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Dr. Christine Hoang - Legislative/Regulatory Update (Congress activities, regulatory activities, AVMA stance)
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Dr. Christine Hoang - Legislative/Regulatory Update (Congress activities, regulatory activities, AVMA stance)

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Legislative/Regulatory Update (Congress activities, regulatory activities, AVMA stance) - Dr. Christine Hoang, Assistant Director, Scientific Activities Division, American Veterinary Medical …

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

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  • Patient record requirement is also in PVME and means if you are recommendingmeds you have to keep record of it
  • Animal medicinal drug use clarification act
  • Last point = we don’t sell drugs for profit therefore vet oversight is not driven by an incentive to make money
  • Generic Animal Drug and Patent Term Restoration Act
  • greater oversight = greater judiciousness because of the VCPR, and the vets making medical decisions according to our policies (judicious use policy) and ethics.
  • Transcript

    • 1. Veterinarians and Antimicrobial UseLegislative & Regulatory UpdateChristine Hoang, DVM, MPH, CPHAmerican Veterinary Medical Associationchoang@avma.org
    • 2. Pew Health Professions Commission inHealth America: Practitioners for 2005“Veterinarians are more knowledgeable about the impact ofanimals and diseases on human health and the role and use ofanimals in the improvement of health and well-being than anyother health professional in most communities. Thusveterinarians should be more directly available to humanhealth providers for consultation on these subjects.”
    • 3. Role of the Veterinarian• AVMA Role of the Veterinarian Policy: Veterinarians should be involved inthe decision-making process for the use of antimicrobials in animalsregardless of the distribution channels through which the antimicrobialswere obtained.– Additionally, the FDA references the veterinarian’s role in their Guidance forIndustry #209 - The Judicious Use of Medically Important Antimicrobial Drugsin Food-Producing Animals in defining greater veterinary oversight.• “Veterinary involvement in the decision-making process associated withthe use of medically important antimicrobial drugs is an important aspectof assuring appropriate use, including judicious prevention use.”• AVMA Judicious Use Policy: “When the decision is reached to useantimicrobials for therapy, veterinarians should strive to optimizetherapeutic efficacy and minimize resistance to antimicrobials to protectpublic and animal health.” … “Judicious use of antimicrobials, when underthe direction of a veterinarian, should meet all requirements of aveterinarian-client-patient relationship.”
    • 4. VCPR = oversightThe veterinarian-client-patient relationship (orVCPR) is the basis for interaction amongveterinarians, their clients, and their patients.• the veterinarian is personally acquainted with thekeeping and care of the patient• The veterinarian provides oversight oftreatment, compliance and outcome• Patient records are maintained
    • 5. AVMA:• MVPA = Model Veterinary PracticeAct• PVME = Principles of VeterinaryMedical EthicsFDA:• AMDUCA = Animal Medicinal DrugUse Clarification Act (AVMA and FDAInfo) for Extra-Label Drug Use• VFD = Veterinary Feed Directive(currently, but is not in the proposeddraft 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 orother 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 orpreliminary 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 ofthe regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and ispersonally acquainted with the keeping and care of the animal(s) by virtue of examination of theanimal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.
    • 7. Model Veterinary Practice ActThe AVMA Model Veterinary Practice Act is to serve as a set of guiding principles for state regulation ofthe practice of veterinary medicine.• The commentary to the model act explains that states may wish to further specify thatwhen establishing a VCPR in the case of large operations, “sufficient knowledge” of thepatient 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 managementprogram for the patient; or– 3) information regarding the local epidemiology of diseases for the appropriate species.
    • 8. Current MVPAhttps://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 healthof 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 preliminarydiagnosis of the medical condition of the patient. This means that the veterinarian is personallyacquainted 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 patientis 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 embodiedin 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 toindividual 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 stateregulatory board may wish to include a specific time period (eg, no less frequent than 6 or 12 months) to better delineate the term “timely” relatingto examinations and visits. The term “timely” should be considered in light of the nature and circumstances of the patient (eg, species, condition ordisease, 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 bemaintained 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 supplementedby means of:1. examination of health, laboratory, or production records; or2. consultation with owners, caretakers or supervisory staff regarding a health management program for the patient; or3. 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 thatall decisions that affect diagnosis, care, and treatment of patients are made by veterinarians.• The responsibilities of the veterinary profession extend…to society in general. Veterinariansare 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 isunethical...• 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 theclient, and the safety of the public.– allow medical judgment to be influenced by agreements by which they stand to profitthrough …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)-“isby or on the lawful written or oral order of a licensed veterinarian withinthe context of a veterinarian-client- patient relationship, as defined by theSecretary”– ADAA – 1996 (summary)• On page 300 - (a) Lawful veterinary feed directive requirement - “to useunder the professional supervision of a licensed veterinarian” … “Anyanimal feed bearing or containing a veterinary feed directive drug shall befed to animals only by or upon a lawful veterinary feed directive issued bya licensed veterinarian in the course of the veterinarians professionalpractice.”
    • 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 thischapter.”– 21 CFR Part 558.6 – “You must issue a VFD only within the confines of a validveterinarian-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 alicensed veterinarian in the course of the veterinarian’s professional practice thatorders the use of a VFD drug in or on an animal feed. This written statementauthorizes the client (the owner of the animal or animals or other caretaker) to obtainand use the VFD drug in or on an animal feed to treat the client’s animals only inaccordance with the directions for use approved, conditionally approved, or indexedby the Food and Drug Administration (FDA).– 21 CFR Part 558.6 - The veterinarian may only issue a VFD for use in animals underhis or her supervision or oversight in the course of his or her professionalpractice, and in compliance with all applicable veterinary licensing and practicerequirements.cccc
