[Congressional Record Volume 140, Number 144 (Thursday, October 6, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: October 6, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
          ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994

  Mr. WAXMAN. Mr. Speaker, I ask unanimous consent that the Committee 
on Energy and Commerce be discharged from further consideration of the 
Senate bill (S. 340) to amend the Federal Food, Drug, and Cosmetic Act 
to clarify the application of the act with respect to alternate uses of 
new animal drugs and new drugs intended for human use, and for other 
purposes, and ask for its immediate consideration in the House.
  The Clerk read the title of the Senate bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from California?
  Mr. MOORHEAD. Mr. Speaker, reserving the right to object, I will not 
object, and I take this reservation for the purpose of asking the 
gentleman from California [Mr. Waxman] to explain this Senate bill.
  Mr. WAXMAN. Mr. Speaker, this bill addresses a problem that has 
plagued veterinarians for many years; namely, the divergence between 
the law and veterinary practice with respect to the prescribing of 
animal drugs.
  Here is what has happened. It is common medical practice for animal 
doctors to use drugs that have been approved by the FDA for unapproved 
uses. In other words, a drug that has been approved for sheep is often 
used in cows. Since there may be no drug approved for cows for a 
particular disease, the veterinarian has little choice but to break the 
law. In fact, as a matter of its enforcement discretion, the FDA 
permits animal doctors to prescribe drugs for unapproved uses.
  In recent years, veterinarians have become increasingly concerned 
about this problem. They have convinced me that the law must be changed 
to take in account the realities of medical practice.
  In drafting this bill, we have recognized that it is essential that 
the FDA know what animal drugs are used in food-producing animals for 
unapproved uses, and that it have the tools that it needs to monitor 
animal drug residue from those uses. I believe that this bill strikes 
the appropriate balance between the need of veterinarians and the need 
to protect the food supply. It will permit veterinarians to use drugs 
for unapproved uses, while giving the FDA the authority to regulate 
those uses and to impose requirements to protect the public health 
where appropriate.
  The bill also contains a provision that would clarify that under the 
Federal Food, Drug, and Cosmetic Act the State of Vermont may retain 
its standard for maple syrup.
  Considerable work has been required to craft the bill. I would like 
to note that Mr. Stenholm introduced the original bill, H.R. 1423, 
which alerted us to this issue. The American Veterinary Medical 
Association has worked very hard and very constructively to develop 
this bill. I would like to acknowledge Kay Holcombe of the Energy and 
Commerce Committee staff and David Meade, our legislative counsel, who 
both made a significant contribution to this legislation.
  I would also like to single out our subcommittee counsel, Mr. Bill 
Schultz, for his work in getting this bill to the point where it is 
today.
  I am pleased that we have been able to resolve this issue, and I urge 
my colleagues to vote in support of this bill.
  (Mr. MOORHEAD. asked and was given permission to revise and extend 
his remarks.)
  Mr. MOORHEAD. Mr. Speaker, further reserving the right to object. I 
am pleased to support this legislation. This bill is a modified version 
of H.R. 1432, a bill introduced by Representative Stenholm which 
currently has 287 cosponsors. The primary purpose of this legislation 
is to permit veterinarians to prescribe approved animal or human drugs 
to species of animals for which the drugs are not currently approved.
  The legislation is necessary because there are an insufficient number 
of drugs approved for all the various disease problems in all the 
animal species. Generally, an animal drug is approved on a species-by-
species basis. For example, if a drug is approved for use in cows, the 
company must also go through the approval process to get that same drug 
approved for use in sheep. This process can be prohibitively expensive 
and, therefore, many animal drugs are not approved for use in multiple 
animals, especially for so-called minor species.
  However, this bill does not address a very significant problem--the 
lack of drugs available to treat animals. A new animal drug application 
review process is required by law to be completed within 6 months. 
However, the reality is that the review process at FDA now averages 4 
years. Hopefully, in the next Congress we can work to try to expedite 
the approval process for new animal drug applications.
  I urge my colleagues to join me in supporting this bill.
  Mr. Speaker, I withdraw my reservation of objection.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from California?
  There was no objection.
  The Clerk read the Senate bill, as follows:

                                 S. 340

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Animal Medicinal Drug Use 
     Clarification Act of 1994''.

     SEC. 2. UNAPPROVED USES.

       (a) General Rule.--Section 512(a) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360b(a)) is amended by 
     adding the following new paragraphs at the end:
       ``(4)(A) Except as provided in subparagraph (B), if an 
     approval of an application filed under subsection (b) is in 
     effect with respect to a particular use or intended use of a 
     new animal drug, the drug shall not be deemed unsafe for the 
     purposes of paragraph (1) and shall be exempt from the 
     requirements of section 502(f) with respect to a different 
     use or intended use of the drug, other than a use in or on 
     animal feed, if such use or intended use--
       ``(i) is by or on the lawful written or oral order of a 
     licensed veterinarian within the context of a veterinarian-
     client-patient relationship, as defined by the Secretary; and
       ``(ii) is in compliance with regulations promulgated by the 
     Secretary that establish the conditions for such different 
     use or intended use.

     The regulations promulgated by the Secretary under clause 
     (ii) may prohibit particular uses of an animal drug and shall 
     not permit such different use of an animal drug if the 
     labeling of another animal drug that contains the same active 
     ingredient and which is in the same dosage form and 
     concentration provides for such different use.
       ``(B) If the Secretary finds that there is a reasonable 
     probability that a use of an animal drug authorized under 
     subparagraph (A) may present a risk to the public health, the 
     Secretary may--
       ``(i) establish a safe level for a residue of an animal 
     drug when it is used for such different use authorized by 
     subparagraph (A); and
       ``(ii) require the development of a practical, analytical 
     method for the detection of residues of such drug above the 
     safe level established under clause (i).

     The use of an animal drug that results in residues exceeding 
     a safe level established under clause (i) shall be considered 
     an unsafe use of such drug under paragraph (1). Safe levels 
     may be established under clause (i) either by regulation or 
     order.
       ``(C) The Secretary may by general regulation provide 
     access to the records of veterinarians to ascertain any use 
     or intended use authorized under subparagraph (A) that the 
     Secretary has determined may present a risk to the public 
     health.
       ``(D) If the Secretary finds, after affording an 
     opportunity for public comment, that a use of an animal drug 
     authorized under subparagraph (A) presents a risk to the 
     public health or that an analytical method required under 
     subparagraph (B) has not been developed and submitted to the 
     Secretary, the Secretary may, by order, prohibit any such 
     use.
       ``(5) If the approval of an application filed under section 
     505 is in effect, the drug under such application shall not 
     be deemed unsafe for purposes of paragraph (1) and shall be 
     exempt from the requirements of section 502(f) with respect 
     to a use or intended use of the drug in animals if such use 
     or intended use--
       ``(A) is by or on the lawful written or oral order of a 
     licensed veterinarian within the context of a veterinarian-
     client-patient relationship, as defined by the Secretary; and
       ``(B) is in compliance with regulations promulgated by the 
     Secretary that establish the conditions for the use or 
     intended use of the drug in animals.''.
       (b) Other Amendments.--
       (1) Section 301.--Section 301 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 331) is amended--
       (A) in paragraph (e), by striking ``507(d) or (g),'' and 
     inserting ``507(d) or (g), 512(a)(4)(C),''; and
       (B) by adding at the end the following:
       ``(u) The failure to comply with any requirements of the 
     provisions of, or any regulations or orders of the Secretary, 
     under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).''.
       (2) Section 512(e).--Section 512(e)(1)(A) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e)(1)(A)) is 
     amended by inserting before the semicolon the following: ``or 
     the condition of use authorized under subsection (a)(4)(A)''.
       (3) Section 512(l).--Section 512(l)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360b(l)(1)) is amended by 
     striking ``relating to experience'' and inserting ``relating 
     to experience, including experience with uses authorized 
     under subsection (a)(4)(A).''
       (c) Regulations.--Not later than 2 years after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services shall promulgate regulations to implement paragraphs 
     (4)(A) and (5) of section 512(a) of the Federal Food, Drug, 
     and Cosmetic Act (as amended by subsection (a)).
       (d) Effective Date.--The amendments made by this section 
     shall take effect upon the adoption of the final regulations 
     under subsection (c).

     SEC. 3. MAPLE SYRUP.

       (a) Preemption.--Section 403(a) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 343-1(a)) is amended--
       (1) in paragraph (1), by inserting at the end the 
     following: ``except that this paragraph does not apply to a 
     standard of identity of a State or political subdivision of a 
     State for maple syrup that is of the type required by 
     sections 401 and 403(g),'';
       (2) in paragraph (2), by inserting at the end the 
     following: ``except that this paragraph does not apply to a 
     requirement of a State or political subdivision of a State 
     that is of the type required by section 403(c) and that is 
     applicable to maple syrup,''; and
       (3) in paragraph (3) by inserting at the end the following: 
     ``except that this paragraph does not apply to a requirement 
     of a State or political subdivision of a State that is of the 
     type required by section 403(h)(1) and that is applicable to 
     maple syrup,''.
       (b) Procedure.--Section 701(e)(1) (21 U.S.C. 371(e)(1)) is 
     amended by striking ``or maple syrup (regulated under section 
     168.140 of title 21, Code of Federal Regulations).''.

  The Senate bill was ordered to be read a third time, was read the 
third time, and passed, and a motion to reconsider was laid on the 
table.

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