The Food and Drug Administration will issue two major proposals Wednesday 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.
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 Wednesday’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.
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 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.
The veterinary drug and animal agriculture industries are largely supportive of FDA’s approach. Groups like the Animal Health Institute, which represents drug companies, and the American Veterinary Medical Association, which represents the veterinarians who work on livestock farms, have been complimentary of the agency’s cooperation with industry and say they support promoting more veterinary oversight of widely-used antibiotics.
Clinton Lewis, Jr., executive vice president and president of U.S operations for Zoetis, the country’s largest animal pharmaceutical company with $4.3 billion in revenue last year, told POLITICO the company is “very appreciative of [FDA’s] open and collaborative approach.” Zoetis is a spinoff of Pfizer’s animal health division.
According to FDA, Zoetis and Elanco, a division of Eli Lilly, are the sponsors of a “large percentage” of the drugs that will be targeted for label changes.
“We agree with [FDA] that this is the fastest way to address their questions and concerns,” said Lewis, who noted the new policy will only affect the small portion of the company’s overall animal feed medicine portfolio that carry growth-promotion claims.
“We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals,” the Animal Health Institute said today in a statement.
Livestock groups have also been broadly supportive of the effort, though some want FDA to adopt a longer timeline.
But the fact that the industry supports the plan has some health advocates concerned it is too riddled with loopholes to work. One of the primary concerns is that growth promotion will continue under the auspices of preventing or controlling diseases.
FDA’s strategy has drawn harsh criticism from Rep. Louise Slaughter (D-N.Y.), the only microbiologist serving in Congress. Slaughter has been incensed about what she feels is a lack of action from FDA on antibiotic-resistance issues. Over the past several years, Slaughter has fired off dozens of letters and press releases blasting the agency and garnered a long list of co-sponsors for legislation to ban certain farm uses of important antibiotics.
Each time there is a drug-resistant foodborne illness outbreak, Slaughter sharply questions FDA. In October, a Salmonella outbreak tied to Foster Farms chicken — caused by a strain resistant to multiple antibiotics — sickened nearly 400 people in 23 states. The congresswoman, along with Rep. Rosa DeLauro (D-Conn.), held a press conference to talk about antibiotic resistance.
Reps. Slaughter and Earl Blumenauer (D-Ore.) sent a letter to the White House Office of Management just this week urging the administration to “swiftly” release its new guidance and proposed rule, but they ask FDA to push for mandatory compliance, calling the guidance approach “anemic and deficient in authority.”
In a statement issued Wednesday, Slaughter further calls the FDA’s voluntary guidance “inadequate.”
“Sadly, this guidance is the biggest step the FDA has taken in a generation to combat the overuse of antibiotics in corporate agriculture, and it falls woefully short of what is needed to address a public health crisis,” she says.
Avinash Kar, a health attorney at the Natural Resources Defense Council, blasted the proposals Wednesday as an “early holiday gift to industry” and a “hollow gesture.”
Still, many public health advocates are glad the agency is trying something.
“We commend FDA for taking the first steps since 1977 to broadly reduce antibiotic overuse in livestock,” said Laura Rogers, director of the Human Health and Industrial Farming campaign at the Pew Charitable Trusts. “There is more work to do, but the agency’s approach is promising — especially after decades of inaction.”
Steven Roach, a senior analyst for the Keep Antibiotics Working Coalition, said the group is “happy that the FDA has finalized this document, so that we can see whether it actually works,” but added that the coalition fears there wont be a reduction in the use of antibiotics.
FDA’s Taylor acknowledged that the agency is at the beginning of a long road.
“There’s significant work to come,” he said. When responding to critics, Taylor often argues that FDA’s voluntary approach is the best shot it has at moving the ball forward. FDA officials say they lack the authority and resources to force changes on each of the 200 or so antibiotics approved for food animals.