[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
REAUTHORIZATION OF ANIMAL DRUG USER FEES: ADUFA AND AGDUFA
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
__________
MARCH 14, 2018
__________
Serial No. 115-109
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
30-574 PDF WASHINGTON : 2018
COMMITTEE ON ENERGY AND COMMERCE
GREG WALDEN, Oregon
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
FRED UPTON, Michigan BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee GENE GREEN, Texas
STEVE SCALISE, Louisiana DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
ADAM KINZINGER, Illinois PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida PAUL TONKO, New York
BILL JOHNSON, Ohio YVETTE D. CLARKE, New York
BILLY LONG, Missouri DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana KURT SCHRADER, Oregon
BILL FLORES, Texas JOSEPH P. KENNEDY, III,
SUSAN W. BROOKS, Indiana Massachusetts
MARKWAYNE MULLIN, Oklahoma TONY CARDENAS, California
RICHARD HUDSON, North Carolina RAUL RUIZ, California
CHRIS COLLINS, New York SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
Subcommittee on Health
MICHAEL C. BURGESS, Texas
Chairman
BRETT GUTHRIE, Kentucky GENE GREEN, Texas
Vice Chairman Ranking Member
JOE BARTON, Texas ELIOT L. ENGEL, New York
FRED UPTON, Michigan JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee DORIS O. MATSUI, California
ROBERT E. LATTA, Ohio KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
LARRY BUCSHON, Indiana TONY CARDENAS, California
SUSAN W. BROOKS, Indiana ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina FRANK PALLONE, Jr., New Jersey (ex
CHRIS COLLINS, New York officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)
(ii)
C O N T E N T S
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Page
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 1
Prepared statement........................................... 3
Hon. G.K. Butterfield, a Representative in Congress from the
State of North Carolina, opening statement..................... 4
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 5
Prepared statement........................................... 6
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 7
Prepared statement........................................... 8
Witnesses
Steven Solomon, D.V.M., Director, Center for Veterinary Medicine,
Food and Drug Administration, Department of Health and Human
Services....................................................... 9
Prepared statement........................................... 11
Answers to submitted questions............................... 103
Rachel Cumberbatch, D.V.M., Director, Regulatory Affairs, Animal
Drugs, Animal Health Institute................................. 44
Prepared statement........................................... 46
Answers to submitted questions............................... 115
Bill Zollers, Ph.D., Chair, Generic Animal Drug Alliance......... 52
Prepared statement........................................... 54
Answers to submitted questions............................... 122
Michael J. Topper, D.V.M., Ph.D., President, American Veterinary
Medical Association............................................ 58
Prepared statement........................................... 60
Answers to submitted questions............................... 127
Submitted Material
Discussion Draft, H.R. ___, the Animal Drug and Animal Generic
Drug User Fee Amendments of 2018............................... 75
Letter of February 26, 2018, from Agricultural Retailers
Association, et al., to Hon. Lamar Alexander, U.S. Senate, et
al., submitted by Mr. Burgess.................................. 101
REAUTHORIZATION OF ANIMAL DRUG USER FEES: ADUFA AND AGDUFA
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WEDNESDAY, MARCH 14, 2018
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:18 a.m., in
room 2322, Rayburn House Office Building, Hon. Michael C.
Burgess (chairman of the subcommittee) presiding.
Members present: Representatives Burgess, Guthrie, Upton,
Shimkus, Blackburn, Latta, Lance, Griffith, Bilirakis, Bucshon,
Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio),
Green, Schakowsky, Butterfield, Schrader, Eshoo, DeGette, and
Pallone (ex officio).
Staff present: Zack Dareshori, Legislative Clerk, Health;
Margaret Tucker Fogarty, Staff Assistant; Ed Kim, Policy
Coordinator, Health; Milly Lothian, Press Assistant and Digital
Coordinator; Jennifer Sherman, Press Secretary; Danielle
Steele, Counsel, Health; Austin Stonebraker, Press Assistant;
Hamlin Wade, Special Advisor for External Affairs; Jacquelyn
Bolen, Minority Professional Staff Member; Jeff Carroll,
Minority Staff Director; Samantha Satchell, Minority Policy
Analyst; Andrew Souvall, Minority Director of Communications;
Kimberlee Trzeciak, Minority Senior Health Policy Advisor; and
C.J. Young, Minority Press Secretary.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I now call the subcommittee to order and
recognize myself 5 minutes for the purpose of an opening
statement.
And the Chair would note that today's hearing marks the
Health Subcommittee's fourth hearing to consider
reauthorization of vital user fee programs at the United States
Food and Drug Administration.
While the bulk of these programs were reauthorized last
year through the FDA Reauthorization Act, our focus today on
reauthorizing the Animal Drug User Fee Act and the Animal
Generic Drug User Fee Act is equally important for the millions
of American families and businesses that rely on the critical
function of the Food and Drug Administration's Center for
Veterinary Medicine.
With this in mind, I expect us to reach a shared commitment
to complete our work while reauthorizing these last set of user
fees and get them to the House floor well in advance of the
expiration date of September 30 of this year.
We did so last year with the FDA user fee reauthorization,
and there is no reason we cannot do so again here.
This morning, we will have two panels of witnesses before
the subcommittee. First, I do want to welcome Dr. Steven
Solomon, the Director for the Center of Veterinary Medicine at
the Food and Drug Administration.
Next, representatives from the Animal Health Institute, the
Generic Animal Drug Alliance, and American Veterinary Medical
Association will share their insights on the current state of
the United States animal drug market and the significance of
reauthorizing the Animal Drug User Fee Agreement and the Animal
Generic Drug User Fee Agreement.
Last month, the Committee on Energy and Commerce and the
Senate Health, Education, Labor, and Pensions Committee
released the Animal Drug User Fee Reauthorization Act of 2018,
a bipartisan discussion draft to renew the FDA's authority to
collect user fees from the manufacturers of brand-name and
generic animal drugs for another 5 years.
Among other things, these user fees help the Food and Drug
Administration's Center for Veterinary Medicine in their timely
review of animal drug applications, market surveillance of
animal drug safety and efficacy, and the quality assurance
measures for animal food as well as food products derived from
animals.
From pet owners and veterinarians to farmers and animal
food producers, updating these user fee agreements is essential
in ensuring that animal drugs are safe and effective for farm
animals and our pets, while keeping our food supply safe.
Reauthorizing these agreements also includes the new
commitment between the FDA and industry on performance goals
and procedures.
This will be the fourth authorization for the Animal Drug
User Fee Agreement since its launch in 2004, and we have seen
it reviewed several times.
Under the proposed agreement, funding for the program will
increase by approximately $6 million annually. All submissions
must be electronic. The Center for Veterinary Medicine is
required to begin implementation of the U.S.-E.U. Good
Manufacturing Practice Mutual Recognition Agreement for
inspections of pharmaceutical manufacturing facilities, and
review time for drug combinations for use in feed is shortened
to 60 days if no additional data is required.
The Animal Generic Drug User Fee Agreement is going through
its third authorization since 2008. The Center for Veterinary
Medicine has met or exceeded nearly all of the performance
goals in each 5-year authorization.
In addition to increasing funding by approximately $10
million annually, the proposed agreement would shorten the
review time for abbreviated new animal drug applications to 60
days and require all approved drugs to include these
applications on the labeling.
Finally, I would like to commend our fellow Health
Subcommittee member, Representative Mark Mullin from Oklahoma,
for championing the House Animal Drug User Fee Agreement and
Animal Generic Drug User Fee Agreement reauthorizations. Thank
you for your hard work on this important measure.
[The prepared statement of Mr. Burgess follows:]
Prepared statement of Hon. Michael C. Burgess
Today's hearing marks the Health Subcommittee's fourth
hearing to consider the reauthorization of vital user fee
programs at the U.S. Food and Drug Administration (FDA). While
the bulk of these programs were reauthorized last year through
the FDA Reauthorization Act of 2017, our focus today on
reauthorizing the Animal Drug User Fee Act (ADUFA) and the
Animal Generic Drug User Fee Act (AGDUFA) is equally important
for the millions of American families and businesses that rely
on the critical functions of FDA's Center for Veterinary
Medicine. With this in mind, I expect us to reach a shared
commitment to complete our work reauthorizing these last set of
user fees and get them to the House floor well in advance of
their expiration on September 30, 2018. We did it last year, so
there is no reason we cannot do it again here.
This morning, we have two panels of witnesses before our
subcommittee. First, I would like to welcome Dr. Steven
Solomon, Director of the Center for Veterinary Medicine at FDA.
Next, representatives from the Animal Health Institute, Generic
Animal Drug Alliance, and American Veterinary Medical
Association will share their insights on the current state of
U.S. animal drug market and the significance of reauthorizing
ADUFA and AGDUFA.
Last month, the Committee on Energy and Commerce and the
Senate Health, Education, Labor, and Pensions Committee
released the Animal Drug User Fee Reauthorization Act of 2018,
a bipartisan discussion draft to renew FDA's authority to
collect user fees from the manufacturers of brand-name and
generic animal drugs for another 5 years. Among other things,
these user fees help fund FDA's Center for Veterinary
Medicine's timely review of animal drug applications, market
surveillance of animal drugs' safety and efficacy, and quality
assurance measures for animal food as well as food products
derived from animals. From pet owners and veterinarians to
farmers and animal food producers, updating these user fee
agreements are essential in ensuring animal drugs are safe and
effective for farm animals and our pets, while keeping our food
supply safe. Reauthorizing these agreements also includes the
new commitments between FDA and industry on performance goals
and procedures.
This will be ADUFA's fourth authorization, and since its
launch in 2004, we have seen review times reduced
significantly. Under the proposed agreement, funding for the
program would increase by approximately $6 million annually,
all submissions must be electronic, the Center for Veterinary
Medicine is required to begin implementation of the U.S.-E.U.
good manufacturing practice Mutual Recognition Agreement for
inspections of pharmaceutical manufacturing facilities, and
review time for drug combinations for use in feed is shortened
to 60 days when no additional data is required.
AGDUFA is going through its third authorization since 2008.
The Center for Veterinary Medicine has met or exceeded nearly
all performance goals in each 5-year authorization period. In
addition to increasing funding by approximately $10 million
annually, the proposed agreement would shorten the review time
for abbreviated new animal drug applications to 60 days and
require all approved drugs to include these applications on the
labeling.
Finally, I would like to commend our fellow Health
Subcommittee member, Representative Mullin, for championing the
House ADUFA/AGDUFA Reauthorization bill. Thank you for all your
hard work on this important measure.
I again want to welcome all of our witnesses and thank you
for being here. I look forward to your testimony.
I yield the balance of my time to Ms. Blackburn of
Tennessee, for a statement.
Mr. Burgess. I again want to welcome all of our witnesses
for being here and look forward to your testimony, and I'll
yield to Mrs. Blackburn of Tennessee.
Mrs. Blackburn. Thank you, Mr. Chairman, and to our
witnesses on each panel, thank you so much for being here. And
I am so grateful for the chairman's leadership and the fact
that we are approaching this in a bipartisan, bicameral manner.
We know that what you do is important. We are pleased to
see the amount of progress that is made in animal drugs,
whether they are for our pets or for livestock that are in the
food supply chain.
We are wanting to focus and get some attention on the
innovation side and how we speed the approval process. So we
will look forward to addressing those issues with you today.
I yield back.
Mr. Burgess. Gentlelady yields back. Chair thanks the
gentlelady.
The Chair recognizes the gentleman from North Carolina as
the substitute ranking member of the subcommittee, and you're
recognized for 5 minutes for the purpose of an opening
statement.
OPENING STATEMENT OF HON. G.K. BUTTERFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NORTH CAROLINA
Mr. Butterfield. Thank you, Mr. Chairman. I'll take it any
way I can get it this morning.
[Laughter.]
Thank you, Mr. Chairman. To the vice chair, Mrs. Blackburn,
thank you so very much for your opening comments.
You're right, I am standing in for the ranking member this
morning, Gene Green, who will be here momentarily, I am told.
Thank you to the Director for your willingness to come
forward and to share your testimony with us today. This
hearing, Mr. Chairman, is so very important and so I associate
my comments with the gentlelady from Tennessee that this is
bipartisan, bicameral, and these are two pieces of legislation
that we must move and do it very quickly.
The Animal Drug User Fee Act is very important. The Animal
Generic Drug User Fee Act is very important to all of us on
this committee.
These user fee agreements are important to millions of
Americans, including those in my home State of North Carolina
who live with companion animals every day.
They are also important to the agriculture community. We
have many stakeholders in this legislation. Some of you may not
be aware that North Carolina, my State, is the second largest
pork producer, the second largest turkey producer, and the
third largest poultry producer in the entire country.
Our agriculture community and family farms are essential to
feeding our Nation, and they depend on medicines to keep their
animals very healthy.
Mr. Chairman, I support reauthorization of these programs.
I look forward to hearing about the innovation that's taking
place in the animal drugs and how we can support the health of
animals and human beings, as well.
Thank you for the time. I yield back.
Mr. Burgess. Gentleman yields back. The Chair thanks the
gentleman.
Chair would now like to recognize the gentleman from
Oregon, chairman of the full committee, Mr. Walden, 5 minutes.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you very much, Mr. Chairman. Thanks for
holding this hearing and good morning to everyone. We look
forward to yet another ``UFA'' hearing.
We have a history of producing bipartisan user fee
reauthorizations, most recently as last year, and so I look
forward to continuing in those efforts with this one.