    • 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 drugson 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 itslabel fails to bear the statement "Caution: Federal law restricts this drugto use by or on the order of a licensed veterinarian." A drug to whichparagraph (1) does not apply shall be deemed to be misbranded if at anytime prior to dispensing its label bears the statement specified in thepreceding sentence.• On page 286-287 under veterinary prescription drugs (see highlightedsection in attached doc on those pages) – This states “shall be dispensedonly by or upon the lawful written or oral order of a licensed veterinarianin the course of the veterinarians professional practice”
    • 15. How Vets work with ProducersWithin the Veterinarian-Client-Patient-Relationship (VCPR) -the producer is the “client” component of that relationship.• assist producers in complying with their industry’s qualityassurance programs (that also contain the concepts below)• work closely with producers to ensure the health andwelfare of their animals• AVMA Judicious Use Policy: “Veterinarians should workwith those responsible for the care of animals to useantimicrobials judiciously regardless of the distributionsystem through which the antimicrobial was obtained.”
    • 16. AVMA EffortsVeterinary Foresight and Expertise inAntimicrobial DiscussionsAVMA Policy: AVMA recognizes thatveterinarians need to be involved in discussionsrelative to judicious use of antimicrobials andfood supply veterinary medicine… to ensure thatrisks and benefits to both humans and animalsare given due consideration.
    • 17. AVMA EffortsNumerous issue specific Task Forces and SteeringCommittees as well as standing Councils andCommittees to provide guidance on these issues.• 2009-2010 AVMA’s Antimicrobial Use Task Force• 2010- present AVMA Steering Committee forFDA Policy on Veterinary Oversight ofAntimicrobials.
    • 18. Streamlining the VFDThe AVMA’s Steering Committee for Veterinary Oversight:– engaged with the FDA as it proposed changes to the Veterinary Feed Directive (VFD) tomake it more workable and to gain greater veterinary oversight. Much of the feedbackprovided by the Steering Committee was incorporated into the FDA’s VFD Draft Text forProposed Regulation published in July 2012• The Veterinary Feed Directive (VFD) is the primary vehicle for greater veterinaryoversight of antimicrobials in feed– continues to collaborate with the FDA to provide guidance from the veterinaryperspective and clarify veterinarians’ role in the oversight of antimicrobial use in animalsas regulatory changes are made to address antimicrobial resistance.
    • 19. Listening Sessions• The FDA has organized, in conjunction with USDA, 5 listeningsessions to be held throughout the country to hear input on theimplementation of its initiative for the judicious use ofantimicrobials in medicated feed or drinking water of food-producing animals.• AVMA is participating in these sessions given the importance androle of the veterinary workforce in implementing changes.• Information gleaned from these listening sessions will be providedto AVMA decision makers (in addition to FDA and USDA) to enhanceunderstanding of the concerns associated with the FDA’s initiativeas we all continue working to enhance veterinary oversight.
    • 20. Legislation• Preservation of Antibiotics for Medical Treatment Act (PAMTA) - To amendthe Federal Food, Drug, and Cosmetic Act to preserve the effectiveness ofmedically important antimicrobials.• Delivering Antimicrobial Transparency in Animals (DATA Act) - To amendthe Federal Food, Drug, and Cosmetic Act to enhance the reportingrequirements 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 animaldrugs and generic new animal drugs.
    • 21. PAMTA• The 113th Congressional version of the bill several changes from previousiterations.• The legislation now covers cephalosporins, bringing the total to eight classes ofmedically 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 anyuse of medically important antibiotics outside of treatment of a sick animal is notpermitted,” according to Slaughter’s office.
    • 22. PAMTA - Definitions• ‘therapeutic use’, with respect to a medically important antimicrobial, means the use ofantimicrobials for the specific purpose of treating an animal with a documented disease orinfection. Such term does not include the continued use of such an antimicrobial in the animalafter 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 diseaseprevention) other than therapeutic use or nonroutine disease control; and– “(ii) includes any repeated or regular pattern of use of medically important antimicrobials for purposesother than therapeutic use or nonroutine disease control.• ‘noncustomary situation’ does not include normal or standard practice and conditions on thepremises that facilitate the transmission of disease.• ‘nonroutine disease control’ means the use of antibiotics on an animal that is not sick butwhere it can be shown that a particular disease or infection is present, or is likely to occurbecause of a specific, noncustomary situation, on the premises at the barn, house, pen, orother level at which the animal is kept.
    • 23. PAMTA - ProhibitionsIt shall be unlawful to administer (including by means of animal feed) a medically important antimicrobial to a food-producing animal fornonroutine disease control unless—– (1) there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producinganimal;– (2) the administration of the medically important antimicrobial to the food-producing animal is necessary to prevent orreduce 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 theshortest 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 inparagraph (1).
    • 24. DATA Act• enhanced reporting requirements• to increase collaboration and coordination with the Secretary ofAgriculture to expand and coordinate the collection of data on the use ofantimicrobial drugs in or on cattle, swine, chickens, turkeys, and suchother 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 Administrationto eliminate injudicious use of antimicrobial drugs in food-producinganimals; and– (B) the effectiveness of the data collection activities conducted by theFDA regarding antimicrobial resistance.
    • 25. ADUFA• authorizes the FDA to collect fees from animal health companies to enable the Center forVeterinary Medicine (CVM) to meet performance standards.• ADUFA II will sunset in September 2013 and is scheduled to be reauthorized this yearLegislative Changes• FDA will allow for multiple conditional approved indications on a single product label andremove the requirement that indexed drugs be labeled “not FDA approved” for MinorUse/Minor Species products• Require notification of drug approvals on FDA’s website with the option to publish in theFederal Register
    • 26. AVMA• www.avma.org• www.kofs.orgConnect with us onchoang@avma.org@AVMAvets@ DrCHoang