[Congressional Record Volume 142, Number 133 (Tuesday, September 24, 1996)]
[Senate]
[Pages S11204-S11209]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ANIMAL DRUG AVAILABILITY ACT
Mr. FRIST. Mr. President, I ask unanimous consent the Labor Committee
be discharged from further consideration of S. 773, and the Senate
immediately proceed to its consideration.
The PRESIDING OFFICER. Without objection, it is so ordered. The clerk
will report.
The assistant legislative clerk read as follows:
A bill (S. 773) 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.
The PRESIDING OFFICER. Is there objection to the immediate
consideration of the bill?
There being no objection, the Senate proceeded to consider the bill.
Amendment No. 5401
(Purpose: To provide for a substitute amendment)
Mr. FRIST. Mr. President, Senator Kassebaum has a substitute at the
desk. I ask for its consideration.
The PRESIDING OFFICER. The clerk will report.
The assistant legislative clerk read as follows:
The Senator from Tennessee [Mr. Frist], for Mrs. Kassebaum,
proposes an amendment numbered 5401.
(The text of the amendment is printed in today's Record under
``Amendments Submitted.'')
Mrs. KASSEBAUM. Mr. President, I wish to thank my colleagues for
agreeing to the passage of S. 773, the Animal Drug Availability Act.
This legislation is designed to address the severe shortage of new
drugs for the treatment of animals. The bill will modernize clinical
testing requirements and make them more predictable and will improve
the efficiency and timeliness of the Food and Drug Administration's
[FDA] review of new animal drug applications, while at the same time
ensuring that new animal drugs are safe for animals and humans and are
effective.
The Senate's passage of this legislation is a testament to what can
be accomplished when the FDA, the regulated industry, and Congress
recognize a problem--in this case, the lack of new drugs for treating
animals--and work together in good faith to craft and enact creative,
reasonable solutions to that problem. Dr. Steve Sundlof, the director
of the FDA's Center for Veterinary Medicine, and his staff deserve
great credit for their dedication to meaningful animal drug law and
regulation reform in this Congress.
I wish especially to thank each of the Members who has cosponsored
and worked with me for the passage of this legislation. Without their
effort and dedication to seeing this bill through the legislative
process, we would not have succeeded in passing this bill today. Our
former majority leader, Senator Dole, and Senators Lugar, Pryor,
Pressler, Gregg, Gorton, Coats, Jeffords, Frist, Harkin, Craig, Inhofe,
Grassley, McConnell, Kyl, Santorum, Heflin, Bond, Kerrey, Bennett,
Helms, Hutchison, Lott, Bumpers, Mack, Ashcroft, Cochran, Roth, Warner,
Ford, Kempthorne, Robb, Nickles, Stevens, Abraham, Daschle, Grams,
Conrad, Burns, Moseley-Braun, Dorgan, Baucus, and Hatch each deserve
great credit for their active support for this legislation.
[[Page S11205]]
I ask unanimous consent a summary of the bill be printed in the
Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 773, The Animal Drug Availability Act--Summary
The Animal Drug Availability Act, S. 773, was introduced on
May 5, 1995, by Senator Kassebaum. It was approved by the
Senate Committee on Labor and Human Resources on March 28,
1996, as part of S. 1744, the FDA Performance and
Accountability Act, and now has a total of 43 bipartisan
Senate cosponsors. Subsequently, S. 773 was refined in close
collaboration with the Food and Drug Administration (FDA),
and the amendment in the nature to S. 773 reflects these
refinements.
S. 773 is designed to address the serious lack of drugs for
treating animals by modernizing and making more predictable
the FDA's requirements for new animal drug testing and
improving the efficiency and timeliness of FDA's review of
new animal drug applications, without compromising either
human or animal safety or product effectiveness.
These reforms include:
1. Determination of effectiveness: The legislation would
clarify the discretionary authority of the FDA to rely on one
adequate and well-controlled investigation for the
determination of the effectiveness of an animal drug. The
study or studies could, but would no longer automatically be
presumed to, require field investigation(s).
2. Combination drugs: The legislation clarifies that when
an already approved animal drugs are used in combination with
one another, the FDA may approve the combination drug as long
as none of the drugs in combination exceeds its established
tolerance or none of the drugs interferes with the working of
another of the drugs.
3. Collaborative protocol design: The legislation provides
for a collaborative protocol design process. The FDA is
required to meet with individuals intending to investigate or
investigating new animal drugs to mutually decide on the
appropriate protocol for the clinical investigation. If the
FDA decides that more than one field investigation will be
necessary, the FDA must set forth its scientific
justification for that decision.