Whether it be livestock or house pets, the owners of these
animals rely on the Food and Drug Administration to ensure the
availability of safe and effective medical products to keep
their animals healthy.
Through the Center for Veterinary Medicine, FDA evaluates
new drugs to determine if the safety and efficacy of those
treatments work for their stated use.
In the case of livestock, CVM must also ensure the drug
will not impact the food supply and not harm the environment or
the health of the livestock producer who administers it.
But the hard work of developing and manufacturing these
drugs is done by the animal drug industry, and these companies
face unique challenges that need to be considered, including
R&D processes that involve developing and manufacturing drugs
for different species of animals with different physiologies.
So, given the success of the human drug user fee programs
in expediting approval of treatments by bolstering resources
for the agency, the FDA and the animal drug industry came
together to propose the animal drug user fee programs.
These programs have succeeded in dramatically reducing
review times by providing the FDA with much-needed additional
resources. So it is a win-win scenario where everyone benefits,
including farmers, pet owners, and veterinarians.
Today, we are considering the reauthorization of those
programs--the Animal Drug User Fee Act and the Animal Generic
Drug User Fee Act--both of which will expire at the end of the
fiscal year.
So it is critical that these programs are passed and signed
into law well before the end of September. Before each
reauthorization, as set forward in statute, FDA meets with the
animal drug industry to reevaluate specific goals for review
time lines, solicits comments from stakeholders and members of
the public to consider additional enhancements, then the final
agreement is delivered to Congress for the program to be
reauthorized.
So for this cycle, that process began in May of 2016, and
after numerous public meetings, the final negotiated
recommendations were sent to Congress in January of this year.
This year's agreements include increased collections from
industry as well as more aggressive performance goals for the
FDA. They also include several process improvements and other
enhancements. We look forward to hearing more about these
agreements from our witnesses today.
Encouraging innovation is a top priority of this committee,
and we want to take this opportunity to examine the animal drug
approval process to ensure the incentives are in place to
encourage innovative treatments to be developed and for generic
animal drugs to be made available.
And we don't often think of the FDA when it comes to animal
drugs, sadly, but these programs are critical and are important
to pet owners of America and our farmers and ranchers that we
rely on to produce food.
And so we appreciate the witness today. We are actually
going to get the wisdom of Solomon today, apparently. So we do
appreciate that.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Good morning, everyone, and thank you for joining us for
yet another ``UFA'' hearing! We have a history of producing
bipartisan user fee reauthorizations, most recently as last
year, and I look forward to continuing those efforts today.
Whether it be livestock or house pets, the owners of these
animals rely on the Food and Drug Administration (FDA) to
ensure the availability of safe and effective medical products
to keep their animals healthy. Through the Center for
Veterinary Medicine, FDA evaluates new drugs to determine the
safety and efficacy of those treatments for their stated use.
In the case of livestock, CVM must also ensure that the drug
will not impact the food supply and not harm the environment or
the health of the livestock producer who administers it.
But the hard work of developing and manufacturing these
drugs is done by the animal drug industry. And these companies
face unique challenges that need to be considered-including an
R&D process that involves developing and manufacturing drugs
for different species of animals with different physiologies.
Given the success of the human drug user fee programs in
expediting approval of treatments by bolstering resources for
the agency, the FDA and the animal drug industry came together
to propose the animal drug user fee programs. These programs
have succeeded in dramatically reducing review times by
providing FDA with much needed additional resources. It's a
win-win scenario where everyone benefits-including farmers, pet
owners, and veterinarians.
Today we are considering the reauthorization of those
programs-the Animal Drug User Fee Act and the Animal Generic
Drug User Fee Act-both of which expire at the end of this
fiscal year. It is critically important that these programs are
passed and signed into law well before the end of September.
Before each reauthorization, as set forward in statute, FDA
meets with the animal drug industry to reevaluate specific
goals for review timelines and solicits comments from
stakeholders and members of the public to consider additional
enhancements. Then the final agreement is delivered to Congress
for the program to be reauthorized.
For this cycle, that process began in May of 2016. After
numerous public meetings, the final negotiated recommendations
were sent to Congress in January of this year. This year's
agreements include increased collections from industry as well
as more aggressive performance goals for FDA. They also include
several process improvements and other enhancements. We look
forward to hearing more about these agreements from today's
witnesses.
Encouraging innovation is a top priority of this committee,
and we want to take this opportunity to examine the animal drug
approval process to ensure the incentives are in place to
encourage innovative treatments to be developed and for generic
animal drugs to be made available.
We don't often think of the FDA when it comes to animal
drugs, but these programs are critically important to the pet
owners of America and our farmers that we rely on to produce
the food that feeds our country.
This is important must-pass legislation and we are
committed to getting it done on time before these user fee
programs expire in September. I'd like to thank our witnesses
for being here with us today, and Mr. Mullin for leading this
legislative effort for our committee.
Mr. Walden. And with that, I would yield the remainder of
my time to Mr. Mullin, I believe, who is seeking time and has
been a real leader on this effort.
So Mark, I'll turn it over to you.
Mr. Mullin. Thank you, Mr. Chairman.
I want to thank you and Chairman Burgess for holding this
hearing. I am proud to be the sponsor of the legislation to
reauthorize the Animal Drug User Fee Act and its generic
version.
ADUFA and AGDUFA will reauthorize user fee agreements
between the FDA and the animal drug industry to help speed the
approval of new and generic drugs for farmers, ranchers,
families, and veterinarians so they can keep their animals and
pets safe and healthy.
In the last reauthorization, the FDA committed to working
with industry to complete recommendations for expanding
conditional approval. I want to reaffirm my commitment to
working with the FDA and to industry to come to a consensus as
early as possible so we can continue to drive innovation.
Thank you to our witnesses for being here today. I look
forward to hearing your testimony regarding the importance of a
clean reauthorization for our farming and ranching communities,
and I yield back.
Thank you.
Mr. Burgess. Chair thanks the gentleman. The gentleman
yields back.
The Chair recognizes the gentleman from New Jersey, the
ranking member of the full committee, Mr. Pallone, 5 minutes
for an opening statement, please.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman. Today we will be
examining the FDA's animal drug user fee program and the animal
generic drug user fee program, and these critical user fee
agreements have helped to accelerate the development of animal
drugs, reduce application review times at FDA, and create a
more predictable and streamlined process for getting animal
drugs to market to help improve the health of our pets and
food-producing animals.
Last month, this committee, along with the HELP Committee
in the Senate, released a bipartisan discussion draft that
reauthorizes FDA's authority to collect user fees from the
animal drug and generic animal drug industries for an
additional 5 years, as the current authorization for these
programs will expire on September 30th.
The discussion draft reflects bipartisan agreement and the
recommendations negotiated between FDA and the animal drug
industry with input from farmers and ranchers, veterinarians,
food and feed producers, and other public health stakeholders.
And these agreements are critically important to pet
owners, veterinarians, and farmers so they have access to safe,
effective, and affordable medications for their animals. And we
want our pets to have the best are possible, and we must ensure
that we keep our food supply safe. The animal drug user fee
program furthers both of these goals.
I expect we will hear also testimony today on FDA's work to
address antimicrobial resistance from the use of antimicrobials
in food-producing animals.
I am very interested in what the Center for Veterinary
Medicine is doing to ensure the continued effectiveness of
antibiotics and how we can protect both animals and humans from
the growing threat of antimicrobial resistance.
And I look forward to helping to move these agreements
through Congress in a timely fashion so the Center for
Veterinary Medicine at FDA can continue its important work.
I don't think anyone else wants my time, and if they don't,
I will yield back.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Today we will be examining the FDA's Animal Drug User Fee
program and the Animal Generic Drug User Fee program. These
critical user fee agreements have helped to accelerate the
development of animal drugs, reduce application review times at
FDA, and create a more predictable and streamlined process for
getting animal drugs to market to help improve the health of
our pets and food-producing animals.
Last month this committee, along with the HELP Committee in
the Senate, released a bipartisan discussion draft that
reauthorizes FDA's authority to collect user fees from the
animal drug and generic animal drug industries for an
additional 5 years, as the current authorization for these
programs will expire on September 30th of this year.
The discussion draft reflects bipartisan agreement and
recommendations negotiated between FDA and the animal drug
industry with input from farmers and ranchers, veterinarians,
food and feed producers, and other public health stakeholders.
These agreements are critically important to pet owners,
veterinarians, and farmers so they have access to safe,
effective, and affordable medications for their animals. We
want our pets to have the best care possible, and we must
ensure that we keep our food supply safe. The animal drug user
fee programs further both of these goals.
I expect we will also hear testimony today on FDA's work to
address antimicrobial resistance from the use of antimicrobials
in food-producing animals. I'm very interested in what the
Center for Veterinary Medicine is doing to ensure the continued
effectiveness of antibiotics and how we can protect both
animals and humans from the growing threat of antimicrobial
resistance.
I look forward to helping to move these agreements through
Congress in a timely fashion so the Center for Veterinary
Medicine at FDA can continue its important work.
I yield back.
Mr. Burgess. Chair thanks the gentleman. Gentleman yields
back.
This concludes the Member opening statements. The Chair
would remind Members, pursuant to committee rules, all Members'
opening statements will be made part of the record.
Again, we want to thank all of our witnesses for being here
today and taking the time to testify before the subcommittee.
Each witness will have an opportunity to give an opening
statement followed by questions from Members.
Our first panel today is Dr. Steven Solomon, the Director
of the Center for Veterinary Medicine, the United States Food
and Drug Administration.
We certainly appreciate you being here this morning, Dr.
Solomon. You are now recognized for 5 minutes to give a summary
of your opening statement, please.
STATEMENT OF STEVEN SOLOMON, D.V.M., DIRECTOR, CENTER FOR
VETERINARY MEDICINE, FOOD AND DRUG ADMINISTRATION, DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Dr. Solomon. Good morning, Chairman Burgess, the acting
ranking member, Chairman Walden, and Ranking Member Pallone. I
am Dr. Steve Solomon, Director for the Center for Veterinary
Medicine at the Food and Drug Administration.
I thank you for the opportunity to discuss FDA's proposals
for the reauthorization of the Animal Drug User Fee Act and the
Animal Generic Drug User Fee Act.
I recently returned to CVM as the Director after working
extensively in other roles in FDA. This is a very good time to
be at CVM for a number of reasons, including the fact that we
are seeing the development of significant and innovative new
animal products.
New animal drugs offer the promise of longer and healthier
life for our pets and other companion animals. For example, FDA
has approved new oncology treatments for dogs, targeting
canine-specific tumors.
The drugs represent a significant advance for veterinary
medicine, which traditionally relies on human oncology
treatments. In recent years, FDA has approved innovative
therapy options that target bone changes to treat a common
cause of performance-ending lameness in horses.
New stem cell therapies offer great promise for future
veterinary treatments and cures. Meanwhile, approval of the
first generic version of a vital heartworm treatment has
alleviated a shortage of this critically important treatment
for dogs and provides an alternative to pet owners.
FDA plays a vital role in animal agriculture by reviewing
the safety and efficacy of new animal drugs for food-producing
animals such as cattle, pigs, and chickens.
For food-producing animals, we also evaluate whether
products derived from treated animals are safe for human
consumption.
Awareness of the public health challenge created by
antimicrobial resistance has led to important changes in animal
agriculture. For example, as an alternative to antimicrobials,
FDA approved a new treatment to prevent mastitis in dairy cows.
At the same time, animal welfare awareness has grown, and we
have approved the first drug to reduce pain in food-producing
animals.
FDA considers timely review of new animal drug safety and
effectiveness to be central to the agency's mission to protect
and promote human and animal health.
ADUFA and AGDUFA are highly successful programs that
enhance the availability of food products for food-producing
and companion animals.
Before their enactment, FDA CVM had a large backlog of
overdue submissions, and sponsors had to wait an average 500 to
700 days for drug review. However, thanks to ADUFA and AGDUFA
user fees, CVM eliminated the backlog in applications and has
dramatically reduced review times.
Both programs enable FDA to maintain an outstanding
scientific and technical workforce, improve timely
communication with drug sponsors, and achieve other
efficiencies in the drug approval process while maintaining
scientific standards for drug safety and efficacy.
Without reauthorization, however, both programs will sunset
on October 1st, 2018. Timely reauthorization is needed to
assure FDA's ability to deliver continued high levels of
performance and ensure there are no disruptions to these
important programs.
The ADUFA IV proposal built on the success of prior ADUFA
achievements and proposes changes to current performance goals
to enhance the review. In it, FDA agrees to maintain current
performance goals for most applications and submissions and to
add four new performance goals to enhance the exchange of
scientific information.
FDA would slash the timeframe for reviewing categorical
exclusion and Animal Drug Availability Act combination
medicated feed requests by two-thirds.
We also establish new goals for presubmission conferences
and tissue residue method demonstrations. ADUFA IV also
includes an FDA commitment to work on the implementation of the
U.S.-European Union Good Manufacturing Practice Inspection
Mutual Recognition Agreement for animal drug facilities.
The AGDUFA III agreement includes significant additional
financial commitments from the animal generic drug industry
that reflect its growth. These resources will help
significantly decrease review time for multiple generic
submissions and provide greater review predictability.
Both the ADUFA and AGDUFA recommendations require 100
percent electronic submission starting next year to facilitate
efficient review.
Additionally, both programs include financial
recommendations to bolster the program's stability. The ADUFA
IV and AGDUFA III agreements, produced with considerable input
from FDA, industry, and other important stakeholders, build on
the achievements of these highly successful programs.
