As part of a government-wide campaign to preserve the effectiveness of antibiotics in treating disease in humans, drugmakers will have to estimate sales of antimicrobials for use in the major species of food animals, such as cattle, hogs, chickens and poultry. FDA said the industry estimates “will complement the data collection plan were are developing to obtain additional on-farm use and (bacterial) resistance data.”
“The collection of data from multiple sources, including enhanced sales data from antimicrobial animal drug sponsors, is needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture,” said FDA’s Center for Veterinary Medicine. By some estimates, livestock account for three-fourths of antibiotic use annually.
Emergence of antibiotic-resistant bacteria jeopardizes one of the greatest discoveries of modern medicine, antimicrobials that prevent infections and speed recovery from illness.
FDA unveiled the new regulation after a year of work and as the livestock industry enters the final stage of a phase-out that began in December 2013 of use of medically important antibiotics to encourage weight gain in food animals. From 2017, such antibiotics will be restricted to prevention and treatment of disease in livestock and will be available only through veterinarians. At present, antibiotics are available over the counter.
“This information will further enhance FDA’s ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine,” said FDA’s William Flynn, deputy director for science policy in the Center for Veterinary Medicine.
The FDA is working with USDA and CDC on a system to collect on-farm usage and resistance data.
Since 2008, drugmakers have provided data on antibiotics sold or distributed for use in food animals. The new FDA rule, scheduled to appear today in the Federal Register, will mean more detail on where the drugs go.
“We’ve been waiting on this for years,” said Rep Louise Slaughter, New York Democrat and proponent of stricter rules on farm use of antibiotics. “I will continue to push FDA to quickly expand its efforts to on-farm surveillance so that new antibiotics remain effective and don’t go the way of current drugs.” The Consumerist quoted Steve Roach of Keep Antibiotics Working campaign as saying the new rules “fall short of what is needed to adequately monitor FDA’s efforts to combat antibiotic resistance.”
Some skeptics say the FDA’s phase-out of medically important antibiotics for weight gain may have limited effect. Producers could say the drugs are needed for disease prevention and continue to use them, they say.