4. Drugs for minor uses and species: The legislation
directs the Secretary to propose legislative or regulatory
options for facilitating the approval of animal drugs for
minor species and minor uses.
5. Drug tolerance setting: The legislation clarifies that
the FDA may approve animal drugs which will not exceed the
tolerance set for that drug, as opposed to requiring the
manufacturer to determine an optimal dose for the drug.
6. Tolerance for unapproved drugs: The legislation provides
the Secretary new authority to set tolerances for new animal
drugs that are not approved in the U.S. but are used in
animals imported for consumption in this country.
7. Veterainary feed directive drugs: The legislation
establishes a new category of animal drugs--``veterinary feed
directive drugs.'' This is a category of drugs between
prescription drugs and over-the-counter drugs. The bill
establishes a number of requirements to ensure that these
drugs can be tracked and that they are used appropriately.
8. Feed mill licensing: The legislation establishes a new
requirement for the licensing of feed mills that are
manufacturing feeds containing animal drugs to ensure
conformity with good manufacturing practices and for other
reasons.
Mr. LUGAR. Mr. President, I am pleased that the Animal Drug
Availability Act (S. 773) is before the full Senate for consideration
today.
As an original cosponsor of this legislation, I recognize the need
for reform of the Food and Drug Administration [FDA] animal drug
approval process. Producers and manufactures of animal drugs have been
concerned with the lengthy time required to gain FDA approval of animal
drugs as well as the lack of new drug options available to treat
livestock and poultry.
The legislation before us today is a consensus bill that is
acceptable to FDA, agricultural procedures, pharmaceutical and animal
health organizations and has garnered bipartisan support in the Senate.
I had written to Senator Kassebaum recently urging prompt action on
this legislation and thank her for her efforts to move this bill
forward.
The bill before us today will provide FDA with greater flexibility to
determine when animal drugs are effective for intended uses; streamline
approval of combination animal drugs when the drugs have been
previously approved separately for the same species and conditions of
use; provide FDA with greater flexibility in whether field
investigations are necessary to prove efficacy; and require
presubmission conferences to help FDA and drug manufacturers to reach
agreement on testing requirements before a drug application is
submitted to FDA. In addition, the bill streamlines the drug
application licenses for feed mills, permits FDA to set import
tolerances for drugs used in other countries, and includes a veterinary
feed directive provision which will make new therapeutic animal drugs
accessible in feed form.
I urge my colleagues to support this important bill.
Mr. GREGG. Mr. President, I rise today to talk about the demise of
one very important piece of legislation--the 1996 FDA reform bill--and
what I hope will be the success of another--the animal drug
availability reform bill. These bills represent important Republican
priorities: American patients and consumers, innovation in medicine and
consumer products, and a smaller role for the Federal Government.
Republicans put forth an FDA reform bill, supported in the Labor
Committee by three of our Democratic colleagues, that puts the needs of
our citizens first. Our goal in developing this legislation was clearly
to expedite the bureaucratic review process at the Food and Drug
Administration, while still recognizing their role in ensuring the
safety of products such as pharmaceuticals, medical devices, and food
additives being introduced into domestic and international commerce.
In the Labor Committee, our discussions focused on the
reprioritization of Agency resources and attitudes in order to achieve
this goal. And while some have characterized these provisions as
extreme, I believe that it is important to recognize that a number of
provisions in the bill that our chairman, the senior Senator from
Kansas [Mrs. Kassebaum] assembled simply recodify current law--albeit
not current practice--by the FDA.
In addition, this legislation contained a number of incremental
improvements to the Food, Drug and Cosmetic Act. While I will freely
admit that many of these provisions do not go as far as the changes
that I advocate, I recognize the balance that Senator Kassebaum was
attempting to strike; that is why I voted in favor of this legislation
in Committee. I also would like to mention the spirit of the
negotiations that I observed Senator Kassebaum engaged in with our
Democratic colleagues and the administration. I thought her approach to
this important issue was eminently fair, balanced, and accommodating.
Mr. President, FDA reform is not a new idea. Like so many of the
issues we take on, discussion and debate about FDA reform has been
going on for many years. For example, the Edwards Commission was
established by charter in 1989 and authorized by then Secretary of
Health and Human Service Dr. Louis Sullivan. This task force was formed
in response to a growing perception that FDA was in crisis. Serious
questions had been raised about the agency's ability to do its job.
After a year of public testimony and study, they published a report
in May, 1991--a detailed analysis of the FDA's inner workings. The
report concluded that the FDA was an agency in crisis. A large part of
the report focused on internal structure, organization and management;
the report recommended individual center adopt mission statements and
that paper work flow studies be conducted agencywide. As a result of
the report, Congress gave FDA substantially more money and staff--but I
think that we all now understand that simply providing the FDA more
resources does not solve the problems they have at the Agency.
