Legislative/Regulatory Update (Congress activities, regulatory activities, AVMA stance) - Dr. Christine Hoang, Assistant Director, Scientific Activities Division, American Veterinary Medical Association, from the 2013 NIAA Merging Values and Technology conference, April 15-17, 2013, Louisville, KY, USA. More presentations at http://www.trufflemedia.com/agmedia/conference/2013-niaa-merging-values-and-technology

1. Veterinarians and Antimicrobial Use
Legislative & Regulatory Update
Christine Hoang, DVM, MPH, CPH
American Veterinary Medical Association
choang@avma.org

2. Pew Health Professions Commission in
Health America: Practitioners for 2005
“Veterinarians are more knowledgeable about the impact of
animals and diseases on human health and the role and use of
animals in the improvement of health and well-being than any
other health professional in most communities. Thus
veterinarians should be more directly available to human
health providers for consultation on these subjects.”

3. Role of the Veterinarian
• AVMA Role of the Veterinarian Policy: Veterinarians should be involved in
the decision-making process for the use of antimicrobials in animals
regardless of the distribution channels through which the antimicrobials
were obtained.
– Additionally, the FDA references the veterinarian’s role in their Guidance for
Industry #209 - The Judicious Use of Medically Important Antimicrobial Drugs
in Food-Producing Animals in defining greater veterinary oversight.
• “Veterinary involvement in the decision-making process associated with
the use of medically important antimicrobial drugs is an important aspect
of assuring appropriate use, including judicious prevention use.”
• AVMA Judicious Use Policy: “When the decision is reached to use
antimicrobials for therapy, veterinarians should strive to optimize
therapeutic efficacy and minimize resistance to antimicrobials to protect
public and animal health.” … “Judicious use of antimicrobials, when under
the direction of a veterinarian, should meet all requirements of a
veterinarian-client-patient relationship.”

4. VCPR = oversight
The veterinarian-client-patient relationship (or
VCPR) is the basis for interaction among
veterinarians, their clients, and their patients.
• the veterinarian is personally acquainted with the
keeping and care of the patient
• The veterinarian provides oversight of
treatment, compliance and outcome
• Patient records are maintained

5. AVMA:
• MVPA = Model Veterinary Practice
Act
• PVME = Principles of Veterinary
Medical Ethics
FDA:
• AMDUCA = Animal Medicinal Drug
Use Clarification Act (AVMA and FDA
Info) for Extra-Label Drug Use
• VFD = Veterinary Feed Directive
(currently, but is not in the proposed
draft text for VFDs)
Where does it live?
• State Practice Acts

6. AMDUCA
• (i) A valid veterinarian-client-patient relationship is one in which:
• (1) A veterinarian has assumed the responsibility for making medical judgments regarding the health of
(an) animal(s) and the need for medical treatment, and the client (the owner of the animal or animals or
other caretaker) has agreed to follow the instructions of the veterinarian;
• (2) There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or
preliminary diagnosis of the medical condition of the animal(s); and
• (3) The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of
the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is
personally acquainted with the keeping and care of the animal(s) by virtue of examination of the
animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

7. Model Veterinary Practice Act
The AVMA Model Veterinary Practice Act is to serve as a set of guiding principles for state regulation of
the practice of veterinary medicine.
• The commentary to the model act explains that states may wish to further specify that
when establishing a VCPR in the case of large operations, “sufficient knowledge” of the
patient can be supplemented by means of:
– 1) examination of health, laboratory, or production records;
– 2) consultation with owners, caretakers or supervisory staff regarding a health management
program for the patient; or
– 3) information regarding the local epidemiology of diseases for the appropriate species.

