[Congressional Record Volume 149, Number 137 (Wednesday, October 1, 2003)]
[House]
[Pages H9054-H9059]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ANIMAL DRUG USER FEE ACT OF 2003
Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill
(H.R. 1260) to amend the Federal Food, Drug, and Cosmetic Act to
establish a program of fees relating to animal drugs.
The Clerk read as follows:
H.R. 1260
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Animal Drug User Fee Act of
2003''.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) Prompt approval of safe and effective new animal drugs
is critical to the improvement of animal health and the
public health.
(2) Animal health and the public health will be served by
making additional funds available for the purpose of
augmenting the resources of the Food and Drug Administration
that are devoted to the process for review of new animal drug
applications.
(3) The fees authorized by this title will be dedicated
toward expediting the animal drug development process and the
review of new and supplemental animal drug applications and
investigational animal drug submissions as set forth in the
goals identified, for purposes of part 4 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, in
the letters from the Secretary of Health and Human Services
to the Chairman of the Committee on Energy and Commerce of
the House of Representatives and the Chairman of the
Committee on Health, Education, Labor, and Pensions of the
Senate as set forth in the Congressional Record.
SEC. 3. FEES RELATING TO ANIMAL DRUGS.
Subchapter C of chapter VII of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at
the end the following part:
``PART 4--FEES RELATING TO ANIMAL DRUGS
``SEC. 739. DEFINITIONS.
``For purposes of this subchapter:
``(1) The term `animal drug application' means an
application for approval of any new animal drug submitted
under section 512(b)(1). Such term does not include either a
new animal drug application submitted under section 512(b)(2)
or a supplemental animal drug application.
``(2) The term `supplemental animal drug application'
means--
``(A) a request to the Secretary to approve a change in an
animal drug application which has been approved; or
``(B) a request to the Secretary to approve a change to an
application approved under section 512(c)(2) for which data
with respect to safety or effectiveness are required.
``(3) The term `animal drug product' means each specific
strength or potency of a particular active ingredient or
ingredients in final dosage form marketed by a particular
manufacturer or distributor, which is uniquely identified by
the labeler code and product code portions of the national
drug code, and for which an animal drug application or a
supplemental animal drug application has been approved.
[[Page H9055]]
``(4) The term `animal drug establishment' means a foreign
or domestic place of business which is at one general
physical location consisting of one or more buildings all of
which are within 5 miles of each other, at which one or more
animal drug products are manufactured in final dosage form.
``(5) The term `investigational animal drug submission'
means--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a new animal drug intended
to be the subject of an animal drug application or a
supplemental animal drug application, or
``(B) the submission of information for the purpose of
enabling the Secretary to evaluate the safety or
effectiveness of an animal drug application or supplemental
animal drug application in the event of their filing.
``(6) The term `animal drug sponsor' means either an
applicant named in an animal drug application, except for an
approved application for which all subject products have been
removed from listing under section 510, or a person who has
submitted an investigational animal drug submission that has
not been terminated or otherwise rendered inactive by the
Secretary.
``(7) The term `final dosage form' means, with respect to
an animal drug product, a finished dosage form which is
approved for administration to an animal without substantial
further manufacturing. Such term includes animal drug
products intended for mixing in animal feeds.
``(8) The term `process for the review of animal drug
applications' means the following activities of the Secretary
with respect to the review of animal drug applications,
supplemental animal drug applications, and investigational
animal drug submissions:
``(A) The activities necessary for the review of animal
drug applications, supplemental animal drug applications, and
investigational animal drug submissions.
``(B) The issuance of action letters which approve animal
drug applications or supplemental animal drug applications or
which set forth in detail the specific deficiencies in
animal drug applications, supplemental animal drug
applications, or investigational animal drug submissions
and, where appropriate, the actions necessary to place
such applications, supplements or submissions in condition
for approval.
``(C) The inspection of animal drug establishments and
other facilities undertaken as part of the Secretary's review
of pending animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.
``(D) Monitoring of research conducted in connection with
the review of animal drug applications, supplemental animal
drug applications, and investigational animal drug
submissions.
``(E) The development of regulations and policy related to
the review of animal drug applications, supplemental animal
drug applications, and investigational animal drug
submissions.
