[Congressional Record Volume 142, Number 133 (Tuesday, September 24, 1996)]
[House]
[Pages H10835-H10841]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ANIMAL DRUG AVAILABILITY ACT OF 1996
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 2508) to amend the Federal Food, Drug, and Cosmetic Act to
provide for improvements in the process of approving and using animal
drugs, and for other purposes, as amended.
The Clerk read as follows:
H.R. 2508
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE.
(a) Short Title.--This Act may be cited as the ``Animal
Drug Availability Act of 1996''.
(b) Reference.--Whenever in this Act an amendment or repeal
is expressed in terms of an amendment to, or repeal of, a
section or other provision, the reference shall be considered
to be made to a section or other provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).
SEC. 2. EVIDENCE OF EFFECTIVENESS.
(a) Original Applications.--Paragraph (3) of section 512(d)
(21 U.S.C. 360b(d)) is amended to read as follows:
``(3) As used in this section, the term `substantial
evidence' means evidence consisting of one or more adequate
and well controlled investigations, such as--
``(A) a study in a target species;
``(B) a study in laboratory animals;
``(C) any field investigation that may be required under
this section and that meets the requirements of subsection
(b)(3) if a presubmission conference is requested by the
applicant;
``(D) a bioequivalence study; or
``(E) an in vitro study;
by experts qualified by scientific training and experience
to evaluate the effectiveness of the drug involved, on the
basis of which it could fairly and reasonably be concluded by
such experts that the drug will have the effect it purports
or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling or
proposed labeling thereof.''.
(b) Conforming Amendments.--
[[Page H10836]]
(1) Clauses (ii) and (iii) of section 512(c)(2)(F) (21
U.S.C. 360b(c)(2)(F)) are each amended--
(A) by striking ``reports of new clinical or field
investigations (other than bioequivalence or residue studies)
and,'' and inserting ``substantial evidence of the
effectiveness of the drug involved, any studies of animal
safety, or,''; and
(B) by striking ``essential to'' and inserting ``required
for''.
(2) Section 512(c)(2)(F)(v) (21 U.S.C. 360b(c)(2)(F)(v)) is
amended--
(A) by striking ``subparagraph (B)(iv)'' each place it
appears and inserting ``clause (iv)'';
(B) by striking ``reports of clinical or field
investigations'' and inserting ``substantial evidence of the
effectiveness of the drug involved, any studies of animal
safety,''; and
(C) by striking ``essential to'' and inserting ``required
for''.
(c) Combination Drugs.--Section 512(d) (21 U.S.C. 360b(d)),
as amended by subsection (a) is amended by adding at the end
the following:
``(4) In a case in which an animal drug contains more than
one active ingredient, or the labeling of the drug
prescribes, recommends, or suggests use of the drug in
combination with one or more other animal drugs, and the
active ingredients or drugs intended for use in the
combination have previously been separately approved for
particular uses and conditions of use for which they are
intended for use in the combination--
``(A) the Secretary shall not issue an order under
paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the
application for such combination on human food safety grounds
unless the Secretary finds that the application fails to
establish that--
``(i) none of the active ingredients or drugs intended for
use in the combination, respectively, at the longest
withdrawal time of any of the active ingredients or drugs in
the combination, respectively, exceeds its established
tolerance; or
``(ii) none of the active ingredients or drugs in the
combination interferes with the methods of analysis for
another of the active ingredients or drugs in the
combination, respectively;
``(B) the Secretary shall not issue an order under
paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the
application for such combination on target animal safety
grounds unless the Secretary finds that--
``(i)(I) there is a substantiated scientific issue,
specific to one or more of the active ingredients or animal
drugs in the combination, that cannot adequately be evaluated
based on information contained in the application for the
combination (including any investigations, studies, or tests
for which the applicant has a right of reference or use from
the person by or for whom the investigations, studies, or
tests were conducted); or
``(II) there is a scientific issue raised by target animal
observations contained in studies submitted to the Secretary
as part of the application; and
``(ii) based on the Secretary's evaluation of the
information contained in the application with respect to the
issues identified in clauses (i)(I) and (II), paragraph
(1)(A), (B), or (D) apply;
``(C) except in the case of a combination that contains a
nontopical antibacterial ingredient or animal drug, the
Secretary shall not issue an order under paragraph (1)(E)
refusing to approve an application for a combination animal
drug intended for use other than in animal feed or drinking
water unless the Secretary finds that the application fails
to demonstrate that--
``(i) there is substantial evidence that any active
ingredient or animal drug intended only for the same use as
another active ingredient or animal drug in the combination
makes a contribution to labeled effectiveness;
``(ii) each active ingredient or animal drug intended for
at least one use that is different from all other active
ingredients or animal drugs used in the combination provides
appropriate concurrent use for the intended target
population; or
``(iii) where based on scientific information the Secretary
has reason to believe the active ingredients or animal drugs
may be physically incompatible or have disparate dosing
regimens, such active ingredients or animal drugs are
physically compatible or do not have disparate dosing
regimens; and
``(D) the Secretary shall not issue an order under
paragraph (1)(E) refusing to approve an application for a
combination animal drug intended for use in animal feed or
drinking water unless the Secretary finds that the
application fails to demonstrate that--
``(i) there is substantial evidence that any active
ingredient or animal drug intended only for the same use as
another active ingredient or animal drug in the combination
makes a contribution to the labeled effectiveness;
``(ii) each of the active ingredients or animal drugs
intended for at least one use that is different from all
other active ingredients or animal drugs used in the
combination provides appropriate concurrent use for the
intended target population;
``(iii) where a combination contains more than one
nontopical antibacterial ingredient or animal drug, there is
substantial evidence that each of the nontopical
antibacterial ingredients or animal drugs makes a
contribution to the labeled effectiveness; or
``(iv) where based on scientific information the Secretary
has reason to believe the active ingredients or animal drugs
intended for use in drinking water may be physically
incompatible, such active ingredients or animal drugs
intended for use in drinking water are physically
compatible.''.
