[Congressional Record Volume 149, Number 158 (Tuesday, November 4, 2003)]
[House]
[Pages H10293-H10297]
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
Senate bill (S. 313) to amend the Federal Food, Drug, and Cosmetic Act
to establish a program of fees relating to animal drugs, as amended.
The Clerk read as follows:
S. 313
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 Act 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
[[Page H10294]]
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.
``(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:
[[Page H10295]]
``(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 $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 paragraph (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 paragraph
(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,
animal drug 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
[[Page H10296]]
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 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 (b), 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 (Mr. Boozman). Pursuant to the rule, the
gentleman from Michigan (Mr. Upton) and the gentlewoman from California
(Ms. Eshoo) each will control 20 minutes.
The Chair recognizes the gentleman from Michigan (Mr. Upton).
General Leave
Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days within which to revise and extend their remarks
and to insert extraneous material on the Senate bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, as the lead sponsor of the House-passed version of the
Animal Drug User Fee Act of 2003, it is my pleasure today to manage S.
313, the Senate version of the same legislation on the floor.
What we are doing today is taking up the Senate-passed version of the
Animal Drug User Fee Act and inserting the updated House language from
H.R. 1260, which was approved by this body by voice last month. We are
doing so because we determined that it was the best way to expedite the
final passage of this much-needed legislation giving the FDA the
authority to begin collecting the user fees this fiscal year needed to
substantially beef up the new animal drug development and review
process.
I would like to take the opportunity again to acknowledge and thank
the gentlewoman from Colorado (Ms. DeGette), my original cosponsor; the
gentleman from Louisiana (Mr. Tauzin), our committee chairman; the
gentleman from Michigan (Mr. Dingell), ranking member; the gentleman
from Florida (Mr. Bilirakis), Health Subcommittee chairman; and the
gentleman from Ohio (Mr. Brown), ranking member; and the Members on
both sides of the aisle who have cosponsored the bill. I am grateful
too for the hard work of our committee staff, Brent Delmonte, Pat
Ronan, John Ford, and for the assistance that we have received from the
FDA and the Animal Health Alliance. And also Jane Williams, my health
care expert, deserves special merit as well.
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 Food and Drug Administration's Center for Veterinary
Medicine the right resources and incentives needed to significantly
improve the animal drug review process. The bill is supported by a
broad coalition of veterinary and producer groups, including the
American Veterinary Medical Association and the American Farm Bureau.
The legislation is sorely needed. Despite a statutory review time of
180 days, the average new animal drug application review currently
takes about 1\1/2\ years and sometimes may drag on for even several
years. This slowdown in review time is jeopardizing the supply of the
new, safe, and effective animal drugs needed to keep our pets, flocks,
and herds healthy and to provide American consumers with a safe and
wholesome food supply.
Under this proposal, 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.
[[Page H10297]]
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.
Mr. Speaker, I encourage my colleagues to vote for this much-needed
bipartisan bill.
Mr. Speaker, I reserve the balance of my time.
Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
I am pleased that we are bringing the Animal Drug User Fee Act to the
floor today. This is a bipartisan bill that enjoys strong support from
a number of veterinary and farm organizations, as well as from a
significant number of Members of Congress.
The Food and Drug Administration is a seriously underfunded agency.
This has always been a source of concern to me given the critical
mission that the FDA has of protecting our food supply, our drug
supply, and protecting consumers. Over the last few years, Congress has
taken a number of steps to rectify the funding shortfall. Last year we
renewed the Prescription Drug User Fee Act for the second time. We also
passed new legislation, the Medical Device User Fee and Modernization
Act, which created a user fee program for medical devices that will
help speed new technology to the patients who need them.
The Animal Drug User Fee Act is the next in this slate of bills that
are aimed at boosting FDA's resources. This bill will provide the FDA's
Center for Veterinary Medicine with an additional $48 million over the
next 5 years. The money will be directed and solely directed to hiring
new staff and acquiring the additional resources needed to approve the
applications for animal drugs in a speedier manner while still
maintaining FDA's gold standard of safety and efficacy.
This bill will touch everyone's life in multiple ways, even though
they may not think so, whether it is through lifesaving medications for
pets or better, less toxic medications for farm animals. It is in
everyone's best interest to have an FDA that is equipped to review
these new drug applications in a safe and in a timely manner.