``(F) Development of standards for products subject to
review.
``(G) Meetings between the agency and the animal drug
sponsor.
``(H) Review of advertising and labeling prior to approval
of an animal drug application or supplemental animal drug
application, but not such activities after an animal drug has
been approved.
``(9) The term `costs of resources allocated for the
process for the review of animal drug applications' means the
expenses incurred in connection with the process for the
review of animal drug applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with respect to
the review of specific animal drug applications, supplemental
animal drug applications, or investigational animal drug
submissions, and costs related to such officers, employees,
committees, and contractors, including costs for travel,
education, and recruitment and other personnel activities,
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources,
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies, and
``(D) collecting fees under section 740 and accounting for
resources allocated for the review of animal drug
applications, supplemental animal drug applications, and
investigational animal drug submissions.
``(10) The term `adjustment factor' applicable to a fiscal
year refers to the formula set forth in section 735(8) with
the base or comparator year being 2003.
``(11) The term `affiliate' refers to the definition set
forth in section 735(9).
``SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
``(a) Types of Fees.--Beginning in fiscal year 2004, the
Secretary shall assess and collect fees in accordance with
this section as follows:
``(1) Animal drug application and supplement fee.--
``(A) In general.--Each person that submits, on or after
September 1, 2003, an animal drug application or a
supplemental animal drug application shall be subject to a
fee as follows:
``(i) A fee established in subsection (b) for an animal
drug application; and
``(ii) A fee established in subsection (b) for a
supplemental animal drug application for which safety or
effectiveness data are required, in an amount that is equal
to 50 percent of the amount of the fee under clause (i).
``(B) Payment.--The fee required by subparagraph (A) shall
be due upon submission of the animal drug application or
supplemental animal drug application.
``(C) Exception for previously filed application or
supplement.--If an animal drug application or a supplemental
animal drug application was submitted by a person that paid
the fee for such application or supplement, was accepted for
filing, and was not approved or was withdrawn (without a
waiver or refund), the submission of an animal drug
application or a supplemental animal drug application for the
same product by the same person (or the person's licensee,
assignee, or successor) shall not be subject to a fee under
subparagraph (A).
``(D) Refund of fee if application refused for filing.--The
Secretary shall refund 75 percent of the fee paid under
subparagraph (B) for any animal drug application or
supplemental animal drug application which is refused for
filing.
``(E) Refund of fee if application withdrawn.--If an animal
drug application or a supplemental animal drug application is
withdrawn after the application or supplement was filed, the
Secretary may refund the fee or portion of the fee paid under
subparagraph B if no substantial work was performed on the
application or supplement after the application or supplement
was filed. The Secretary shall have the sole discretion to
refund the fee under this paragraph. A determination by the
Secretary concerning a refund under this paragraph shall not
be reviewable.
``(2) Animal drug product fee.--Each person--
``(A) who is named as the applicant in an animal drug
application or supplemental animal drug application for an
animal drug product which has been submitted for listing
under section 510, and
``(B) who, after September 1, 2003, had pending before the
Secretary an animal drug application or supplemental animal
drug application;
shall pay for each such animal drug product the annual fee
established in subsection (b). Such fee shall be payable for
the fiscal year in which the animal drug product is first
submitted for listing under section 510, or is submitted for
relisting under section 510 if the animal drug product has
been withdrawn from listing and relisted. After such fee is
paid for that fiscal year, such fee shall be payable on or
before January 31 of each year. Such fee shall be paid only
once for each animal drug product for a fiscal year in which
the fee is payable.
``(3) Animal drug establishment fee.--Each person--
``(A) who owns or operates, directly or through an
affiliate, an animal drug establishment, and
``(B) who is named as the applicant in an animal drug
application or supplemental animal drug application for an
animal drug product which has been submitted for listing
under section 510, and
``(C) who, after September 1, 2003, had pending before the
Secretary an animal drug application or supplemental animal
drug application,
shall be assessed an annual fee established in subsection (b)
for each animal drug establishment listed in its approved
animal drug application as an establishment that manufactures
the animal drug product named in the application. The annual
establishment fee shall be assessed in each fiscal year in
which the animal drug product named in the application is
assessed a fee under paragraph (2) unless the animal drug
establishment listed in the application does not engage in
the manufacture of the animal drug product during the fiscal
year. The fee shall be paid on or before January 31 of each
year. The establishment shall be assessed only one fee per
fiscal year under this section, provided, however, that where
a single establishment manufactures both animal drug products
and prescription drug products, as defined in section 735(3),
such establishment shall be assessed both the animal drug
establishment fee and the prescription drug establishment
fee, as set forth in section 736(a)(2), within a single
fiscal year.