(d) Presubmission Conference.--Section 512(b) (21 U.S.C.
360b(b)) is amended by adding at the end the following:
``(3) Any person intending to file an application under
paragraph (1) or a request for an investigational exemption
under subsection (j) shall be entitled to one or more
conferences prior to such submission to reach an agreement
acceptable to the Secretary establishing a submission or an
investigational requirement, which may include a requirement
for a field investigation. A decision establishing a
submission or an investigational requirement shall bind the
Secretary and the applicant or requestor unless (A) the
Secretary and the applicant or requestor mutually agree to
modify the requirement, or (B) the Secretary by written order
determines that a substantiated scientific requirement
essential to the determination of safety or effectiveness of
the animal drug involved has appeared after the conference.
No later than 25 calendar days after each such conference,
the Secretary shall provide a written order setting forth a
scientific justification specific to the animal drug and
intended uses under consideration if the agreement referred
to in the first sentence requires more than one field
investigation as being essential to provide substantial
evidence of effectiveness for the intended uses of the drug.
Nothing in this paragraph shall be construed as compelling
the Secretary to require a field investigation.''.
(e) Implementation.--
(1) In general.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue proposed regulations implementing the
amendments made by this Act as described in paragraph (2)(A)
of this subsection, and not later than 18 months after the
date of enactment of this Act, the Secretary shall issue
final regulations implementing such amendments. Not later
than 12 months after the date of enactment of this Act, the
Secretary shall issue proposed regulations implementing the
other amendments made by this Act as described in paragraphs
(2)(B) and (2)(C) of this subsection, and not later than 24
months after the date of enactment of this Act, the Secretary
shall issue final regulations implementing such amendments.
(2) Contents.--In issuing regulations implementing the
amendments made by this Act, and in taking an action to
review an application for approval of a new animal drug under
section 512 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b), or a request for an investigational exemption
for a new animal drug under subsection (j) of such section,
that is pending or has been submitted prior to the effective
date of the regulations, the Secretary shall--
(A) further define the term ``adequate and well
controlled'', as used in subsection (d)(3) of section 512 of
such Act, to require that field investigations be designed
and conducted in a scientifically sound manner, taking into
account practical conditions in the field and differences
between field conditions and laboratory conditions;
(B) further define the term ``substantial evidence'', as
defined in subsection (d)(3) of such section, in a manner
that encourages the submission of applications and
supplemental applications; and
(C) take into account the proposals contained in the
citizen petition (FDA Docket No. 91P-0434/CP) jointly
submitted by the American Veterinary Medical Association and
the Animal Health Institute, dated October 21, 1991.
Until the regulations required by subparagraph (A) are
issued, nothing in the regulations published at 21 C.F.R.
514.111(a)(5) (April 1, 1996) shall be construed to compel
the Secretary of Health and Human Services to require a field
investigation under section 512(d)(1)(E) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)(E)) or to apply
any of its provisions in a manner inconsistent with the
considerations for scientifically sound field investigations
set forth in subparagraph (A).
(f) Minor Species and Uses.--The Secretary of Health and
Human Services shall consider legislative and regulatory
options for facilitating the approval under section 512 of
the Federal Food, Drug, and Cosmetic Act of animal drugs
intended for minor species and for minor uses and, within 18
months after the date of enactment of this Act, announce
proposals for legislative or regulatory change to the
approval process under such section for animal drugs intended
for use in minor species or for minor uses.
SEC. 3. LIMITATION ON RESIDUES.
Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended
to read as follows:
``(F) upon the basis of information submitted to the
Secretary as part of the application or any other information
before the Secretary with respect to such drug, any use
prescribed, recommended, or suggested in labeling proposed
for such drug will result in a residue of such drug in excess
of a tolerance found by the Secretary to be safe for such
drug;''.
SEC. 4. IMPORT TOLERANCES.
Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the
following new paragraph at the end:
``(6) For purposes of section 402(a)(2)(D), a use or
intended use of a new animal drug
[[Page H10837]]
shall not be deemed unsafe under this section if the
Secretary establishes a tolerance for such drug and any
edible portion of any animal imported into the United States
does not contain residues exceeding such tolerance. In
establishing such tolerance, the Secretary shall rely on data
sufficient to demonstrate that a proposed tolerance is safe
based on similar food safety criteria used by the Secretary
to establish tolerances for applications for new animal drugs
filed under subsection (b)(1). The Secretary may consider and
rely on data submitted by the drug manufacturer, including
data submitted to appropriate regulatory authorities in any
country where the new animal drug is lawfully used or data
available from a relevant international organization, to the
extent such data are not inconsistent with the criteria used
by the Secretary to establish a tolerance for applications
for new animal drugs filed under subsection (b)(1). For
purposes of this paragraph, `relevant international
organization' means the Codex Alimenterius Commission or
other international organization deemed appropriate by the
Secretary. The Secretary may, under procedures specified by
regulation, revoke a tolerance established under this
paragraph if information demonstrates that the use of the new
animal drug under actual use conditions results in food being
imported into the United States with residues exceeding the
tolerance or if scientific evidence shows the tolerance to be
unsafe.''.
SEC. 5. VETERINARY FEED DIRECTIVES.
(a) Section 503.--Section 503(f)(1)(A) (21 U.S.C.
353(f)(1)(A)) is amended by inserting after ``other than
man'' the following: ``, other than a veterinary feed
directive drug intended for use in animal feed or an animal
feed bearing or containing a veterinary feed directive
drug,''.