They will ensure FDA has the resources needed to conduct
timely reviews and assist drug sponsors in fostering
innovation, enhancing access to safe and effective therapies
for food-producing and companion animals.
FDA looks forward to working with the committee to achieve
a timely reauthorization of these important human and animal
health programs.
Thank you for the opportunity to discuss the ADUFA and
AGDUFA programs, and I'd be happy to answer any questions.
[The prepared statement of Dr. Solomon follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Chair thanks the gentleman, and I do want to
thank you for taking time to give us testimony this morning.
We will move into the portion of the hearing where Members'
questions are heard. I will begin by recognizing myself for 5
minutes.
And Dr. Solomon, you referenced the implementation of the
U.S.-European Union Good Manufacturing Process Inspection. What
are some of the particular challenges that you face with that?
Has that been more straightforward or more difficult than
you would have anticipated?
Dr. Solomon. So thank you for that question.
We are still in the early stages of doing that. The E.U.
GMP Inspection Mutual Recognition Agreement started on the
human side, and it then will move over to the veterinary side
later on.
So on the human side, it's been making good progress. Once
again, lots of countries in the E.U., they need to be assessed.
What we've discovered is that not all the authorities in the
E.U. have the same authorities on the human side as they do on
the animal drug side.
So, as we progress through it and looking at the animal
drug side, we are going to utilize the information that the
human side has collected as part of their agreement. But as we
move into it we are going to need to look at the countries and
conduct assessments of them that has separate authorities in
the E.U. countries for the animal side.
Mr. Burgess. So there is an increase in funding in the
proposed legislation that Mr. Mullin has given us. How do you
propose that the Food and Drug Administration is going to
utilize the additional resources, and perhaps how is that going
to help us improve the review process?
Dr. Solomon. So we are going to be hiring additional
reviewers on both sides to meet the new performance
commitments. There will be approximately 20 new reviewers in
different disciplines on the animal drug user fee side and
around 30 new people hired on the generic drug user fee side,
and some of those resources will be able to be used for
implementation of the E.U. agreement where we need to go over
to the E.U. and get the assessments of the other countries'
regulatory authorities and oversight over GMP animal
facilities.
Mr. Burgess. Just for a point of reference, how large is
the workforce, currently?
Dr. Solomon. So the current user fees represent around 35
percent of the staff on the animal drug review side and around
60 percent on the generic drug user fee side. Those are covered
by user fees.
Mr. Burgess. OK. So there are more aggressive approval
goals that are laid out in this--in this reauthorization. You
have already alluded to it somewhat, but, again, could you just
briefly delineate the steps the FDA will be taking to meet
these goals?
Dr. Solomon. Certainly. So we've already been doing
planning in anticipation of getting this. Part of the process
is going to be earlier communication.
We have a phase review process in CVM where we really
interact with the industry very early in the process, where
they're still in developmental stage process.
We want to enhance that early communication. Before the
industry is developing a drug, let's meet with them early and
make sure we understand what the data requirements--what type
of clinical studies are going to need to be done so that we can
very quickly decide what those are.
We are also reducing timeframes for some unique aspects of
the categorical exclusion in some of our environment findings.
On the generic drug side, we are dramatically reducing the
timeframes to be able to get generic animal drugs to the market
sooner.
Mr. Burgess. So, on the issue of the electronic submissions
that I believe are going to be required in this
reauthorization, obviously, there are going to be benefits to
electronic submission. Would you care to share those with us?
Dr. Solomon. Thank you.
So electronic submission is a big step in trying to do it.
When I first started at CVM 28 years ago, there used to be
trucks backing up with these volumes and volumes of paper that
needed to be reviewed.
Trying to then take those and give them to the different
disciplines was quite a challenge. The electronic review
process makes the review much more efficient.
Everyone and all the different scientists have access to
the data in a much more expedient way and makes it a much more
efficient process of review.
Mr. Burgess. Well, again, I thank you for being here this
morning. Thank you for your testimony and taking our questions.
I would now like to recognize Mr. Butterfield from North
Carolina for your questions, please.
Mr. Butterfield. Thank you very much, Mr. Chairman.
Dr. Solomon, thank you for your testimony today. Dr.
Solomon, I've heard from some of my colleagues and some of my
constituents about expanding the use of what is called
conditional approval, and it's my understanding that the FDA
believes that it needs legislation to provide authority to
allow this conditional approval to be used for major uses in
major species.
Am I right or wrong about that?
Dr. Solomon. You are correct.
So Congress gave us statutory authority back in 2004 for
use of conditional approval in minor species or minor use in
major species.
What that does is, the applicants' sponsors still need to
prove the safety, the environmental controls, the human food
safety, but allows a 5-year timeframe to demonstrate the
efficacy of the product while it can be on the market.
We've had discussions with industry that, in order to help
spur innovation, trying to get this applied to major species
under certain conditions, the conditions being that it's got to
be for serious illness or disease in major species that really
have unmet veterinary medical needs or public health needs and
for studies that have difficulty in demonstrating efficacy.
So things that we would envision would be more chronic
disease conditions, things like congestive heart failure or
chronic renal disease, osteoarthritis--things that it would be
difficult to do the efficacy studies because you need to
measure things over time.
We think additional approval would be a welcome addition to
try and get additional products on the market.
Mr. Butterfield. Can you describe the safety requirements
that must be met for conditional approval?
Dr. Solomon. So the safety requirements have to be met
exactly the same as for any other approval. So there is no
difference in the safety that needs to be demonstrated before
marketing.
The only difference on conditional approval is the
timeframe for efficacy requirements, which can be up to 5 years
after the product starts marketing.
Mr. Butterfield. Would any of the drug companies that we
deal with have an incentive to provide a drug under conditional
approval that it does not believe to be effective?
Dr. Solomon. So there's a requirement in the conditional
approval that they need to submit status reports on an annual
basis, as least as it's currently applied to minor use, minor
species, on the progress they're making on the efficacy
requirements. And then, if they do not meet it, they need to
come in at 5 years for the full standard for efficacy, which
means substantial evidence of efficacy at the end of that 5
period.
If not, the way the MUMS Act works and what we would hope
in any future one, is that product is no longer allowed to be
marketed. So it gives them time to do the efficacy studies--
those challenging efficacy studies that are meeting unmet
veterinary medical needs.
Mr. Butterfield. Dr. Solomon, I appreciate the work that
the FDA has done to expedite the process of approval for animal
drugs, and I really appreciate your testimony earlier about how
it was 28 years ago when the trucks would back up to your
building. I can just envision that now.
In your testimony, you mentioned that the agreement
recommends that 100 percent of the applications be submitted
electronically and only 58 percent of applications were
submitted in fiscal year 2017 that way.
Will the FDA provide any support to help with that
transition to electronic applications, what I call 21st century
technology?
Dr. Solomon. Yes. So we recognize that, on the pioneer
side, most of the submissions are coming in on electronic on
the generic side. These are generally smaller companies, newer
companies.
We want to provide assistance to try and get there, and it
also includes some IT enhancements in the funding to help CVM
support making that transition over so we can get everyone to
the 100 percent submission goal.
Mr. Butterfield. And are the sponsors ready to make that
transition, or do they have some anxiety about it?
Dr. Solomon. I think they're generally anxious to try and
do it. I think they see the efficiencies in it. But I think
it's a great question for the panel coming up.
Mr. Butterfield. All right. All right. Thank you.
I yield back, Mr. Chair.
Mr. Burgess. Gentleman yields back. Chair thanks the
gentleman.
Chair recognizes the gentleman from Kentucky, the vice
chairman of the committee, Mr. Guthrie.
Mr. Guthrie. Thank you very much.
Actually, I can't let the chairman's comment of the wisdom
of Solomon this morning go. I know you probably hear that all
the time, and I apologize.
But trying to be a little more disciplined myself, as
Solomon talked about, and trying to read the proverbs of the
day--of the chapter of the month, and so today being the 14th
Proverbs--and if you read Proverbs every day, there's always
something you're going to face.
So Proverbs 14:4 says, ``Where there are no oxen, the
manger is empty, but from the strength of an ox come abundant
harvests.'' So what we are doing here goes back to
understanding we have to have a good agriculture, even back in
the Bible times----
[Laughter.]
Mr. Guthrie [continuing]. And proclaimed by Solomon, which
is the standard of wisdom.
And some of the questions they've already--I guess some of
your testimony piqued all of our interest, because I am going
to kind of touch on it again because I was going to ask that.
But first, can you please explain ADUFA IV performance
goals, specifically centered around shortening the review
timeframe for combination medicated fees?
Dr. Solomon. Sure.
So this was an agreement that we worked on during the
previous timeframe. So there's a number of medicated fees that
combine various different drugs, usually for different type
conditions.
So there might be some combination that there might be a
need for an antiparasitic drug, for, say, Coxidia. At the same
time they may be treating a bacterial-infection-type area.
So, in the medicated feed area, we wanted to not subject
each of them to a separate approval requirement when each drug
had already gone through an approval combination.
When we put these two combinations together, we need to
make sure that they're not interfering with each other--the two
drugs together.
Putting drugs in the feed supply is often the most
efficient way to get it into food-producing animals.
So we worked with the industry to come up with a shortened
timeframe to evaluate these drugs when they combine them
together in medicated feeds.
Mr. Guthrie. OK. Thanks.
And the second question, I was going to talk about the
electronic submission, and it was kind of asked but at the very
end you said that would be a good question for the next panel,
why we haven't gotten a higher percentage from 58 to 100
percent, and we'll do that--ask them that.
What kind of challenges are you seeing from--for some
reason, they're not--obviously, I don't know if it's all their
issues for not getting the 100 percent, but what kind of
challenges, from your perspective, do you think the next panel
should be looking at to address?
Dr. Solomon. So I think my understanding is, this is mainly
some of the newer companies. Often, we have companies that are
new on the generic side to this and just simply haven't
developed the structure for all the electronic pieces.
We give lots of guidance on what we expect in a submission,
how to put it together, how to facilitate the electronic entry.
We have a pathway for moving it.
We are going to try and provide, you know, help desk
assistance for anyone that needs assistance in getting that
electronic review.
So we all benefit from getting the electronic review
process, and we want to work with the industry to get to that
objective.
Mr. Guthrie. Do you think 100 percent is attainable by
2019?
Dr. Solomon. We will work closely with them to try and meet
that goal.
Mr. Guthrie. That's a good answer.
So, and Dr. Burgess talked a little bit about the U.S.-
European Union good manufacturing practices for animal drug
facilities. What is the timeframe for this agreement?
And I know you said they're doing the human and then the
animal. But what's the timeframe for the agreement, and when do
you expect to see that?
Dr. Solomon. So, the way the agreement is drafted, the
agreement got signed on the human side in March of 2017, and
they're still going through the assessment. A number of the
E.U. countries have already been reviewed and are now part of
the agreement.
In December, we met with the European Union to lay out our
goals and objectives for trying to move it on the animal side,
and we have an objective by making a determination by July of
2019 whether we are going to be successful in moving that
agreement forward in the timeframe for meeting that assessment
so we can evaluate the GMP conditions on the animal side of the
house.
Mr. Guthrie. OK. Well, thank you very much, and that
concludes my questions. I appreciate your testimony.
I yield back.
Mr. Burgess. Chair thanks the gentleman. Gentleman yields
back.
Chair recognizes the gentleman from Oregon, Dr. Schrader, 5
minutes for questions, please.
Mr. Schrader. Thank you very much, Mr. Chairman. I
appreciate it.
Welcome, Dr. Solomon.
Dr. Solomon. Thank you.
Mr. Schrader. Very impressive, the results you guys have
gotten as a result of the previous ADUFA agreements. The
performance measures speak for themselves--95 to 100 percent
success in all the different areas.
Most agencies would die to have that sort of track record
at the end of the day, and you're stepping up and willing to
reduce time lines and do some more with a little assistance
from industry.
I guess the comment I would make is that it's just great to
see these public-private partnerships. I mean, that's ideally
the way things are supposed to work. We are in this together.
It's not one versus the other, but helping one another get the
job done for humans and, in this case, for our animal friends.
As a veterinarian, I am very interested in the conditional
use approval process. Frankly, in the animal field, we are a
smaller population, usually not quite as remunerative as it is
with our human medical colleagues, and as a result the
conditional use process is critical for us to be able to access
some of these medications in a more timely manner and make them
available to our patients, and, frankly, some of the work
that's done on our patients benefits our human colleagues at
the end of the day.
So I am very interested in the potential expansion of the
conditional use process, you know, when you were before the
HELP Committee, you indicated that you felt that at least for
the minor species, minor use, it was working pretty well. But
we are getting a little behind the time line. It was 2015, I
think, at one point, and looking at the expansion of the scope,
you alluded to it, I think, in your comments both to the Chair
and to Mr. Butterfield.
But when do you think we are going to be finishing this
expansion and hopefully getting to full conditional use for the
major species as well as the minor?
Mr. Solomon. So thank you for your interest in our issues.
So, once again, it needs statutory language to expand it for
the additional approval in major species.
Once again, this is not for all uses. This is for
significant, serious disease conditions, unmet veterinary or
medical needs.
We certainly could see this for certain zoonotic diseases
that may arise where you need to get a drug out. You want to
show that the product is safe, which needs to be shown
beforehand. Some of the efficacy requirements may come later,
but in critical public health issues, which I am sure you
recognize, it might be out there.
So we met earlier this year with the drug industry. We
shared the interest in moving this forward. Our staffs have
been working really closely on this issue over the past month
and a half.
