[Congressional Record Volume 140, Number 142 (Tuesday, October 4, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: October 4, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
          THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS

  Mr. FORD. Mr. President, I ask unanimous consent that the Labor 
Committee be discharged from further consideration of S. 340, a bill 
regarding alternate uses of new animal drugs and new drugs intended for 
human use; and that the Senate proceed its immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report.
  The legislative clerk read as follows:

       A bill (S. 340) to amend the Federal Food, Drug, and 
     Cosmetic Act with respect to alternate uses of new animal 
     drugs and new drugs intended for human use, 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.
  Mr. FORD. Mr. President, I send a substitute amendment to the desk on 
behalf of Senator Heflin, and I ask that the amendment be agreed to, 
that the bill be read a third time and passed; the motion to reconsider 
be laid on the table and that any statements thereon appear at the 
appropriate place in the Record as though read.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 2612

  Mr. FORD offered an amendment No. 2612 for Mr. Heflin.
  The amendment is as follows:

       Strike all after the enacting clause, and insert in lieu 
     thereof the following:

     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), 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 403A(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 section 
     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).''.

  Mr. HEFLIN. Mr. President, I rise today in support of S. 340, 
legislation In introduced last year with Senators Shelby and Pressler, 
which will decriminalize the every day practice of veterinary medicine. 
No other licensed professions are forced to repeatedly break the law in 
order to responsibly carry out their professional duties. Due to an 
unintended consequence of legislation passed nearly 30 years ago, 
whenever a veterinarian uses an approved animal drug other than in 
strict accordance with its label, he or she is breaking the law. S. 340 
permits the extra-label use of approved animal drugs under a 
veterinarian's prescription, within the context of a valid 
veterinarian-client-patient relationship and in accordance with FDA's 
regulation. S. 340 frees veterinarians from their criminal burden and 
permits them to legally practice in the most responsible and humane 
manner, while protecting consumers and their pets.
  Extra-label drug use is an important issue for farmers and ranchers, 
veterinarians, pet owners, and consumers. For many years, FDA has 
recognized that the current Food, Drug and Cosmetic Act places 
veterinarians in an untenable position. On the one hand, the 
Veterinarian's Oath pledges the veterinarian to use ``scientific 
knowledge and skills for the benefit of society through the protection 
of animal health, the relief of animal suffering, the conservation of 
livestock resources, the promotion of public health, and the 
advancement of medical knowledge.'' On the other hand, the use of many 
effective drugs is illegal because they are not specifically labeled 
for the use intended by the veterinary medical practitioners.
  Unfortunately, it is not cost-effective for a pharmaceutical company 
to seek an approved label for all species and for which a drug is 
beneficial and safe. This bill gives veterinarians the ability to 
prevent pain, suffering, and death in their animal patients. Clearly, a 
drug like insulin, which was tested in dogs prior to its use in human 
beings, can be an effective therapy for diabetes in dogs, even though 
the product has never been formally approved for that use. Other 
medications, such as analgesics or anesthetics, may not be approved in 
cattle or goats, but are invaluable in relieving pain and making 
surgical procedures bearable. Can you imagine that in the United 
Kingdom it is illegal to dehorn a goat without an anesthetic--and that 
in the United States it is currently illegal to use one? By authorizing 
judicious extra-label use, this bill will rectify that situation.
  At the same time, S. 340 gives FDA full access to the tools necessary 
to assure the continue safety of the food supply and to keep unwanted 
and illegal residues of animal drugs from contaminating our food. The 
bill grants FDA the authority it needs to restrict any use of animal 
drugs that pose a risk to public health.
  This bill authorizes FDA to incorporate in its initial regulations 
the list of prohibited extra-label uses of drugs specifically listed by 
the name in the current compliance policy guide. Any new restrictions 
would have to go through the procedures established in this law prior 
to being prohibited.
  As the law is laid out, if the Secretary of Health and Human Services 
finds that there is reasonable probability that the use of an animal 
drug may present a risk to the public health, the Secretary may 
establish safe levels for residues of that animal drug and require 
development of an analytical method that will enable diction of any 
residues above the safe level. Residues that exceed the safe level will 
be considered unsafe and enforcement action may be taken against the 
parties responsible for those residues. If appropriate safe levels 
cannot be scientifically established, or if the analytical method is 
not developed, the Secretary may, after affording an opportunity for 
public comment, prohibit the specific unapproved use of that drug that 
is of public health concern. All uses that are not of public health 
concern. All uses that are not of public health concern would still be 
permitted under these conditions.
  The Secretary is also empowered to provide access to the prescribing 
records of veterinarians related to a specific unapproved use of an 
animal drug, once the Secretary has determined that specific use may 
present a risk to the public health.
  The bill also prohibits the unapproved use of an animal drug when 
another drug is labeled for that use and that species, but only in 
cases where the product approved for that use contains the same active 
ingredient and is in the same dosage form and concentration as the 
other drug. This preserves the veterinarian's latitude for scientific 
judgment in cases where slight differences in the drugs' composition 
may be significant, while at the same time rewards the pharmaceutical 
manufacturers who have been the investment in securing a specific 
approval for their product. This restriction applies only to approved 
animal drugs.
  S. 340 permits the extra-label use of human drugs in animals, subject 
to a valid veterinarian-client-patient relationship and a 
veterinarian's prescription, in accordance with FDA's regulations. 
Human drugs are used most extensively in companion animals, and in 
enacting S. 340, Congress intends to assist consumers and their pets by 
retaining access to the most medically effective, lowest cost products 
available.
  Mr. President, this bill is cosponsored by 70 Members of this body 
and 290 Members of the House. Animal owners, farmers and ranchers, 
veterinarian, humane groups and manufacturers of animal health products 
have joined together to support this important legislation.