8. Current MVPA
https://www.avma.org/KB/Policies/Pages/Model-Veterinary-Practice-Act.aspx
“Veterinarian-client-patient relationship” means that all of the following are required:
– The veterinarian has assumed the responsibility for making medical judgments regarding the health
of the patient and the client has agreed to follow the veterinarian’s instructions.
– The veterinarian has sufficient knowledge of the patient to initiate at least a general or preliminary
diagnosis of the medical condition of the patient. This means that the veterinarian is personally
acquainted with the keeping and care of the patient by virtue of:
• a timely examination of the patient by the veterinarian, or
• medically appropriate and timely visits by the veterinarian to the operation where the patient
is managed.
– The veterinarian is readily available for follow-up evaluation or has arranged for the following:
• veterinary emergency coverage, and
• continuing care and treatment.
– The veterinarian provides oversight of treatment, compliance and outcome.
– Patient records are maintained.

9. Commentary to Section 2• The definition of “veterinarian-client-patient relationship” (VCPR) in subsection 20 was changed in 2012, and is now different from that embodied
in federal regulation 21 CFR 530.3(i) relating to extralabel drug use.
• In 2012, subsection 14 was revised to define “patient” as “an animal or group of animals.” Therefore, the definition of VCPR can be applied to
individual animals as well as a group or groups of animals within an operation (production system).
• The AVMA recognizes that individual states may wish to more clearly define specific terms within the definition of VCPR. For example, a state
regulatory board may wish to include a specific time period (eg, no less frequent than 6 or 12 months) to better delineate the term “timely” relating
to examinations and visits. The term “timely” should be considered in light of the nature and circumstances of the patient (eg, species, condition or
disease, or operation).
• In 2012, subsections 20-b and 20-c were revised for purposes of clarification. Subsection 20-d was added to state that patient records must be
maintained to establish a VCPR.
• States may also wish to further specify that when establishing a VCPR in the case of large operations, “sufficient knowledge” can be supplemented
by means of:
1. examination of health, laboratory, or production records; or
2. consultation with owners, caretakers or supervisory staff regarding a health management program for the patient; or
3. information regarding the local epidemiology of diseases for the appropriate species.

10. Principles of Veterinary Medical Ethics
• Regardless of practice ownership, the interests of the patient, client, and public require that
all decisions that affect diagnosis, care, and treatment of patients are made by veterinarians.
• The responsibilities of the veterinary profession extend…to society in general. Veterinarians
are encouraged… to provide their services for activities that protect public health.
• Dispensing or prescribing a prescription product requires a VCPR
– Without a VCPR, veterinarians merchandising or… use of any pharmaceutical is
unethical...
• Veterinarians are responsible for choosing the treatment regimens for their patients.
• It is against our ethics to:
– be influenced by considerations other than the needs of the patient, the welfare of the
client, and the safety of the public.
– allow medical judgment to be influenced by agreements by which they stand to profit
through …products.

11. Prescription Requirements
• 21 USC chapter 9
– Established by AMDUCA for Extra-Label Drug Use– 1994 (summary) & FRN
• On pages 437 & 438 under New animal drugs in Section 360b (4)&(5)-“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”
– ADAA – 1996 (summary)
• On page 300 - (a) Lawful veterinary feed directive requirement - “to use
under the professional supervision of a licensed veterinarian” … “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.”

12. CFR Verbiage on VCPR and VFDs• Veterinary Feed Directive; Current Regulation
– 21 CFR Part 558.3 - “A veterinarian may issue a VFD only if a valid
– veterinarian-client-patient relationship exists, as defined in § 530.3(i) of this
chapter.”
– 21 CFR Part 558.6 – “You must issue a VFD only within the confines of a valid
veterinarian-client- patient relationship (see definition at § 530.3(i) of this chapter)”
• Veterinary Feed Directive; Draft Text for Proposed Regulation
– 21 CFR Part 558.3 - A ‘‘veterinary feed directive’’ is a written statement issued by a
licensed veterinarian in the course of the veterinarian’s professional practice that
orders the use of a VFD drug in or on an animal feed. This written statement
authorizes the client (the owner of the animal or animals or other caretaker) to obtain
and use the VFD drug in or on an animal feed to treat the client’s animals only in
accordance with the directions for use approved, conditionally approved, or indexed
by the Food and Drug Administration (FDA).
– 21 CFR Part 558.6 - The veterinarian may only issue a VFD for use in animals under
his or her supervision or oversight in the course of his or her professional
practice, and in compliance with all applicable veterinary licensing and practice
requirements.
c
c
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13. Next…
• State Practice Acts
• MVPA, PVME, other AVMA policies
• Species specific “BMP’s” ???