And, if Congress is interested in the conditional approval,
we would love the opportunity to provide some technical
assistance on that issue.
Mr. Schrader. Great. I would like to see that move forward,
because there are unmet needs and there are some difficult
processes. Neither one of those, I think, would be a good
justification for some of the changes in the conditional
approval process to be very helpful.
Getting back to the minor-uses-major-species and minor
species piece, my understanding from the testimony, there's
only been four, really, applications and only one been
approved.
Is there a problem in the process here, or do you need some
more help from us?
Dr. Solomon. So it is a little disappointing. We'd hoped
that we'd have--that incentive would be more products out
there. Of the four products, one was an aquiculture product
that got approved--clearly, a needed area of resources.
Two of them demonstrate some of the challenges. So two were
drugs to fight cancer. One drug, simply the firm withdrew it
because it was not demonstrating efficacy. They didn't have the
right doses, so they determined, ``Let me take this off the
market, go do some more work and come back.''
One just couldn't get the efficacy standard and therefore
had to be withdrawn, and we have another one that's currently
in the pipeline that looks promising.
Mr. Schrader. You're seeing the incentives seem to be OK?
It's just maybe a company is getting used to the process or
getting familiar with the opportunity?
Dr. Solomon. Once again, firms that are looking for the--
usually in the minor species--are generally small firms, and
while the economic incentives for major species are often a
challenge compared to the human side, it's even more
challenging on the minor species side.
Mr. Schrader. OK.
And then ADUFA III accelerated the process quite a little
bit, replaced the end review amendment process and shorter
second-round reviews.
Any problems with safety as a result of doing those things?
Any problems crop up as a result of making the process more
efficient?
Dr. Solomon. No. I think safety is always a paramount
concern and, once again, our process doesn't just stop with the
approval process.
We have postmarketing activities that monitor the safety of
drugs. We have the largest adverse event database in the world.
We work with other countries on harmonizing that data, and
we use that date if we ever have to make adjustments to a
product and work with industry to continue to ensure the safe
use of animal drugs.
Mr. Schrader. Very good. Thank you, and I yield back.
Mr. Burgess. Chair thanks the gentleman. The gentleman
yields back.
The Chair recognizes the gentleman from Indiana, Dr.
Bucshon, 5 minutes for questions, please.
Mr. Bucshon. Thank you, Mr. Chairman.
This year's ADUFA includes a new goal for tissue residue
method validation.
First, can you explain what this is, in layman's terms, and
then describe how this validation of tissue residue methods may
have led to delays in the approval of new drugs in the past?
And then could you walk us through how you plan to meet the
new review goal of 120 days for this measure?
Dr. Solomon. So thank you.
So a tissue residue method is for an animal drug that's
going to be used in food-producing animals. We need to develop
a method--industry needs to develop a method and then we need
to do validation of the method to make sure that the levels and
the determination of the safety in meat, milk, or eggs has been
determined and this is the method that would be used to
evaluate that in the food supply once the product's on the
market.
We have an office of research as part of CVM that does this
work. This is the first time we actually put a goal time period
to be able to meet the objective of developing the tissue
residue method and validating that method, and because of the
agreement we are now able to hire additional resources and
research scientists that can work out in our office of research
to be able to support the tissue residue method.
Mr. Bucshon. So protecting the public health and providing
the best animal health and welfare can only be achieved through
continued advancements in innovation.
I hear of a need for more innovation in animal health due
to the unmet medical needs. What are some of the ways the
agency can spur innovation to meet some of these needs?
Dr. Solomon. So we are doing a lot of different work to
communicate with firms early and be able to get new products on
the market.
One of the ways is we do different surrogate end points.
One example is, there's a disease called Addison's disease,
which is a low level of cortisol. Cortisol levels are hard to
measure because they're a natural hormone in the body, so we've
used surrogate end points to measure sodium and potassium
ratios rather than looking at the end point. We use different
clinical designs.
So I talked earlier about the use of drugs in food-
producing animals. So, if you're trying to reduce pain you
can't ask the cow, you know, ``On a score of zero to 10, how
painful are you?``
So we actually worked on it in designing a method with the
firm that the animals have a foot lameness problem and we
actually figured out how to use pressure mats to determine how
much weight they're putting on it.
If they're less painful, these pressure mats will be able
to weigh the difference about how much weight they're putting
on those mats. So we use those methods.
We use data from foreign countries so we approved a drug
for noise aversion. Dogs--some animals get very scared when
there's thunder or fireworks, and so we use data actually
gathered in European studies, transferred that data because we
work closely with our international colleagues to try and get
that data to be able to suffice and reduce the number of
animals that are used in studies.
We use other methods such as--we approved a drug for a
follicle-stimulating hormone, which is a drug for super
ovulation. We did that review using literature review and meta-
analysis without having to use clinical studies.
We used every technique that we can to try and get
innovative products to market by early communication with the
firm in designing how these studies should look.
Mr. Bucshon. Great. Thank you.
I yield back, Mr. Chairman.
Mr. Burgess. Chair thanks the gentleman. Gentleman yields
back.
Chair recognizes the gentlelady from Indiana, Mrs. Brooks,
5 minutes for questions, please.
Mrs. Brooks. Thank you, Mr. Chairman, and thank you for
being here.
Can you talk a little bit about the improved wait times and
what the average wait times are for pioneer drug review
responses and generic drug review responses, respectively?
Dr. Solomon. So there's two ways that a firm can put drugs
onto the market. One way is to wait and put all their
submissions of all their technical sections--their target
animal safety, their efficacy studies, their environmental
review, their human food safety if it's for food-producing
animals--and submit that.
We determined a long time, working with industry, a much
better way is to do a phase review process where the firms come
in much earlier in the developmental process, meet with us
early, talk about those kinds of design of the studies there,
and therefore work on each section as they have the appropriate
resources and they're gathering the data, submit that data to
us, and then that technical section gets a review.
So the wait times are a little--it's not the same way as it
is on the human side, because most of these are phased review
processes.
We are working with the firm as they're doing the studies,
submitting those pieces, and we are continuing to meet our--
that's the way that the performance goals are written to have
the timeframes.
As mentioned now several times, we've been very successful
in achieving our timeframe for each of those actual submission
timeframes.
Mrs. Brooks. I understand, though, that prior to the ADUFA
fee process and user fee programs that there used to be, like,
500 days average wait time, 700 for generic. What have you
gotten those down to, on average, now? And I appreciate it's an
average but----
Dr. Solomon. Right.
Mrs. Brooks [continuing]. What kind of timeframe are we
looking at now?
Dr. Solomon. So we are getting closer towards these 180-day
timeframes. You know, it depends how many times--what the work
looked like, the quality of the submissions.
But we've dramatically reduced the timeframes from where we
used to be prior to the use fees.
Mrs. Brooks. And congratulations. Anything else you need
with respect to either the process or resources to increase
that wait time--or, to decrease that wait time, rather?
Dr. Solomon. The user fee agreements and our work with
industry are important to get reauthorized. So we are anxious
to get that done.
Mrs. Brooks. Can you talk to us a little bit about what are
some of the unmet needs in animal medicines? And I am sure
there are many.
Dr. Solomon. Right.
Mrs. Brooks. Some of the most concerning ones to you.
Dr. Solomon. So continued oncology treatment for cancer
treatments. As our pets are living longer, we are getting more
cancers in our companion animals. Right now, a lot of the drugs
used are human oncology treatments. The veterinarians would
greatly appreciate the opportunity to be able to have drugs
that have been demonstrated for the efficacious--for the canine
or equine or the horse or the dog or the cat-type tumors.
The chronic renal diseases, as our pets are living longer,
they're getting more care. We are seeing more osteoarthritis,
arthritic conditions, the same thing we see at our older ages.
We'd love to have drugs for renal disease, congestive heart
disease problems that we see. There's no shortage of unmet
veterinary medical needs out there.
Mrs. Brooks. And finally, can you talk to us a little bit
about the conditional approval process and hearing more about
how that will impact the industry?
Dr. Solomon. So, once again, we think conditional approval
for those type diseases I just talked about where, once again,
they come in with their package as normal for safety.
They come in for the same package for the environmental
controls, human food safety--all those conditions. It's only on
the efficacy. So it changes the requirement from a reasonable--
substantial evidence of efficacy, too.
They have to show reasonable expectation and they need to
meet that standard within the next 5 years and with the current
proposals that we are looking at.
So it gives them time for those diseases that are more
chronic, insidious diseases that are harder to measure during a
clinical trial because you're monitoring these conditions over
a much longer period of time.
Mrs. Brooks. Thank you. I yield back.
Mr. Burgess. Chair thanks the gentlelady. The gentlelady
yields back.
The Chair recognizes the gentlemen from New York, Mr.
Collins, 5 minutes for questions, please.
Mr. Collins. Thank you, Mr. Chairman. Thank you, Dr.
Solomon. I am going to step back just a second. As we added
these user fees, I am assuming all that money goes towards
personnel in your office?
Dr. Solomon. Correct.
Mr. Collins. And whether percentage of your budget or the
number of folks, how significant is this to your staffing
levels?
Dr. Solomon. So on the pioneer side on animal drug, it
supports 28 percent of our animal drug review costs--what our
costs are to run the program--and on the generic drug, it's 62
percent. So there are significant contributions to our
overall----
Mr. Collins. But absolutely a direct result, this money is
what's bringing our wait times down?
Dr. Solomon. Absolutely.
Mr. Collins. So when you mentioned, you know, some
veterinarians are using human drugs, is there an approval
process they have to go through, cancer or otherwise, to take a
human cancer treatment and use it in an animal? Do they have to
come to your agency to get approval to do that?
Dr. Solomon. They do not. So there is authorization for
extra-label use and veterinarians can use human drugs in
animals without a review. That preference would be from the
veterinary community, to have drugs that are specifically
approved for animals. And so that's why the conditional
approval, for example, would be advantageous.
Mr. Collins. If they do this, I mean, I would think it
would helpful to the industry if they also compile data at some
point so other veterinarians could have a better feel whether
this drug is working or not.
Is that just option--it's not mandatory that they do so as
they're using----
Dr. Solomon. So many of these drugs approved in humans may
have gone through animal studies. So a lot of times
veterinarians will take a look at those animal studies and, in
fact, we've had drugs that have been approved.
Much of the work was done during the human approval. We had
some drugs for pain in animals. We had some drugs for appetite
stimulation in dogs. Much of the work, when they came in with a
submission, was done for those drugs when they were approved on
the human side, and that information was transferred over,
submitted to the approval process, and we went through
approval.
Mr. Collins. Although I think a lot of the animal portions
of human drug trials are more for safety issues than efficacy?
Dr. Solomon. That's correct.
Mr. Collins. So, now, I am very familiar with the human
side. But on the animal side, is there the equivalent of a
phase one, a phase two, a phase three, or is it just a lot more
data driven--they do their work, they come to you with a
submission? Or do they have to go through anything remotely
resembling what we do in human trials?
Dr. Solomon. So there are some similarities about the type
of data that they need to submit. We use a different process
than the phased process.
But they do go through those same type of aspects. So they
do clinical trials on a small number of animals to evaluate
safety. They look at safety issues by giving various doses of
the drug to determine the safety.
Once safety is looked at, then they start doing efficacy
trials, and that may be both clinical trials and field trials
that may be done throughout the----
Mr. Collins. But, I mean, that's almost exactly the way we
do human trials. But is it as formalized, or is folks
developing animal drugs have a lot more latitude in all those
areas to bring a drug to market and then--is your involvement
more of a review of that data that they've built without being
quite under the same scrutiny as human trials?
Dr. Solomon. So we don't put them through the phases in the
same way the same type data is collected. But we work very
closely with them on each of those aspects.
So they come in early in the developmental process, sit
down with us, what's it going to demonstrate to show the target
animal safety? What are we going to need for the clinical
efficacy?
Each drug is unique, because once again we are using
different approaches. Are we using different surrogate end
points? Are we using data from human trials? Are we----
Mr. Collins. Well, my time is almost up. But is the patent
protection similar for this development as it is, and then
generics can come on board after 17 years or whatever it
happens to be?
Dr. Solomon. So I need to get back to you on the patent
issues. We do have exclusivity issues where the drugs are
either for 3 years or 5 years when a pioneer comes on before a
generic product can come on the market.
Mr. Collins. So significantly reduced time compared to
human drugs?
Dr. Solomon. On the exclusive marketing, yes.
Mr. Collins. Very good. Well, thank you. This is very
informative.
I yield back.
Mr. Burgess. Chair thanks the gentleman. The gentleman
yields back.
The Chair recognizes the gentleman from Florida, Mr.
Bilirakis, 5 minutes for questioning.
Mr. Bilirakis. Thank you, Mr. Chairman. Appreciate it.
Dr. Solomon, would you briefly explain how ADUFA and AGDUFA
improved FDA regulations as far as the public health is
concerned and how the most recent proposed changes will benefit
FDA and public health?
Dr. Solomon. So, by getting new products, new animal drugs
to the market, many of these drugs are very important for food-
producing animals, which directly affects public health.
When we get a new antimicrobial, for example, for use for
treating a disease in food-producing animals, we have the
resources to try and do the human food safety aspect of that
review.
That review includes all the toxicology review, the residue
review, which I talked about before with the tissue residue
method. But it also looks at the microbial review process. Is
this a product that could affect humans and is medically
important in humans, and therefore could cause antimicrobial
resistance? So that's all part of the review process that
directly affects public health.
Mr. Bilirakis. OK. Very good.
How has consolidation in the industry impacted the review
process?