``(4) Animal drug sponsor fee.--Each person--
``(A) who meets the definition of an animal drug sponsor
within a fiscal year; and
``(B) who, after September 1, 2003, had pending before the
Secretary an animal drug application, a supplemental animal
drug application, or an investigational animal drug
submission,
shall be assessed an annual fee established under subsection
(b). The fee shall be paid on or before January 31 of each
year. Each animal drug sponsor shall pay only one such fee
each fiscal year.
``(b) Fee Amounts.--Except as provided in subsection (a)(1)
and subsections (c), (d), (f), and (g), the fees required
under subsection (a) shall be established to generate fee
revenue amounts as follows:
``(1) Total fee revenues for application and supplement
fees.--The total fee revenues to be collected in animal drug
application fees under subsection (a)(1)(A)(i) and
supplemental animal drug application fees under subsection
(a)(1)(A)(ii) shall be
[[Page H9056]]
$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year
2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.
``(2) Total fee revenues for product fees.--The total fee
revenues to be collected in product fees under subsection
(a)(2) shall be $1,250,000 in fiscal year 2004, $2,000,000 in
fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007,
and 2008.
``(3) Total fee revenues for establishment fees.--The total
fee revenues to be collected in establishment fees under
subsection (a)(3) shall be $1,250,000 in fiscal year 2004,
$2,000,000 in fiscal year 2005, and $2,500,000 in fiscal
years 2006, 2007, and 2008.
``(4) Total fee revenues for sponsor fees.--The total fee
revenues to be collected in sponsor fees under subsection
(a)(4) shall be $1,250,000 in fiscal year 2004, $2,000,000 in
fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007,
and 2008.
``(c) Adjustments.--
``(1) Inflation adjustment.--The revenues established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year to
reflect the greater of--
``(A) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items;
United States city average) for the 12-month period ending
June 30 preceding the fiscal year for which fees are being
established; or
``(B) the total percentage change for the previous fiscal
year in basic pay under the General Schedule in accordance
with section 5332 of title 5, United States Code, as adjusted
by any locality-based comparability payment pursuant to
section 5304 of such title for Federal employees stationed in
the District of Columbia.
The adjustment made each fiscal year by this subsection will
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2004 under this
subsection.
``(2) Workload adjustment.--After the fee revenues are
adjusted for inflation in accordance with subparagraph (1),
the fee revenues shall be further adjusted each fiscal year
after fiscal year 2004 to reflect changes in review workload.
With respect to such adjustment:
``(A) This adjustment shall be determined by the Secretary
based on a weighted average of the change in the total number
of animal drug applications, supplemental animal drug
applications for which data with respect to safety or
effectiveness are required, manufacturing supplemental
animal drug applications, investigational animal drug
study submissions, and investigational animal drug
protocol submissions submitted to the Secretary. The
Secretary shall publish in the Federal Register the fees
resulting from this adjustment and the supporting
methodologies.
``(B) Under no circumstances shall this workload adjustment
result in fee revenues for a fiscal year that are less than
the fee revenues for that fiscal year established in
subsection (b), as adjusted for inflation under subparagraph
(c)(1).
``(3) Final year adjustment.--For fiscal year 2008, the
Secretary may further increase the fees to provide for up to
3 months of operating reserves of carryover user fees for the
process for the review of animal drug applications for the
first 3 months of fiscal year 2009. If the Food and Drug
Administration has carryover balances for the process for the
review of animal drug applications in excess of 3 months of
such operating reserves, then this adjustment will not be
made. If this adjustment is necessary, then the rationale for
the amount of the increase shall be contained in the annual
notice setting fees for fiscal year 2008.
