keep food animals healthy. 

5. Pet owners benefit by having their animals live longer and healthier lives, increasing their enjoyment of these companions. 

6. Consumers reap the food safety benefits that come as a result of the availability 

of additional tools to keep food animals healthy.These widespread benefits are why 

a broad coalition of companion animal interests and animal agriculture interests 

support this legislation. Attached to my testimony is a copy of a coalition letter sent 

to you earlier this year from this broad mix of groups asking for congressional action 

on this bill. 

PROTECTIONS IN PLACE TO PROTECT PUBLIC HEALTH

We would like to emphasize that the regulatory process this bill will support is 

one of the most protective of human health in the world. This bill does not in any 

way alter or change the rigorous pre- and post-approval animal safety and food safety standards. FDA/CVM’s has a rigorous and robust approval process that takes into 

account safety throughout the lifecycle of the product, including safety to the animal, safety to humans, a thorough process for measuring the potential transfer of 

antimicrobial resistant bacteria between animals and humans, environmental safety, animal handler safety and drug experience reporting and adverse reaction evaluation to assess post-market safety. 

We strongly believe this bill intensifies CVM’s public health focus by increasing 

the resources used to meet that mission. The timely availability of animal medicines 

approved by FDA protects public health. A process that is cumbersome and inefficient delays those products that are safe and effective and encourages the use of 

untested and illegally compounded products in an attempt to address unmet animal 

health needs. These types of treatments can create a health hazard for the animals 

and jeopardize food safety. Increasing agency resources and setting achievable timeframes will only help improve the agency’s ability to meet its high safety standards. 

The rigorous review process and monitoring systems in place are at the heart of 

a broad system of protections that ensure that all medicines, including antibiotics, 

are safe for animals and humans. Antibiotics for use in animals must meet all the 

same requirements as antibiotics used in humans, with two additional requirements: first, sponsors must show the meat from animals in which the product is 

used is safe for human consumption. Second, beginning in 2003, CVM instituted 

Guidance for Industry (GFI) # 152, which outlines a qualitative risk assessment 

process that is applied to all antibiotics approved for use in animals. This guidance 

process is designed to measure the risk of antibiotic resistant bacteria being transferred from animals to humans if the product is approved. Based on this risk, FDA 

makes decisions to either deny or approve the produce with certain restrictions to 

significantly reduce risk. Restrictions can include requiring a veterinary prescription, prohibiting extra-label use and prohibiting use in certain species. The methodology is very conservative—meaning it is very difficult to get an antibiotic approved. 

Further, the guidance is sufficiently broad so that if new, previously unidentified 

or undescribed, resistant organisms or genes were to become of concern, the Agency 

can act swiftly to take this information into account. The existing guidance allows 

the Agency sufficient flexibility to allocate resources appropriately to changing 

issues of safety related to resistance emergence. 

The GFI # 152 process applies not only to new submissions, but to all existing 

products as well. FDA has established a priority list for the re-evaluation of all antibiotics currently approved and marketed. Most of the drugs on the list are antiVerDate Nov 24 2008 12:45 Apr 08, 2010 Jkt 037690 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-123 SCOM1 PsN: JIMC
37 

biotics administered in animal feed for the prevention and control of animal diseases 

or to increased the weight gains and improve feed efficiency. The re-review under 

Guidance 152 was stimulated by new funding that FDA received and continues to 

receive via annual appropriated money specifically earmarked for these reviews. 

Bear in mind, though, the evaluation of these products did not begin with Guidance 

152. In response to concerns raised some 30 years ago, the Bureau of Veterinary 

Medicine in FDA, in the 1970s, required sponsors of these products to conduct tests 

to determine the potential for resistance to be selected in the animals and to be 

transferred to bacteria that could cause human disease. While the standards and 

science may have changed over the years, the safety of these products has been an 

ongoing exercise at FDA. Moreover, published quantitative risk assessments performed by both the agency and individual product sponsors have generally affirmed 

that the risks to human health from these antibiotics in animal feed under approved 

conditions of use are quite low. 

We fully support efforts by the agency to continue to evaluate the safety of these 

products using all available scientific data under a sound risk assessment approach 

in order the determine the true risk to public health and guide appropriate risk 

management interventions to protect public health. 

In addition to the rigorous review process and the additional public and private 

risk assessments that have been conducted, there are other post-approval layers of 

protection to ensure the safe use of antibiotics. 

MONITORING PROGRAMS

USDA’s Food Safety and Inspection Service monitor meat samples for the presence of antibiotic residues as a check on the observance of the withdrawal times set 

by FDA. It is very uncommon for FSIS to find a violative residue, an indication that 

products are being used according to label directions. 

The National Antimicrobial Resistance Monitoring System (NARMS) is a multiagency program coordinated by FDA to monitor the possible emergence of antibiotic 

resistant bacteria and allow for implementation of management and control measures if needed. The three agencies involved are: •The USDA Agricultural Research Service (ARS), which collects samples from 

slaughter and processing facilities to monitor for antibiotic resistance trends in farm 

animals; •The FDA, which monitors for resistant bacteria in retail meats; 

•The Centers for Disease Control and Prevention (CDC), which collects isolates, 

or samples, from public health laboratories to monitor for the emergence of antibiotic resistant food-borne pathogens in humans. 

