FDA ordered to reconsider antibiotic regulations

The ruling, delivered by Judge Theodore Katz in New York, requires the FDA to follow through on a notice issued in 1977, announcing its intention to withdraw approval of the use of penicillin and tetracyclines in livestock for growth-promoting purposes unless drug sponsors could prove them to be safe.

The National Chicken Council (NCC) expressed disappointment over the ruling. Vice-president of communications Thomas Super told GlobalMeatNews​: "The National Chicken Council is disappointed with the decision made by a US district court judge requiring the Food and Drug Administration (FDA) to use an administrative process on subtherapeutic antibiotic use for animal agriculture. ​[The] FDA has clearly articulated its goal of eliminating subtherapeutic use and extending veterinary oversight using a collaborative, stakeholder process. [The] FDA has said the collaborative, stakeholder process, which includes the release of guidance documents that were expected to publish in the near future, is a more efficient way of achieving these goals than the process being forced by the court.​

"The number one priority for US chicken farmers is to raise healthy, top quality birds, because doing so is not only an ethical obligation, it is the foundation of a safe and wholesome chicken supply. ​
"One of the tools in the toolbox to ensure animal health and produce wholesome animal protein is the limited use of FDA-approved antibiotics to treat and prevent disease.  These antibiotics are used judiciously with veterinary oversight in the chicken industry.  Poultry producers follow label instructions for administration and strict withdrawal procedures.  The majority of the antibiotics that may be used in poultry production are not used in human medicine."​

The National Pork Producers’ Council (NPPC) said the pig industry was already making efforts to use antibiotics responsibly, but that their use was essential for to keep animals healthy. NPPC chief veterinarian Liz Wagstrom told GlobalMeatNews​: “What is important from the pork industry’s viewpoint is that pork producers work with their veterinarians to determine how to most responsibly apply antibiotics to preserve their usefulness.  ​

“Antibiotics are one tool that producers and veterinarians use to keep our animals healthy and to provide a safe and nutritious product for our consumers. We count on evidence, such as the peer-reviewed risk assessments, that show that the use of these antibiotics in food animal production results in a negligible risk to public health. ​

“The ruling requires that the FDA start again the process of considering removing these label claims, but the court ruling does not presume to determine if the products should be banned. We have no knowledge of the FDA’s plans to address this ruling.”​

Wagstrom added that the FDA was expected to release its Guidance for Industry 209, which lays out a collaborative process for animal health companies to work with the Administration on subtherapeutic label claims. “We don’t know how the Guidance 209 process will impact the steps that the court ruling is requiring of FDA,”​ she said.

The FDA now has 60 days to appeal the ruling.

Following the 1977 announcement, several drug companies requested hearings, but the FDA never held any, neither took any further action. In May 2011, the National Resources Defense Council (NRDC) filed an action seeking a court order compelling the FDA to complete the withdrawal proceedings for antibiotics included in the 1977 notices. In December 2011, the FDA withdrew the original notices on the grounds that they were outdated. Judge Katz added that, in the interlude, more evidence had emerged of the link between subtherapeutic use of antibiotics in livestock and antimicrobial resistance.