Nonprofit Groups Sue FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed, Seek Approval Withdrawals and Citizen Petition Response

By Kurt R. Karst

A group of nonprofit organizations has filed a Complaint seeking to compel FDA, by a court-ordered deadline, to withdraw approval for subtherapeutic uses of penicillin and tetracyclines in animal feed and to issue a final response to two Citizen Petitions submitted to the Agency – one on March 9, 1999 (FDA Docket No. 1999P-0485), and another on April 7, 2005 (FDA Docket No. 2005P-0139). The Complaint, which alse requests declarations that FDA’s failure to withdraw approvals and delay in responding to the Citizen Petitions violate the Administrative Procedure Act (“APA”), was filed by the Natural Resources Defense Council (“NRDC”), the Center for Science in the Public Interest (“CSPI”), the Food Animal Concerns Trust (“FACT”), Public Citizen, and the Union of Concerned Scientists (“UCS”) in the U.S. District Court for the Southern District of New York on May 25, 2011.

The addition of low doses of antibiotics to livestock feed (e.g., chickens, turkeys, swine, cattle, and sheep) to ward off disease and promote growth has been going on for many decades, to the point that, according to the Complaint, “[t]oday, approximately 80 percent of all antibiotics used in the United States are used in livestock.” FDA first approved the use of penicillin and chlortetracycline as animal feed additives in 1951, and the use of oxytetracycline as early as 1954.

Not long after these approvals, however, concerns about the long-term use of antibiotics in animals, and antibiotic resistance in particular, were raised. In the 1970s, FDA convened a task force to look into the issue. The recommendations from the task force, including that “antibiotics used in human medicine be prohibited from use in animal feed unless they met safety criteria established by FDA,” led FDA to propose (in 1973) the withdrawal of approvals for subtherapeutic uses of antibiotics in animal feed unless data submitted to FDA resolved certain safety concerns. After evaluating data and information submitted to FDA, the Agency issued Federal Register notices in 1977 with respect to penicillin and certain uses of tetracyclines proposing to withdraw all uses of penicillin and nearly all subtherapeutic uses of tetracyclines in animal feed. Shortly thereafter, Congress stepped in and requested that FDA conduct further research before taking action on the withdrawal proposals. This and other intervention by Congress led to the publication of several reports and studies in 1980, 1984, and 1988.

Activity surrounding the issue of the long-term use of antibiotics in livestock continued in the 1990s with more reports. In 2003, FDA issued a guidance document – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern – discussing the Agency’s “recommended approach for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern.” In 2004, “FDA sent letters to several manufacturers of approved animal feed products containing penicillin and tetracyclines, explaining that the administrative record did not contain sufficient information to alleviate FDA’s concerns about ‘the use of these products and their possible role in the emergence and dissemination of antimicrobial resistance,” according to the Complaint. In 2010, FDA issued a draft guidance document – The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals – concluding that the “overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production purposes is not in the interest of protecting and promoting the public health.”

Meanwhile, CSPI, FACT, Public Citizen, and UCS (several of the Plaintiffs named in the May 25, 2011 Complaint) petitioned FDA in 1999 and 2005 requesting that FDA “rescind approvals for subtherapeutic uses in livestock of any antibiotic used in (or related to those used in) human medicine” (1999), and “withdraw approvals for herdwidelflockwide uses of [specific] antibiotics in chicken, swine, and beef cattle for purposes of growth promotion (including weight gain and feed efficiency) and disease prevention and control (except for nonroutine use where a bacterial infection has been diagnosed within a herd or flock)” (2005). FDA tentatively responded to the petitions – see, e.g., here – but has not yet issued final responses.

The Plaintiffs allege in their Complaint that FDA, in violation of the APA, failed to comply with the Agency’s statutory duty to withdraw approvals of subtherapeutic uses of penicillin and tetracyclines in animal feed as required by FDC Act § 512(e)(1). The Plaintiffs further contend that FDA’s failure to timely respond to the 1999 and 2005 Citizen Petitions with a final decision is an unreasonable delay in violation of the APA. On both claims, the Plaintiffs request a judgment compelling FDA to take action by a court-odered deadline.