FDA antibiotics

The FDA’s new guidelines for antibiotics will apply to producers of swine, chickens, cattle and other livestock.

It’s about to get harder for livestock producers to buy antibiotics over-the-counter or order them online.

In 2020, the U.S. Food and Drug Administration is pushing its antibiotic stewardship guidelines further, aiming to require a veterinarian’s prescription for all medically important antimicrobials by 2023.

“Medically important” is a designation for antibiotics crucial to curing human diseases.

The FDA’s move is an effort to slow the spread of antibiotic-resistant “superbugs” — bacteria that have developed immunity to antibiotic medicines. According to the federal Centers for Disease Control and Prevention, drug-resistant bacteria kill 35,000 people in the U.S. each year — that’s one every 15 minutes — and even more animals.

Advocates say the FDA’s plan will save lives. Critics say the guidelines are pointless because they are merely recommendations.

“It’s not a regulation,” said Ellen Silbergeld, a professor at Johns Hopkins University who has worked with the World Health Organization on antibiotic resistance. “It’s not enforceable. It’s meaningless. If you want to make any difference fighting antibiotic resistance, you’ve got to do something that has teeth in it.”

When scientist Alexander Fleming discovered antibiotics in 1928, the drugs were not intended for animals. But in 1950, an American company, Lederle Laboratories, found that chickens grew faster when fed chlortetracycline. The popularity of antibiotics catapulted. The drugs were used to fatten animals, prevent disease and treat illness.

Researchers later realized antibiotic overuse contributed to the proliferation of drug-resistant bacteria, according to Silbergeld.

The FDA’s new plan, which seeks to promote better drug management, is not the first of its kind.

A prescription is already required for most livestock antibiotics. In 2013, the FDA introduced a Guidance for Industry document, called GFI 213. Over three years, it phased in veterinarian oversight in prescribing medically important antimicrobial drugs used in the feed or drinking water of food-producing animals.

The drugs had previously been available over-the-counter.

GFI 213 also changed industry labeling so producers could no longer use antibiotics labeled to promote growth.

FDA’s new plan is called GFI 263, which will be implemented in stages through 2023 and aims to make the remaining three categories of injectable antibiotics available only with a veterinarian’s prescription.

The comment period for the draft version closed Dec. 24. FDA estimates the final version will be issued later this year.

Some critics, however, point out that a guidance document like GFI 263 is different from a rule or law, because it is unenforceable and establishes no legal responsibility. It should be viewed only as a list of recommendations, they say.

This means pharmaceutical companies are not required to comply with FDA’s recommendations. The plan is a voluntary, opt-in program. But once companies have opted in, requirements become legally binding.

By 2017, every company impacted by GFI 213 either complied with FDA’s recommendations or withdrew their medications from the market. Whether companies comply with GFI 263 remains to be seen.

Silbergeld of Johns Hopkins University said the guidelines may look like a success but do not solve the problem.

The changes ahead may be slow, but an FDA spokesperson said farmers should be educated about prescription changes and prepare themselves.

Veterinarian relationships

Dr. William Flynn, deputy director for science policy in FDA’s Center for Veterinary Medicine, said he encourages farmers to establish closer relationships with their veterinarians.

The issue of antibiotic stewardship, explained Flynn, cuts across the human health, veterinary and environmental sectors and requires collaboration.

Prepare for emergencies

Because emergencies happen and a veterinarian may not always be available in time, an FDA spokesperson advises producers to work with their veterinarians to get prescriptions in advance so they have products on hand in case of emergency.

Although a prescription-only status requires veterinary approval for an antibiotic, it does not require the veterinarian to be on-site to administer it.

Limit the need

Flynn said he encourages farmers to work with their veterinarians to identify strategies for reducing the incidence of disease, in turn reducing their need to reach for an antibiotic.

This may include talking with a veterinarian to identify husbandry, housing or production practices that could be improved to reduce disease — for example, providing livestock with larger living quarters, improving hygiene and ventilation and reducing stress so animals are less susceptible to infection.

Recommended for you