Dr. Solomon. So, on the pioneer side, there's been
considerable consolidation that's taken place. From our
perspective, they become more familiar with it and therefore
the submissions--they understand better the products out there.
It also has an effect that sometimes it reduces the number
of applications. So when a company has had mergers in several
drugs, they often look at their portfolio, and it may result in
some products being withdrawn from the market.
Mr. Bilirakis. OK. What are the consequences of not
reauthorizing these user fee programs?
Dr. Solomon. So I hope no one wants to go down that path,
because it's significant.
Mr. Bilirakis. Tell us why.
Dr. Solomon. Again, we've achieved these timely review
processes. It would create instability in the industry. We've
become very predictable on the timeframes and the pathways for
these products.
It would be significant in terms of our staff. We have 115
staff that are currently employed using the user fees.
Depending on the timing of when reauthorization would look, we
would have to give notices, and it would make great challenges
for our future staffing.
People would not want to come to work for the Center of
Veterinary Medicine, where we have outstanding scientists and
reviewers, veterinarians that come on if there was uncertainty
about this pathway.
Mr. Bilirakis. Well, thank you.
Mr. Chairman, I yield back the balance of my time. Thank
you.
Mr. Burgess. Chair thanks he gentleman. The gentleman
yields back.
The Chair recognizes the gentleman from Virginia, Mr.
Griffith, 5 minutes for questions, please.
Mr. Griffith. Thank you very much.
All right. So what can we do to help to bring some of these
ideas that you talked about, the antimicrobials that are being
used, and trying to make sure that we have drugs for the
animals but that they don't affect humans?
What can we do to move that process along to make it a
little quicker?
Dr. Solomon. So we are working very closely on the
antimicrobial resistance issue. It's a significant public
health issue.
We work on judicious use policies, both on the human side--
my counterparts work on the human side, we work on the animal
side of that issue.
We work closely with industry to withdraw all the claims
for use that was production uses for feed efficiency and growth
promotion. Industry worked over the past 3 years. As of January
of last year, all those were withdrawn.
We continue to work at monitoring both sales of
antimicrobials and monitoring, through our national antibiotic
resistance monitoring system, antibiotic usage.
Our colleagues at the American Veterinary Medical
Association put out to the veterinary profession principles of
good stewardship of antimicrobial use and principles about how
to apply that and the definitions associated with that. Our
American Association of Veterinary Medical Colleges has
developed curriculum to be able to educate the new generation
on what judicious use looks like.
We continue to need to work both domestically and
internationally on getting better data to monitor antimicrobial
resistance over time.
Mr. Griffith. All right, I am going to shift gears on you,
and feel free to tell me that it's not my department, but I had
some folks come to me recently--and I represent the part of
Virginia that has Virginia Tech, where a lot of research is
being done--and they were talking about genetically modified
calves.
And when they finished with their testing on, you know,
rearranging the genes in the calf, they have to kill the
mother. I am trying to figure out why. Do you have any help--
can you help me there?
Because why would the mom be affected by a genetically
modified calf when the calf is placed there out of a test tube,
and it has nothing to do with her other than she's the vehicle
in which the calf is being----
Dr. Solomon. So I don't think I can answer the question on
the mother.
Mr. Griffith. And that's fair. I thought that might be the
case.
Dr. Solomon. But in a genetically modified animal, they do
need to go to a review process to make sure these animals are
safe, and if someone's going to eat them that the modification
makes it safe for people to eat.
Mr. Griffith. And I recognize it's not necessarily your
field, but it's something we might want to look at at some
point, Mr. Chairman, is that they get that with the genetically
modified calf, and so when they finish their experiment they
understand they have to kill the calf. But I can't figure it
out.
Now, you know, it's not my field. So maybe there's a small
country lawyer--there's some obvious answer. But if you could
maybe see if you could find me the right person to answer that
question. Why does the mother have to be killed because, you
know, the mama is a valuable asset, and when you're doing
research and you suddenly have to start killing off assets
that--I can't figure out nor could this individual who brought
this to me figure out why the mother also has to be killed.
The calf, I get. You don't want to put that calf into the
marketplace, and maybe you don't want to put mom in the
marketplace, but you could use her again if she's able to have
more than one. They're not able to do that right now. But I
appreciate it.
Dr. Solomon. We are happy to take a look into the issue.
Mr. Griffith. And I appreciate that.
And with that, Mr. Chairman, most of my questions having
previously been asked, I yield back.
Mr. Burgess. Chair thanks the gentleman. Gentleman yields
back.
Chair recognizes the gentleman from Illinois, Mr. Shimkus,
5 minutes for questions.
Mr. Shimkus. Thank you, Mr. Chairman. Sorry I am late. We
were at another hearing. I am sure you have heard that before,
and I wish I would have been here for Kurt Schrader's
questions, since he's a veterinarian, and I would have loved to
hear. Maybe I will check his questions for the record.
But the last--we started going into this antimicrobial
resistance discussion, and the only thing I wanted to raise
was--and I know you have all talked about the conditional
approval authority extensively, which is good.
How might you, in this antimicrobial resistance, can expand
and improve your antimicrobial resistance provision as we move
to--I call it AGDUFA--AGDUFA III?
Dr. Solomon. So I think there's opportunities under--if
conditional approval for serious medical conditions that are
treating public health issues, there's opportunities for
alternatives to antibiotics to be potentially used under
conditional approval, and I think we'd welcome those
opportunities. We have approved a drug that's an alternative to
antibiotics. It's given to dairy cows to try and prevent
mastitis. It increases the number of neutrophils in the bone
marrow to be able to fight infections. I think we are looking
for other innovations that could be used as alternatives to
antimicrobials, and I think conditional approval may be another
incentive to try and get those products to the market.
Mr. Shimkus. Yes, and I should have asked this question
first to set up the second one, but what are the barriers you
have right now under current law on this debate?
Dr. Solomon. So the conditional approval Congress approved
for only minor use in major species or minor species.
In order to use it in major species under the unique
conditions that we've defined, it needs new statutory authority
because it was--right now, efficacy needs to be demonstrated at
the same time as target animal safety, human food safety, the
environmental review process.
The conditional approval allows all the human food safety.
The other pieces--the technical sections to be reviewed allows
the product on the market 5 years. Industry can demonstrate the
efficacy, comes back in and gets the full approval.
Mr. Shimkus. Do you agree with that, Schrader?
Mr. Schrader. Yes. Yes, I do. I mean, he outlined a current
process and stuff. But we do need to expand the conditional use
opportunities for major species. I think----
Mr. Shimkus. Good enough for me. Yield back my time. Thank
you.
Mr. Burgess. Chair thanks the gentleman. Gentleman yields
back.
The Chair recognizes the gentleman from Oklahoma, Mr.
Mullin, 5 minutes for questions, please.
Mr. Mullin. Well, that is good timing. Thank you, Mr.
Chairman, and Dr. Solomon, thank you so much for you taking the
time to be with us.
A couple questions that I have. Wwhat is the timing? We've
been talking a lot about conditional approvals. What's the
timing on this? Do we know what we are looking at, how we can
more predict in the industry level?
Dr. Solomon. So, once again, I think we've worked very hard
with industry over the long period of time but more
expeditiously recently to try and get a common understanding of
conditional approval.
I think there's a good understanding of the scope that
we've described here about its use for challenging efficacy
issues, serious medical conditions.
So we'd be interested in, you know, if Congress wants to
take this on we'd welcome the opportunity to give some
technical assistance to it.
There may be some remaining issues that would need to be
worked through, through either a guidance or a regulatory
process. But getting the statutory authority while ADUFA/AGDUFA
would be an opportunity.
Mr. Mullin. Do you know what you would need from Congress?
Because I am committed to working with you, and the industry is
wanting to work with you.
We are wanting to see this move forward, I mean, because
under--I mean, as we know, underneath the idea, which passed in
2004, we've only seen, what, four different drugs that's
actually been able to come out of it, and I don't think that
was the intent. Originally, the intent was to help incentivize
the industry on coming up with new ways and new paths to
build--to be able to produce and enhance the treatment for the
animals.
So what would you need from Congress? How could I work with
you? Because, in all seriousness, I really want to see this go
as far as what Congress I think first intended in 2004 for it
to go to.
Dr. Solomon. So once again, in 2004, it was for the minor
species and minor uses.
Mr. Mullin. Right.
Dr. Solomon. We are now having discussions--can we expand
that to major species under unique conditions? We would welcome
the opportunity to work on technical assistance to try and----
Mr. Mullin. Who needs to be at the table on that?
Dr. Solomon. The industry is, clearly, at the table.
Mr. Mullin. Right.
Dr. Solomon. American Veterinary Medical Association, a lot
of people that are sitting here today.
Mr. Mullin. Are we the ones missing at the table then? I
mean, you said you're welcome to work with Congress on this. I
am just looking for a path. How do we need to inject ourselves
into this conversation without confusing it?
Dr. Solomon. I think technical assistance for some language
that I think has been floating around. Once again, this is a
recent development.
We recognize this. We've recognized timeframes are
challenging, but we welcome the opportunity to try and get this
important piece added.
Mr. Mullin. Well, we worked with industry some as far as
looking for language that's needed. Have you had a time to look
at it yet?
Dr. Solomon. So we've had staff working very closely with
the industry on that piece.
Mr. Mullin. But you haven't got a look at it yet?
Dr. Solomon. We would like the opportunity, sort of taking
that language if we get requested by Congress and be able to
provide formal agency review of it.
Mr. Mullin. I guess that's where I am confused. Is it
simply me saying, ``I want you to look at it,'' or is there--
and I am confused here--does it take actual legislation for us
to give you----
Dr. Solomon. I think its only request that if Congress is--
which sounds, you know, a lot of interest here on conditional
approval. If you came to us we'd be happy to provide technical
assistance to give a formal agency position to try and have it
in front of you to decide to include it in the ADUFA/AGDUFA----
Mr. Mullin. Well, let me talk with the committee so I am
not stepping in front of the chairman on this and find out for
sure what the committee wants.
But I was under the understanding that's where we are
wanting to move to. But I will get back to you personally, and
then I look forward to working with you moving forward with it.
Dr. Solomon. We welcome that opportunity. Thank you.
Mr. Mullin. Thank you, sir.
And with that, Mr. Chairman, I will yield back.
Mr. Burgess. Gentleman yields back.
The Chair would observe that the gentleman might want to
work with the primary author of the bill. Oh, that is the
gentleman. So, yes.
[Laughter.]
But we will work with you, Mr. Mullin.
Mr. Mullin. I don't want to overstep the committee because
you have been very gracious to me.
Mr. Burgess. We will work with you, absolutely.
Chair now recognizes the gentleman from Texas, Mr. Green, 5
minutes for your questions, please.
Mr. Green. Thank you, Mr. Chairman. I apologize for being
late.
Thank you, Dr. Solomon, for being here today, and as you
explained in your testimony, over the last 2 years FDA has been
working to finalize recommendations for reauthorization of the
animal drug user fees and has held negotiations with regulated
animal drug and generic animal drug industries in order to
reach an agreement on both financial and performance goals for
the next 5 years.
These recommendations were finalized and transmitted to
Congress for consideration early this year. Dr. Solomon, you
noted that the FDA is currently delivering predictability--high
levels of performance against the ADUFA and AGDUFA goal
commitments for a timely review.
Under ADUFA IV and AGDUFA III, do you believe this high
level of performance will continue?
Dr. Solomon. With the additional resources that have been
negotiated and put forward, yes, we are committed to continue
to meet the high levels of performance.
Mr. Green. Is this why the performance recommendations for
most of the submission types for pioneer drugs remains
consistent with the current goals?
Dr. Solomon. That's correct.
So once again, we've reduced timeframes for most of those
submissions. We added four new areas this time, of particular
importance to some of those commitments for early communication
with the industry early in the development process.
Mr. Green. For generic animal drug submissions, FDA's
performance goal review times have been shortened. Can you
explain how the FDA plans to meet those new timeframes?
Dr. Solomon. So there was significant new resources
associated with the generic drug. The industry really wanted to
be able to get the generic drugs to the market sooner, and so
they committed additional resources.
We plan on hiring the scientific support staff to be able
to conduct those reviews. There has been a tremendous increase
in generic drug submissions over the past couple years.
The workload has increased tremendously. In fact, we had
over a 50 percent increase in the last year on generic drug
submissions.
Mr. Green. Thank you.
Can you explain how the financial recommendations in the
AGDUFA III negotiated agreement have changed from AGDUFA II?
Additionally, can you explain the rationale for those changes?
Is it mainly just an increased funding?
Dr. Solomon. So there's increased funding. We also made the
funds more readily available. So one of the conditions is,
historically there used to be a process where, if there's
excess collections of funds, you'd have to wait to the last
year of the agreement in order to be able to use them.
We negotiated with industry. They would like and we would
like to be able to use those funds earlier. There were some
changes in the inflation index that took place to make it a
variable inflation index, and there was changing the base years
that we were using for the negotiations. So all agreed upon.
Mr. Green. Are there any other performance and financial
recommendations from the new proposal that should be
highlighted?
Dr. Solomon. The tremendous changes on the generic drug
side dramatically reduce the timeframes associated with those.
So I think the industry and FDA would be very excited about
meeting those new timeframes, because they're significant
reductions.
Mr. Green. I want to thank you, Dr. Solomon. These
performance and financial goals are critical aspects to the
ADUFA and the AGDUFA programs and will chart the course for the
next 5 years.
I am pleased that the FDA and the animal health industries
have reached agreement and look forward to the swift
reauthorization of these important programs.
