Five nonprofit organizations are suing federal drug authorities whom they accuse of failing to restrict antimicrobial use in livestock, despite the risks of harm to humans.
The lawsuit, filed May 25 against the Food and Drug Administration, also alleges that the agency failed to respond to two citizen petitions filed in 1999 and 2005 that asked the agency to withdraw approvals for some uses of antimicrobials in agriculture.
The Natural Resources Defense Council, the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists filed the joint lawsuit against the FDA; FDA Commissioner Margaret Hamburg, MD; the FDA Center for Veterinary Medicine; the CVM director, Dr. Bernadette M. Dunham; the Department of Health and Human Services; and HHS Secretary Kathleen Sebelius.
An FDA spokeswoman declined to answer questions on the suit or related topics and stated that the agency would not comment on pending litigation.
In the suit, which was filed in the federal district court in New York, the nonprofits claim that the FDA didn't act as required to withdraw agency approval for unsafe uses of animal drugs, despite having evidence since 1977 that subtherapeutic use of penicillin and tetracycline antimicrobials in animal feed was selecting for resistant bacteria that could be transferred to humans.
In addition, the suit states that four of the organizations had been parties on two petitions that implored the FDA to withdraw approval for the nontherapeutic use in livestock of antimicrobials important for human medicine, and that the FDA did not fully respond to the petitions. The Natural Resources Defense Council was not involved in filing those petitions.
The FDA has given tentative responses to both petitions, including statements that the agency needs to evaluate each drug separately when considering withdrawals and allow for an administrative hearing. The responses note that contested withdrawals consume extensive amounts of time and resources.
Replies to both petitions state that only after the FDA had made decisions about whether to withdraw approval for specific drugs related to the requests could the agency grant or deny the petitions.