To date, the program has produced 7 years of data representing over 50,000 animals and 11,000 human Salmonella isolates. Most bacterial species isolated from 

humans and tested for resistance against drug classes potentially related to animal 

usage have shown stable or declining resistance patterns. Most of the multiple-drug 

resistance types, such as Salmonella typhimurium DT104 show stable or declining 

prevalence in both food animals and humans since 1996, according to an expert report issued in 2006 by the Institute of Food Technologists entitled ‘‘Antimicrobial 

Resistance: Implications for the Food System.’’ 

JUDICIOUS USE PRINCIPLES

Responsible, or judicious, use programs that are specific to different livestock species give veterinarians and producers specific guidelines to help them safely and 

properly use of antibiotics in their health management systems. Generally, these 

guidelines have been prepared collaboratively by FDA, CDC, and veterinary groups. 

There remains a great deal of confusion about how antibiotics are used in animal 

agriculture. CVM approves these products for four specific purposes: 

1. Disease treatment 

2. Disease prevention 

3. Disease control 

4. Growth promotion, as measured by the amount of feed needed to produce a 

pound of animal weight or increased rate of weight gain. 

Many assume in-feed uses equate to growth promotion, but this confuses the use 

with the route of administration. In fact, any of the four uses can be administered 

via feed, as that is the only practical way to administer medication to large flocks 

or herds. In most cases, a veterinarian is involved in this process, recommending 

feed that is specifically formulated for the health management system used for the 

flock or herd. 

Perhaps the most discussed, and most misunderstood use, is the growth promotion use. The Animal Health Institute collects annual data from its members on 

38 

the amount of antibiotics sold for use in animals. As part of that survey, we ask 

members to estimate the amount sold that is used for growth promotion. In 2006, 

that amount was 4.6 percent of the total. Each year we publically release the results 

of this survey, and a copy of the 2006 results is attached to my testimony. 

There is one other note about growth promotion: when the European Union 

phased out the use of antibiotics for growth promotion, according to data from the 

Danish government, animal death and disease rose, requiring a greater amount of 

antibiotics to be used to treat disease. Clearly, as has been discussed in many peerreviewed articles, this use also had the effect of suppressing disease that did not 

necessarily produce symptoms. 

Mr. Chairman, CVM has a rigorous, science-based approval process that provides 

to the American public the products necessary to protect public health by protecting 

animal health. Every year scientists uncover new diseases in animals, some of 

which potentially pose a threat to human health. As more animals are raised to feed 

the planet and as animals are reared closer to people, we will continue to need new 

medicines to protect animal and human health. 

The reauthorization of ADUFA will continue to provide the agency the resources 

necessary to maintain and improve this approval process, provide new and innovative products to allow our pets to live longer and healthier lives and contribute to 

food safety by keeping food animals healthy. I urge you to move a clean ADUFA 

bill in a timely manner so this program can continue without interruption. 

Mr. PALLONE. Thank you, Doctor. 

Ms. Batliner. 

STATEMENT OF STEPHANIE BATLINER, CHAIRPERSON, GENERIC ANIMAL DRUG ALLIANCE; DIRECTOR, PRE-MARKET 

REGULATORY AFFAIRS, IVX ANIMAL HEALTH, INC. 

Ms. BATLINER. Good morning. I appreciate the opportunity to be 

here this morning. My name is Stephanie Batliner and I am here 

in my capacity as the chairperson of the Generic Animal Alliance. 

The Generic Animal Drug Alliance is an independent professional 

trade organization that represents the interests of sponsors, manufacturers and distributors of generic animal drugs before regulatory 

agencies and Congress. 

FDA approved and regulated generic animal drugs are essential 

to both pet owners and food producers to reduce costs and increase 

accessibility to important pharmaceuticals. Through access to and 

affordability of therapeutic pharmaceuticals, the generic animal 

health industry aids in the protection of our Nation’s food supply 

and the safety of our Nation’s pet owners. It is critical to the success of the animal health generic drug industry to have a predictable and efficient CVM review process for the approval of abbreviated new animal drug applications, or ANADAs. The current review cycle time frames, as we have discussed earlier this morning, 

are an untenable situation both for industry and for CVM. The 

statutory review time frame for an ANADA is 180 days. Currently, 

review times for ANADAs are over 600 days and climbing, and this 

is far beyond anything that is reasonable and practical. It is important to point out that often an animal drug application will go 

through multiple cycles of review so right now it is pretty well accepted that it will take 4 or 5 years from first submission to time 

of approval for a generic animal drug. 

