FDA Releases New Guidelines, Proposes Rule on Antibiotic Use in Agriculture

Posted December 13, 2013

The U.S. Food and Drug Administration (FDA) recently issued two major proposals in its effort to curb “injudicious” use of antibiotics in agriculture, according to a Politico article available here.

Antibiotics have been used in meat production as a growth-promoter and to keep disease from spreading among concentrated animal feeding operations.  Health advocates, however, argue that stricter limits are needed due to a growing problem of antibiotic-resistant infections – “which now kill 23,000 Americans and rack up millions in added health care costs each year.”

On Wednesday, FDA released a Guidance, which “asks veterinary drug companies to remove growth-promotion claims from antibiotics that are important for human medicine.”  The drug companies have 90 days to notify FDA if they will voluntarily follow the guidance.

FDA also released a proposed rule, “which requires antibiotics currently sold over the counter in large quantities that can be added to feed and water” to require a prescription from a veterinarian.”

Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, said that after the 90-day period, the agency intends to publicly release an update of the percentage of companies which have agreed to follow the guidance.

Animal pharmaceutical companies support the changes.  Clinton Lewis, Jr. executive vice president and president of U.S. operations for Zoetis, said the company is “very appreciative of [FDA’s] open and collaborative approach.”

The Animal Health Institute said it supported the policy and pledged to “continue to work with FDA on its implementation,” according to an Agri-Pulse article available here.

Representatives from the National Pork Producers Council (NPPC) and the American Veterinary Medical Association (AVMA) said they had worked with FDA on the guidelines and were pleased with the results.

For more information on antibiotic use in agriculture and antibiotic resistance, a recent post from this blog is available here and an article from the Congressional Research Service is available here.