The U.S. Food and Drug Administration (FDA) has announced a series of five meetings to provide the public with opportunities to discuss and provide critical feedback on the challenges faced by livestock producers and veterinarians as FDA phases in veterinary oversight of the therapeutic use of certain medically important antimicrobials.
FDA is seeking input as it moves forward to further develop and implement its strategy to promote the judicious use in food-producing animals of antibiotics that are important in treating humans.
The meetings are intended to provide a forum to discuss potential challenges faced by animal producers in areas that may lack access to adequate veterinary services and to explore possible options for minimizing adverse impacts. The meetings are jointly sponsored by FDA and the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service.
FDA has worked with many stakeholder groups and USDA to develop a strategy that it believes will be successful in reducing antimicrobial resistance while minimizing adverse impacts on animal health and disruption to the animal agriculture industry. The agency took the following steps toward implementing this strategy:
- Issuing a guidance for industry entitled “Judicious Use of Medically Important Antimicrobials in Food Producing Animals1,” which establishes the 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 the remaining therapeutic uses of such drugs.
- Issuing a draft guidance that will assist drug companies seeking to voluntarily revise product labels to remove production uses and to voluntarily change the marketing status of these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.
- Providing 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 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. Once the status of the product changes from over the counter (OTC) to prescription (Rx) or VFD, producers will no longer be able to purchase the animal drug or medicated feed product directly from suppliers, unless the producer has a valid prescription or order from a licensed veterinarian.
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. This change also has potential impacts on practicing veterinarians depending on their practice (business) model.
The dates and locations for the meetings are:
- April 9, 2013, in Bowling Green, KY.
- April 23, 2013, in Olympia, WA.
- May 8, 2013, in Fort Collins, CO.
- May 21, 2013, in Pierre, SD.
- June 4, 2013, in College Station, TX.
FDA will also seek public input and additional feedback through other forums, such as webinars, as it works collaboratively with USDA, veterinary and producer organizations to address this important issue.
Comments also may be made to the FDA Docket No. FDA-2012-N-1046 at any time. Additional information on the meetings and agenda can be found at:
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