Our support for a user fee program stems from our experience 

in witnessing the successes accomplished under ADUFA. The performance goals were consistently met by the Center for Veterinary 

Medicine resulting in shortened regulatory review cycle time 

frames. During our discussions with CVM on how to approach the 

39 

problem of generic review times, we were able to define boundaries 

necessitated by the economics of the generic animal drug industry 

and still arrive at an outcome that ensures a stable, reliable revenue source to support the review process at CVM in a manner not 

currently met by appropriated funds. 

The legislative language and associated performance goals contained within the proposal for AGDUFA are very similar to that 

enacted with ADUFA 2003. There are, however, several important 

differences between the two programs. In AGDUFA, participants 

will not pay an establishment fee. The sponsor fee prescribed within AGDUFA is tiered to provide relief to sponsors who hold fewer 

ANADA approvals and the performance goals for AGDUFA do not 

return generic application review times to statutory requirements. 

Rather, 270 days is the highest level of performance that the generic animal drug industry could afford. While we are pleased with 

the overall content of the legislative proposal, additional funding 

requirements for CVM became apparent during our negotiations. 

The purpose of AGDUFA is to supplement the resources used specifically for review of applications and administration of the regulatory process, not to alter the existing stringent requirements for 

approval of a generic animal drug. 

Generic Animal Drug Alliance believes that it is important also 

to express our support for the reauthorization of ADUFA. Many of 

our member companies do participate in user fee activities on the 

pioneer side and as such have been contributing user fees over this 

past 5 years of the first round of ADUFA. 

In summary, GADA supports the legislation to authorize the Animal Generic Drug User Fee Act. The current review process is untenable for sponsors of legal, safe and effective products and is favorable to entities who would promote untested and illegally compounded products to fulfill unmet animal health needs. Access to 

generic animal drugs that have been approved and are regulated 

by CVM increases the public health through improved quality of 

life for companion animals and increased safety of the food supply. 

Thank you. 

[The prepared statement of Ms. Batliner follows:] 

40 

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43 

44 

45 

46 

Mr. PALLONE. Thank you. 

Mr. Martin. 

STATEMENT OF ROBERT MARTIN, EXECUTIVE DIRECTOR, PEW 

COMMISSION ON INDUSTRIAL FARM ANIMAL PRODUCTION 

Mr. MARTIN. Good morning, Mr. Chairman and members of the 

Healthcare Subcommittee. My name is Robert Martin and I am the 

executive director of the Pew Commission on Industrial Farm Animal Production and I very much appreciate the opportunity to appear here today at this important hearing. 

The Pew Commission on Industrial Farm Animal Production is 

an independent commission funded by a grant from the Pew Charitable Trust to Johns Hopkins Bloomberg School of Public Health to 

investigate the problems associated with industrial farm animal 

production operations and to make consensus recommendations to 

solve them. Fifteen commissioners with diverse backgrounds began 

meeting in early 2006 to start their evidence-based review of the 

problems caused by industrial farm animal production. 

Over the last 2 years the Commission conducted 11 meetings and 

received thousands of pages of material submitted by a wide range 

of stakeholders and interested parties. Two public hearings were 

held to hear concerns from the generic public with IFAP issues. 

Eight technical reports were commissioned from leading academics 

to provide information on the Commission’s areas of interest, and 

the commissioners themselves brought expertise in animal agriculture, public health, animal health, medicine, ethics and rural sociology to our discussion. In addition, the Commission visited several IFAP production facilities. We visited broiler production, swine 

production, dairy production, egg production as well as a large cattle feedlot. 

The Commission’s findings make clear that the present system of 

producing food animals in the United States is not sustainable and 

presents an unacceptable level of risk to public health, damage to 

the environment as well as unnecessary harm to the animals we 

raise for food. In addition, the current system of industrial food 

animal production is detrimental to rural communities. 

The Commission released its full report on April 29, 2008, that 

included 24 primary recommendations. The Commission was so 

concerned about the indiscriminate use of antibiotics in food animal 

production and the potential threat that causes to public health 

that five of those main recommendations deal with antibiotic use, 

and those five general recommendations are, number one, restrict 

the use of antimicrobials in food animal production to reduce the 

risk of antimicrobial resistance to medically important antibiotics; 

number two, clarify antimicrobial definitions to provide clear estimates of use and facilitate clear policies on antimicrobial use, improve monitoring and reporting of antimicrobial use in food animal 

production in order to accurately assess the quantity and methods 

of antimicrobial use in animal agriculture, improve monitoring and 

surveillance of antimicrobial resistance in the food supply, the environment, animal health and the human population in order to refine our knowledge of antimicrobial resistance and its impact on 

human health, and five, to increase veterinary oversight of all antimicrobial use in food animal production to prevent this overuse. 

47 

One of the things that I think shocked the Commission more 

than anything was when we started looking at these issues and in 

particular antimicrobial use that we couldn’t get a definitive 

amount that is used in food animal production. The range is 30 

percent on the low side to 70 percent on the high side but they 

were quite concerned that no entity is compiling the amount used 

and how it is used and the types used, and even at the low end, 

30 percent, that is a significant amount of antibiotics being fed to 

animals indiscriminately and on the high end, it would be quite 

alarming. I think that they were also very concerned about the lack 

of post-market activities in food animal use and hence the development of several of our recommendations on monitoring and assessing the impact. 