(b) Section 504.--The Federal Food, Drug, and Cosmetic Act
is amended by inserting after section 503 the following:
``veterinary feed directive drugs
``Sec. 504. (a)(1) A drug intended for use in or on animal
feed which is limited by an approved application filed
pursuant to section 512(b) to use under the professional
supervision of a licensed veterinarian is a veterinary feed
directive drug. Any animal feed bearing or containing a
veterinary feed directive drug shall be fed to animals only
by or upon a lawful veterinary feed directive issued by a
licensed veterinarian in the course of the veterinarian's
professional practice. When labeled, distributed, held, and
used in accordance with this section, a veterinary feed
directive drug and any animal feed bearing or containing a
veterinary feed directive drug shall be exempt from section
502(f).
``(2) A veterinary feed directive is lawful if it--
``(A) contains such information as the Secretary may by
general regulation or by order require; and
``(B) is in compliance with the conditions and indications
for use of the drug set forth in the notice published
pursuant to section 512(i).
``(3)(A) Any persons involved in the distribution or use of
animal feed bearing or containing a veterinary feed directive
drug and the licensed veterinarian issuing the veterinary
feed directive shall maintain a copy of the veterinary feed
directive applicable to each such feed, except in the case of
a person distributing such feed to another person for further
distribution. Such person distributing the feed shall
maintain a written acknowledgment from the person to whom the
feed is shipped stating that that person shall not ship or
move such feed to an animal production facility without a
veterinary feed directive or ship such feed to another person
for further distribution unless that person has provided the
same written acknowledgment to its immediate supplier.
``(B) Every person required under subparagraph (A) to
maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and verify
such records.
``(C) Any person who distributes animal feed bearing or
containing a veterinary feed directive drug shall upon first
engaging in such distribution notify the Secretary of that
person's name and place of business. The failure to provide
such notification shall be deemed to be an act which results
in the drug being misbranded.
``(b) A veterinary feed directive drug and any feed bearing
or containing a veterinary feed directive drug shall be
deemed to be misbranded if their labeling fails to bear such
cautionary statement and such other information as the
Secretary may by general regulation or by order prescribe, or
their advertising fails to conform to the conditions and
indications for use published pursuant to section 512(i) or
fails to contain the general cautionary statement prescribed
by the Secretary.
``(c) Neither a drug subject to this section, nor animal
feed bearing or containing such a drug, shall be deemed to be
a prescription article under any Federal or State law.''.
(c) Conforming Amendment.--Section 512 (21 U.S.C. 360b) is
amended in subsection (i) by inserting after ``(including
special labeling requirements'' the following: ``and any
requirement that an animal feed bearing or containing the new
animal drug be limited to use under the professional
supervision of a licensed veterinarian''.
(d) Section 301(e).--Section 301(e) (21 U.S.C. 331(e)) is
amended by inserting after ``by section 412'' the following:
``, 504,''; and by inserting after ``under section 412,'' the
following: ``504,''.
SEC. 6. FEED MILL LICENSES.
(a) Section 512(a).--Paragraphs (1) and (2) of section
512(a) (21 U.S.C. 360b(a)) are amended to read as follows:
``(a)(1) A new animal drug shall, with respect to any
particular use or intended use of such drug, be deemed unsafe
for the purposes of section 501(a)(5) and section
402(a)(2)(D) unless --
``(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such use or
intended use of such drug, and
``(B) such drug, its labeling, and such use conform to such
approved application.
A new animal drug shall also be deemed unsafe for such
purposes in the event of removal from the establishment of a
manufacturer, packer, or distributor of such drug for use in
the manufacture of animal feed in any State unless at the
time of such removal such manufacturer, packer, or
distributor has an unrevoked written statement from the
consignee of such drug, or notice from the Secretary, to the
effect that, with respect to the use of such drug in animal
feed, such consignee (i) holds a license issued under
subsection (m) and has in its possession current approved
labeling for such drug in animal feed; or (ii) will, if the
consignee is not a user of the drug, ship such drug only to a
holder of a license issued under subsection (m).
``(2) An animal feed bearing or containing a new animal
drug shall, with respect to any particular use or intended
use of such animal feed be deemed unsafe for the purposes of
section 501(a)(6) unless--
``(A) there is in effect an approval of an application
filed pursuant to subsection (b) with respect to such drug,
as used in such animal feed,
``(B) such animal feed is manufactured at a site for which
there is in effect a license issued pursuant to subsection
(m)(1) to manufacture such animal feed, and
``(C) such animal feed and its labeling, distribution,
holding, and use conform to the conditions and indications of
use published pursuant to subsection (i) .''.
(b) Section 512(m).--Section 512(m) (21 U.S.C. 360b(m)) is
amended to read as follows:
``(m)(1) Any person may file with the Secretary an
application for a license to manufacture animal feeds bearing
or containing new animal drugs. Such person shall submit to
the Secretary as part of the application (A) a full statement
of the business name and address of the specific facility at
which the manufacturing is to take place and the facility's
registration number, (B) the name and signature of the
responsible individual or individuals for that facility, (C)
a certification that the animal feeds bearing or containing
new animal drugs are manufactured and labeled in accordance
with the applicable regulations published pursuant to
subsection (i), and (D) a certification that the methods used
in, and the facilities and controls used for, manufacturing,
processing, packaging, and holding such animal feeds are in
conformity with current good manufacturing practice as
described in section 501(a)(2)(B).
``(2) Within 90 days after the filing of an application
pursuant to paragraph (1), or such additional period as may
be agreed upon by the Secretary and the applicant, the
Secretary shall (A) issue an order approving the application
if the Secretary then finds that none of the grounds for
denying approval specified in paragraph (3) applies, or (B)
give the applicant notice of an opportunity for a hearing
before the Secretary under paragraph (3) on the question
whether such application is approvable. The procedure
governing such a hearing shall be the procedure set forth in
the last two sentences of subsection (c)(1).