``(4) Annual fee setting.--The Secretary shall establish,
60 days before the start of each fiscal year beginning after
September 30, 2003, for that fiscal year, animal drug
application fees, supplemental animal drug application fees,
animal drug sponsor fees, animal drug establishment fees, and
animal drug product fees based on the revenue amounts
established under subsection (b) and the adjustments provided
under this subsection.
``(5) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of animal drug applications.
``(d) Fee Waiver or Reduction.--
``(1) In general.--The Secretary shall grant a waiver from
or a reduction of 1 or more fees assessed under subsection
(a) where the Secretary finds that--
``(A) the assessment of the fee would present a significant
barrier to innovation because of limited resources available
to such person or other circumstances,
``(B) the fees to be paid by such person will exceed the
anticipated present and future costs incurred by the
Secretary in conducting the process for the review of animal
drug applications for such person,
``(C) the animal drug application or supplemental animal
drug application is intended solely to provide for use of the
animal drug in--
``(i) a Type B medicated feed (as defined in section
558.3(b)(3) of title 21, Code of Federal Regulations (or any
successor regulation)) intended for use in the manufacture of
Type C free-choice medicated feeds, or
``(ii) a Type C free-choice medicated feed (as defined in
section 558.3(b)(4) of title 21, Code of Federal Regulations
(or any successor regulation)),
``(D) the animal drug application or supplemental animal
drug application is intended solely to provide for a minor
use or minor species indication, or
``(E) the sponsor involved is a small business submitting
its first animal drug application to the Secretary for
review.
``(2) Use of standard costs.--In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
``(3) Rules for small businesses.--
``(A) Definition.--In paragraph (1)(E), the term `small
business' means an entity that has fewer than 500 employees,
including employees of affiliates.
``(B) Waiver of application fee.--The Secretary shall waive
under paragraph (1)(E) the application fee for the first
animal drug application that a small business or its
affiliate submits to the Secretary for review. After a small
business or its affiliate is granted such a waiver, the small
business or its affiliate shall pay application fees for all
subsequent animal drug applications and supplemental animal
drug applications for which safety or effectiveness data are
required in the same manner as an entity that does not
qualify as a small business.
``(C) Certification.--The Secretary shall require any
person who applies for a waiver under paragraph (1)(E) to
certify their qualification for the waiver. The Secretary
shall periodically publish in the Federal Register a list of
persons making such certifications.
``(e) Effect of Failure To Pay Fees.--An animal drug
application or supplemental animal drug application submitted
by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for filing by
the Secretary until all fees owed by such person have been
paid. An investigational animal drug submission under
section 739(5)(B) that is submitted by a person subject to
fees under subsection (a) shall be considered incomplete
and shall not be accepted for review by the Secretary
until all fees owed by such person have been paid. The
Secretary may discontinue review of any animal drug
application, supplemental animal drug application or
investigational animal drug submission from a person if
such person has not submitted for payment all fees owed
under this section by 30 days after the date upon which
they are due.
``(f) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after fiscal year
2003 unless appropriations for salaries and expenses of the
Food and Drug Administration for such fiscal year (excluding
the amount of fees appropriated for such fiscal year) are
equal to or greater than the amount of appropriations for the
salaries and expenses of the Food and Drug Administration for
the fiscal year 2003 (excluding the amount of fees
appropriated for such fiscal year) multiplied by the
adjustment factor applicable to the fiscal year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year
because of paragraph (1) and if at a later date in such
fiscal year the Secretary may assess such fees, the Secretary
may assess and collect such fees, without any modification in
the rate, for animal drug applications, supplemental animal
drug applications, investigational animal drug submissions,
sponsors, animal drug establishments and animal drug products
at any time in such fiscal year notwithstanding the
provisions of subsection (a) relating to the date fees are to
be paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to be
appropriated to remain available until expended. Such sums as
may be necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account
for salary and expenses with such fiscal year limitation. The
sums transferred shall be available solely for the process
for the review of animal drug applications.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this section--
``(i) shall be retained in each fiscal year in an amount
not to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation for such fiscal year,
and
``(ii) shall only be collected and available to defray
increases in the costs of the resources allocated for the
process for the review of animal drug applications (including
increases in such costs for an additional number of full-time
equivalent positions in the Department of Health and Human
Services to be engaged in such process) over such costs,
excluding costs paid from fees collected under this section,
for fiscal year 2003 multiplied by the adjustment factor.