14. Prescription Requirements
• 21 USC chapter 9
– Established by GADPTRA – 1988 (summary)
• The language is in the USC in Section 353(f) Veterinary prescription drugs
on page 287 where it states “(4) A drug which is subject to paragraph (1)
shall be deemed to be misbranded if at any time prior to dispensing its
label fails to bear the statement "Caution: Federal law restricts this drug
to use by or on the order of a licensed veterinarian." A drug to which
paragraph (1) does not apply shall be deemed to be misbranded if at any
time prior to dispensing its label bears the statement specified in the
preceding sentence.
• On page 286-287 under veterinary prescription drugs (see highlighted
section in attached doc on those pages) – This states “shall be dispensed
only by or upon the lawful written or oral order of a licensed veterinarian
in the course of the veterinarian's professional practice”

15. How Vets work with Producers
Within the Veterinarian-Client-Patient-Relationship (VCPR) -
the producer is the “client” component of that relationship.
• assist producers in complying with their industry’s quality
assurance programs (that also contain the concepts below)
• work closely with producers to ensure the health and
welfare of their animals
• AVMA Judicious Use Policy: “Veterinarians should work
with those responsible for the care of animals to use
antimicrobials judiciously regardless of the distribution
system through which the antimicrobial was obtained.”

16. AVMA Efforts
Veterinary Foresight and Expertise in
Antimicrobial Discussions
AVMA Policy: AVMA recognizes that
veterinarians need to be involved in discussions
relative to judicious use of antimicrobials and
food supply veterinary medicine… to ensure that
risks and benefits to both humans and animals
are given due consideration.

17. AVMA Efforts
Numerous issue specific Task Forces and Steering
Committees as well as standing Councils and
Committees to provide guidance on these issues.
• 2009-2010 AVMA’s Antimicrobial Use Task Force
• 2010- present AVMA Steering Committee for
FDA Policy on Veterinary Oversight of
Antimicrobials.

18. Streamlining the VFD
The AVMA’s Steering Committee for Veterinary Oversight:
– engaged with the FDA as it proposed changes to the Veterinary Feed Directive (VFD) to
make it more workable and to gain greater veterinary oversight. Much of the feedback
provided by the Steering Committee was incorporated into the FDA’s VFD Draft Text for
Proposed Regulation published in July 2012
• The Veterinary Feed Directive (VFD) is the primary vehicle for greater veterinary
oversight of antimicrobials in feed
– continues to collaborate with the FDA to provide guidance from the veterinary
perspective and clarify veterinarians’ role in the oversight of antimicrobial use in animals
as regulatory changes are made to address antimicrobial resistance.

19. Listening Sessions
• The FDA has organized, in conjunction with USDA, 5 listening
sessions to be held throughout the country to hear input on the
implementation of its initiative for the judicious use of
antimicrobials in medicated feed or drinking water of food-
producing animals.
• AVMA is participating in these sessions given the importance and
role of the veterinary workforce in implementing changes.
• Information gleaned from these listening sessions will be provided
to AVMA decision makers (in addition to FDA and USDA) to enhance
understanding of the concerns associated with the FDA’s initiative
as we all continue working to enhance veterinary oversight.

