The Food and Drug Administration will issue two major proposals today in an effort to cut back on antibiotics used on farms that can spur drug-resistant superbugs, making a final push to limit drugs fed to animals before they’re turned into steaks and pork chops.
The move — just the latest by the agency to tighten regulation of the American food supply — puts drug companies on notice and starts the clock on the Obama administration’s three-year strategy to rein in the use of antibiotics. It comes on the heels of a recent effort to ban trans fats and a handful of other sweeping new food safety regulations.
Antibiotics have become essential to meat producers as they help fatten chickens, pigs and cattle more quickly and keep diseases from spreading among thousands of animals in close quarters. Health advocates, however, have for decades sought stricter limits, arguing that science shows this practice contributes to the growing problem of antibiotic-resistant infections — which now kill 23,000 Americans and rack up millions in added health care costs each year.
(Also on POLITICO: Full agriculture policy coverage)
Scientists also blame antibiotics’ overuse in human medicine, but — since agriculture consumes the vast majority of antibiotics sold in the U.S. — animal drug use is increasingly under fire. In 2011, nearly 30 million pounds of these drugs were sold for animals, compared to just under 8 million pounds for humans.
After years of deliberating, and revealing drafts in early 2012, the FDA will release two key finalized documents today aimed at tackling what the agency calls “injudicious” use of certain antibiotics on farms.
“We see this as a very big step forward in the effort to tackle the problem of antibiotic resistance,” Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, who oversees the food side of the agency, told POLITICO. “We all realize the time has come to take this step and move beyond these growth promotion uses.”
The first part of today’s announcement is the release of a long-awaited guidance, which essentially asks veterinary drug companies to remove growth-promotion claims from antibiotics that are important for human medicine. The agency is giving all drug companies 90 days to notify FDA if they will voluntarily agree to do so. After a lot of private sector engagement, FDA officials say they are optimistic most will and the companies that don’t could face regulatory action.
(Also on POLITICO: Full health policy coverage)
The second part of the plan is a proposed rule to require antibiotics currently sold over the counter in large quantities that can be added to feed and water to — for the first time — require prescriptions from veterinarians.
Farmers and ranchers will still be able to use medically important antibiotics for what FDA considers judicious uses — to prevent, treat or control diseases — but the goal is to curb the practice of administering the drugs at low dose levels to entire flocks or herds.
FDA’s announcement today will start clocks ticking on both fronts. Drug companies will have three months to notify the agency if they intend to go along with their strategy. FDA, meanwhile, will have three years to implement its plan and evaluate if it’s working.
Taylor told POLITICO the agency intends to publicly release an update, after the 90-day period, on what percentage of companies have agreed to go forward with removing their growth-promotion claims from a wide variety of pharmaceutical feed additives.
“That will be an important benchmark of success,” said Taylor.