``(B) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (A)(ii) in any
fiscal year if the costs funded by appropriations and
allocated for the process for the review of animal drug
applications--
``(i) are not more than 3 percent below the level specified
in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the level specified
in subparagraph (A)(ii), and fees assessed for the fiscal
year following the subsequent fiscal year are decreased by
the
[[Page H9057]]
amount in excess of 3 percent by which such costs fell below
the level specified in subparagraph (A)(ii); and
``(II) such costs are not more than 5 percent below the
level specified in subparagraph (A)(ii).
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section--
``(A) $5,000,000 for fiscal year 2004;
``(B) $8,000,000 for fiscal year 2005;
``(C) $10,000,000 for fiscal year 2006;
``(D) $10,000,000 for fiscal year 2007; and
``(E) $10,000,000 for fiscal year 2008;
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by animal drug application fees, supplemental
animal drug application fees, animal drug sponsor fees,
animal drug establishment fees, and animal drug product fees.
``(4) Offset.--Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees
specified in appropriations Acts for such fiscal year shall
be credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for a subsequent fiscal year.
``(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States
Code.
``(i) Written Requests for Waivers, Reductions, and
Refunds.--To qualify for consideration for a waiver or
reduction under subsection (d), or for a refund of any fee
collected in accordance with subsection (a), a person shall
submit to the Secretary a written request for such waiver,
reduction, or refund not later than 180 days after such
fee is due.
``(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of animal drug applications, be reduced to
offset the number of officers, employees, and advisory
committees so engaged.
``(k) Abbreviated New Animal Drug Applications.--The
Secretary shall--
``(1) to the extent practicable, segregate the review of
abbreviated new animal drug applications from the process for
the review of animal drug applications, and
``(2) adopt other administrative procedures to ensure that
review times of abbreviated new animal drug applications do
not increase from their current level due to activities under
the user fee program.''.
SEC. 4. ACCOUNTABILITY AND REPORTS.
(a) Public Accountability.--
(1) Consultation.--In developing recommendations to
Congress for the goals and plans for meeting the goals for
the process for the review of animal drug applications for
the fiscal years after fiscal year 2008, and for the
reauthorization of sections 739 and 740 of the Federal Food,
Drug, and Cosmetic Act (as added by section 3), the Secretary
of Health and Human Services (referred to in this section as
the ``Secretary'') shall consult with the Committee on Energy
and Commerce of the House of Representatives, the Committee
on Health, Education, Labor, and Pensions of the Senate,
appropriate scientific and academic experts, veterinary
professionals, representatives of consumer advocacy groups,
and the regulated industry.
(2) Recommendations.--The Secretary shall--
(A) publish in the Federal Register recommendations under
paragraph (1), after negotiations with the regulated
industry;
(B) present the recommendations to the Committees referred
to in that paragraph;
(C) hold a meeting at which the public may comment on the
recommendations; and
(D) provide for a period of 30 days for the public to
provide written comments on the recommendations.
(b) Performance Reports.--Beginning with fiscal year 2004,
not later than 60 days after the end of each fiscal year
during which fees are collected under part 4 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act,
the Secretary shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report concerning the progress of the Food and Drug
Administration in achieving the goals identified in the
letters described in section 2(3) of this Act toward
expediting the animal drug development process and the review
of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal
year, the future plans of the Food and Drug Administration
for meeting the goals, the review times for abbreviated new
animal drug applications, and the administrative procedures
adopted by the Food and Drug Administration to ensure that
review times for abbreviated new animal drug applications are
not increased from their current level due to activities
under the user fee program.
(c) Fiscal Report.--Beginning with fiscal year 2004, not
later than 120 days after the end of each fiscal year during
which fees are collected under the part described in
subsection (a), the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
SEC. 5. SUNSET.
The amendments made by section 3 shall not be in effect
after October 1, 2008, and section 4 shall not be in effect
after 120 days after such date.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Michigan (Mr. Upton) and the gentleman from Ohio (Mr. Brown) each will
control 20 minutes.
The Chair recognizes the gentleman from Michigan (Mr. Upton).
Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, as the lead sponsor of the Animal Drug User Fee Act of
2003, I am very pleased that we are taking up this bill on the House
floor today. Closely modeled after the very successful Prescription
Drug User Fee Act of 1992 for human drugs, the Animal Drug User Fee Act
is designed to give the FDA's Center for Veterinary Medicine the
resources and incentives needed to significantly improve the animal
drug review process.
This bill was unanimously approved by the Committee on Energy and
Commerce and is supported by a broad coalition of veterinary and
producer groups, including the American Veterinary Medical Association
and the American Farm Bureau, to name just two of the coalition
members.
We would not be here on the floor today were it not for the strong
bipartisan support that this legislation received in our committee. I
would like to especially acknowledge my original cosponsor and author
of the bill, the gentlewoman from Colorado (Ms. DeGette), committee
chairman and ranking member, the gentleman from Louisiana (Mr. Tauzin)
and the gentleman from Michigan (Mr. Dingell), our Subcommittee on
Health Chair, the gentleman from Florida (Mr. Bilirakis), and the
ranking member, the gentleman from Ohio (Mr. Brown), who is here today,
as well as the Members on both sides of the aisle who have cosponsored
this legislation.
I am grateful, too, for the hard work of our committee staff, Brent
Delmonte, Patrick Ronan, and John Ford and for the assistance we have
received from the FDA and the Animal Health Alliance, particularly my
staff, Jane Williams.
This legislation is sorely needed. Despite a statutory review time of
180 days, the average new animal drug application review currently
takes about a year and a half and it may drag on for even longer. The
slowdown in review time is jeopardizing the supply of new, safe and
effective animal drugs needed to keep our pets, flocks and herds
healthy and help provide American consumers with a safe and wholesome
food supply.
Under this proposal, H.R. 1260, the additional revenues generated
from fees paid by the pioneer animal drug industry would be dedicated
for use in expediting the testing and review of new animal drugs in
accordance with the performance goals that have been mutually agreed
upon by the FDA and the animal drug industry.
As FDA Commissioner Mark McClellan has noted, a faster, more
predictable review process is expected to spur more spending on
research and development by the industry, promoting animal health by
increasing the availability and diversity of new, safe and effective
products.
I encourage my colleagues to vote for this much-needed bipartisan
bill.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may
consume.
I rise in support of the Animal Drug User Fee Act. I thank the
gentleman from Michigan (Mr. Upton), also the gentleman from Florida
(Mr. Bilirakis), the gentleman from Louisiana (Mr. Tauzin), and the
gentleman from Michigan (Mr. Dingell) for their excellent work on this
bill, especially the work that the gentlewoman from Colorado (Ms.
DeGette) did as the author of this legislation.
[[Page H9058]]
H.R. 1260, Mr. Speaker, builds on a successful program for fee-funded
expedited review of new human drug applications authorized in 1992 by
something called the Prescription Drug User Fee Act, known as PDUFA,
the congressional acronym that we are wont to do around here.
{time} 1200
We also reauthorized PDUFA some years ago. Congress has done a
generally good job in speeding the approval process through the
Prescription Drug User Fee Act. We have done not quite as good a job on
expediting the approval of generic drugs, something that we need to
work with the FDA to accelerate. It takes oftentimes as long as 18
months for a generic drug, something that costs consumers money by the
slowness of the approval process.
I think this legislation on animal drugs is almost as important as
those other two in terms of what it does with pets, what it does with
zoos, and especially what it does with cattle and poultry. We have
found, Mr. Speaker, in terms of an issue of antibiotic resistance where
we have drugs that are on the market to cure animals, and sometimes
those drugs have lost their effectiveness, as they have in the human
population, and it is important that this legislation, H.R. 1260, the
gentleman from Michigan's (Mr. Upton) bill, get through Congress
because it does, in fact, help to put more drugs on the market, more
antibiotics in some indications to deal with the problems of antibiotic
resistance.
We have had debates on the House floor that the gentleman from
Florida (Mr. Bilirakis) has been part of on this whole issue of
antibiotic resistance. We have seen the use of nontherapeutic drugs
given for prophylactic purposes to cattle and poultry, given for growth
treatments for cattle and poultry where there has been some residue
from those drugs in the human population that have caused problems with
antibiotic resistance, both in the animals and, after human
consumption, in human beings. And it is especially important in light
of the fact that we really have not fixed that problem. We still use
far too many drugs for nontherapeutic purposes for cattle and poultry.