20. Legislation
• Preservation of Antibiotics for Medical Treatment Act (PAMTA) - To amend
the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of
medically important antimicrobials.
• Delivering Antimicrobial Transparency in Animals (DATA Act) - To amend
the Federal Food, Drug, and Cosmetic Act to enhance the reporting
requirements pertaining to use of antimicrobial drugs in food animals.
• Animal Drug User Fee Act (ADUFA) - To amend the Federal Food, Drug,
and Cosmetic Act to reauthorize user fee programs relating to new animal
drugs and generic new animal drugs.

21. PAMTA
• The 113th Congressional version of the bill several changes from previous
iterations.
• The legislation now covers cephalosporins, bringing the total to eight classes of
medically important antibiotics that would be banned from “non-therapeutic”
uses (any kind of penicillin, tetracycline, macrolide, lincosamide, streptogramin,
aminoglycoside, sulfonamide, or cephalosporin).
• The measure also clarifies what is considered non-therapeutic “to ensure that any
use of medically important antibiotics outside of treatment of a sick animal is not
permitted,” according to Slaughter’s office.

22. PAMTA - Definitions
• ‘therapeutic use’, with respect to a medically important antimicrobial, means the use of
antimicrobials for the specific purpose of treating an animal with a documented disease or
infection. Such term does not include the continued use of such an antimicrobial in the animal
after the disease or infection is resolved.
• ‘nontherapeutic use’—
– “(i) means administration of antibiotics to an animal through feed and water (or, in poultry hatcheries,
through any means) for purposes (such as growth promotion, feed efficiency, weight gain, or disease
prevention) other than therapeutic use or nonroutine disease control; and
– “(ii) includes any repeated or regular pattern of use of medically important antimicrobials for purposes
other than therapeutic use or nonroutine disease control.
• ‘noncustomary situation’ does not include normal or standard practice and conditions on the
premises that facilitate the transmission of disease.
• ‘nonroutine disease control’ means the use of antibiotics on an animal that is not sick but
where it can be shown that a particular disease or infection is present, or is likely to occur
because of a specific, noncustomary situation, on the premises at the barn, house, pen, or
other level at which the animal is kept.

23. PAMTA - Prohibitions
It shall be unlawful to administer (including by means of animal feed) a medically important antimicrobial to a food-producing animal for
nonroutine disease control unless—
– (1) there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing
animal;
– (2) the administration of the medically important antimicrobial to the food-producing animal is necessary to prevent or
reduce the risk of transmission of the disease or infection described in paragraph (1);
– (3) the medically important antimicrobial is administered to the food-producing animal for nonroutine disease control for the
shortest duration possible to prevent or reduce the risk of transmission of the disease or infection described in paragraph (1)
to the animal; and
– (4) the medically important antimicrobial is administered—
• (A) at a scale no greater than the barn, house, or pen level; and
• (B) to the fewest animals possible to prevent or reduce the risk of transmission of the disease or infection described in
paragraph (1).

24. DATA Act
• enhanced reporting requirements
• to increase collaboration and coordination with the Secretary of
Agriculture to expand and coordinate the collection of data on the use of
antimicrobial drugs in or on cattle, swine, chickens, turkeys, and such
other food-producing animal species.
• to publish a final version of draft guidance #213
• to conduct a study evaluating
– (A) the voluntary approach used by the Food and Drug Administration
to eliminate injudicious use of antimicrobial drugs in food-producing
animals; and
– (B) the effectiveness of the data collection activities conducted by the
FDA regarding antimicrobial resistance.

25. ADUFA
• authorizes the FDA to collect fees from animal health companies to enable the Center for
Veterinary Medicine (CVM) to meet performance standards.
• ADUFA II will sunset in September 2013 and is scheduled to be reauthorized this year
Legislative Changes
• FDA will allow for multiple conditional approved indications on a single product label and
remove the requirement that indexed drugs be labeled “not FDA approved” for Minor
Use/Minor Species products
• Require notification of drug approvals on FDA’s website with the option to publish in the
Federal Register

26. AVMA
• www.avma.org
• www.kofs.org
Connect with us on
choang@avma.org
@AVMAvets
@ DrCHoang