Thirty five years after the Food and Drug Administration determined the routine use of antibiotics in livestock feed could pose a danger to human health, a federal court Thursday compelled the agency to act on that knowledge.
The ruling, which came in response to a lawsuit filed last year by the National Resources Defense Council and others, requires the FDA to restrict the non-therapeutic use of most penicillins and tetracyclines in livestock unless manufacturers can prove their safety.
Although there is currently no timetable for action, plaintiffs believe the Federal District Court's ruling represents a massive breakthrough.
"This is a huge step forward," said Avinash Kar, NRDC health attorney. "For 35 years the FDA has done nothing on this issue and let the livestock industry police itself. In that time, the overuse of antibiotics in healthy animals has skyrocketed – contributing to the rise of antibiotic-resistant bacteria that endanger human health. Today, we take a long overdue step toward ensuring that we preserve these life-saving medicines for those who need them most – people."
Friday afternoon the FDA responded to the court's decision saying only, "We are studying the opinion and considering appropriate next steps."
The Animal Health Institute, which represents the animal pharmaceutical industry, characterized the ruling as a step back.
In a prepared statement, it contended that it could "delay the process of eliminating the sub therapeutic (growth promotion) use of medically important antibiotics" by turning it into an administrative process rather than the current voluntary collaborative process that critics complain lacks sufficient teeth.
"FDA has said the collaborative, stakeholder process is a more efficient way of achieving these goals than the process being forced by the court," the AHI statement said. "It is unfortunate that time and resources will now be diverted to responding to the court decision."
Indeed, many had expected this "collaborative" process to produce a final set of voluntary guidelines last week. But they were never finalized or released. According to the ruling, even if the FDA does release such non-binding guidance on antibiotic use, it will not eliminate the need for safety hearings.
Many who support the ruling believe that safety will be extremely difficult to prove given the mounting evidence--including that produced by FDA research--linking the routine use of antibiotics on healthy animals (for growth promotion) with deadly antibiotic resistant infections in humans.
The ruling, in fact, noted that in the 35 years since the FDA presented its concerns on the issue, "the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown."
The court ruling said: "Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be--and has been--transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products."
In January the FDA ruled to restrict the use of another class of antibiotics called cephalosporins from routine use in animal rearing, noting its intent to "reduce the risk of cephalosporin resistance in certain bacterial pathogens. If cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects."
The new ruling would add some penicillins and most tetracyclines to the list. But U.S. Rep Louise Slaughter--who often notes that that she's the only microbiologist in Congress--believes the restrictions must go further.
"This is a good first step," she wrote in a statement, "but to really get in front of this problem we must address all classes of antibiotics in farm animals that are important to human health. That's why I will continue to press for passage of PAMTA (Preservation of Antibiotics for Medical Treatment Act)."
The act is a bill Slaughter introduced in 2007 that would restrict the non-therapeutic use of seven medically important classes of antibiotics to humans in livestock rearing.