It is important that this legislation passes because I think H.R. 1260
will help us deal with that.
I again ask for support for this legislation. It matters for our
pets. It matters for zoos. It matters for production of cattle and
poultry, and it ultimately matters in human health. I ask my colleagues
to support H.R. 1260.
Mr. Speaker, I reserve the balance of my time.
Mr. UPTON. Mr. Speaker, I yield 3 minutes to the gentleman from
Florida (Mr. Stearns), my friend and an important supporter of this
legislation, a member of the Committee on Energy and Commerce.
(Mr. STEARNS asked and was given permission to revise and extend his
remarks.)
Mr. STEARNS. Mr. Speaker, I thank my distinguished colleague, who is
chairman of the Telecommunications and the Internet Subcommittee and
has been very active in this, for yielding me this time.
I obviously rise in support of H.R. 1260, the Animal Drug User Fee
Act. By funding more FDA drug reviewers, Mr. Speaker, this act will
help accelerate approval of important veterinarian drugs, resulting in
the comfort and treatment of countless companions, pets, zoo animals
and livestock.
This is very important. I am proud of the major veterinary school in
my congressional district. The College of Veterinary Medicine in the
University of Florida, Florida's only veterinary college, offers
comprehensive service to the public through a fourfold mission:
teaching, research, extension to the community, and patient care. And I
am proud, Mr. Speaker, to be wearing a University of Florida tie in
honor of their efforts and their leadership this morning. In fact, at
this school, no creature is too small, too large, too pesky, or too
dangerous for these fine veterinarians to treat, such as the endangered
Florida panthers or even some exotic tropical birds. They have a
Performance Animal Physiology Clinic, a Pharmacology and Disease
Division, which, in fact, studies humane treatment of equine and
greyhound species, athletes among pets. All of these animals, all of
them, will benefit from innovative pharmaceuticals that are brought to
the market in a more expedited manner.
In addition, one of the Nation's foremost thoroughbred horse
industries is located in my hometown of Ocala, Florida. We are actually
known as the horse capital of the world. We have 460 horse farms
located in Ocala and in Marion County. The Florida Thoroughbred
Breeders' and Owners' Association, Florida Thoroughbred Charities, and
other equine-related concerns all serve a tremendously important part
of our economy and this Nation's entertainment.
Do they demand the best medicines available in the world, available
as quickly as possible for their pets and their assets? Absolutely.
This bill will help, and that is why I am pleased to support this, and
I thank the gentleman from Michigan (Mr. Upton) for his very energetic
work on behalf of this, and, of course, for my vet school and horse-
owning friends in Florida's 6th Congressional District.
Mr. BROWN of Ohio. Mr. Speaker, I yield 4 minutes to the gentlewoman
from Colorado (Ms. DeGette), author of the bill.
Ms. DeGETTE. Mr. Speaker, I would like to add my thanks to the
gentleman from Michigan (Mr. Upton) for taking the lead on this
important piece of legislation and also for his diligence in making
sure that it was brought to the floor today and the leadership on both
sides of the aisle of the House subcommittee of the Committee on Energy
and Commerce. It is always a pleasure to write and pass a bill with
full bipartisan support.
The bill will improve the public's health, the efficiency of FDA's
drug approval process, and perhaps most importantly to some, the health
of the family pet and of our livestock in this country. In our society,
pets have become even more important to Americans, and just like with
humans, pharmaceuticals have helped improve the quality of our pets
lives. My sister has a 16-year-old dog that is on insulin and several
antiinflammatory drugs for arthritis just like senior citizens in this
country, and her pet's health has been helped by these drugs, and
thereby her family's situation has been improved, and they are happy to
have their pet.
Unfortunately, up until now, drugs have not been able to be approved
with speed like they are for humans, and the Animal Drug User Fee Act
is closely modeled after the Prescription Drug User Fee Act, which was
enacted 10 years ago. The purpose of this legislation is twofold: to
increase resources available to the FDA so that it may speed up the
approval process for pharmaceuticals, and also to maintain monitoring
of the safety and efficacy of all pharmaceuticals. Decreasing delays of
the approval process is a necessary step to keeping up with medical
innovation, and this applies to drug for animals as well as for humans.
