To the dismay of consumer and sustainable agriculture advocates, the Food and Drug Administration Wednesday rejected two petitions to ban certain antibiotics from being used in food animal production.
The petitions were filed in 1999 and 2005 by the Center for Science in the Public Interest, Environmental Defense, the American Academy of Pediatrics, the American Public Health Association, Food Animal Concerns Trust (FACT), and the Union of Concerned scientists. Both petitions asked the agency to withdrawal its approval of certain antimicrobial drugs that are considered important for human medicine, like penicillins, tetracyclines, aminoglycosides, streptogramins, macrolides, lincomycin and sulfonamides.
The groups argue that these antimicrobial shouldn’t be used for growth promotion and disease prevention to help preserve the efficacy of the drugs for human health purposes. In its response to the 2005 petition — which came after advocates sued the FDA last spring — the agency acknowledged shared concern and “the need to address concerns related to the role that antimicrobial drug use in food-producing animals plays in the emergence and selection of antimicrobial drug resistant bacteria.”
But the agency cited statutory hurdles — such as a notice to the drug maker and an evidentiary hearing on the matter — as reason to deny the petition. “FDA cannot withdraw approval of a new animal drug until the legally-mandated process is complete.”
Instead, FDA is “currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.”
Consumer and public health interests are, unsurprisingly, not pleased with the response.
“Instead of adhering to its mission to protect consumers, the FDA is waiting for the drug companies to voluntarily do what the Agency is legally mandated to do,” said Steven Roach, FACT’s Public Health Program Director. “For this reason we do not see the FDA’s plan as an answer to the petitions or the problem of antibiotic resistance.”
After waiting more than a decade for a ruling on their petition, CSPI issued a short statement Wednesday.
“We are disappointed that, after 12 long years, the FDA rejected our petition and a more recent petition to ban non-medical uses of antibiotics in animals,” said Michael Jacobsen, CSPI’s executive director. “The industry’s irresponsible use of antibiotics in livestock increases the prevalence of antibiotic-resistant pathogens, and those germs can cause infections in humans that are difficult or impossible to treat. The industry has long failed to cooperate voluntarily, and the FDA should take binding action. Consumers cannot afford another decade of delay.”
In its response to CSPI, FDA cited various reasons for not initiating a formal withdrawal proceeding (which would begin the process to meet the statutory hurdles). “The agency’s experience with contested, formal withdrawal proceedings is that the process can consume extensive periods of time and agency resources,” said FDA in the denial letter. The agency cited the withdrawal of diethylstilbestrol (DES) in 1979, which took a full seven years to complete, and the withdrawal of enrofloxacin in poultry, which took almost five years and cost FDA approximately $3.3 million.
DES is a synthetic growth hormone that was used both clinically and in the beef and poultry industry in the 1960s. It was eventually found to cause breast, prostate, and vaginal cancer. Enrofloxacin is an antibiotic that was FDA-approved for subtherapeutic use in poultry until it was found to promote antibiotic resistant strains of Campylobacter.