I want to thank the gentlewoman from Colorado (Ms. DeGette), who
cannot be here. She is the one who really should be standing here
rather than myself, and the gentleman from New York (Mr. Towns) for all
of their hard work they put in on this bill with the gentleman from
Michigan (Mr. Upton), its sponsor. It is to their credit that it will
be law. I also want to thank the gentleman from Michigan (Mr. Dingell),
our distinguished ranking member, and certainly his staff, John Ford,
whom over and over and over again does superb work and tireless work in
this specific case to help bring this bill through the committee and to
the floor of the House. So to the gentleman from Michigan (Mr. Upton),
our chairman, I salute him. This is a great day for him on the floor
because both the E-911 Implementation Act of 2003 and certainly this
bill, the Animal Drug User Fee Act of 2003, are very important ones
that push the edges of the envelope out and really help to protect
consumers and the people of our country. So I salute him.
Mr. Speaker, I have no further requests for time, and I yield back
the balance of my time.
Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume.
I want to thank the gentlewoman from California (Ms. Eshoo), a very
able replacement for the gentlewoman from Colorado (Ms. DeGette), who I
too regret she is not here. This has been a bipartisan effort from get-
go.
Mr. TAUZIN. Mr. Speaker, I am proud to rise in favor of S. 313, the
Animal Drug User Fee Act (``ADUFA''), sponsored in the House by my good
friend from Michigan, Mr. Upton.
This legislation, modeled after the successful Prescription Drug User
Fee Act (PDUFA), is designed to decrease the review time of new animal
drugs at the Center for Veterinary Medicine (CVM) of the Food and Drug
Administration (FDA). This legislation is essential to the health of
pets and livestock, as well as food safety. CVM is currently
experiencing sizable delays in its review of drug applications. These
delays are problematic for CVM, drug sponsors, pet owners,
veterinarians, and livestock producers.
Simply put, the CVM needs an infusion of funds to address review
shortcomings. The slowdown of the approval process threatens to reduce
the tools available to livestock and poultry producers to produce
vibrant stock and to combat animal disease. The slowdown of the
approval process also threatens the health and well being of family
pets and zoo animals. Further, delays at CVM have a chilling effect on
the animal health industry's investment in important research and
development, threatening the pipeline of new products.
In conclusion, this is a very modest program, but one that is
desperately needed. The pace of animal drug reviews has slowed in
recent years and the FDA needs the proper resources to hire more
reviewers. Please join me in supporting S. 313, The Animal Drug User
Fee Act of 2003.
Mr. GREEN of Texas. Mr. Speaker, I rise today in support of S. 313,
the Animal Drug User Fee Act. This legislation is modeled after the
successful Prescription Drug User Fee Act, which ensures that consumers
have timely access to lifesaving drugs. ADUFA would establish the same
expedited process to ensure that pets and livestock also have access to
groundbreaking pharmaceuticals.
Despite a current requirement that limits the review time of a new
animal drug application to 180 days, the review process takes an
average of 1.5 years to complete, with some applications taking several
years. Eighty-eight percent of original new animal drug applications
are overdue, the longest day being 717 days.
Mr. Speaker, we wouldn't stand for that kind of delay for people, and
I don't think that Man's Best Friend, or the livestock that feeds all
Americans, should have to either. I support this legislation, and am
happy to see it on our agenda.
However, I would point out that this House has not yet acted on
legislation which would authorize the FDA to require pharmaceuticals
manufacturers to test their products on children. For too long, doctors
have been guessing about how best to treat our children. Kids are being
used as guinea pigs because pharmaceutical companies haven't done the
testing necessary to ensure that their products are safe and effective
for kids. Many of us have been fighting for several years to ``codify
the rule,'' and I am anxious to work on legislation that would do that.
As important as animals are, nothing is more important than the health
and safety of our children.
It is high time for us to put the interests of our children first. I
urge the leadership of the House of Representatives to take up
legislation which would ensure that the FDA has the authority it needs
to require prescription drug manufacturers to test their products for
children.
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 Senate bill, S. 313, as amended.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the Senate bill, as amended, was
passed.
A motion to reconsider was laid on the table.
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