The monitoring is an essential function that safeguards the public's
health.
Ensuring the safety and efficacy of pharmaceuticals is of paramount
importance. I am well aware of some of the issues with PDUFA, some of
which were discussed by the gentleman from Ohio (Mr. Brown), but I feel
strongly that we must increase the FDA's work capacity. This bill has
been carefully crafted on both sides of the aisle to avoid the problems
of the past, and as my colleagues have heard, it was unanimously passed
by the Committee on Energy and Commerce.
This bill, ADUFA, requires the Center for Veterinary Medicine at the
FDA to meet performance standards in exchange for a 5-year infusion of
funds.
By collecting fees from animal drug manufacturers, the FDA will be
able to decrease the review time of new drug applications. These
delays, which have been considerable in the past, prevent
pharmaceuticals from entering the market. I am very pleased that the
FDA has also worked very closely with us on the bill and is willing to
implement the new program.
Increasing access to animal drugs not only helps lengthen and improve
the lives of the family pet, but it will also, and perhaps more
importantly, have a wide-ranging impact on our Nation's food supply and
will improve prevention of food-borne disease epidemics. For example,
for more than 40 years, antibiotics have played a critical role in
keeping our Nation's food animals healthy. Without such treatments,
illness would be transmitted to humans,
[[Page H9059]]
and the livestock market would be more susceptible to devastation.
Therefore, we must continue to develop new treatments and quickly bring
them to market, but we cannot do that without the speedy approval of
the FDA.
I am particularly concerned about the food and medicine supply of
this country. This commitment to safety that we are showing today
through this legislation starts with the FDA's examination and approval
of new pharmaceuticals and continues as these legal drugs are
manufactured and distributed throughout the Nation. Commitment to
safety must always be a part of the system.
The benefits of this bill are substantial, and, therefore, I am very
pleased to cosponsor the bill. Vote yes on H.R. 1260, the Animal Drug
User Fee Act.
Mr. GOODLATTE. Mr. Speaker, animal medicines are used to assist
livestock producers raising and maintaining healthy, high quality stock
and ultimately, in delivering safe and wholesome food to American
dinner tables. They are also used to keep pets healthy, which
contributes to the quality of life for millions of companion animal
owners.
The Food and Drug Administration's Center for Veterinary Medicine
(CVM) is currently experiencing unprecedented delays in its review of
new product submissions. The delays are severe and problematic for the
submission sponsors, for CVM, and for veterinarians, livestock and
poultry producers, and pet owners in need of new and innovative
products to combat animal disease--at a time when animal disease around
the world is capturing headlines. The deadlock at the Center also has a
chilling effect on the animal health industry's investment in important
research and development, threatening the pipeline of products that
will be important to livestock and poultry producers in managing their
production in the future. The lack of these tools imperils not only
animal health but also has implications for the food supply and food
safety.
In 1966 Congress, with industry support, enacted the Animal Drug
Availability Act to streamline drug review and approval procedures.
Contrary to Congressional intent and despite additional resources, it
is now more difficult than ever to get new products approved.
Unfortunately, this situation is detrimental to veterinarians, to
livestock and poultry producers, to food producers and to the public.
As a result, it is important for Congress and the Administration to
take action to ensure that the CVM can better manage its resources and
personnel and make institutional changes to fulfill its mandated
mission and responsibilities.
Modeled after the successful Prescription Drug User Fee Act, the
Animal Drug User Fee Act will increase efficiencies in review times for
new animal pharmaceuticals by providing CVM with additional resources
to allow for improved communication between FDA and product sponsors
and more expeditious FDA actions on applications.
Mr. Speaker, I congratulate Congressman Upton for his leadership and
that of the full Committee on Energy and Commerce for bringing this
important legislation to the floor today and urge all Members to
support it.
Mr. BROWN of Ohio. Mr. Speaker, I yield back the balance of my time.
Mr. UPTON. Mr. Speaker, I have no further requests for time, and I
yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Michigan (Mr. Upton) that the House suspend the rules
and pass the bill, H.R. 1260.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
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