FDA issues new guidelines to limit antimicrobial overuse in food animals

The U.S. Food and Drug Administration (FDA) recently issued three documents designed to curb the overuse of certain antimicrobials in food-producing animals for so-called “production” purposes and instead promote their use for therapeutic reasons only. Currently, some farmers and animal producers use certain antimicrobials for the purposes of enhancing growth and feed efficiency in their food-producing animals, a practice many believe to be contributing to the resistance of bacteria and other microbes to medically important drugs.

Now, in order to preserve the effectiveness of these drugs for treating diseases in humans, the FDA is proposing a voluntary initiative to phase out the production use of medically important drugs and integrate veterinary oversight when these drugs are used therapeutically in food-producing animals. Additionally, the guidelines recommend that drug companies modify the language used on their drug labels, voluntarily removing production use information and providing disease prevention, control and treatment uses when appropriate.

The following documents were published in the Federal Register:

• Guidelines that recommend phasing out certain drugs for production use and initiating veterinary oversight for therapeutic use of these drugs.
• Guidelines for drug companies to voluntarily remove production uses of antimicrobials from their FDA-approved product labels and add disease prevention, control and treatment uses when appropriate.
• Guidelines for veterinarians to authorize the use of certain animal drugs in feed.

“It is critical that we take action to protect public health,” FDA Commissioner Margaret A. Hamburg, MD, said in a public statement. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people remain safe and effective.”

The American Veterinary Medical Association (AVMA) hasn’t issued a formal comment on the guidance documents yet, but stated, “The AVMA commends the FDA for reaching out to the veterinary and public health communities, the animal agriculture community, animal drug sponsors, the USDA and all other interested stakeholders in developing a collaborative, practical strategy that addresses antimicrobial resistance concerns while remaining protective of both human and animal health.”

Although the proposed guidelines suggest a change for the better, some doubt the impact the recommendations will actually have. Stephen McDonnell, founder and CEO of Applegate, a producer of natural and organic meats and cheeses, released the following statement: “The FDA has made a move in the right direction, but there’s a long way to go. We know consumers want antibiotic misuse in animal agriculture to stop, and the recommendations issued today encourage the industry to do that, but fall way short of requiring it.”

Also, a federal district court judge in New York has ordered the FDA to move forward with a promise made in 1977 to start proceedings addressing concerns over subtherapeutic, or production, use of antimicrobials in food animals. More than 30 years ago the FDA filed notices that proposed proceedings to withdraw approvals for subtherapeutic uses of certain drugs, but hearing dates were never set and the FDA eventually withdrew those notices, saying they were outdated.