``(3) If the Secretary, after due notice to the applicant
in accordance with paragraph (2) and giving the applicant an
opportunity for a hearing in accordance with such paragraph,
finds, on the basis of information submitted to the Secretary
as part of the application, on the basis of a preapproval
inspection, or on the basis of any other information before
the Secretary--
``(A) that the application is incomplete, false, or
misleading in any particular;
``(B) that the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing
of such animal feed are inadequate to preserve the identity,
strength, quality, and purity of the new animal drug therein;
or
``(C) that the facility manufactures animal feeds bearing
or containing new animal drugs in a manner that does not
accord with the specifications for manufacture or labels
animal feeds bearing or containing new animal drugs in a
manner that does not accord with the conditions or
indications of use that are published pursuant to subsection
(i),
the Secretary shall issue an order refusing to approve the
application. If, after such notice and opportunity for
hearing, the Secretary finds that subparagraphs (A) through
(C) do not apply, the Secretary shall issue an order
approving the application. An order under this subsection
approving an application for a license to manufacture animal
feeds bearing or containing new animal drugs shall permit a
facility to manufacture only those animal feeds bearing or
containing new animal drugs for which there are in effect
regulations pursuant to subsection (i) relating to
[[Page H10838]]
the use of such drugs in or on such animal feed.
``(4)(A) The Secretary shall, after due notice and
opportunity for hearing to the applicant, revoke a license to
manufacture animal feeds bearing or containing new animal
drugs under this subsection if the Secretary finds--
``(i) that the application for such license contains any
untrue statement of a material fact; or
``(ii) that the applicant has made changes that would cause
the application to contain any untrue statements of material
fact or that would affect the safety or effectiveness of the
animal feeds manufactured at the facility unless the
applicant has supplemented the application by filing with the
Secretary adequate information respecting all such changes
and unless there is in effect an approval of the supplemental
application.
If the Secretary (or in the Secretary's absence the officer
acting as the Secretary) finds that there is an imminent
hazard to the health of humans or of the animals for which
such animal feed is intended, the Secretary may suspend the
license immediately, and give the applicant prompt notice of
the action and afford the applicant the opportunity for an
expedited hearing under this subsection; but the authority
conferred by this sentence shall not be delegated.
``(B) The Secretary may also, after due notice and
opportunity for hearing to the applicant, revoke a license to
manufacture animal feed under this subsection if the
Secretary finds--
``(i) that the applicant has failed to establish a system
for maintaining required records, or has repeatedly or
deliberately failed to maintain such records or to make
required reports in accordance with a regulation or order
under paragraph (5)(A) of this subsection or section
504(a)(3)(A), or the applicant has refused to permit access
to, or copying or verification of, such records as required
by subparagraph (B) of such paragraph or section
504(a)(3)(B);
``(ii) that on the basis of new information before the
Secretary, evaluated together with the evidence before the
Secretary when such license was issued, the methods used in,
or the facilities and controls used for, the manufacture,
processing, packing, and holding of such animal feed are
inadequate to assure and preserve the identity, strength,
quality, and purity of the new animal drug therein, and were
not made adequate within a reasonable time after receipt of
written notice from the Secretary, specifying the matter
complained of;
``(iii) that on the basis of new information before the
Secretary, evaluated together with the evidence before the
Secretary when such license was issued, the labeling of any
animal feeds, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained
of; or
``(iv) that on the basis of new information before the
Secretary, evaluated together with the evidence before the
Secretary when such license was issued, the facility has
manufactured, processed, packed, or held animal feed bearing
or containing a new animal drug adulterated under section
501(a)(6) and the facility did not discontinue the
manufacture, processing, packing, or holding of such animal
feed within a reasonable time after receipt of written notice
from the Secretary specifying the matter complained of.
``(C) The Secretary may also revoke a license to
manufacture animal feeds under this subsection if an
applicant gives notice to the Secretary of intention to
discontinue the manufacture of all animal feed covered under
this subsection and waives an opportunity for a hearing on
the matter.
``(D) Any order under this paragraph shall state the
findings upon which it is based.
``(5) When a license to manufacture animal feeds bearing or
containing new animal drugs has been issued--
``(A) the applicant shall establish and maintain such
records, and make such reports to the Secretary, or (at the
option of the Secretary) to the appropriate person or persons
holding an approved application filed under subsection (b),
as the Secretary may by general regulation, or by order with
respect to such application, prescribe on the basis of a
finding that such records and reports are necessary in order
to enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking
subsection (e) or paragraph (4); and
``(B) every person required under this subsection to
maintain records, and every person in charge or custody
thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and verify
such records.
``(6) To the extent consistent with the public health, the
Secretary may promulgate regulations for exempting from the
operation of this subsection facilities that manufacture,
process, pack, or hold animal feeds bearing or containing new
animal drugs.''.
(c) Transitional Provision.--A person engaged in the
manufacture of animal feeds bearing or containing new animal
drugs who holds at least one approved medicated feed
application for an animal feed bearing or containing new
animal drugs, the manufacture of which was not otherwise
exempt from the requirement for an approved medicated feed
application on the date of the enactment of this Act, shall
be deemed to hold a license for the manufacturing site
identified in the approved medicated feed application. The
revocation of license provisions of section 512(m)(4) of the
Federal Food, Drug, and Cosmetic Act, as amended by this Act,
shall apply to such licenses. Such license shall expire
within 18 months from the date of enactment of this Act
unless the person submits to the Secretary a completed
license application for the manufacturing site accompanied by
a copy of an approved medicated feed application for such
site, which license application shall be deemed to be
approved upon receipt by the Secretary.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Florida [Mr. Bilirakis] and the gentleman from New York [Mr. Manton]
each will control 20 minutes.
The Chair recognizes the gentleman from California [Mr. Bilirakis].
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
(Mr. BILIRAKIS asked and was given permission to revise and extend
his remarks.)
Mr. BILIRAKIS. Mr. Speaker, I rise in strong support of H.R. 2508,
The Animal Drug Availability Act of 1996. The bill will better protect
our animals by streamlining the approval and marketing of new animal
drugs and medicated feeds.
