The Food and Drug Administration (FDA) is implementing a voluntary strategy to promote the judicious (appropriate) use in food-producing animals of antibiotics that are important in treating humans. The goal of the strategy is to protect public health and help curb the development of resistant drugs and in turn help to reduce the number of infections in humans that are difficult to treat because existing antibiotics have become ineffective. A public meeting was held at Western Kentucky University on April 9, 2013 to “provide an opportunity for public dialogue and feedback on challenges faced by the animal agriculture industry and practicing veterinarians as FDA implements its initiative for the judicious use of medically important antimicrobials in medicated feed or drinking water of food-producing animals.” This meeting was offered because FDA is seeking input as it moves ahead with its strategy to promote the judicious use in food-producing animals of antibiotics that are important in treating humans. This three-pronged approach includes:
• Issuing a guidance for industry (Guidance #209), entitled “Judicious Use of Medically Important Antimicrobials in Food Producing Animals,” which establishes a framework for phasing out production uses (growth promotion and feed efficiency) of antimicrobials important in treating humans, and phasing in veterinary oversight of the remaining therapeutic uses of such drugs. This GFI was finalized on April 11, 2012 and can be found at: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf
• Issuing a draft guidance (Guidance #213) that will help drug companies voluntarily revise product labels to remove production uses (feed efficiency and growth promotion) and add instead disease prevention, control, and treatment uses. This guidance document also advises companies on how 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 and practicality of existing Veterinary Feed Directive (VFD) requirements. VFD drugs are drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. Which drugs currently used in food animals are the focus of FDA’s strategy? The voluntary strategy is primarily focused on medically important antimicrobial drugs that: