The Food and Drug Administration on April 11 announced steps to “promote the judicious use of medically important antibiotics in food-producing animals.” The aim is to reduce the threat that use of antibiotics in animal agriculture for purposes other than those that are, indeed, medically necessary may over time render ineffective antimicrobial drugs essential for treating disease in humans.
“It is critical that we take action to protect public health,” said Margaret A. Hamburg, FDA commissioner. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”
The FDA published in the April 11 Federal Register three documents it said would help veterinarians, farmers and animal producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems.
The first document published was a final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, which recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs. The document was issued as a draft guidance (Guidance 209) in 2010.
The FDA also published a new draft guidance, open for public comment, which will assist drug companies in revising their FDA-approved product labels for medically important drugs to no longer include use for feed efficiency or growth promotion, and include veterinary oversight or consultation.
The third document was a draft proposed veterinary feed directive regulation, also open for public comment, which streamlines and modernizes the current regulation that governs veterinary authorization for the use of certain drugs in animal feed.
“The US Department of Agriculture worked with the FDA to ensure that the voices of livestock producers across the country were taken into account,” said John Clifford, the USDA’s chief veterinary medical officer. “And we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition.”
Consumer groups applauded the actions but indicated the FDA should do much more to end non-therapeutic use of antibiotics in raising food animals.
“This is an important step in protecting the public from the proliferation of antibiotic-resistant bacteria,” said Paige Tomaselli, attorney for the Center for Food Safety. “But it’s high time that FDA takes drastic measures to eliminate all non-therapeutic uses of all antibiotics in food animal production.” Tomaselli said the Center for Food Safety will keep pressure on the FDA to ensure “it stays the course to implement the guidances and the proposed rule.”
Caroline Smith DeWaal, food safety director, Center for Science in the Public Interest, was more critical of the FDA’s approach.
“The FDA’s new policies intended to reduce the overuse of important antibiotics in animal production are tragically flawed,” she said. “They rely too heavily on the drug industry and animal producers to act voluntarily in the best interest of consumers.”
Responding to criticisms alleging the FDA approach was too timid, Michael Taylor, FDA’s deputy commissioner for foods, said collaboration would be quicker than confrontation, which could lead to litigation and delay the process.
Food animal producer groups voiced concerns. Tom Talbot, a California beef producer, large animal veterinarian and chairman of the National Cattlemen’s Beef Association’s (NCBA) cattle health and well-being committee, said, “The NCBA is pleased that FDA has resisted unscientific calls to completely ban the use of antibiotics and antimicrobials in cattle and other livestock species. However, we remain concerned with regulatory actions that are not based on peer-reviewed science or that set the precedent to take animal care and health decisions out of the hands of veterinarians.”
Talbot noted the NCBA expressed concern with FDA’s Guidance 209 in 2010 asserting the recommendations it contained lacked scientific support.
“Antimicrobial resistance is a multifaceted, extremely complex issue that cannot be adequately addressed solely by focusing on the use of antibiotics in animal agriculture,” Talbot said. “Prudent and responsible evaluation of this issue must consider animal, human and industrial use of antibiotics. While we appreciate the agency working with industry on the implementation of Guidance 209, we remain convinced that a strong science foundation is critical before moving forward with this guidance.”
Talbot said giving veterinarians greater oversight of antibiotic use in food animals may be a commendable goal, but cattlemen are concerned with the feasibility of implementing the veterinary feed directives given hurdles such as a shortage of veterinarians in many rural areas and the increased record-keeping burden veterinarians would face.
“The guidance could eliminate antibiotics uses that are extremely important to the health of animals,” cautioned R.C. Hunt, a pork producer from Wilson, NC, and president of the National Pork Producers Council. “And the requirement for veterinary feed directives could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.
“The FDA did not provide compelling evidence nor did it state that antibiotics use in livestock production is unsafe.”
Hunt pointed out that the agency already has authority to withdraw unsafe products.
“Pork producers work with veterinarians to carefully consider if antibiotics are necessary and which ones to use, and we use them to keep animals healthy and to produce safe food,” he said.