With that, again, thank you for the opportunity to appear and I 

will be happy to answer any questions. 

[The prepared statement of Mr. Martin follows:] 

48 

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52 

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56 

57 

58 

59 

60 

Mr. PALLONE. Thank you, Mr. Martin. Thank all of you. We will 

take some questions now and I will start with myself. 

I did want to start with Mr. Martin. In your testimony, you discussed the need to pass legislation such as the Preservation of 

Antibiotics for Medical Treatment Act of 2007 as introduced by 

Representative Slaughter. My understanding of this bill is that it 

shifts the burden of proving that the use of an antibiotic drug in 

food animals is no longer safe for human health from the FDA to 

the manufacturer of that product. Is that correct? 

Mr. MARTIN. Yes. 

Mr. PALLONE. Can you tell us why you think it is important for 

the manufacturer to bear that burden as opposed to the FDA? 

Mr. MARTIN. Well, I think the manufacturer bears some responsibility in the sales of the product and I think we looked at frankly 

a lack of resources at the FDA. 

Mr. PALLONE. Now, can you talk about the differences between 

the provisions in that bill, PAMTA, I guess it is, and the Guidance 

for Industry Number 152 that was issued by the FDA? 

Mr. MARTIN. I am not an expert on PAMTA or Guidance 152. 

Mr. PALLONE. So you don’t want to comment. All right. Do you 

want to get back to us? 

Mr. MARTIN. I will. 

Mr. PALLONE. All right. Get back to us in writing. That would 

be fine. Now, another question. One thing that the ADUFA and 

AGDUFA proposals have been criticized for is their lack of any 

post-market safety provisions. Specifically, there is no authorization for the use of ADUFA funds for post-market safety activities. 

We spent a lot of time talking about antimicrobial resistance today 

and I think that fits in this category of post-market safety as well 

as pre-market safety but I am wondering if there are any other 

types of post-market activity that you think the committee should 

consider authorizing for use of ADUFA funds. I will give you an example. Under PADUFA from last year, we allowed monies to go for 

collecting, developing, and reviewing safety information on the 

drugs including adverse event reporting, and we expanded the list 

of authorities that FDA could use PADUFA feeds for and expanded 

the amount of user fees collected to fund those authorities. What 

is your opinion? 

Mr. MARTIN. I think that would be appropriate. The Pew Commission did not actually review that specifically but given our position, I think that would be appropriate. I think that a portion of 

the fees could go to activities like reviewing animal antibiotics already on the market under FDA’s new standards for pre-market 

approval and collecting data on how it is used in animals and expanding the national antimicrobial resistance surveillance system. 

Mr. PALLONE. OK. Do you want get back to us with a list of authorities you think that the FDA should have to improve post-market safety? 

Mr. MARTIN. Sure. 

Mr. PALLONE. And I guess also how much funding you think we 

would need to expand those authorities. I will ask you another 

question, Mr. Martin, and then I will move to Ms. Batliner. One 

complaint I have heard about ADUFA is that there been a shift in 

resources away from other missions so that CVM could meet the 

61 

requirements of ADUFA. Are you aware of that criticism and could 

you comment on what functions might not be adequately funded at 

FDA due to ADUFA funding? 

Mr. MARTIN. We didn’t really get into that in any detail, and our 

recommendations and positions are consensus, so I really can’t 

stray too far from what has been presented. 

Mr. PALLONE. All right. Ms. Batliner, do you care to comment on 

that? Do you think that ADUFA funding has had any impact on 

shifting resources away from the review of generic animal drug 

submissions to meet timeliness goals of ADUFA? 

Ms. BATLINER. Well, certainly the generic application review 

times have grown during the time that ADUFA was in effect. My 

understanding from discussions with the Center for Veterinary 

Medicine is that in 2003, the appropriated monies devoted to generic application review were locked in place, so to speak. Since we 

as an industry were not supplying user fees, we continued to receive the amount of appropriated funds for generic review that we 

had received in 2003. In that time, the workload has increased dramatically, so I do not believe that they have shifted resources but 

rather limited the resources that were engaged in generic application review. 

Mr. PALLONE. Now, is that the only thing that has led to the increase in the review times or are there other things you want to 

mention? 

Ms. BATLINER. I really believe that is a resource issue at CVM 

and the number of reviewers that they are allocating for generic 

application review. 

Mr. PALLONE. OK. Now, I understand that the Administration’s 

proposal would bring enough fees to improve the review time for 

the generic animal submissions but as you mentioned, FDA still 

would not be able to complete reviews by the statutory deadline, 

180 days. Do you want to give us a sense of how much more money 

it would have taken in terms of collecting additional fees to reach 

that goal? 

Ms. BATLINER. I believe $47 million was the figure that we were 

provided when we began discussions with CVM about returning to 

statutory review times. 

Mr. PALLONE. Forty-seven million dollars? 

Ms. BATLINER. I believe so. 