A broad bipartisan consensus has enabled us to develop this important
legislation which will bring needed flexibility to the FDA animal drug
review processes.
Among its improvements, the legislation redefines ``substantial
evidence'' to provide FDA with greater flexibility to determine what
types of studies, including field investigations, are necessary and
appropriate for demonstrating the effectiveness of any specific animal
drug product. The bill requires FDA to issue regulations defining
substantial evidence and adequate and well-controlled field
investigations taking into account the practical conditions that exist
in the field.
To improve cooperation between FDA and industry, the bill requires
FDA to hold a presubmission conference at the request of a sponsor
submitting a new animal drug application or a request for an
investigational exemption.
The legislation also streamlines the process for the approval of
combination animal drug products when the individual active ingredients
or animal drugs used in combination have been approved previously. In
addition it authorizes FDA to establish a scientifically based safe
tolerance for new animal drugs.
The bill creates a new class of animal drugs, veterinary feed
directive drugs, intended for use in feed under the professional
supervision of a licensed veterinarian. The bill streamlines the
requirements for feed mills that make medicated feeds. Finally, the
bill authorizes FDA to establish import tolerances for new animal drugs
not approved in the United States.
In conclusion, I want to thank Members on both sides of the aisle who
support the Animal Drug Availability Act of 1996.
Mr. Speaker, I reserve the balance of my time.
Mr. MANTON. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, the Animal Drug Availability Act makes important changes
to the process by which the Food and Drug Administration reviews
applications for new animal drugs.
We have heard a great deal in this Congress about reforming
Government and streamlining regulation. This legislation demonstrates
that these goals can be accomplished if all of the interested parties
are willing to negotiate. This amendment to H.R. 2508 is the result of
compromise between the FDA and the animal drug coalition. It is
bipartisan, and it achieves reforms responsibly and carefully.
We are pleased that this legislation incorporates FDA proposals
included in the Vice President's reinventing Government initiatives,
one that will reduce unnecessary requirements and paperwork associated
with feed mill licensing and another that will authorize FDA to
establish import tolerances for animal drugs not approved for use in
the United States.
The provisions of this bill complete a task begun with enactment in
1994 of the Animal Medicinal Drug Use Clarification Act. When the House
passed that important legislation, we knew that expanding drug
availability would require addressing the underlying issue
[[Page H10839]]
that there are not enough new animal drugs available for veterinarians
to treat all the diseases and conditions that affect animals. That is
the issue dealt with by H.R. 2508.
The legislation does this through simplifying the process if
determining an animal drug's effectiveness; establishing a process by
which FDA and the animal drug sponsor can agree in advance about what
the sponsor must provide FDA to facilitate the approval of the new
product; providing a streamlined process for FDA to review combination
drugs; and establishing a new category of animal drugs, called
Veterinary Feed Directive drugs.
Mr. Speaker, this is good legislation. It will help FDA work more
efficiently, and it will help get safe and effective new animal drugs
on the market more quickly. It illustrates that a cooperative effort
between a regulatory agency, its regulated community, and Congress can
produce results that all parties find acceptable. This is how
regulatory reform can and should work.
I support this legislation, and I urge my colleagues to support it.
Mr. Speaker, I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield 2 minutes to the gentleman from
Wisconsin [Mr. Klug] who will speak on behalf of himself and a few
hundred thousand cattle in Wisconsin.
The SPEAKER pro tempore. Including the dairy farmers of the Chair.
Mr. KLUG. Mr. Speaker, 319,000 dairy cows, to be more specific.
Mr. Speaker, I would like to thank my colleague, the gentleman from
Florida [Mr. Bilirakis], for his terrific work on behalf of this
legislation, and also the full chairman of committee, the gentleman
from Virginia [Mr. Bliley], and my colleague, the gentleman from
Colorado [Mr. Allard], one of the few veterinarians in Congress, who
has been such a strong advocate for this piece of legislation.
Mr. Speaker, as you know, for the last year the Committee on Commerce
has been struggling with the ways to modernize the Food and Drug
Administration, which now regulates a quarter of this Nation's economy.
We have high hopes in the next session of Congress we will be able to
streamline the process to approve prescription drugs and also medical
devices.
Part of what we have been able to accomplish this session of Congress
are two major changes in terms of the FDA's responsibility in food
content. One of them is the modernization of the Delaney clause, and
then this piece of legislation we have in front of us today.
As we know, the current law requires animal drugs to be approved in 6
months, but it actually takes an average of 58 months. Only 1 in 7,500
chemicals ever makes it through the current approval process. In the
past 5 years the FDA has approved only four new drugs for food-
producing animals.
Realistically, without this bill minor use products would never be
brought to market, and the time and expense of bringing a new animal
drug to market is already discouraging drug companies from pursuing
approval for important medications.
This legislation today will establish a procedure by which the agency
and company can sit down ahead of time to discuss the approval
requirements for a new drug. It would create a new category of drugs
that can be prescribed by a veterinarian and administered by a farmer
in the animal's feed and it would refocus the regulation of the use of
two or more drugs simultaneously on the need to prove the safety to
humans.
This piece of legislation has the support of 160 cosponsors in the
House, the Clinton administration supports it, FDA Commissioner Kessler
supports it, industry supports the bill, and I strongly support this
bill and encourage my fellow committee members, as well as my
colleagues in the House, to approve it as well.
Mr. BILIRAKIS. Mr. Speaker, I yield 3 minutes to the gentleman from
Colorado [Mr. Allard], a sponsor of this very much needed legislation.
Mr. ALLARD. Mr. Speaker, I thank the gentleman for yielding me time.
Mr. Speaker, first of all, I would like to extend my thanks to other
members of the committee, the gentleman from Florida [Mr. Bilirakis],
the gentleman from Virginia [Mr. Bliley], the gentleman from Iowa [Mr.
