A U.S. Food and Drug Administration plan to phase out the use of medically important antimicrobials in livestock feed and drinking water has won the overwhelming support of the veterinary drug industry. The FDA reported March 26 that 25 companies would request the withdrawal of drug approvals received for food production uses and transfer the remaining therapeutic uses to the oversight of veterinarians. Besides healing sick animals such as cattle, poultry and hogs, the drugs sometimes are used to improve feed efficiency or enhance growth. The voluntary strategy is outlined in Guidance for Industry 213, which the FDA developed in its campaign to reduce the threat of antimicrobial resistance in animals and people. The companies that signed on make virtually all of the over-the-counter drugs used in the feed and water provided to food animals. Among the drug makers are industry heavyweights such as Elanco Animal Health and Zoetis Inc. and smaller companies like Cross Vetpharm Group Ltd. and Pennfield Oil Co. Only one company declined to sponsor Guidance 213. An FDA spokesperson, citing confidentiality, declined to identify the holdout. Guidance 213 gives the drug companies three years to voluntarily revise FDA-approved labels by removing production indications and bringing therapeutic uses under a Veterinary Feed Directive. The strategy averts what could have become a drawn-out regulatory process. “The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal,” said Michael Taylor, the deputy commissioner for foods and veterinary medicine. The Animal Health Institute, a Washington, D.C., drug industry trade group, echoed its members’ support of Guidance 213. “We understand that consumers have concerns about medically important antibiotics being used to promote growth,” President and CEO Alexander S. Mathews said. “We hope this change in regulation and control will increase consumer confidence and lead to a more productive discussion about animal welfare, sustainability and public health.” Sick and at-risk animals will still get the medicines they need, said Bernadette Dunham, DVM, Ph.D., director of FDA’s Center for Veterinary Medicine. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working—and will continue to work—to make this transition as seamless as possible,” Dr. Dunham said. Guidance 213 doesn't eliminate drugs from a veterinarian’s arsenal. Antibiotics such as tylosin, which comes with claims for weight gain and feed efficiency, will still be used to treat sick pigs, said Tom Burkgren, DVM, MBA, executive director of the American Association of Swine Veterinarians. “As an association, we support the continued process behind 213 as far as judicious use by veterinarians,” he said. The threat of disease when medicated feed and water are absent is somewhat higher, Dr. Burkgren said. “The best example of that was … when the Danes basically banned the use of growth-promotion and feed-efficiency claims and got rid of those antibiotics,” he said. “There was a real uptick in illness, especially in weanling pigs. There was both uptick in diarrhea and respiratory disease.” The American Veterinary Medicine Association threw its support behind Guidance 213 when the final strategy was announced in December. “The AVMA has long advocated that greater veterinary oversight of the use of antimicrobials on the farm is a benefit to human and animal health,” said President Clark Fobian, DVM. The Schaumburg, Ill., organization consulted with the Center for Veterinary Medicine as the plans were drawn up. “The AVMA is pleased that its recommendations were thoughtfully considered and that many of them are reflected in the final guidance,” the organization reported. The consumer group Keep Antibiotics Working argued that Guidance 213 doesn’t go far enough. The Chicago-based coalition questioned whether the veterinary industry is ready, stating, “Many veterinarians do not accept that antibiotic use in food animals contributes to a human health risk, so they cannot be relied upon to rein in overuse.” Burkgren, whose swine association represents 900 U.S. members, said the relationship between veterinarians and producers will only get stronger. “There's going to an adjustment period as we go through this,” he added.
