On Monday, November 7, much to the dismay of the sustainable agriculture community, the U.S. Food and Drug Administration (FDA) denied two citizen petitions that asked the Agency to ban certain uses of antibiotics in food animals.
The petitions, filed in 1999 and 2005, urge the FDA to withdraw the approvals for antibiotics given to animals in feed or water for purposes other than disease treatment if the antibiotics are also used in human medicine. The petitions were filed by Environmental Defense, Center for Science in the Public Interest, Food Animal Concerns Trust, Union of Concerned Scientists and other groups because evidence shows that use of antibiotics for non-therapeutic purposes in livestock production can lead antibiotic resistance within human populations. The groups argue that these antimicrobial drugs shouldn’t be used for growth promotion and disease prevention, but rather for treating diagnosed illnesses.
The response to these long-standing citizen petitions came after several of the petitioners filed suit in May against the FDA for not responding. In its response to the petitions, the agency expressed shared concern with the public and the need to address this issue, yet proceeded to deny the petitions on the basis of statutory hurdles such as a notice to the drug maker and an evidentiary hearing on the matter. It argues that taking these drugs off the market would simply be too expensive, resource intensive, and cumbersome: “The agency’s experience with contested, formal withdrawal proceedings is that the process can consume extensive periods of time and agency resources.”
Instead, FDA is “currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.” The proposed alternative is collaborating with the pharmaceutical companies that produce these antibiotics to voluntarily take them off the market for animal feed.
As expected, consumer and public health interests are not pleased by this alternative proposal.
“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. There is absolutely no reason to believe that drug companies will voluntarily reduce sales of antibiotics and act against their own financial self-interest. Without reductions in antibiotics used it is impossible for there to be any public health benefit.” said Steven Roach, Public Health Program Director of Food Animal Concerns Trust (FACT). “For this reason we do not see the FDA’s plan as an answer to the petitions or the problem of antibiotic resistance.”
FACT’s Executive Director Richard Wood declared that, “reducing antibiotic overuse is essential for making sure antibiotics will keep working for years to come – to treat our sick children, families and animals. It is outrageous that the FDA considers voluntary self-regulation by drug companies to be enough. It is clearly not.”