The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) are co-sponsors in a series of half-day meetings with food animal producers and veterinarians on the impact of antimicrobial resistance, specifically in areas lacking adequate veterinary services. The FDA aims to discuss challenges faced by livestock producers and veterinarians as the agency phases in veterinary oversight of therapeutic antimicrobial use.
The FDA has developed a strategic plan that aims to reduce antimicrobial resistance and minimize adverse impacts on animal health but also tries to ease the transition for the agricultural industry. “FDA acknowledges that the proposed change in the marketing status of certain antimicrobial drugs to require the involvement of a licensed veterinarian will have practical implications for animal producers and practicing veterinarians,” a release states.
Producers who once purchased certain animal drugs or medicated feed products over the counter directly from suppliers will now require a valid prescription or order from a licensed veterinarian to do so. “The impact of this change on producers may vary depending on the extent to which a given producer already has access to and utilizes veterinary services,” the FDA says. “This change also has potential impacts on practicing veterinarians depending on their practice [business] model.”
The FDA plans to use input from the five public meetings as it continues to develop and implement its strategic plan for judicious antibiotic use in food animals. The agency has already taken the following steps:
• Issued an industry guide titled “Judicious Use of Medically Important Antimicrobials in Food Producing Animals,” which establishes a framework for phasing out production uses (i.e., growth promotion and feed efficiency) of antimicrobials important in treating humans and phasing in veterinary oversight of therapeutic use of these drugs.
• Issued a draft guidance to assist drug companies seeking to voluntarily remove production uses from their product labels and to voluntarily change the marketing status of medically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 and are limited to use under the professional supervision of a licensed veterinarian.
The first meeting in Bowling Green, Ky., occurred April 9, with the second to follow April 23 in Olympia, Wash. Meetings will continue May 8 in Fort Collins, Colo., May 21 in Pierre, S.D., and June 4 in College Station, Texas. Public input and additional feedback can be provided through scheduled webinars and FDA Docket No. FDA-2012-N-1046. For more information on the FDA’s guidance on judicious use of antimicrobials, go to fda.gov.