Ganske], the gentleman from Wisconsin [Mr. Klug], who we just heard on
the floor, and then the gentleman from Michigan [Mr. Dingell]. I
appreciate all of their efforts in making sure that this legislation
came out of committee in good shape. I know they worked very hard to
make sure that we ended up with a good piece of legislation.
Mr. Speaker, this has been a bipartisan effort, both Democrats and
Republicans working together with the administration to reform the Food
and Drug Administration as they apply the laws as they apply to animal
drugs.
This is the second major reform of the Food and Drug Administration.
The first was the Delaney reform, and then this is the second step,
which is the animal Food and Drug Administration reform. Both of these
provisions are going to be a great help to the agricultural community.
We are looking at a crisis as far as approval of animal drugs is
concerned. The drugs are being approved at a very slow rate, and it is
having an impact on the type of quality and care, not only to the
livestock, but also to pets.
To further compound this problem, over the past several years, the
Food and Drug Administration has taken a number of drugs off of the
market, and the research has not been moving along at an adequate
enough rate to replace the loss of these particular products. As a
consequence of that, we have lost animals to disease and also had an
increased mortality rate on animals, which also cuts down on
production.
When a drug has finally been approved after some time, and I would
say, again, an internal audit by the FDA shows it takes an average of
58 months to approve a new drug, this law will take it down to where it
actually will take only 6 months.
{time} 1600
Because of this, the number of drugs that have been approved over the
last 23 years have dwindled. We used to have about 60 drugs approved in
1 year, about two decades ago, in 1973; and now, this last year, we
have only had 10 approved. This certainly is not keeping up with
science.
This is a tremendous disincentive for drug companies to create new
products when it takes this long extended length of period for
approval. And now, in order to develop a new product, we are looking at
a cost of anywhere from $15 to $200 million, and yet most of these
animal drugs have a very limited market and will generate sales of only
a million dollars or less.
I think this legislation is going to help solve this problem. It will
help make these drugs available for animals, both pets and in the
livestock industry, and it is going to move forward many of the
advances that should be moved forward and made available to the public.
In conclusion, I want to thank again the members of the committee for
all their hard work on this issue and I hope that we will continue to
move forward in our efforts to reform the Food and Drug Administration.
Mr. MANTON. Mr. Speaker, I yield 3 minutes to the gentleman from
Florida [Mr. Deutsch].
Mr. DEUTSCH. Mr. Speaker, I too rise today in support of the Animal
Drug Availability Act. This is Congress at its best, a bipartisan
effort which is going to really streamline the efforts at the FDA, that
is going to help really major livestock, poultry producers, commercial
feed industry, veterinarians, some animal owners, and pharmaceutical
companies as well.
Currently it takes the FDA an average of 58 months to a new animal
drug, and the cost of bringing a drug to the approval stage in some
instances can approach $200 million.
If the consensus bill becomes law, it will give the FDA greater
flexibility in determining the type and number of studies it can accept
as proof of an animal drug's efficacy.
It will reduce efficacy testing when a drug company seeks approval to
use in combination two drugs that are already approved individually.
It will eliminate the requirement that a time-consuming field
investigation be used in all instances to prove efficacy.
It will create a presubmission conference at which the FDA drug
companies will agree before an application is submitted on the types of
tests needed to approve a drug's effectiveness.
And it will increase veterinary oversight in dispensing of certain
feed drugs.
[[Page H10840]]
In addition, the bill implements two items from the National
Performance Review. It would allow FDA to set tolerance for drugs used
on farm animals whose meat ultimately is imported into the United
States. It also would reduce significantly the paperwork involved in
licensing of a feed mill to mix animal drugs with feed.
The consensus bill maintains all human and animal health protections
in current law.
Having spoken to individual veterinarians and pet owners, who have
unfortunately been denied access to some of the drugs that hopefully
will be readily accessible as soon as this bill is adopted, I can again
speak from their personal experiences of how valuable I believe this
bill will be once it is adopted into law.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to
the gentleman from Nebraska [Mr. Bereuter], who, if he does not have
the largest animal drug manufacturer in his district, I understand he
certainly has one of the largest.
(Mr. BEREUTER asked and was given permission to revise and extend his
remarks.)
Mr. BEREUTER. Mr. Speaker, I thank the distinguished gentleman from
Florida for yielding me this time.
I rise in support of H.R. 2508, the Animal Drug Availability Act. As
original cosponsor of this important legislation, I would like to
commend the distinguished gentlemen from Florida and New York, and the
gentleman from Virginia, Mr. Bliley, and the gentleman from Michigan,
Mr. Dingell, the ranking member, for bringing this work to the floor
today. Certainly I also commend my distinguished colleague from
Colorado, Mr. Allard, for his initiative in introducing the bill.
Mr. Speaker, this legislation is clearly needed to streamline the
bureaucracy and improve the current, outdated process of approving new
animal health products. Our Nation's livestock producers deserve to
have the best new products available in a timely and efficient manner.
This is commonsense legislation which has strong, bipartisan support in
Congress and broad support in the agricultural and veterinary science
communities.
The need for change is obvious. Although research and development
costs have increased dramatically in recent decades, the number of new
animal health products being approved by the Food and Drug
Administration's Center for Veterinary Medicine has declined. The
Animal Drug Availability Act modifies requirements for proving
efficacy, streamlines the bureaucracy involved in approving new claims
for products used in the treatment of minor species, simplifies
requirements for combination drugs, and makes other improvements in the
current process. Mr. Speaker, quite simply, this legislation will
improve the ability of manufacturers to provide the animal health
products needed by our Nation's farmers and pet owners, among others.
Therefore, this Member strongly urges his colleagues to support H.R.
2508, the Animal Drug Availability Act.
