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The FDA is looking into companies that advertise antibiotics as a way to bulk up livestock, which the agency says undermines its efforts to take growth promotion off drug labels.

“We   understand the concern that drug manufacturers may promote extra-label production uses for products approved only for therapeutic use, thereby undermining the spirit and intent of [agency guidance],” the FDA said in a statement provided to POLITICO.

The agency issued landmark guidance in December that said using antibiotics to make pigs and other farm animals grow faster, as opposed to helping treat or prevent disease, isn’t appropriate because it contributes to antimicrobial resistance in bacteria. Then in March, the FDA lauded 25 companies for joining the agency’s initiative to remove growth enhancement from the labels of their antibiotic products for livestock.

Now the agency is concerned those companies will continue to push their products as tools to help pack pounds on the animals.

“We understand your concern,” wrote Erik Mettler, the FDA’s associate commissioner for the Office of Foods and Veterinary Medicine, to a public health advocate who complained about the issue, “and, as part of the [Guidance for Industry] #213 implementation process, we intend to look for ways to reinforce the importance of the principles of judicious and appropriate use, including engaging animal drug manufacturers on the appropriate use of promotional materials.”

The statement came in response to a letter from Steven Roach, director of food safety the advocacy group Keep Antibiotics Working, who wrote to the FDA last month after noticing that Novartis – one of the companies that has pledged to voluntarily change its labels – was promoting an antibiotic product on its website as a means to bulk up swine.

Pigs that ate feed medicated with the antibiotic Denagard plus chlortetracycline gained an extra 5.7 pounds compared with nonmedicated swine, providing a higher return on investment, the company’s website said at the time.

Novartis’ product “is approved in swine to control dysentery and to treat pneumonia and enteric disease, yet the marketing materials emphasize its benefits for production,” Roach wrote, later telling POLITICO that FDA officials subsequently invited him to meet with them later this month. “The materials tout benefits to performance in terms of daily gain, body weight achieved, feed to gain ration, and return on investment, all indicators of productivity, not animal health.”

But Novartis did not break any FDA rules in marketing weight gain as an effect of the drug, and the company stressed throughout the online material that the purpose of Denagard plus CTC is to treat disease, said Ron Phillips, a spokesman for the Animal Health Institute, which represents Novartis and other companies that make drugs for livestock.

“The product in question here is clearly labeled for a disease control,” Phillips said. “It’s not a secret to anybody that both humans and animals that are healthy grow more efficiently, and that’s the only point that’s being made.

“All marketing materials – just like the label on the product – are approved and cleared through FDA,” he added. “It’s simply a misreading of what’s going on.”

Novartis’ spokespersons did not return calls for immediate comment Tuesday afternoon.

Novartis has since changed the wording of its online promotional material to say: “By controlling disease, Denagard plus CTC-medicated pigs showed significantly higher daily gain and achieved a significantly higher body weight at the end of the trial period than OTC pigs (+3.9 lbs.) and nonmedicated pigs (+5.7 lbs.).”

Rep Louise Slaughter (D-N.Y.) said in reaction to Novartis’ marketing materials that the situation proves the fallacy of the FDA’s voluntary guidance.

“This latest effort to undermine regulations on antibiotic use in agriculture proves that the FDA’s voluntary guidance is riddled with loopholes and completely inadequate to halt the growing antibiotic resistance crisis in this country,” Slaughter said.

The FDA, in the statement given to POLITICO, stressed that it was going to engage animal drug manufacturers “on the appropriate use of promotional materials.”

“We are in the early stages of implementing this strategy,” the FDA said. “Important issues will arise along the way, and we are committed to addressing them.

Please sign the Organic Consumers Association petition to the FDA demanding a mandatory, not voluntary ban, on subtherapeutic doses of antibiotics for livestock.