Veterinarians, farmers prepare for FDA antimicrobial changes

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Veterinarians and producers will be at the forefront as the livestock industry implements FDA’s Guidance for Industry 209 and 213, phasing out end of growth and performance uses of medically important antimicrobials, and the proposed rule requiring  a veterinary feed directive (VFD) for most antimicrobials used in feed. To help stakeholders sort through the requirements, GlobalVetLink this week hosted a "Veterinarian Feed Directive Guidance for Industry 209 and Digital Documentation Webinar," featuring Kansas State University veterinarian Mike Apley, DVM, PhD, ACVCP.

Due to concerns over antibiotic resistance in recent years, Apley says the industry has seen an accelerated rate of change in antimicrobial regulations. He notes six areas of actual or potential changes.

  1. Withdrawal of growth-promotion and feed-efficiency uses in food animals for medically important antimicrobials and greater veterinary oversight.
  2. Potential expansion of reporting requirements for antimicrobial use in food animals.
  3. Possible additional legislation to remove antimicrobial uses for disease control and prevention in food animals.
  4. New methods for residue testing and tighter rules to prevent residues from the USDA’s Food Safety Inspection Service )FSIS).
  5. Use of  Animal Medicinal Drug Use Clarification Act (AMDUCA) rules as regulatory tools to attempt to decrease use of targeted drug classes in food animals.
  6. Potential for FDA’s Center for Veterinary Medicine (CVM) to call a hearing on the hazard status of tetracyclines and penicillin in food animals. CVM filed a notice of intent for a hearing more than 30 years ago but did not hold the hearing. The notice remains on the books and advocacy groups have pressured FDA to move forward with a hearing.

As for point number-one, FDA finalized its Guidance for Industry (GFI) 209 in April 2012, focusing on the judicious use of antimicrobials in food animals. The framework included the principles of phasing in such measures as 1) limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health; and 2) limiting such drugs to uses in food-producing animals that include veterinary oversight or consultation.

GFI 213, finalized in December 2013, provides a road map for implementing the principles in GFI 209, including guidance for drug sponsors to voluntarily withdraw performance uses from specific antimicrobials and combination products. The FDA-CVM website includes a list of affected products. In March, CVM provided an update saying 25 of 26 affected drug sponsors had agreed to comply.

Also in December 2013, FDA-CVM published a proposed Veterinary Feed Directive (VFD) rule, and a comment period on the proposed rule ended in March 2014. This rule will require producers to work through a veterinarian to obtain and file a VFD for use of medically important antimicrobials in feed. While the rule expands the list of VFD drugs, it intends to provide flexibility by revising the current VFD requirement for a valid veterinarian-client-patient relationship (VCPR), replacing it with veterinarian “supervision or oversight,” and saying veterinarians ordering the use of VFD drugs must do so “in compliance with all applicable veterinary licensing and practice requirements.”

Apley says the FDA-CVM seems to be allowing individual states and their veterinary associations to define the parameters of “supervision and oversight,” many of which likely will align with the traditional VCPR. In any case, he says, veterinarians will decide whether or not the use of a covered drug in a particular situation is judicious. Veterinarians must be at the forefront in balancing their clients’ economic priorities, animal health and welfare, feed safety and the priorities of consumers and regulatory agencies.

Apley encourages veterinarians to work within the framework of these evolving rules to become more involved in their clients’ operations. A key question for veterinarians, he says, is whether they will retain their relevancy to antimicrobial-use decisions. Or, he asks, will they just sign authorizations based on regulatory formulary developed out of political pressure exerted on regulatory agencies?

Web conference host Heather Van Lin, with GlobalVetLink, says the company currently is updating its FeedLink system to allow veterinarians to easily and accurately submit electronic VFD documents and maintain records in compliance with the proposed VFD rule. She also notes that a recording of the web conference will soon be available on the GlobalVetLink website.

For more information:

FDA Guidance for Industry 209

FDA Guidance for Industry 213

FDA proposed veterinary feed directive rule


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