FDA proposes animal antibiotics go behind the counter

Over-the-counter antibiotics for livestock may be a thing of the past.

The FDA issued a draft guidance for industry Sept. 25 that recommended manufacturers of “medically important antimicrobial drugs” used in animals that are currently available over-the-counter make their drugs available by prescription only.

The drugs on the list include more than 100 antibiotic drugs, like penicillin G, tetracycline and erythromycin.

While it may be difficult for some people with limited veterinary access, veterinarians say it’s a good thing and won’t be as restrictive as some believe.

“Producers should develop a relationship with a veterinarian before they have an emergent need,” said Fred Gingrich, executive director of the American Association of Bovine Practitioners. “If they do that, then this should not have an impact on them whatsoever.”

Before taking the executive director position in 2017, Gingrich practiced at a veterinary clinic for more than 20 years in Ashland, Ohio. He acknowledged the change will take some getting used to because farmers are used to buying these drugs over-the-counter. But it’s for the better.

The proposed change is an effort to curb the development of antibiotic resistance. It’s part of the FDA’s five-year action plan, released last September, that aims to support more responsible antimicrobial use. The guidance is voluntary.

Slowing misuse

A draft guidance for industry recommending antibiotics administered in feed or drinking water be made available only through a veterinarian was implemented in January 2017. This type of antibiotic represented about 95% of the market. But other antibiotics, like injectables, stayed over-the-counter.

“When they did that sales of antibiotics decreased 43%,” Gingrich said. “That demonstrated to the FDA that perhaps moving these products to veterinary oversight does greatly influence judicious use, where veterinarians can assist their clients in making sure antibiotics are used appropriately.”

Justin Kieffer, a clinical veterinarian, said he’s seen overuse and misuse of antibiotics in ruminants. That’s why he supports moving these drugs to require veterinary oversight.

Kieffer, who is also an assistant professor in Ohio State University’s department of animal sciences, sees this as an opportunity for farmers and other producers to start a vet-client-patient relationship with a veterinarian.

That means the vet has knowledge of your operation, has provided care to your animals and is available for follow-up care and emergencies, Kieffer said.

He said the guidance would not prevent farmers from stocking up on medications in case of an emergency, “providing you have planned ahead and worked with your veterinarian.”

Remote access

Small producers and those in remote areas may see an impact to access to antibiotics, Kieffer said.

“There are some areas of the country with no large animal vets, and there are also areas where producers cannot or will not pay for veterinary care, this is a reality of our current situation,” he said. “This is an opportunity for producers and vets to come together to work on proper antimicrobial use.”

For those manufacturers that want to participate in the guidance, the FDA is proposing a two-year implementation period after the agency after a final guidance is issued. There is a public comment period for anyone to give feedback on draft guidance for industry #263 running through Dec. 24. Then a final guidance will be issued later.

(Reporter Rachel Wagoner can be contacted at 800-837-3419 or rachel@farmanddairy.com.)