Mr. BILIRAKIS. Mr. Speaker, I yield 3 minutes to the gentleman from
Iowa [Mr. Ganske], who, as we know, performed a humanitarian act in
South America during the break and has come back with a fairly serious
sickness.
As I understand it, he came back specifically today to speak on this
particular piece of legislation because he feels very strongly about
it.
The SPEAKER pro tempore (Mr. Gunderson). If the gentleman from Iowa
would suspend for just a moment, I know the Chair speaks for all
Members in welcoming him back.
The gentleman from Iowa is now recognized.
Mr. GANSKE. Mr. Speaker, first let me thank Members of both sides of
the aisle for their get-well wishes. I appreciate it very much.
Earlier this month I was seriously ill and so I want to speak about
this bill in a little different vein, so to speak.
There will be a lot of talk about how this bill will economically be
beneficial to farmers, and that is true, and this will help our
country, I think, compete internationally in terms of livestock
production.
But I want to speak about something else. We have not had new drugs
to treat animals, have many of them, for a long time, and this bill
will streamline the process and help us get new ones. There is a term
called animal husbandry. It is an old term. It has been applied to
farmers, but I think it is appropriate.
When a farmer has a herd or has a flock, and they come down with a
respiratory infection and they are suffering and they are sick, that
farmer is not thinking just about the economic impact. He is looking at
his flock and he is looking at his herds and he knows they are sick and
he knows they are suffering. And if you talk to a family that has had a
pet and their pet dog or cat becomes sick, they see the suffering in
that animal.
I have been the beneficiary recently of modern medicine and some good
antibiotics and good medicines and I think it is time that we make the
modern technology that we have had on the human side more available on
the animal side as well.
I really think it is the only humanitarian thing to do. It will be
beneficial economically, but even more importantly, I think it will
help prevent animals from suffering when they are sick. I urge all of
my colleagues to vote for this bipartisan bill.
Mr. MILLER of California. Mr. Speaker, I am pleased to be an original
cosponsor of H.R. 3217, the National Invasive Species Act, which we
consider today. This legislation embodies a reasonable approach to
addressing economic and environmental concerns while maintaining
sensitivity to the maritime industry. It will establish a national
voluntary ballast management program for vessels visiting U.S. ports.
In addition to ballast management, this legislation will provide for
research, education, and new technology to investigate and prevent
species introduction in coastal and inland waters. In short, it is a
major step toward protecting our natural resources.
Prevention of further species introductions can occur to a great
extent by ballast exchange as provided in this legislation. I only
caution that the ballast exchange provisions in this bill are based on
a large part on a good faith agreement with industry to take
appropriate responsibility for the consequences of ballast transport.
Based on industry's support of this bill, I believe that agreement is
sound. However, I would encourage the Coast Guard to be diligent in
monitoring compliance and assessing the effectiveness of those
voluntary guidelines, and, where necessary, make mandatory regulations
to ensure protection for regions that are critically impacted by
nonindigenous species.
Some regions of our country such as the San Francisco Bay-Delta
Estuary are especially susceptible to species introduction from ballast
water. There are greater than 200 nonindegenous species identified so
far in the bay-delta with one new species established every 12 weeks.
In fact, the bay-delta is recognized as the most invaded aquatic
ecosystem in North America. These nonindigenous species are having
serious consequences on California's aquatic ecosystem, water supplies,
fisheries, and agricultural industry. This legislation will address
those consequences through prevention as well as research efforts in
the bay-delta. Understanding the patterns of species introductions and
reducing the occurrence of those introductions is imperative in
promoting the economic and ecological health of the bay-delta as well
as the rest of our coastal regions.
I thank Mr. LaTourette for his leadership on this bill. I would also
thank my colleague from California, Mr. Filner, as well as Chairman
Shuster and Mr. Oberstar, for working with me to include provisions
which address critical concerns in California.
Mr. HASTERT. Mr. Speaker, I rise in strong support of H.R. 2508, the
Animal Drug Availability Act of 1995. I'd like to commend the gentleman
from Colorado [Mr. Allard] for crafting a bill that enjoys such broad,
bipartisan support. I know of no opposition to this bill.
This bill is critical to animal agriculture and is sorely needed to
improve the animal drug approval process. Currently, it takes the FDA
an average of 58 months to approve a new animal drug, and the cost of
bringing a drug to approval in some instances can be as high as $200
million. This bill will streamline the approval process for animal
drugs, making safe drugs available more quickly and less expensively.
Clearly, the pork, cattle, poultry, and wool producers in my district
in Illinois will benefit tremendously from this legislation, as will
every pet owner in the country. But the benefits of this bill go far
beyond making life a little easier for our farmers and for our animals.
Ultimately, the real benefactors of this legislation will be every
consumer across America, as safe, cheaper animal products are made more
available.
The bill before us today represents a consensus that has been
negotiated with the
[[Page H10841]]
FDA. It enjoys broad bipartisan congressional support, and the full
support of the administration. I urge quick passage today of the Animal
Drug Availability Act. Thank you; I yield back the balance of my time.
Mr. BLILEY. Mr. Speaker, we now take up a bill that is important to
protect animal health at home and on the farm. The animal health
industry keeps our pets healthy--including some 130 million dogs and
cats--and agricultural animals that are vital to our food supply. The
animal health industry protects human health by safeguarding the health
of food and domestic animals.
I have heard repeated concern from Members on both sides of the aisle
that our FDA system for reviewing animal drug products needs
significant improvement. Their concern reflects the frustration of
diverse groups including agricultural interests, the animal drug
industry, veterinarians, and animal producer groups.
Our arsenal of drugs to fight animal disease is not growing.
The FDA review process for animal drugs is much too slow--instead of
6 months, the process has averaged up to 5 years.
Some industry has become discouraged and divested animal drug
development capability.
