In a move intended to curb the growth in the number of anti-microbial resistant infections, federal regulators Wednesday called on pharmaceutical companies
to voluntarily phase out the use of antibiotics for the purpose of enhancing growth in animals raised for meat production.
The Food and Drug Administration
issued final guidelines asking drugmakers to revise labels to remove references to animal production in antibiotics that are deemed “medically important” for humans.
“We know that the widespread use of antibiotics in animal production and human medicine can contribute to antimicrobial resistance,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. “And we know antimicrobial resistance has significant public health
For years, some livestock growers have included antibiotics within animal feed or drinking water to help animals gain weight without having to increase the amount they eat.
Public health advocates have criticized the practice for years, arguing such widespread use of antimicrobials has led to a rise in “super bugs” resistant to any current antibiotics and making them impossible to treat.
Under the FDA's final rules, after drugmakers remove the indication for animal growth from labels, livestock growers would be banned from using the antibiotics without a prescription from a veterinarian for treatment of a sick animal. “With these changes there will be fewer approved uses and the remaining uses will be under tighter control to minimize the impact on resistance,” Taylor said.
Taylor said drug companies have 90 days to inform the agency whether they intend to follow the guidelines. If they decide to abide by the rules, they have three years to implement the change. After the 90-day period, the FDA will evaluate the participation rate among drugmakers to see if further action is warranted.
The FDA has already received such assurances from two of the largest pharmaceutical firms within the animal health industry—Zoetis and Elanco, a subsidiary of Eli Lilly.
“Zoetis supports the FDA's efforts to voluntarily phase-out growth promotion indications for medically important antibiotics in food producing animals,” the company said in a written statement. Elanco also showed support for the new guidelines, stating it intended to “voluntarily narrow use of shared-class antibiotics—ones shared by animals and humans—for “therapeutic purposes of treating, controlling and preventing diseases in animals under the supervision of a veterinarian.”
About 70% of medically important antibiotics are sold for food animals, according to the Pew Charitable Trust. According to the FDA, nearly 30 million pounds of antibiotics were sold in the U.S. in 2011 for the purpose of meat and poultry production.
Laura Rogers, director of the Pew Charitable Trusts' Campaign on Human Health and Industrial Farming, said the guidance FDA issued was a good first step toward bringing down the rate at which antibiotics are used, but cautioned more needed to be done in order to lessen the risks posed by antimicrobial-resistant infections.
“I think what heartens me is that that's actually the message of FDA,” Rogers said. “This isn't the end game.”
Rogers said she was further encouraged by the immediate show of support the guidelines received from Zoetis and Elanco.
“They're already stepping forward,” Rogers said. “So that's already proof that it's going to work.” Follow Steven Ross Johnson on Twitter: @MHSjohnson