Mr. PALLONE. All right. Thank you very much. 

Mr. Deal. 

Mr. DEAL. Thank you. Mr. Martin, you heard my questioning of 

the prior panel about this question of what is an appropriate use 

of antibiotics, antimicrobials with regard to therapeutic versus nontherapeutic usage, and I think the first panel agreed that appropriate therapeutic usage of these drugs would be for disease prevention, disease control and disease treatment. Do you agree with 

that? 

Mr. MARTIN. Well, the Commission defines therapeutic use as appropriate in food animals with diagnosed microbial disease. So ours 

is narrower than— 

Mr. DEAL. So you would be only at the point that they have been 

diagnosed with something, not for prevention of something? 

Mr. MARTIN. Right. 

62 

Mr. DEAL. Why would you think that it would be humane or even 

in the public health if an animal is going to be subject to a disease 

to use an antibiotic to prevent that from occurring? 

Mr. MARTIN. Well, we do have a definition of prophylactic use 

that states that they can be used in healthy animals in advance of 

an expected exposure to an infectious agent or after such exposure 

but before a laboratory confirmed clinical disease is determined by 

a licensed professional. So we do have a provision for prophylactic. 

Mr. DEAL. It is still a little bit narrower than the general prevention, right? 

Mr. MARTIN. Right. 

Mr. DEAL. Let me ask you this. As we know, we think we are 

the food basket of the world but we still import a lot of food products into this country. Did your commission undertake to determine what foreign counties that are importing food into this country, meat products in particular, for example, how their use of antibiotics compared or contrasted with the usage here in the United 

States? 

Mr. MARTIN. No, we did not. I mean, we looked at some developments in Europe for the impact on the pool of resistant bacteria 

but we did not have the time to do an in-depth analysis. 

Mr. DEAL. Probably at some point that is something somebody 

needs to take a look at, wouldn’t you think? 

Mr. MARTIN. Yes. 

Mr. DEAL. Because we are in a competitive world market and 

what other countries do, especially if they import in our country, 

we need to be at least on hopefully a proverbial level playing field 

in a competitive environment. Now, back to the definition of therapeutic versus non-therapeutic. The non-therapeutic usage would be 

what? 

Mr. MARTIN. We define that as use for additive or for growth promotion, feed efficiency, weight gain, routine disease prevention in 

the absence of documented exposure or other routine purposes in 

animal production. So I think our linchpin is documented exposure. 

Mr. DEAL. So where does the Pew Commission come down with 

regard to use of antimicrobials for those purposes, the non-therapeutic purposes? 

Mr. MARTIN. Well, we would like to phase out and ban the use 

of antimicrobials for non-therapeutic uses. 

Mr. DEAL. OK. Just in general knowledge without having done 

an in-depth survey, I think you know that the usage for those nontherapeutic usages is pretty universal around the world, that they 

are being used for those non-therapeutic purposes, are you not? 

Mr. MARTIN. Well, I think there have been some restrictions recently in Europe since 1996—well, I think 1989 in Sweden, 1986 

in Denmark and now I think the E.U. is moving— 

Mr. DEAL. That is the growth hormones, et cetera? 

Mr. MARTIN. Yes. Well, and non-therapeutic use of 

antimicrobials. 

Mr. DEAL. All right. Thank you all. 

Mr. PALLONE. The gentlewoman from Illinois, Ms. Schakowsky. 

Ms. SCHAKOWSKY. To follow up on that, I was looking at the 

other countries that have banned. It was Sweden in 1986, Denmark it says in 1998, and the European Union in 2006, but I was 

63 

interested to see that the report also determined that the overall 

health of the animals, mainly swine, was not affected and the cost 

to producers was not significant, and I imagine that one of the arguments that would be used in favor of continuing the use as we 

do for these antibiotics would be the cost. So your report found otherwise. Can you expand on that at all? 

Mr. MARTIN. Yes. We looked at, I think, the data in Denmark 

and it showed that therapeutic use went up for a short time but 

once the instituted better animal husbandry practices, spreading 

the animals out and cleaning their stalls more frequently, that the 

therapeutic use went down. We have done an economic analysis, 

one of our technical reports, that compares that industrial farm 

model that is common today with gestation crates and liquid waste 

management systems compared to a, it is another intensive-type 

operation called a hoop barn for swine, that requires a little more 

interaction by the managers. They have to be a little more involved 

with the animals instead of them being housed in rows in gestation 

crates, and we have actually found that the cost when you account 

for the environmental and health impacts of the current system, internalize those costs instead of externalizing that and compare 

them to the hoop barn system, that the hoop barn systems are actually cheaper. 

Ms. SCHAKOWSKY. I wonder if—pronounce your name again for 

me, Doctor. 

Dr. CARNEVALE. Carnevale. 

Ms. SCHAKOWSKY. I wonder if you wanted to comment on that. 

It seems as if, if in fact the animals are as healthy and the costs 

may even be somewhat less and therefore the impact on public 

health would be improved, that this is kind of a no-brainer. Why 

wouldn’t we ban the use for, we are saying for non-therapeutic use? 