Mr. Allard, Mr. Ganske, Mr. Klug, have been among those who said that
it's time to take action and make changes. I particularly want to thank
Mr. Ganske who has come from his hospital bed to be here today to
demonstrate his support. Even the administration recognized the need to
reform to streamline animal drug regulation and made its own proposals
that were consistent with our views.
The committee considered animal drug regulations as part of a broader
initiative to streamline FDA regulation. We have made significant
progress and I am very pleased that today we take up the completed
animal drug reforms in H.R. 2508.
The committee efforts have been helped by collaboration from the
administration, the animal health coalition, veterinarians, and others
interested in safeguarding our animals. I would like to thank each of
them and their dedicated staff for their hard work.
H.R. 2508 will facilitate the approval and marketing of new animal
drugs and medicated feeds. It builds needed flexibility into the FDA
animal drug review processes to enable more efficient approval and more
expeditious marketing of safe and effective animal drugs.
H.R. 2508 accomplishes streamlines without decreasing FDA's existing
authority to ensure that animal drug products are safe for the animals
that use them and for the humans who consume animal food products.
Our reforms are sensible, pragmatic, and above all else, protective
of public health. Of this accomplishment, I believe we can rightly be
proud.
Mr. STENHOLM. Mr. Speaker, H.R. 2508 is an example of how serious
reform can and should occur. The Animal Drug Availability Act of 1995
enjoys broad support from camps that do not always see things from the
same viewpoint, however, both the FDA and the regulated community agree
on the reform embodied in H.R. 2508. Additionally, the users of animal
drugs, the veterinarians, and the various animal agriculture groups
representing farmers and ranchers that raise beef, pork, and poultry
all support this bill. The Animal Drug Availability Act represents what
can be accomplished when all involved, regulators, those regulated, and
the end users sit down and sincerely listen to each other.
Unfortunately, the larger issue of FDA reform has been slowed for a
variety of reasons. Hopefully, this bill should serve as an example of
how future Congresses can approach larger FDA reform and of the
progress that can result from bipartisan discussion open to all
stakeholders.
H.R. 2508, the Animal Drug Availability Act of 1995, represents
common sense reform that reduces regulatory hurdles for efficacy
testing and preserves safety testing. Let me say that again. The Animal
Drug Availability Act does not reduce evaluation of products on the
basis of human safety, nor does it reduce the FDA's ability to require
target animal safety information. Essential safety standards for humans
and animals would not be weakened in any way. The effect of the reform
should be a speedier approval process without jeopardizing safety
confidence.
Animal health products many times do not command lucrative markets
and it is difficult to justify investment into research and development
for a new product or an additional approved use on a label if markets
are limited or absent. Currently a large commitment in time and money
is required to prove a product's efficacy claims. This bill would give
the FDA greater flexibility in determining the type and number of
studies it can accept as proof of an animal drug's efficacy.
Streamlining the process and eliminating unnecessary field trials
should speed the time to an approval decision and hopefully reduce some
negative economic pressures being applied by the regulatory system.
Small markets or limited economic incentives, do not mean that drugs
for animals are not important. Take for instance the cattleman who has
experienced difficult times with low cattle prices who may be trying to
diversify and is starting to raise ostriches or pheasants, or a farmer
who is involved in aquaculture, or even the wildlife or zoo
veterinarian who deals with very unique patients. These are examples of
animals that as a species represent few in number and generate very
little economic incentive for a drug manufacturer to pursue R&D in that
area . . .the so-called minor use/minor species problem of animal
drugs. The legislation that legalized extra label drug use in animals
by veterinarians was sponsored by this Member and others in the last
Congress--the Animal Medicinal Drug Clarification Act of 1994. Extra
label drug use will always be necessary, however, this bill will
potentially help reduce the reliance on using drugs extra label. It can
offer an opportunity for FDA to evaluate how the Animal Medicinal Drug
Use Clarification Act and the Animal Drug Availability Act could
efficiently work together.
It is with some pride, as sponsor of the legislation that dealt with
extra label use of animal drugs and now as one of the original
cosponsors of the Animal Drug Availability Act, that this House is here
addressing this issue on the Suspension Calendar. I am proud that
animal drug regulatory reform may very well become an example of how
larger FDA regulatory reform can be accomplished. I ask my colleagues
to support H.R. 2508 and encourage the Senate to act quickly so that
the President can sign this appropriate reform into law.
Mr. ROBERTS. Mr. Speaker, I rise in strong support of this
legislation which is vital to the future health of the Nation's
livestock and poultry industry in rural districts throughout this
country. H.R. 2508, the Animal Drug Availability Act, is a
noncontroversial, bipartisan bill that streamlines and significantly
improves the process by which animal drugs are approved. The bill
expands the types of studies FDA can accept as proof of a drug's
efficacy; requires FDA and drug companies to agree to test protocols
before a company submits a drug application for approval; eliminates
time-consuming field investigations, unless they are the only way to
prove a drug's efficacy; eliminates some efficacy testing when a
company seeks to use two individually approved drugs in combination;
creates veterinary feed directive drugs which increase veterinarian
involvement in dispensing animal drugs; and eliminates much of the
licensing paperwork for feed mills that dispense animal drugs.
The bottom line: this bill is perhaps the most significant thing this
Congress can do to help the livestock and poultry industry reduce their
cost of production and become more competitive.
The cumbersome and lengthy process of getting animal drug approvals
from FDA has led to several U.S. animal drug companies setting up
plants overseas. Passage of this bill will also help stem the flow of
jobs--well paying jobs--from this country.
I am pleased to finally get a chance to discuss and vote on this
important piece of legislation and I would strongly urge my colleagues
to vote in favor of its passage.
Mr. MANTON. Mr. Speaker, I have no further requests for time, and I
yield back the balance of my time.
Mr. BILIRAKIS. 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 Florida [Mr. Bilirakis] that the House suspend the rules
and pass the bill, H.R. 2508, as amended.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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