And Mr. Chairman, I yield back.
Mr. Burgess. Chair thanks the gentleman.
The Chair recognizes the gentleman from North Carolina, Mr.
Hudson, 5 minutes for your questions, please.
Mr. Hudson. Thank you, Mr. Chairman. Thank you, Dr.
Solomon, for your time today.
In my home State of North Carolina, agriculture is the
number-one industry. Poultry is the number-one sector, making
up 40 percent of our State's total farm income.
All told, it's about $4 billion a year, or 10 percent of
our total State product. One issue that pops up continually for
our chicken and turkey farmers is blackhead disease. This
highly transmittable disease can wipe out an entire turkey
flock in weeks, disrupts breeding cycles for chickens, causes
millions of dollars in damage to my farmers back home.
This disease occurs sporadically but has a high impact
every time it strikes a farmer's flock. Unfortunately, no
medication exists at this moment to treat or cure this disease,
meaning that if your flock is hit, it's guaranteed to hurt.
Because this disease requires a spontaneous biological
event to occur, it's almost impossible to create controlled
trials to study the disease or the efficacy of the drug.
One thing my colleagues, Markwayne Mullin and Dr. Bucshon,
noted earlier and I've been examining is the conditional
approval that's gotten a lot of attention here in this
hearing--a pathway for major use, major species.
Blackhead disease is just one disease of many where a
conditional approval pathway would help drug makers get
medications to farmers and pet owners that are currently
unviable for the traditional approval pathway.
So in your testimony you note that the CVM is committed to
continuing to explore conditional pathways. Do you agree that
the conditional approval pathway for major use in major species
would help bring innovative therapies that can treat diseases
like blackhead disease to market?
Dr. Solomon. I do. We've done a lot of work on blackhead.
We've recognized that's one of those unmet veterinary medical
needs out there.
We've asked for the industry, in the turkey industry that
suffers from this the most, that they may be eligible under our
minor use, minor species, but we need data presented to try and
do that.
If they're unable to meet that, then this new conditional
approval proposal would be welcome. It's a challenging disease
to treat because of many of the sporadic conditions, seasonal
nature of it. It would be one that, you know, demonstrating
efficacy over a longer period of time could be valuable tool in
the arsenal.
Mr. Hudson. Right. Well, I appreciate that, and my
colleague Markwayne Mullin and others have I think clearly
established that we want to work with you on this and, you
know, we welcome any feedback you have on any requirements that
make conditional approval pathway feasible--you know, what you
need from us to move forward on this, and rather than continue
to beat that dead horse, I would just ask do we have your
commitment that we'll move as quick as we can together to find
a way forward on this?
Dr. Solomon. We are ready, willing, and able to work with
you on that issue.
Mr. Hudson. Great. I appreciate that very much.
Unrelated to conditional use, but just out of curiosity for
me: Off the top of your head, what's the longest amount of time
that CVM has spent reviewing a single drug?
Dr. Solomon. That's probably the genetically engineered
salmon, which went on for a significant period of time for a
lot of different reasons.
Mr. Hudson. What do you think just in general the reasons
for long review cycles are?
Dr. Solomon. So for that particular review, that was
unique--the first genetically engineered animal for food-
producing animals. You need to develop how are you going to
evaluate the safety, the efficacy of something that's so new
and novel.
It was one also of great concern from an environmental
area, which is part of our requirement, you know, what's the
potential for a genetically engineered animal to get loose--
either get into the wild, even though they're sterile animals--
poses lots of different challenges, looking at our typical
review process with something unique.
Now that we've been through those processes, we've answered
many of those questions.
Mr. Hudson. Well, just in a more typical review process,
you know, what are some of the reasons that these sometimes
take longer?
Dr. Solomon. So data quality is an important issue for us.
We constantly are working with the industry--the more higher
quality the data, then we'd have to go back to these issues.
Efficacy requirements in certain disease conditions can be
very challenging. We've been challenged, for example, on
heartworm disease. We try and--as there's been resistance to
various new--some of the different parasites--it becomes more
difficult to demonstrate efficacy over a period of time.
So it's kind of, evolution of some of the disease
conditions over time poses challenges on proving efficacy.
Mr. Hudson. Well, I appreciate your testimony very much.
Mr. Chairman, I will yield back.
Mr. Burgess. Chair thanks the gentleman.
Chair recognizes the gentleman from Georgia, 5 minutes for
your questions, please.
Mr. Carter. Thank you, Mr. Chairman.
Thank you, Dr. Solomon, for being here. Appreciate that
very much.
Let me ask you something. It's my understanding in a new
animal drug application that the drug sponsors are responsible
or submitting information, and it's quite detailed and quite
thorough.
From what I understand, in the application it's going to
include information on the drug's chemistry, the composition,
the component ingredients, manufacturing methods, facilities
and controls, proposed labeling--on and on and on.
And not only that, but also if the drug product is intended
for use in a food-producing animal, that it also has to be
proven for human use, and I am just--and all this burden falls
on the drug sponsors.
And it just appears that it's more than even what--the
guidelines for animal drug are more stringent than they are for
human drug applications. And I am just interested to know,
first of all, do you think that's true, and secondly, if it is,
why is that?
Dr. Solomon. So, just to take a step back, so with all due
respect to my human colleagues on review, they have one species
to deal with.
Often we have to deal with multiple species. So many of the
applications, they don't want to market it in multiple species
at the same time.
And that's a challenge, because there's different
pharmacology versus pharmakinetics in different species out
there. We also have the responsibility in food-producing
animals to make sure that this is going to be safe for humans.
So, once again, I think our safety and efficacy and
environmental reviews are very similar to the human side. But
when it comes to either multiple species or the human food
safety issues, they're unique to the animal side. But that's
part of our responsibility to the American public to make sure
that the food is safe.
Mr. Carter. Fair enough. Good answer. Thank you.
I want to talk to you about animal drug compounding. This
is certainly something that the FDA has--or drug compounding
period is something the FDA has been involved in here recently,
and rightfully so.
But when it comes to animal drug compounding, it's my
understanding that it's legal only in very specific
circumstances, according to the FDA, and as a result of the
Drug Quality Security Act, there were some changes that were
made and, from what I understand, the FDA rescinded their
initial guidelines and that they are now looking at and coming
up with new guidelines.
Are you familiar with that, and what kind of time line are
we looking at here?
Dr. Solomon. So we did have a guidance on compounding. As
you're very well aware, it's a challenging issue to find the
right balance.
There is some need for compounding out there. We don't want
that to either prove a safety issue to animals, and we don't
want that to undermine the approval of pioneer or generic
drugs.
So compounding within a veterinarian/client/patient
relationship is something important because veterinarians need
access to that. So our previous guidance, there was confusion
about applying the DQSA, the Drug Quality Security Act, which
does not apply to the animal side of the house.
Mr. Carter. Right.
Dr. Solomon. We wanted to clarify that it was never
intended to apply to that.
Mr. Carter. Thank you.
Dr. Solomon. It also--back to my multiple species issues,
the previous guidance only addressed compounding for companion
animals, and as I've sort of talked about several times now, we
have the challenge of compounding for food-producing animals,
companion animals, and minor species.
So we decided to rescind that compounding guidance. We are
working on it. We expect over the next several months to be
able to issue a new compounding guidance, where it would be,
once again, cover the whole spectrum of the species, be clear
about not applying the DQSA, trying to apply that right balance
of where compounding is appropriate, and we'd welcome the
opportunity once that's out to come brief Congress.
Mr. Carter. OK. Are you soliciting the input of the animal
drug compounders while you're formulating this?
Dr. Solomon. We are talking to lots of stakeholders and,
once again, this will be another proposal. So we welcome the
opportunity when this comes out for a proposal to continue to
engage with folks.
Mr. Carter. Well, thank you for mentioning accessibility,
because that's extremely important. I can tell you, as a
practicing pharmacist for over 30 years before I became a
Member of Congress, this was something we typically worked with
our veterinarians and, you know, it was very detailed.
So the accessibility part of it is very important, as well.
Good. Thank you very much, and I yield back, Mr. Chairman.
Mr. Burgess. Gentleman yields back. The Chair thanks the
gentleman.
I believe that concludes questions from Members for your
panel, Dr. Solomon. We do, again, want to thank you for being
with us and providing your expert testimony today, and
certainly as we work through this we will take what you have
shared with us today to heart.
And we are going to have the briefest of transitions to our
second panel. Dr. Solomon, you're excused, and we'll ask our
second panel to take their places.
Dr. Solomon. Thank you very much.
[Pause.]
Mr. Burgess. So I thank our second panel of witnesses, and
I want to thank you for being here today, taking time to
testify before the subcommittee.
We are going to give each of you an opportunity to give an
opening statement, and that will be followed by questions from
Members.
So today, on our second panel we are going to hear from Dr.
Rachel Cumberbatch, the Director of Regulatory Affairs, Animal
Drugs, at the Animal Health Institute; Mr. Bill Zollers,
chairman of Generic Animal Drug Alliance; and Dr. Michael
Topper, president of the American Veterinary Medical
Association.
We appreciate each of you being here with us today.
Dr. Cumberbatch, you're now recognized for 5 minutes to
summarize your opening statement.
STATEMENTS OF RACHEL CUMBERBATCH, D.V.M., DIRECTOR, REGULATORY
AFFAIRS, ANIMAL DRUGS, ANIMAL HEALTH INSTITUTE; BILL ZOLLERS,
PH.D., CHAIR, GENERIC ANIMAL DRUG ALLIANCE; AND MICHAEL J.
TOPPER, D.V.M., PH.D., PRESIDENT, AMERICAN VETERINARY MEDICAL
ASSOCIATION
STATEMENT OF RACHEL CUMBERBATCH
Dr. Cumberbatch. Thank you, Mr. Chairman.
I am a veterinarian here today on behalf of the Animal
Health Institute, a trade association that represents companies
that make medicines for animals.
I am here to ask Congress to reauthorize the animal drug
user fee program, also known as ADUFA, and to provide a pathway
for sponsors to meet unmet medical needs by enhancing
opportunities for innovation.
The animal health industry makes important contributions to
the American economy. Fueled by $9.9 billion in sales of
medicine, the U.S. animal health industry employs over 21,000
workers and generates more than $1.2 billion in wages.
It accounts for $1.2 billion in taxes and maintains a
positive trade balance. Furthermore, animal health products
directly contribute to the economy of other industries,
including veterinary services, animal production, meat and
dairy production, and pet services.
Combined, these four industries generated $548 billion in
output, created more than 1.4 million jobs, and paid over $52
billion in wages in 2016 alone.
These contributions extend to every State, in every
congressional district where people own pets and families rely
on the availability of safe food.
The Animal Health Institute strongly supports the ADUFA
program. This new agreement builds on the success of this
program. Funding will increase from $118 million in ADUFA III
to a total of $150 million in this 5-year agreement.
This includes a one-time influx of funds that will be
devoted to information technology so that CVM can transition to
electronic filing of new animal drug submissions and can
eliminate all paper submissions.
Current inflation and workload adjustment factors remain as
they are while AHI has agreed to allow FDA to reinvest surplus
funds into the program.
Existing sentinel timeframes will remain the same or be
slightly reduced, and all current review process changes from
the previous ADUFA agreement will remain in place.
There is one important piece of business from ADUFA III
which we are asking Congress to help us complete. ADUFA III
contained a provision that FDA and AHI would enter into
discussions on how to more broadly extend the conditional
approval process.
Conditional approval is currently available only for minor
uses and minor species products. These efforts aim to find a
way to expand a pathway to major species applications.
Those discussions took place and were productive, bringing
each side to near agreement on an approach. However, when we
got to the ADUFA IV, CVM was precluded from discussing this
issue as part of the agreement.
More than a year ago, this committee commendably came
together and approved the 21st Century Cures Act to spur
innovation in human therapies. By all indications, it is
working, and now we ask that you include in this legislation a
measure to similarly spur innovation in animal health.
Conditional approval for animal health products exist at
the EPA as well as the U.S. Department of Agriculture and, as
we said, it also exists for minor use, minor species at the
FDA.
Expanding the current authority to major species would
drive innovation and, most importantly it would lead to the
approval of new products for serious diseases which there are
no available treatments and which it is difficult for clinical
effectiveness to be proven via controlled studies.
Thank you for holding this hearing on this important piece
of legislation, and thank you for the opportunity to speak to
you today about how keeping animals and humans safe using
medicines also helps with public health.
Thank you.
[The prepared statement of Dr. Cumberbatch follows:]
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Mr. Burgess. Thank you for your testimony.
Dr. Zollers, you're recognized for 5 minutes for a summary
of your opening statement, please.
STATEMENT OF BILL ZOLLERS
Dr. Zollers. Thank you.
Good morning. My name is Bill Zollers, and I serve as the
chairman of the Generic Animal Drug Alliance, also known as
GADA.
We are an independent professional trade organization that
represents the interests of the generic animal drug industry.
We represent sponsors, manufacturers, distributors, suppliers,
and service providers of generic animal drugs.
Our products and processes are regulated by the FDA Center
for Veterinary Medicine. Our members are focused on the
development, regulatory approval, and marketing of high-quality
generic drugs to livestock and pets.
I would like to thank the committee for inviting me to
testify today on behalf of GADA in support of the
reauthorization of the Animal Generic Drug User Fee Act.
The GADA has previously provided testimony to this
subcommittee in support of AGDUFA I in 2008 and AGDUFA II in
2013.