Why wouldn’t we? 

Dr. CARNEVALE. Well, let me comment on that. First of all, the 

AVMA, American Veterinary Medical Association, defines therapeutic use as prevention, treatment, and control, and in fact, so do 

other international organizations like Codex and the World Health 

Organization. They also define those uses as therapeutic, to get 

back to Mr. Deal’s question. With regard to the information we 

have from Europe, there was a study in Denmark by the World 

Health Organization called the Fullam Report and in fact it is not 

true that there was no impact to animal health. There was. There 

was a tremendous loss of baby pigs when they withdrew those 

antimicrobials. 

Ms. SCHAKOWSKY. Well, Mr. Martin acknowledged that at first 

there was some effect but that with a change in various procedures, that that is no longer true. 

Dr. CARNEVALE. Well, what happened is, they had to increase 

their use of therapeutic antibiotics, and in fact, that use continues 

to go up. Now, the overall use of antimicrobials is down but the 

other important thing in that report that I want to emphasize is 

the experts in that report concluded that any human health impact 

before or after the ban was negligible. So in fact, there is not really 

good enough that the ban in Denmark or the European Union has 

had any impact on human health at all. 

64 

Ms. SCHAKOWSKY. Well, do you think the use of antibiotics in 

general does have an effect? I mean, what is your conclusion on 

human health? 

Dr. CARNEVALE. Yes, certainly the use of antimicrobials in humans and animals can lead to resistance, absolutely. There is no 

question about that. That is why we need to use them prudently 

and that is why the AVMA has adopted a set of prudent use guidelines— 

Ms. SCHAKOWSKY. But why would you conclude that if the decrease in use has had a negligible effect? 

Dr. CARNEVALE. Why I would conclude that? 

Ms. SCHAKOWSKY. Why would you conclude that it actually does 

have an impact, significant impact on human health if the reduction in its use doesn’t—you are arguing two things, that the reduction didn’t really matter but that in fact reducing the use does matter. 

Dr. CARNEVALE. Well, I am saying that uncontrolled use could 

have adverse consequences. We do not have uncontrolled use in the 

United States. 

Ms. SCHAKOWSKY. Do we have a good percentage of how many 

of our food animals are treated with antibiotics? 

Dr. CARNEVALE. I do not know the percentage. I do know— 

Ms. SCHAKOWSKY. Does anybody? No, I don’t mean just on this 

panel. Is it known? Is it documented? Do we know that? Because 

didn’t you say, Mr. Martin, that it was hard to figure out if it was 

30 percent or 70 percent? 

Mr. MARTIN. Yes, we couldn’t find anybody that was documenting it. 

Dr. CARNEVALE. There are data, I recall, from USDA called the 

National Animal Health Monitoring System, and they have recorded periodically in doing studies on various classes of livestock 

and poultry, they have concluded how much use. I don’t have those 

numbers available to me but I think they are in those reports. 

Ms. SCHAKOWSKY. I see I have gone over time. Thank you, Mr. 

Chairman. 

Mr. PALLONE. I don’t have any additional questions so if any 

member wants to continue. Go ahead, Mr. Matheson. 

Mr. MATHESON. Thank you. It sort of plays again on what my 

colleague was just asking, and on the first panel I was asking 

about use data and the fact we don’t have enough use data, so I 

think you are on the right track. 

Mr. Martin, I wanted to just ask you a couple of quick questions. 

By way of introduction, I and a number of my colleagues on this 

committee have introduced the Strategies to Address the Antimicrobial Resistance Act. We call it the STAAR Act. It is a bill that 

provides a multi-pronged approach to address the threat of antibiotic resistance including enhanced research, surveillance, and 

data collection, and specifically, my bill requires animal and human 

antibiotic drug manufacturers to provide the FDA with human and 

animal antibiotic use data. In the case of animals, the information 

would be submitted on a calendar-year basis by volume separately 

for use by species. In summaries the data would be publicly available but the bill would protect confidential business information. A 

few years ago, the Government Accountability Office looked at the 

65 

possible impact on humans of animal antibiotic use. Specifically the 

GAO stated that Federal agencies do not collect the critical data on 

antibiotic use in animals that they need to support research on the 

human health risk. So that kind of led into my question, which is, 

do you believe we need this type of data to better determine any 

relationship between use in animals and antibiotic resistance in 

humans? 

Mr. MARTIN. Yes, and the Commission was aware of your legislation and the companion bill in the Senate by I believe Senators 

Brown and Hatch. 

Mr. MATHESON. Yes. 

Mr. MARTIN. There is a similar bill there. 

Mr. MATHESON. It seems to me it is another piece of the puzzle 

to help determine whatever public policy strategies we need to address antibiotic resistance. 

Mr. MARTIN. Yes. 

Mr. MATHESON. It is my understanding that European countries 

have purchased data from IMS Health Global Services to support 

their epidemiological research. Are you familiar with this data? 

Mr. MARTIN. No, I am not. 

