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.
- Withdrawal of growth-promotion and feed-efficiency uses in food animals for medically important antimicrobials and greater veterinary oversight.
- Potential expansion of reporting requirements for antimicrobial use in food animals.
- Possible additional legislation to remove antimicrobial uses for disease control and prevention in food animals.
- New methods for residue testing and tighter rules to prevent residues from the USDA’s Food Safety Inspection Service )FSIS).
- 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.
- 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.