The FDA will host a series of meetings during April, May and June to allow public input on the issue of antimicrobial use in animal agriculture. The agency is moving forward to implement its strategy to promote judicious use of drugs important in human medicine, and phasing in veterinary oversight of the therapeutic use of certain antimicrobials.
The meetings, which are jointly sponsored by FDA and the USDA’s Animal and Plant Health Inspection Service, are scheduled for the following dates and locations:
- April 9, 2013, in Bowling Green, Ken.
- April 23, 2013, in Olympia, Wash.
- May 8, 2013, in Fort Collins, Colo.
- May 21, 2013, in Pierre, S.D.
- June 4, 2013, in College Station, Texas
Find details on times and specific locations for each meeting here.
Regardless of attendance at the public meetings, interested parties can submit either electronic or written comments on this issue. Details on FDA’s proposals and directions for submitting comments are available on the Federal Register.
The agency has announced the following steps toward implementing their judicious use strategy:
- Issued a guidance for industry, entitled “Judicious Use of Medically Important Antimicrobials in Food Producing Animals,” which establishes the framework for phasing out production uses of antimicrobials important in treating humans, and phasing in veterinary oversight of the remaining therapeutic uses of such drugs.
- Issued a draft guidance that will assist drug companies seeking to voluntarily revise product labels to remove production uses and to voluntarily change the marketing status of these medically important antimicrobials to include veterinary oversight or supervision.
- Provided draft text for a proposed regulation intended to improve the efficiency of existing Veterinary Feed Directive (VFD) requirements. VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian.
FDA acknowledges that the proposed change will have practical implications for livestock producers and veterinarians. Once the status of the product changes from OTC to Rx or VFD, producers will no longer be able to purchase the drug or medicated feed product directly from suppliers without a valid prescription or order from a licensed veterinarian. The impact of the proposed rules on individual veterinarians and producers will depend on the extent of existing relationships, producer access to veterinary services and veterinarians’ practice models.