Just like with human generic drugs, generic animal drugs
provide cost-effective alternatives to pioneer drugs. Lower-
cost generic animal drug options help contribute to the safety
of the Nation's food supply, the treatment of diseases in
animals, and the ability of owners to provide care to their pet
family members.
However, the potential cost savings from generic animal
drugs cannot be achieved without broad availability. It is
critical that the CVM regulatory review and approval process
for generic drugs is both efficient and predictable.
Prior to the implementation of AGDUFA I, a CVM review cycle
of a generic application could take as long as 2 years. In most
cases, multiple review cycles are needed. So if an application
required three review cycles, it could easily take more than 6
to 8 years to receive approval.
In the time it took to get an application approved, the
market for a generic drug could change, making it no longer
cost effective. This created a disincentive for companies to
pursue generic animal drug approvals and denied the public
cost-effective generic drugs.
The industry remembers this time in our history. No one
involved in the approval process for generic drugs wants to see
these conditions return. Therefore, the industry is stepping up
again to support reauthorization of AGDUFA.
Since AGDUFA began, CVM has reduced the review time of an
application to a more predictable 270 days. We believe the
shorter review times are helping contribute to the growth of
our industry.
As part of the current reauthorization of AGDUFA III, the
industry has agreed to significantly increase our financial
contributions so that generic submissions could receive even
shorter review periods that are equivalent to pioneer drug
submissions.
As currently written, AGDUFA III will further shorten some
critical submission review times from 270 days to 180 days.
The industry is comprised of many small companies and
product markets that are much smaller than those for human
generic drugs. Therefore, it remains vital that congressional
appropriations continue to be provided to the Center for
Veterinary Medicine to significantly support the review of
generic drug applications.
Appropriations must continue at an increased level that
enables CVM to meet its public health mission and the important
public policy goal of providing generic drug options for
farmers and pet owners.
We believe AGDUFA III provides the review time targets that
industry requires to counterbalance the financial investment
being made in support of CVM's needed resources to build
capacity and balance the realities of a small but growing
generics industry.
The proposed AGDUFA III enhancement concerning e-
submissions should make the approval process more efficient.
Also, the proposed revisions to the overcollections that offset
provisions will more immediately reduce the financial burden if
overpayments are made by the industry.
Overall, we are hopeful that the reduction and review times
will lead to a shortened time from project initiation to
approval, allowing generic products to come to market sooner.
In conclusion, the GADA supports the proposed legislation
for reauthorization of AGDUFA.
Thank you.
[The prepared statement of Dr. Zollers follows:]
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Mr. Burgess. Chair thanks the gentleman.
Dr. Topper, you're recognized for 5 minutes for a summary
of your opening statement, please.
STATEMENT OF MICHAEL J. TOPPER
Dr. Topper. Thank you, and good morning.
Like was stated, I am Dr. Mike Topper. I have the privilege
of being the president of the American Veterinary Medical
Association, and on behalf of the AVMA I appreciate the
opportunity to discuss the importance of reauthorizing the
Animal Drug User Fee Act and the Animal Generic Drug User Fee
Act.
The AVMA was founded in 1863, and we represent over 91,000
individual member veterinarians engaged in the many segments of
professional veterinary medicine, including private practice,
public health, biomedical research, and many others.
The FDA Center for Veterinary Medicine's collection and
effective utilization of user fees are important to
veterinarians.
By providing new animal drugs with a predictable pathway to
market, these fees help provide veterinarians with access to
new and additional tools that can potentially improve treatment
outcomes, provide alternatives to existing therapies, fill
unmet medical needs in veterinary medicine, and ultimately
improve patient care, which is the center of veterinary
practice.
The AVMA supports user fees for new animal drug
applications when the fees are supplemental to appropriations
and directed toward expediting the review process for new
animal drug products.
There simply are not enough approved drugs for use in
animals. Comparisons of FDA data show there are 23 times the
number of approved labeled indications for human use as there
are for animal use, and when comparing animal drug products
approved for minor use and minor species to its human model,
which is the orphan drug program, that number increases to 26
times.
Thankfully, through the Animal Medicinal Drug Use
Clarification Act of 1994 and its extra-label drug use
provision, veterinarians are provided with greater treatment
options.
Of course, there are necessary and appropriate restrictions
of extra-label drug use in food-producing animals.
In instances where extra-label drug use is allowed in food
and companion animals, it is a vital tool that allows
veterinarians to use animal and human medications labeled for
certain indications for other clinical instances in which that
therapy may be effective but for which it is not labeled.
Our veterinary medical education, clinical training, and
understanding of the pharmaceutical products we use enable us
to navigate these uncertain waters. But driving innovation and
increasing the number of improved medications will ultimately
lead to better patient care, especially in instances where
extra-label drug use is prohibited.
Some diseases and conditions lack treatment options due to
the extended course of the disease or the difficult nature of
study.
Examples in which human drugs are used in an extra-label
manner in animals include treatments for heart disease, pain
management, gastrointestinal disorders, diabetes, immune-
mediating diseases, and cancer.
While university studies, data collected in foreign
countries, anecdotal evidence, and other alternative
information all assist in selecting appropriate extra-label
therapies, the knowledge that a drug used for therapy has been
fully evaluated by the FDA and shown to be safe and effective
is invaluable.
We have also been encouraged by recent attention given to
the topic of expanding conditional approval beyond minor use
and minor species. Extending its applicability to major uses
and major species would increase the tools in a veterinarian's
pharmaceutical tool box.
A greater number of approved animal drugs helps to ensure
that veterinary patients receive the best care, and this is the
goal of clinical veterinarians across the country.
So thank you for the opportunity to speak on this important
topic today. We appreciate the attention the subcommittee is
giving to this issue and the commitment to addressing the unmet
needs in veterinary medicine.
Timely passage of this legislation is needed to continue
programs that increase the availability of pharmaceutical
resources in the treatment of animal diseases.
We look forward to working to increase the number of
approved animal drugs for the benefit of our patients, their
owners, and our communities.
Thank you again, and I am happy to answer any questions.
[The prepared statement of Dr. Topper follows:]
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Mr. Burgess. Thank you, Dr. Topper, and I want to thank
each of you for your testimony, and we'll move into the second
round of questions from Members. Let me begin by recognizing
myself for 5 minutes.
And let me just ask in a very general sense--and I will ask
it to each of you--how the adoption of the user fees, going
back to their initiation, how does it fundamentally change the
industry?
So I realize that's pretty broad, and you have already
addressed that to some degree. But give me the sound bite, and
Dr. Cumberbatch, we'll start with you and then we'll come down
the line.
Dr. Cumberbatch. Thank you very much for the question.
The user fee programs has helped with consistency. Sponsors
now know when they will hear back from FDA. Also, as Dr.
Solomon mentioned, it has allowed them to hire and to increase
the number of reviewers, which has been very important for
helping them meet the goals of the time lines.
Thank you.
Mr. Burgess. Yes, Dr. Zollers.
Dr. Zollers. Yes. As Dr. Solomon indicated, on the generic
side of things, we've seen a tremendous increase in workload on
the CVM side, and I think that in itself talks to the success
of the user fee program.
Ten years ago, when we had 2-year review cycles and we had
12 or 14 members of GADA at that time, and now today we have
270-day review cycles, an increased workload, and over 30
members of GADA. So that is all indicative of the growth of our
industry.
Mr. Burgess. Dr. Topper.
Dr. Topper. Yes, sir. I agree with my colleagues. It has
really helped in bringing new animal drugs to the market
faster, and we need to continue with this because that's what
our patients need.
Mr. Burgess. So, now, we've been through--I guess this is
the fourth iteration for the animal drug user fee and the third
for the generic animal drug user fee.
How has that evolved over time? Do you think that is
something where we've been able to build on the previous levels
and increase the availability and timeliness of products?
And, again, Dr. Cumberbatch, we'll start with you and then
come down the line.
Dr. Cumberbatch. Thank you.
In ADUFA I we began with decreasing the backlog, and now we
are moved on to looking at how we can improve efficiency. From
here, we will look at how communication can be improved and
work towards ADUFA goals not just during negotiations for this
agreement but all through the 5-year agreement and able to work
together to look at how do we best review products and
ultimately get additional tools for veterinarians onto the
market.
Mr. Burgess. Yes, Dr. Zollers.
Dr. Zollers. Yes, I would agree with a lot of what Rachel
just said.
Again, for AGDUFA I, getting through that shock and awe of
the 2-year review cycle and now getting it down to something
manageable, now we are focused on how do we reduce the
timeframe from the time we initiate the project until it's
actually approved.
And we are having very good conversations and good
communication with CVM throughout this process, and we'll
continue to so we can try to improve this process even more
before we get to AGDUFA IV 5 years from now.
Mr. Burgess. Yes, sir. Dr. Topper.
Dr. Topper. And, yes, sir, we have been building up all
along, and we look forward to this new one building even
better, moving things faster, and if we build different things
into this, as we heard earlier, it'll just make it better.
Mr. Burgess. To that end--and we'll start with you this
time, Dr. Topper, and move back the other way. The electronic
submission--do you see that as being--ultimately that's going
to be helpful, correct?
Dr. Topper. Yes, sir. It should speed it up. It should
decrease the cost to somebody who's providing, because it's
electronic and they don't have to back up that truckload or
send a computer or a hard drive in.
So it will be readily available to the reviewers, and they
will not have to transcribe it from paper to their own
electronic means.
Mr. Burgess. Dr. Zollers.
Dr. Zollers. Yes. We are totally in favor of the electronic
system.
Mr. Burgess. Dr. Cumberbatch.
Dr. Cumberbatch. As Dr. Solomon mentioned, a majority of
sponsors of pioneers drugs use the electronic submission system
already.
What we do see is a need to look at the efficiency--how
much data are we putting in. Electronic submissions are very
helpful for CVM in getting those to the reviewers.
What we are trying to find is a good way for sponsors to be
able to get this information in an efficient way.
Mr. Burgess. Well, I want to thank each of you for your
testimony today, and Dr. Topper, in your testimony you talked
about, you know, kind of the differences between humans and
animals, having spent a lifetime in practicing medicine, to
think that you have got those--both the major and minor classes
of animals to consider.
You give the anti-inflammatory that you gave to your dog to
your cat, and you're in big trouble. I am sensitive to the
problems that you face, and we want you to be able to do your
best work. So thank you each for testifying today.
Mr. Green, I will recognize you for 5 minutes for
questions, please.
Mr. Green. Thank you, Mr. Chairman. I hope you didn't have
any patients that would bite you.
[Laughter.]
Mr. Burgess. How much time do you have?
[Laughter.]
Mr. Green. He was an OB/GYN. Thank you, Mr. Chairman.
Dr. Topper, I am interested in your perspective as a
veterinarian on the use of antimicrobials in food-producing
animals and the growing public health concerns regarding
antimicrobial resistance.
I understand that the use of the medically important
antimicrobial drugs in treating food-producing animals is
necessary, but I also have concern over the overuse and what
steps both the FDA and the animal health providers should be
taking to reduce the risks of resistance.
Can you explain how these antimicrobial resistance happens
and what impact it can have on both the animal and human
health?
Dr. Topper. Yes, sir. I can talk to the first part, for
sure, about how the AVMA along with other of our colleagues are
very much concerned about antimicrobial resistance, and we are
taking as many steps for our members and providing them with
information about the judicious use of antimicrobials, as you
heard Dr. Solomon talk about, and we have just developed a
stewardship for our members to follow in looking at these.
So we have been taking an active role in working with the
Centers for Veterinary Medicine for the veterinary fee
directive so that all antimicrobials that are put in food have
to be under the direction of a veterinarian-client-patient
relationship and they have to have that fee directive.
Most of the other veterinarians, we know through their
judicious use of the antimicrobials, they are working to reduce
the number that are being used. So we support that.
To talk about how antimicrobial resistance happens would
probably be a lot longer than we would have here. And so we can
probably provide you with plenty of literature as to how that
antimicrobial resistance occurs. But I am not ready to talk
about it at this time, if that's OK.
Mr. Green. How has greater data collection improved
veterinarian awareness regarding the overuse of the
antimicrobial drugs, and what additional steps should the FDA
be taking to address the concerns?
Dr. Topper. Well, the FDA is monitoring. We we do the
residue, like Dr. Solomon talked about, during the formulation
and the approval process of the drug. They have to be able to
detect it in the meat products. And so, as they approve those
methods, that will help detect the antimicrobial uses, as they
go forward.
Mr. Green. OK. Do you know what the American Veterinarian
Medical Association is doing to educate its members on the
importance of addressing these antimicrobial resistances, and
how can veterinarians be good stewards of antimicrobials when
treating food-producing animals?
Dr. Topper. Yes, sir. Like I said, we do have and along
with our industry partners--that's the bovine practitioners,
the swine veterinarians, and the avian pathologists--have
developed therapeutic guidelines for the judicious use of
antibiotics, and we have just approved in our AVMA's house of
delegates our stewardship policy and the core principles of
antibiotic use.
So we are very much educating our members, and they do
understand that there is this great need in public health.
Mr. Green. Well, part of our other jurisdiction on this
committee is the need to do medical research and looking at the
next, you know, vaccinations, the next treatment, because we do
have a growing resistance of--both in humans and I was going to
see if that happens with animals--that you use these
antimicrobials and then over a period of time they develop a
resistance to them. Does that happen in animals as well as we
see in humans?
Dr. Topper. Yes, sir, it does happen in animals also.
Again, as we talked about, different species react to different
antibiotics in different ways. So it is a problem in animals
also.
