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1 1 (March 28, 2014)

handle is hein.crs/govccus0001 and id is 1 raw text is: '. ~**\**\ &~ ~ riE SE .$rCh &~ ~ ~ March 28, 2014 Antibiotic Use in Food Animals: FDA's Current Activities The U.S. Food and Drug Administration (FDA), which evaluates human and animal drugs for safety and effectiveness, is concerned that public health may be at risk from certain antibiotic uses in food animals. According to FDA, foods of animal origin may be contaminated with pathogens that cause certain types of foodborne infections, and antibiotic use in animals that produce these foods may render the infections less amenable to treatment, due to antibiotic resistance. In response, FDA has issued two guidance documents for industry that define judicious use of antibiotics, ask animal drug companies voluntarily to stop labeling antibiotics for production uses, and call for more veterinary oversight. FDA says a voluntary approach is the fastest and most efficient way to tighten control over the use of medically important antibiotics. Regulatory action may require FDA to conduct product-by-product evaluations that could require more time and resources. Some stakeholders, mainly led by consumer groups, say that use of antibiotics in food animals leads inevitably to drug resistance in foodborne pathogens, and that such use should be curtailed. Other stakeholders, mainly led by industry groups, say that untreatable human infections due to resistance result from misuse of antibiotics in the healthcare system. FDA asserts that concerns about antibiotic-resistant human infections resulting from antibiotic use in food animals are well documented, and FDA generally possesses broad authority to regulate these drugs based on this public health effect. An antimicrobial is a drug that acts against many pathogens, including bacteria, viruses, fungi, or parasites. An antibiotic is an antimicrobial drug that acts against bacteria. Most drugs of concern in this discussion are antibiotics. FDA uses the broader term antimicrobial in its publications. FDA has approved three uses (called label indications) of antibiotics in food animals: treatment of disease, prevention or control of disease, and growth enhancement. First, livestock and poultry producers use antibiotics to treat sick animals, usually at a high dose for a short period of time. Second, antibiotics may be used, sometimes at a reduced dosage, to prevent disease during times when animals may be more susceptible to infections (for example, after weaning or during transport) or control disease when present in a part of a flock or herd. Lastly, low doses of antibiotics may be fed to animals over a longer period of time to increase growth rates or improve feed efficiency. Currently, antibiotics may be dispensed to food animals in several ways. Some types may be purchased over-the- counter (OTC) and used by producers. Antibiotics added to feed must be accompanied by a veterinary feed directive (VFD), a special type of veterinary prescription for this purpose. Veterinarians may prescribe antibiotics used through other routes, such as injection. Although veterinarians may prescribe most drugs extra-label (using a drug for a species or indication other than those on the label), restrictions already exist on extra-label use of antibiotics in food animals. Finally, certain types of drugs, including some types of antibiotics, are prohibited for use in food animals under any circumstances. 'DA's &k to~t Lkmft. AndinM, Antibiol The FDA Center for Veterinary Medicine (CVM) oversees the agency's efforts to assure the safety and effectiveness of animal drugs, as required under Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 360b). CVM issues guidance documents for industry which provide FDA's current thinking on issues. Guidance documents do not necessarily establish legally enforceable responsibilities, but provide recommendations for the industry. At a July 2009 hearing before the House Committee on Rules, the Obama Administration signaled that it would address the use of antibiotics in food-producing animals. For the first time, an FDA official stated that the use of antimicrobials for growth promotion or feed efficiency was not a judicious use. In June 2010, FDA released the draft Guidance for Industry #209 (GFI #209), The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. The final version of GFI #209 was released April 2012. In GFI #209, FDA states that a proactive approach is necessary to reduce antibiotic resistance and preserve the effectiveness of medically important antibiotics for humans and animals. FDA offers two principles for the use of antimicrobials. (1) The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health. (2) The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation. .O 'T p\w gnom ggmm mppm qq\ a , q 'S I 11LIANJILiN,

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