                    extra-label use of animal drugs

  Mr. PRESSLER. Mr. President, today's action culminates 3 years of 
hard work with my colleagues Senators Heflin and Shelby. I have worked 
closely with them and the veterinary industry to pass this legislation 
clarifying Food and Drug Administration [FDA] procedures regarding 
extra-label use of animal drugs.
  I was first approached by veterinarians in South Dakota about the 
need for this legislation. Dr. Robert D. Snyder, a veterinarian from 
Groton, SD made a compelling argument regarding the need for this 
legislation in 1992. I worked closely with Dr. Snyder, and with leaders 
of the South Dakota Veterinary Association, including Dr. James Bailey 
and Dr. Fred Hubbard, on behalf of all veterinarians in South Dakota, 
to get this legislation passed. They are to be commended for their hard 
work and diligence in achieving this goal.
  The tireless efforts of the American Veterinary Association were also 
key in getting this legislation passed. I also want to thank my 
colleagues for supporting this bill, including the 69 Senators who 
cosponsored this measure.
  The bill is a straightforward approach to resolving the current 
conflict between modern veterinary medicine and the law.
  Current law prohibits the use of an animal drug for purposes other 
than those listed on the drug's label. It is not economically feasible 
under the present animal drug approval process to seek an approved 
label for all species and uses for which a drug is beneficial and safe. 
If a veterinarian is working to save the life of a cow or calf and the 
only effective treatment is a drug labeled only for horses, the letter 
of the law says a veterinarian cannot use the drug to save the cow or 
calf. This bill rectifies that situation and would allow the 
veterinarian to save the life of the animal without being in conflict 
with the law.
  This is an important issue for South Dakota's 34,000 farmers and 
ranchers and my State's veterinarians and consumers. After visiting 
with several veterinarians and discussing their daily routines and 
practices, I became convinced that extra-label drug use is necessary. 
Currently approved therapies are insufficient to treat the conditions 
veterinarians routinely face in practice. All too often, veterinarians 
face situations in which an animal's health is immediately threatened 
and suffering or death would result from failure to provide prompt and 
effective treatment.
  Mr. President, the FDA recognizes that a veterinarian, on occasion, 
will find it necessary to use an approved drug for a use not listed on 
the drug's label. In fact, the FDA has stated it will not institute 
regulatory action against licensed veterinarians for using or 
prescribing any drugs legally obtained. Thus, this bill codifies 
existing FDA practice.
  This Nation's veterinarians use drugs in an extra-label manner to 
save animals' lives, and to prevent suffering. This bill provides the 
FDA and veterinarians with a clear, easily enforceable statute. The 
bill permits the FDA to develop practical and constructive regulations 
to define violations of the Food, Drug and Cosmetic Act. Most important 
to many of my constituents, it will resolve existing conflicts between 
modern veterinary medicine and the law.
  Mr. President, I will continue to work for enactment of this bill 
this year.
  So the bill was deemed read a third time, and passed, 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 403A(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).''.

                          ____________________