The Food and Drug Administration (FDA) has released industry guidance and a draft regulation about a new voluntary initiative intended to decrease the use of antimicrobials in agricultural animals. According to an April 11, 2012, press release, FDA has issued final guidance for industry titled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” which “recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.” The agency has also published draft guidance that urges animal pharmaceutical companies to voluntarily remove “production uses of antibiotics from their FDA-approved product labels” and “add, where appropriate, scientifically-supported disease prevention, control, and treatment uses.” These two sets of guidance are supplemented with a proposed veterinary feed directive outlining “ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.”

The move follows FDA’s recent decision to curb the extra-label use of cephalosporin in livestock due to concerns over increased antibiotic resistance in both humans and animals. “It is critical that we take action to protect public health,” said FDA Commissioner Margaret Hamburg. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”

Meanwhile, FDA’s announcement has drawn praise from the Center for Food Safety (CFS), which described the “3 year phase-out” strategy “a win for consumers, food safety advocates, and medical community.” The Center for Science in the Public Interest (CSPI), however, was less sanguine, concluding that FDA’s plan is already “tragically flawed” insofar as it relies on voluntary industry compliance. “The problem of antimicrobial resistance, and the contribution of animal agriculture to that problem, is urgent and global,” said CSPI Food Safety Director Caroline Smith DeWaal in an April 11 statement. “The United States needs to take a leadership role in bringing comprehensive, effective action, in both the agricultural and medical spheres, to bear. The time for half-measures and voluntary steps has passed.” See CFS Press Release, April 11, 2012.

 

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For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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