Mr. President, I originally had high hopes for FDA reform this
Congress. On March 16, 1995, in a speech at an environmental facility
in Virginia announcing phase II of the Reinventing Government
initiative, the President even acknowledged that FDA reform was a vital
issue. In RE-GO II, the administration issued specific recommendations
for the reform of the FDA to be achieved through legislative and
regulatory changes. However, I was concerned by the quotation used from
the President's rhetoric on the first page of the follow up white
paper: ``The Food and Drug Administration has made American drugs and
medical devices the envy of the world and in demaind all over the
world.''
I believe that it is this sort of perception that has gotten us to
the point where we are today: a regulatory system that no longer has
clear boundaries or delineated goals, is anticompetitive, and has an
attitude that we must function as ``the FDA to the
[[Page S11206]]
world.'' Former Commissioner Dr. Charles Edwards put it more
appropriately when he said that, ``The mission of the FDA is consumer
protection. Unfortunately, the FDA has tended to confuse its mission
with the power to promote what it deems to be appropriate personal and
professional behavior.'' No matter--the administration's white paper of
reforms proved to be more of a red herring than anything else.
The FDA has demonstrated a lack of investment on their part in the
private sectors' efforts to bring cutting edge medicine to American
patients. Businesses do not engage in activities lightly, especially
small business making substantial investments in their own future. The
FDA has also indicated an unwillingness to let scientists determine the
standard of science, to let doctors freely practice medicine, and to
allow patients to be informed about their range of options.
To the FDA, it all seems to be about money. The authorized user
fees--or taxes placed on the backs of companies working to provide
innovative health care solutions--in the Administration's budget
request continue to grow. The Administration also continues to annually
request two unauthorized user fees: one would levy a new tax on medical
device manufacturers and another would be an important inspection fee.
Increasing taxes will not solve the problems that persist at the Food
and Drug Administration.
Peter Barton Hutt, former FDA General Counsel, summed this up well in
a speech before the Utah International Medical Device Congress in 1993.
He stated, ``User fees is a false issue. If we do not change the
philosophy of the FDA reviewers about the criteria for approving either
Section 510(k) notifications or PMA applications, we can triple the
number of people in the FDA and not get one additional application
approved.'' It is these sort of changes in philosophy, as well as
corrections to the fiscal priorities, that we are seeking at the FDA
through our reform efforts. But, unfortunately, Congress cannot
legislate attitude.
I also remain unconvinced that new user fees would ever be sunset,
even if the application backlog is cleared. I think the discussion we
will soon begin in regard to the renegotiation of PDUFA will be
revealing on this count. I also have yet to see any proposal that would
refund user fees to any company if the product review was not completed
within the statutory timeline--this is an agency that wants to function
like a business without regard to the rules of business--``Get what you
pay for.'' I don't see why businesses should be expected to tolerate
this.
In recent years, there also seems to have been a marked shift from
product approval to enforcement at FDA. While there is no clear cut
cause for this sea change, the intimidation that has resulted from
these actions is great. There is, of course, no way to accurately
measure the chilling effect this may be having on relevant industries.
But this police state mentality has spilled over into the appropriate
regulation of product safety.
Companies are terrified that they will be made the victim of a public
campaign in the media. The FDA is reputed for its role in propagating
widespread fear of retaliation against any company that would cooperate
with Congress in its examination of the FDA's mission and regulatory
practices. We have found that a number of individuals and companies
fear retribution in the form of delayed FDA product reviews and
regulatory discrimination if they should criticize the agency. This
fear has led to hesitancy on the part of potential witnesses to provide
committees with the testimony that they need in order to make an
informed judgment on the policies and practices of the agency.
Commissioner Kessler has argued that the industry perceives issues to
be something other than what they actually are, such as the Reference
List being viewed as a ``black list.'' While we appreciated the
assurances made to the Labor Committee by the Commissioner that such
fears are unfounded, I have yet to learn what affirmative steps the FDA
has taken to reassure those regulated by the agency that they may feel
completely comfortable exercising their right to speak freely to the
Congress, without threat of retribution or retaliation from the agency.
I have to wonder how many stories continue to go untold, how many
problems go unexplored, how many questions remain unanswered.