Mr. MATHESON. I am glad you mentioned there is a companion 

bill in the Senate as well, and I think it helps address some of the 

issues we raised today. 

Mr. Chairman, that concludes my line of questioning. I will yield 

back. 

Mr. PALLONE. I am going to go around again if anybody has additional questions. I don’t, but Mr. Deal and then Ms. Schakowsky 

if you do. 

Mr. DEAL. I just have a couple of quick ones, and Dr. Carnevale, 

I would address them to you. What safeguards does the Animal 

Health Institute have in place to prevent antibiotic resistance? Do 

you have any safeguards that your organization has put in place? 

Dr. CARNEVALE. Well, the Animal Health Institute is a trade association. We don’t have any specific safeguards. Our companies 

certainly do. They have good stewardship programs on their individual products. They have field personnel out there to make sure 

that producers and veterinarians know how these drugs should be 

used, know how they should be used according to label and to reduce the presence of antibiotic resistance. I also mentioned before 

that the American Veterinary Medical Association has gotten together their specialty groups that deal with each class of animals, 

whether it be poultry, livestock and even companion animals, as a 

matter of fact, and they put together guidelines for veterinarians 

to follow on how to appropriately use antibiotics to reduce the 

chance of resistance development. 

Mr. DEAL. And within the agriculture community itself, are you 

aware of policies that they put in place to try to reduce the use of 

these antibiotics and especially as they relate to antibiotic resistance in humans? 

Dr. CARNEVALE. Yes. As a matter of fact, I can cite one, and that 

is the Pork Quality Assurance Program, which in fact they have 

worked very hard, the Pork Board has worked very hard to get 

their producers to know how to use antibiotics appropriately, know 

how to control diseases, and that is an integrated program that 

66 

they have in operation which at the heart of it involves the use of 

antimicrobials in an appropriate fashion. So I think that is a model 

program. 

Mr. DEAL. Thank you. That is all. 

Mr. PALLONE. Anyone else? Ms. Schakowsky? 

Ms. SCHAKOWSKY. Let me just ask Mr. Martin, if you could just 

elaborate a little bit exactly how antibiotic resistance is generated 

as a result of using antibiotics in animals because some have argued that we actually can’t know whether antibiotic resistance is 

a result of the use of antibiotics in animals as opposed to humans, 

and I wondered if you could respond to that, and Ms. Batliner, if 

you wanted to say something, go ahead. 

Mr. MARTIN. Dr. Carnevale even said that all antibiotic use leads 

to resistance, some resistance, and I think it gets a little bit back 

to the data collection issue. If 30 percent of the antibiotics used in 

the country are fed to animals for growth promotion and non-therapeutic ways, that by logic has to add to the antimicrobial resistance 

pool in the environment. If it is 70 percent, it is quite a problem. 

We had two physicians on the Commission and one veterinarian, 

and their beliefs are that once it is in the environment, that—and 

it is not their beliefs, their training and learning. You know, once 

it is excreted out of the animal and goes, in the case of a swine 

facility, flushed into an open cesspool where it is collected for a few 

weeks and then sprayed on the ground without treatment, that is 

the method of disposal of swine waste, that gets into the groundwater. Johns Hopkins is doing a study now, the School of Public 

Health is doing a study now. They are looking into antibiotic-resistant bacteria that were found in dolphins off Woods Hole in Massachusetts that has been linked back to effluents in North Carolina, 

coastal effluents in North Carolina. So the transmission—I mean, 

bacteria are like any living thing. When they are put under stress, 

they adapt and change to survive, and bacteria uniquely can transfer their resistance and antimicrobial-resistant bacteria can transfer that resistance to a bacteria that has never been exposed. 

Ms. SCHAKOWSKY. Is it not a matter of eating the treated meat? 

Mr. MARTIN. No, that is not the real exposure risk. 

Ms. SCHAKOWSKY. That is not the exposure risk. OK. 

Mr. MARTIN. That is the Commission’s viewpoint. It is in the environment, and workers that are in industrial farm animal production facilities for prolonged periods can carry that resistant bacteria 

out into the community. In traditional farming systems, the farmer 

may be interacting with the animals for several short periods of 

time over a day. In an industrial production facility, the workers 

are in the barns with the animals for extended periods of time 

being exposed. So it is more that kind of transmission out into the 

community— 

Ms. SCHAKOWSKY. What about milk from cows that are treated? 

Mr. MARTIN. The FDA has very strict rules about anything showing up in milk. I mean, they are very strict about hormones and 

antibiotics. We found it is more of an environmental concern and 

particularly with swine production, getting into groundwater, 

whether some of the lagoons will overflow into rivers in a flood or 

a heavy rain. The University of Iowa has done studies about higher 

rates of asthma and exposure to pathogens up to 5 miles in a 

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downwind plume from hog CAFOs, and the EPA now is undergoing 

a fairly intensive monitoring program to see exactly what is in the 

air coming out of industrial operations. But it is really not, from 

the Commission’s viewpoint, it is not—you don’t ingest it in the 

meat because it is being fed to the animal. It is more in the environmental impact. 