Mr. Green. And the concern about growing antimicrobial
resistance is a real one and further compounded by the need for
the development of new antibiotics and will still be effective
in the face of the resistance, and I hope we continue to work
closely with the CVM and the CDR to ensure that safe and
effective antibiotics are available when needed.
Dr. Topper. Yes, sir.
Mr. Green. Mr. Chairman, I will yield back my time.
Mr. Burgess. Chair thanks the gentleman. Gentleman yields
back.
Chair recognizes the gentleman from Oklahoma, 5 minutes for
your questions, please.
Mr. Mullin. Thank you, Mr. Chairman, and I want to thank
the panel for the great work and the time and dedication you
have spent to bring us to this point.
Working with the agency and industry I know is no easy
task. But that's how we--as you can see, that's the best way,
the easiest way for us to move forward with any type of
legislation. So thank you both--everybody for being here.
Dr. Cumberbatch, I want to ask you a question. Can you
explain the difference between the animal market and the human
drug market and elaborate on some of the differences and the
challenges that we face?
Dr. Cumberbatch. Absolutely. Thank you.
You know, as Dr. Solomon said, size is one of the
differences in the animal market and the human market. Also, as
a veterinarian, when I talk about a treatment protocol, price
has to be one of the topics that we talk about and what the
availability is of the medication and what my expectation is as
a veterinarian that this is going to work for your particular
situation.
And it is important to have very good data so that I can
share that with an animal owner, and that is why it's important
to have new, innovative, well-studied drugs on the market for
veterinarians to use.
Mr. Mullin. So what do you think are some of the unmet
needs that are in the animal market that we need to try to
address?
Dr. Cumberbatch. We've had the opportunity to hear about a
number, but osteoarthritis is one that I know we see every day.
I hear stories where the cat's hiding under the bed or ``My dog
doesn't want to play ball anymore--he seems more tired,'' or
``My horse won't jump.''
You know, these seem like changes in behavior, but that's
sometimes pain, and it's--osteoarthritis can happen over a
period of time, and it's difficult to study because it does
take that time.
In cattle, we have chronic diseases as well like Johne's
disease that eventually is fatal, and most importantly, it
decreases production and can spread throughout a herd, and
that's devastating to our small farmers.
Mr. Mullin. Well, as a cattle owner, which--you know, I
don't think we could quite make a living off our cattle because
I still think the fastest way to become a millionaire running
cattle is start with two million--you will get to a million.
[Laughter.]
But I am glad I have other things that can help offset the
ranch. But it's still a way of life. It's the way I was raised.
It's the way we raise our kids.
You know, the biggest traffic jam coming out of our house
is usually the cattle that want to, for some reason, hang
around the driveway and use the bathroom on it. But that's a
whole another thing.
But there are issues that we run about--my colleague from
Texas was talking about the antibiotics and the overuse of it.
But there has to be a common area that's reached here,
because I can tell you personally in our experience--and I am
surrounded by other cattle owners--when we took away the
ability to actually buy medicated feed, it actually cost the
consumers more and, in my opinion, can be even more
devastating, moving forward, because unlike children, you're
not out there watching your cattle necessarily every day on a
one-on-one basis.
When you buy cattle out of a stockyard or a sale barn, you
buy a trailer full of them. Before you mix them into your herd,
you want to be able to make sure that they've not carrying
something that is going to infect the herd.
We've seen an increase, especially in my area this year,
because we have such high swings with temperatures from low to
high, with pneumonia coming in.
And used to, when we would bring our cattle back from the
barns, which it is very common for them to develop a cough, as
you guys are aware of, or a runny nose, we could catch a lot of
that before we'd turn them out into the pastures, because we
would feed them some medicated feed.
Now we are running into a situation where we have a choice.
Instead of sending them just medicated feed, which we are not
going to overuse because it's too expensive to use all the
time, we have to vaccinate them to be preemptive on this by
having to give them a shot that they may not need or we take
the chance of infecting the entire herd.
So which one is--as us, which one do we decide to do? It's
very expensive to sit there and time consuming to give
everybody a shot when you're buying them in pot bellies--which
pot bellies, by the way, for us are those big trailers--and
you're dumping them to the lot.
So when we are having this conversation about
overmedicating, I understand the concerns--me too. But there
has to be some common area to work with. And so, while we've
been working with the panel, make sure you're not leaving out
the stakeholders like myself or other cattle producers or the
stockyards, because I know you have been hearing from the
stockyards on this, too.
So I want to work, moving forward, with this. But I don't
know that what we've done right now is the right approach.
So with that, Mr. Chairman, I will yield back.
Mr. Burgess. Gentleman yields back. Chair thanks the
gentleman.
Chair recognizes the gentleman from Oregon, Dr. Schrader, 5
minutes for your questions, please.
Mr. Schrader. Thank you very much, Mr. Chairman.
I will kind of jump on Markwayne's discussion a little bit,
because I think there's a lot of misinformation out there over
the use of antimicrobials and their contribution to human
resistance to drugs.
There certainly could be a factor. I spent a lot of time
reading a lot of the studies that have been generated since the
'70s, and there's lots of inference but no study that I've seen
there's any direct causation.
That doesn't mean we shouldn't be judicious or smart about
how we use antimicrobials in veterinary medicine or on the
ranch.
I think every one of us wants to do the right thing, and I
would applaud the CVM's recent suggestions that, you know, in
certain situations when there is the right climatic conditions
or whatever that, under proper veterinary supervision, that
certain therapeutic uses of antimicrobials could be used on a
mass basis to prevent more disease and, frankly, suffering to
these animals that Markwayne and others raise on our farms and
ranches.
So I just want us to be cognizant of that, and I will tell
you this: In my veterinary practice there were times when, if I
did not use an antimicrobial at the appropriate time, that the
disease spread would have been much bigger, and there was also
a chance for a virulence to increase and these animals--or
these bugs, if you will--to mutate and go stronger yet.
And to my good colleague from Texas, the real world of
resistance is called biology. You know, if you ever watched
``Jurassic Park''--might have been a fun movie, but one thing
that is absolutely true there is the real-world plants and
animals mutate over time. That could be for good things, and it
could also be for bad things.
So whether or not we get engaged at all in trying to
prevent that, things are still going to change. We should do
our best to, you know, fight resistance in the ways we can.
But it's going to happen anyway, and that's why drug
innovation--the whole hearing we are having here today for our
animal friends--speed these things to marketplace, because we
are going to need ever newer and smarter ways to treat these
animals, whether it's on an anti-inflammatory, antimicrobial
side.
So ending my soliloquy here, Dr. Topper, do you see
expanding conditional approval as negatively affecting FDA
safety and efficacy standards in any way?
Dr. Topper. No, sir, because, like Dr. Solomon said, they
will be doing this all along, and it will just get some of
these drugs that are right now maybe out on extra-label drug
use. But we still have that great unmet medical need, and this
will help very much if this is added to the bill.
Mr. Schrader. I would agree.
Talking about extra-label use, a little different than
conditional use. How do the two processes work in synergy, or
how are they different?
Dr. Topper. I will do my best, to my knowledge of them. The
extra-label drug use, again, are approved drugs that are
already on the market. They have met FDA efficacy. They may be
for humans or they may be for another animal species. So,
hopefully, they were safe in that species.
This conditional would be specific for the species intended
for use. So it would then have the same safety studies done for
that species, and the efficacy would be increased upon as time
goes along.
So the difference would be that it will be--in my knowledge
that it would be for the species intended for use and not just
using something approved for a different----
Mr. Schrader. And to your earlier comments, it's just
another tool in the toolbox for enabling veterinarians who,
again, the market--real-world marketplace--cost matters. Dr.
Zollers, say, can't yet take advantage of all these great new
drugs necessarily that are coming out.
I think it was the chairman and others indicated or you had
indicated earlier, you know, 23 human products for every
veterinary product that's developed out there.
So this is just a great way, a safe way, an efficacious way
for veterinarians to have access, hopefully, to some of the
same opportunities that we do in the human field, and I would
argue that our food safety is critical to human safety--the
whole public health aspect that Dr. Cumberbatch talked about.
Dr. Cumberbatch, if I could come to you. You know, again,
we talked earlier about very few conditional approvals have
even been requested, much less granted at this time.
From your standpoint--maybe Dr. Zollers, if you have an
opinion on this--you know, what are the barriers? Is it just
familiarity with this new process, or are there some barriers,
given some of these companies are pretty small?
Dr. Cumberbatch. Thank you, Dr. Schrader.
You know, right now conditional approval is for minor use,
minor species, and by definition that is a very small market.
And so, by expanding this, it would allow companies to
bring forward products to a bigger market for that unmet need
and in no way would this be taking away or preventing companies
from coming forward and still utilizing MUMS as it currently
is.
Mr. Schrader. All right. Dr. Zollers, if I may, real quick.
Dr. Zollers. Yes. I would just say right now small
companies--it comes down to how much money can they make in
revenue, can they make with this process, and a lot of them, a
lot of times these just don't pan out.
Mr. Schrader. Got you.
Thank you, and I yield back, Mr. Chairman.
Mr. Burgess. Chair thanks the gentleman. Gentleman yields
back.
Chair recognizes the gentleman from Georgia, 5 minutes for
your questions, please.
Mr. Carter. Thank you, Mr. Chairman, and thank all of you
all for being here.
Dr. Cumberbatch, I will start with you. Earlier, when Dr.
Solomon was here, they asked him about the process by which the
new animal drug application process and how thorough it was and
how much information that the drug manufacturers had to submit
along with a new animal drug application.
And I just wanted to ask you, from your perspective, do you
think that's an impediment for new animal drug breakthroughs in
any way, that it's so detailed and so, for lack of a better
word, so laborious?
Dr. Cumberbatch. Bringing a new product to market takes
time. It takes investment. In fact, we have a survey that shows
that it can take up to 10 years and $100 million to bring a
product to market.
Now, as we were talking about with Congressman Mullin, as
well, at the end of the day it comes down to what can an animal
owner pay for this. These products need to be at a reasonable
price point, as well.
And so, yes, having a long review, an expensive review,
ultimately can hinder our ability to get new products onto the
market.
Mr. Carter. So you do believe that perhaps just a different
level of data might be sufficient and still provide the
protection that we need and--because there is a balancing act,
we all know there, and, quite honestly, from my perspective,
FDA, a lot of times, has--not just FDA but all of Federal
agencies have the tendency to overreact sometimes and
overrequire.
So is it your feeling that it could be done safely with
less information?
Dr. Cumberbatch. We are committed to working with FDA to
look at those efficiencies while making sure that we maintain
safety and quality in the products.
Mr. Carter. Mr. Chairman, we don't have any kind of
abbreviated like we do with the drug approvals--we don't have
any kind of abbreviated application in this area, do we?
Mr. Burgess. In the generic space, you certainly do.
Mr. Carter. In the generic space for animal control?
Mr. Burgess. Yes.
Mr. Carter. We do? OK. But not for the new drugs, and
obviously that wouldn't work as well.
Let me ask you, Dr. Cumberbatch--I will start with you.
From what I understand, the electronic submission that the
applications are going to have to be submitted electronically
starting on October of 2018--do you think you're all going to
be prepared for that? Are you ready for that? Is that
sufficient time?
Dr. Cumberbatch. The pioneer companies have been utilizing
the e-submitter, and so I am confident, yes, AHI members will
be ready for that transition.
Mr. Carter. Any recommendations in that process that, you
know, thus far you having input into that process?
Dr. Cumberbatch. The communication is key. Developing the
templates that they use for the e-submission. The time that it
would take for a sponsor to put the data in that they collect
is important. It adds to that time and that administrative
burden.
And so increased communication, working together on what
those templates look like. They have also hoped to provide
webinars and training. These are all very important.
Mr. Carter. Great.
Dr. Topper, just very quickly I wanted to ask you--you
know, one of the concerns and certainly one of the experiences
I had as a practicing pharmacist was the price of some of these
medications, particularly for the companion animals and, you
know, unlike human patients where you have insurance and have a
co-pay, you know, there is no insurance or co-pay for these
animals and for these types of drugs particularly.
Is there anything that you can really recommend that
manufacturers might be able to do to lower the cost of some of
these medications besides take a cut in profit?
Dr. Topper. Well, you raise a very difficult issue, and
it's a complex issue. To ensure that the drugs are safe and
efficacious, then they have to go through this process.
So anything we can do to speed up the process and make it
more efficient, hopefully, will result in drug-lowering costs
and, especially as the drugs move to generic types, then that
should lower the cost also. But it's complicated, as we know,
even in human medicine.
Mr. Carter. Great. Well, I thank all of you for being here.
It's been a very interesting hearing today.
Thank you, Mr. Chairman. I yield back.
Mr. Burgess. Gentleman yields back. The Chair thanks the
gentleman.
Seeing no additional Members wishing to ask questions, Mr.
Green, did you have anything on redirect?
Mr. Green. No, Mr. Chairman. I think the job's been done,
but I do have some concerns because our next half will be
trying to find, you know, some of the solutions for the drug
resistance we have. But appreciate the efforts.
Mr. Burgess. Very well.
Again, seeing no further Members wishing to ask questions,
I want to thank our witnesses for being here today. I would
like to submit statements from the following for the record:
the Agriculture Value Chain Coalition.
Pursuant to committee rules, I remind Members they have 10
business days to submit additional questions for the record. I
ask that witnesses submit their response within 10 business
days upon receipt of those questions.
And without objection, the subcommittee is adjourned.
[Whereupon, at 12:20 p.m., the committee was adjourned.]
[Material submitted for inclusion in the record follows:]
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