However, Mr. President, I am pleased to note that a couple of FDA-
related problems have been resolved this Congress. One dealt with the
untenable restrictions placed on U.S. manufacturers regarding their
ability to export products approved for use in other countries, but not
yet approved for domestic commerce. Working closely with my colleague
from Utah, Senator Hatch, we engaged in a lengthy dialog with ranking
minority member of the Labor Committee, Mr. Kennedy. The result was
passage of reform of sections 801 and 802 of the Federal Food, Drug and
Cosmetic Act, provisions which govern the import and export of FDA-
regulated products. Subsequently, these provisions were signed into
law, a major victory for U.S. manufacturers who are no longer obligated
to build factories and send jobs and investment capital overseas.
A second major issue that was partially resolved dealt with the
ridiculously unscientific Delaney Clause. Countless experts and
virtually every former Commissioner have stated the fact that a ``zero
risk'' standard is not only unscientific, but virtually immeasurable.
As analytical examinations have improved, science has been able to
detect ever-shrinking amounts of trace chemicals in our food supply--
excellent science means that minute, formerly undetectable amounts of
pesticides and chemicals can be detected, and even though they pose no
threat over a human lifetime, would be banned under the unrealistic
Delaney scheme. Fortunately, this Congress had the bipartisan wisdom to
institute a realistic, scientifically based standard in place of the
Delaney Clause as it related to the regulation of pesticides. Congress
recognized that in this day and age ``zero risk'' would come close to
meaning ``zero food.'' The Delaney reform signed into law takes us out
of the realm of the theory of a health treat, and into a food safety
realm that balances health considerations with an abundant, affordable
food supply.
And, Mr. President, I am hopeful that we will add this animal drug
reform compromise to the list of items we have accomplished this
Congress. I understand from my colleague from Kansas that this
legislation is the result of a real effort on the part of the FDA, the
relevant industry, and her staff. I also understand that the House has
taken action on this matter, so there is a realistic chance for these
provisions to become law--the type of all that we can all feel good
about, a law that balances consumer safety with an appropriate level of
Federal regulation.
I also hope that we will have an opportunity to clear the way for one
other related measure before Congress adjourns--the biomaterials bill
that Senators Gorton, Lieberman, and McCain have been championing for
many months. This legislation, which provides reasonable relief to the
suppliers of critical raw materials. This relief is necessary to ensure
that life-sustaining and life-enhancing devices will remain readily
available to American patients.
Mr. President, let me just conclude by saying that the discussion of
FDA reform will continue into the next Congress. This is a high
priority for many of us, as it is such a high priority for American
patients and consumers on a daily basis. We will continue to work hard
to define an appropriate role for the Federal Government--for the FDA--
in the lives of our citizens.
Mr. HARKIN. Mr. President, I am pleased to that we are today seeing
Senate passage of this important legislation. I especially want to
thank Senator Kassebaum for her efforts in working out the details of
this consensus bill and in arranging for its passage as a freestanding
measure. I also want to thank Senator Kennedy for his cooperation and
efforts in clearing the bill for passage.
I am proud to be an original cosponsor of the legislation. It has
been very gratifying to have been a part of the process of reaching
agreement on the provisions of this bill among representatives of the
animal drug industry, livestock and poultry producer organizations,
consumers and the Food and Drug Administration. In particular, I would
like to commend Dr. Stephen Sundlof, Director of the Center for
Veterinary Medicine at FDA for his hard
[[Page S11207]]
work and cooperation in reaching consensus on this bill. This has been
an exemplary effort in reaching a common-sense balance between the need
for adequate regulation and the practical realities of livestock and
poultry production.
The bill does not in any way weaken the protections for human health
contained in current law pertaining to animal drugs. The bill does,
however, streamline the animal drug approval process, primarily by
removing unnecessary and duplicative testing and investigation
requirements found in current law. By reducing unnecessary requirements
in the approval process, the approval of new animal drugs will become
less costly and time consuming. That is very important, since the
livestock and poultry industries are facing a near crisis caused by the
lack of approved new drugs. For example, there has been only one new
drug approved for use in swine since 1990, and that drug cannot be
marketed as a practical matter until this legislation passes.
The bill also contains a much needed resolution of the problems
associated with veterinary oversight in dispensing of drugs for use in
livestock and poultry feeds.
This legislation is a huge step forward in improving FDA's animal
drug approval process and a real victory for livestock and poultry
producers, consumers and producers of animal drugs.
Mr. FRIST. Mr. President, I ask unanimous consent the amendment be
agreed to, the bill be deemed read a third time and passed, the motion
to reconsider be laid upon the table, and that any statement relating
to the bill appear at this point in the Record.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment (No. 5401) was agreed to.
The bill (S. 773), as amended, was deemed read for a third time and
passed, as follows:
S. 773
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.--
(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
[[Page S11208]]
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 US.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 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
[[Page S11209]]
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 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.
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