FDA ordered to reconsider ‘antibiotic’ petitionsPrint
In the federal district court in Manhattan, Judge Theodore H. Katz ordered the Food and Drug Administration (FDA) to reconsider petitions that asked the agency to withdraw approval of some antibiotics used in food-producing animals, criticizing the agency for relying on industry for oversight of those drugs.
In his ruling, Judge Katz said that the agency has done “shockingly little” to address antibiotic use in food-producing animals and their potential impact on human health. He called FDA’s denial of both petitions – filed in 1999 and 2005 – “arbitrary and capricious.”
Earlier this spring, FDA issued guidance designed to limit the use of some antimicrobial medicines in animal agriculture, while increasing veterinarian oversight requirements for their use.
Under this new FDA policy, all antimicrobial medicines approved for use in animal agriculture will be used only for therapeutic purposes, such as disease treatment, control and prevention, and only under licensed veterinarian supervision.
Three FDA documents published in the Federal Register: 1) provides guidance giving veterinarians more oversight in the therapeutic uses of drugs to treat livestock, while recommending phasing out use of medically important drugs in production agriculture; 2) provides guides for drug companies to voluntarily remove production uses of antibiotics from their FDA-approved product labels, changing those labels to emphasize therapeutic uses, with increased veterinary oversight; and 3) outlines ways veterinarians can authorize the use of certain animal drugs in feed.
The Animal Health Institute (AHI), whose membership includes animal pharmaceutical and vaccine companies, said the court decision adds confusion to FDA’s efforts to phase in veterinary oversight of antibiotics, saying the court has now ordered FDA to initiate two different, competing and resource-intensive processes.
“The opinion cites the lack of risk assessments as one basis for its action,” according to an AHI statement. “In fact, several risk assessments have been published in peer-reviewed journals, and FDA has performed its own risk assessment on one compound. All these scientific assessments reached the same conclusion: The actual human health risk of the use of antibiotic use in animals resulting in the inability of the drug to treat human disease is extremely small – in one instance, less than the risk of dying from a bee sting. Research also shows antibiotics are one of the many tools used to enhance food safety.”
AHI said it will continue to support and work with FDA on veterinary oversight and elimination of growth uses for medically important compounds. This cooperative process will help avoid the unintended consequences of increased animal disease that have resulted from legislated bans in Europe, AHI said.
In a related matter, a coalition of agricultural organizations sent a letter to U.S. Rep. Louise Slaughter (D-N.Y.), who is the primary author of the “Preservation of Antibiotics for Medical Treatment Act” (H.R. 965), which seeks to ban the use in livestock and poultry production of several classes of antibiotics employed for preventing and controlling diseases and for promoting nutritional efficiency.
Slaughter in February asked food companies to submit to her, by June 15, their purchasing policies related to antibiotic use in food animals.
“Antibiotic used in veterinary medicine are reviewed and approved by FDA,” the coalition stated in its letter. “For animal antibiotics, the safety assessment is more stringent than that for human antibiotics in three ways: 1) If there are risks to humans, FDA will not approve the antibiotic for animals; 2) FDA requires a food safety assessment to ensure meat is safe; and 3) FDA studies the pharmaceutical thoroughly to guarantee it does not increase the risk of antibiotic-resistant bacteria in food. The coalition further explained that FDA recently issued new regulations that effectively prohibit the use in food animals of “medically important” antibiotics for improving nutritional efficiency. The rules also ensure veterinarians will be involved in overseeing all uses of these products.
The coalition cited several published, peer-reviewed risk assessments showing any threat to human health from antibiotic use in livestock and poultry production is negligible, and pointed out many of the bacterial illnesses becoming resistant to antibiotics in human medicine have little or no link to antibiotic use in food animals.
Members of the coalition include the American Farm Bureau Federation, American Feed Industry Association, American Meat Institute, AHI, American Veterinary Medical Association, National Cattleman’s Beef Association, National Chicken Council, National Milk Producers Federation, National Pork Producers Council, National Meat Association and the National Turkey Federation.