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FDA Seeking To Curb Ag Use of Antibiotics, Review Antibacterial Soaps

SCIENCE POLICY

Jeffrey L. Fox

 
Offıcials of the Food and Drug Administration (FDA) last December announced a plan for phasing out the use of antibiotics for promoting growth in animals such as chickens, hogs, and cattle for food production.

In a separate move in December, the agency directed manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term use and more effective than ordinary soaps in preventing infections. The plan to phase out low-dose, farm use of antibiotics is voluntary, not regulatory, and it puts considerable responsibility on veterinarians to ensure that such drugs are used appropriately. It calls on manufacturers to change such drugs from having over-thecounter (OTC) status to making them prescription only. Agency offıcials say that the two major suppliers of antibiotics for use in feeds, Elanco of Greenfıeld, Ind., and Zoestis of Florham Park, N.J., are promising to comply with the new policy.

As part of recent efforts to address antibiotic resistance, the FDA has directed manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term use and more effective than ordinary soaps in preventing infections. (Photo © BrianAJackson/iStockphoto.)Largely because these changes are to be voluntary and without agency enforcement measures, however, the broader response to this FDA initiative varies widely, ranging from enthusiasm to deep skepticism. Further, critics of the agency plan are concerned that it will not take full effect for three or more years and that its allowance of antibiotic use for “preventive” purposes might be a loophole for their future use for growth promotion under this different rubric.

 “Our fear is that there will be no reduction in antibiotic use as companies either ignore the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention,” says Steven Roach, Senior Analyst for Keep Antibiotics Working, a coalition of consumer and advocacy groups in Washington, D.C. On this matter, FDA is counting on veterinarians to “play an important role to ensure the products are used judiciously and appropriately,” says William Flynn, deputy director for the FDA Center for Veterinary Medicine.

 Members of the American Veterinary Medical Association (AVMA) in Schaumburg, Ill., appear eager to accept that mandate. “AVMA has long advocated that greater veterinary oversight of the use of antimicrobials on the farm is a benefıt to human and animal health,” says its president Clark Fobian. The organization “applauds” the new agency plan and, among other things, praises it for allowing “greater flexibility by deferring to the profession and individual states for specifıc criteria on professional conduct related to veterinary supervision or oversight.”

 However, animal feed producers consider the timeline too fast in part because there are not enough veterinarians to handle these new duties. “There are some 15 or so chemical entities that are approved as animal drugs and over 120 different uses that will be affected by changes FDA is proposing,” says Richard Sellers, a vice president of the American Feed Industry Association in Arlington, Va. “AFIA continues to be concerned about the lack of veterinarians trained to complete [required formulary changes] as well as the lack of large animal veterinarians in general.”

 “Something good is going on at FDA,” says microbiologist Stuart Levy of Tufts University School of Medicine in Boston, Mass., who has spent years pleading with agency offıcials and members of Congress to address both issues because each has an important impact on antibiotic resistance. “I disagree with those who say FDA’s plan is not strong. It highlights the importance of drug resistance; assesses the practice of smearing the world with low levels of antibiotics, draws attention to the fact that they’re not needed, and that European farmers are showing that this practice is no longer effective and is merely an excuse for not improving animal hygiene.” In short, he adds, “We’d all like it stronger, but I’ll take what I can get.”

Jeffrey L. Fox is the Microbe Current Topics and Features Editor.

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