Activist groups, including the Natural Resources Defense Council (NRDC) and the Center for Science in the Public Interest, have filed a citizen petition with the U.S. Food & Drug Administration urging the agency to withdraw approval of seven antibiotics for disease prevention use in livestock and poultry.
NRDC said due in part to a 2011 NRDC lawsuit seeking the withdrawal of certain antibiotic uses in livestock, FDA created a voluntary program in 2013 to curb the overuse of antibiotics given to farm animals, but the Second Circuit Court of Appeals allowed FDA to pursue the voluntary program instead of immediately withdrawing specific use of the antibiotics.
The day before the groups filed the petition, FDA announced a comment period about therapeutic uses of medically important antimicrobials. The agency seeks information about: (1) “underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases”; (2) “more targeted antimicrobial use regimens for these diseases and husbandry practices that may help avoid the need for these antimicrobials or that may help make more targeted antimicrobial use regimens more effective,” and (3) “strategies for updating affected labeling of drug products that do not currently include a defined duration of use.”
NRDC argued that FDA’s action to recommend that pharmaceutical companies put a limit on the duration of use for some antibiotic products will “likely have little to no effect.”
NRDC was joined in filing the petition by the Center for Science in the Public Interest, Earthjustice, Food Animal Concerns Trust, Public Citizen, CalPIRG and U.S. PIRG.
According to the Animal Health Institute (AHI), this petition mischaracterizes the FDA policy, the way antibiotics are used currently and how they will be used after implementation by Jan. 1, 2017. AHI urged FDA to reject the petition and continue to focus on the collaborative efforts to implement the new judicious use policy.
AHI and its member companies, along with the producer, veterinary and animal feed communities, are all working to implement FDA’s new policy on antibiotics by the end of this year. By Jan. 1, 2017, FDA’s policy will require that medically important antibiotics used in animal feed and water be used only to fight disease under the supervision of a veterinarian. It will not permit use of these products for the purpose of growth promotion. As FDA has explained, the bulk of these changes will be implemented simultaneously at the end of this year and many member companies have already begun making the necessary changes. This process was the product of a years-long effort to gain a consensus among all stakeholders.
All remaining uses of medically important antibiotics will be therapeutic, or targeted, uses, AHI said. The FDA-approved label for each product – which must be followed exactly — designates a specific disease or pathogen to be targeted by the use of the antibiotic. Veterinarians will not be able to order these products for growth promotion under the guise of prevention, as the petitioners imply, both because it will be illegal for them to do so and because the doses and duration of therapy are not the same as those that were approved for growth promotion.
The ability to both treat and prevent disease is critical to both human and animal health, AHI emphasized, noting that it is inhumane and unethical to ask producers and veterinarians to allow animals to suffer when it is clear disease threats exist.