Ms. SCHAKOWSKY. Thank you. Go ahead. 

Dr. CARNEVALE. Can I comment on that? Yes, certainly you can 

find resistance. A lot of the resistance that might be in the environment frankly could be due to human use as well as animal use. 

You can find resistance. The issue is not finding resistance. The 

issue is, what is the risk of the presence of that resistance to 

human health, and that is why it is important that we stress risk 

assessment. That is why the FDA and international organizations 

have taken on the task of trying to determine what the risk of this 

potential resistance that might occur is to human health. In many 

cases, when they look at the data, they look at the farm-to-table 

continuum, if you will. They find that for many of these antibiotics, 

there is a very low risk of this resistance leading to a human 

health concern. That doesn’t mean we don’t use the antibiotics 

properly to try to make sure that we don’t create—we create as little resistance as we can. Resistance also is not permanent. In many 

cases you can use a drug, you can get resistance to it. As soon as 

you remove the drug, the resistance goes away. So it is not an allor-none situation. It is a very complex area, and this is why we 

think risk assessment is the way to get at the concerns. We fully 

support the FDA conducting risk assessments on a pre- and postapproval basis. In fact, Mr. Chairman, I would note that the House 

Agriculture Appropriations Committee in fact gave FDA about $1 

million 5 years ago and it appears in their budget every year to 

conduct post-approval reviews of these antibiotics, so that process 

is going on with funding from Congress. Thank you. 

Mr. PALLONE. Thank you. You know, it was kind of interesting 

because I listened to all the comments about the dangers from diseases that can be borne by animals yet you also read these articles 

or statements about how—I remember reading something the other 

day about how it is good for kids to have pets because if they don’t 

have pets, they don’t go out on the street and get exposed to diseases and things and they don’t develop resistance to it. So who 

knows. I guess it is very complicated. 

I think we are done. Thank you. This was very helpful. And as 

I mentioned, we do intend to move this bill in a timely fashion because we know the deadline is looming for the authorization. I 

guess it expires at the end of the fiscal year, so we are well aware 

of that and we appreciate your comments today. And I will say 

again that if members want to submit written questions, they will 

be submitted to the clerk within the next 10 days and then you will 

be notified soon after that. 

So thank you again, and without objection, this meeting of the 

subcommittee is adjourned. 

[Whereupon, at 11:56 a.m., the subcommittee was adjourned.] 

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STATEMENT OF HON. JIM MATHESON

Thank you for holding this hearing today, Mr. Chairman and Ranking Member 

Deal. 

I understand that we are here today to consider a timely reauthorization of the 

Animal Drug User Fee Act as well as the creation of a new program, the Animal 

Generic Drug User Fee Act. While I look forward to working with my colleagues on 

the committee on both of these proposals, I would like to use my time today highlighting the issue of antibiotic resistance. 

I, along with several of my colleagues on this committee, introduced legislation 

H.R. 3697, Strategies to Address Antimicrobial Resistance Act. Senators Brown/ 

Hatch/Durbin have introduced the Senate companion bill. The STAAR Act provides 

a comprehensive approach to the antimicrobial resistance crisis. It provides strategies and authorizes critically needed funding to strengthen federal antimicrobial resistance surveillance, prevention and control, and research efforts. This legislation 

has the support of several infectious disease leaders including: The Infectious Disease Society, The Pediatric Infectious Disease Society, The American Medical Association, The American Public Health Association, and Premier Hospitals, an alliance 

of 1700 nonprofit hospitals across America. 

Antibiotic use presents unique challenges to drug safety. They are researched and 

developed to respond to infectious organisms that continue to mutate and build resistance to the product even after approval. Even if we all demonstrate good judgment and use antibiotics wisely, eventually, the bad bugs become resistant. 

In 2004, the GAO issued a report entitled: ‘‘Antibiotic Resistance Federal Agencies 

Need to Better Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals’’. In this report, the GAO states: ‘‘Although they have made some progress in 

monitoring antibiotic resistance, federal agencies do not collect the critical data on 

antibiotic use in animals that they need to support research on the human health 

risk. The data that could help this research include the types and quantities of antibiotics sold for use in animals, the purpose of their use (such as disease treatment 

or growth promotion), the species in which they are used, and the method used to 

administer them. These types of data are needed to study the linkages between antibiotic use in animals and the human risk from antibiotic resistance and to develop 

and evaluate strategies for mitigating resistance.’’ While I do not oppose antibiotic 

use in sick animals—I want to be sure we have the best information to determine 

the full extent, if any, that antibiotic use in animals contributes to antibiotic resistance in humans. 

It will take a coordinated effort and a partnership between manufacturers, federal 

agencies, providers, and patients to truly make a difference in slowing the trend of 

antimicrobial resistance. It is my hope that Congress and this committee will address provisions to protect antibiotic safety and effectiveness, as well as improve access to new antibiotics. 

I look forward to hearing from our witnesses and will yield back the balance of 

my time. 

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