FDA Guidance Will Affect Medicated Feed For Beef Cattle
DR. JEREMY POWELL
FAYETTEVILLE, ARK.
In December 2013, the U.S. Food and Drug Administration (FDA) released its guidance for industry #213 (GFI #213). Through these recommendations, the FDA has focused on phasing out the use of antimicrobial drugs administered to food-producing animals in medicated feed or drinking water for “production indications.” These production indications would include the use of a medicated feed product for increased rate of weight gain or improved feed efficiency. These guidelines direct drug sponsors to specifically seek changes in antibiotic medicated feed labeling that has been determined to be important in human medicine with the intent to address growing concerns regarding antibiotic drug resistance.
The guidance declares that using certain antibiotic medications in food-producing animals to promote growth or improve feed efficiency is not considered judicious or responsible. However, the FDA points out that the use of these medicated feed antibiotics for the prevention and treatment of disease is considered responsible when the medicine has evidence of efficacy for a specific disease. Therefore, the medicated feed products may still be labeled and used for the purpose of disease control and prevention. The FDA suggested a three-year phase-in for their proposal, allowing sufficient time for pharmaceutical companies to make proposed product label changes and for livestock producers to prepare for resulting changes in their management practices.
Drug sponsors were given a three-month period in which to indicate whether or not they intend to voluntarily comply in the removal of “production indications” from their affected drug labels. So far, all but one pharmaceutical company have com mitted in writing to comply with the new voluntary guidelines. The companies that have pledged compliance market over 99 per cent of the drugs affected by GFI #213. In a recent press release, the FDA indicated it was encouraged by the strong response from pharmaceutical companies’ willingness to comply, and it intends to continue monitoring participation and provide public updates periodically.
In another coordinated action, the FDA is proposing to change many medicated feed antibiotics from their current over-the-counter (OTC) status to use by Veterinary Feed Directive (VFD) or, in other words, by veterinary prescription only. In the pro posed rule, the FDA notes that the majority of antibiotic medicated feed products can currently be used by livestock producers without veterinary oversight or consultation. As the FDA begins to implement their proposed framework set forth in GFI #213, the agency intends for the VFD to provide effective supervision and management of medicated feed products used in food producing animals. For more information regarding the FDA’s proposed guide lines, click on the following web site: http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm299624.pdf . ∆
DR. JEREMY POWELL: Professor, veterinarian, University of Arkansas