Food Safety Advocates Blast Voluntary Nature Of New FDA Plan To Limit Use of Antibiotics in Farm Animals

A long-delayed plan to reduce the use of antibiotics in farm animals is drawing heat from some food safety advocates and cautious praise from industry associations and drugmakers.

The new proposal, announced Wednesday by the Food and Drug Administration, comes in response to growing concerns that overuse of antimicrobial drugs is contributing to the rapid evolution of antibiotic-resistant strains of human bacteria and infections, which infect more than 2 million people and kill more than 23,000 each year in the United States, according to the Centers for Disease Control and Prevention.

The FDA’s plan is being heralded by leading industry associations and companies as an important step toward curbing the dangerous overuse of medically important antibiotics to increase agricultural efficiency, but critics are disappointed that the plan is to be voluntarily implemented by the very companies that manufacture the vital drugs.

The plan sets up a three-year timetable for the veterinary oversight and elimination of the use of medically important antibiotics to promote growth in food animals. Once a company voluntarily implements the changes laid out in the plan, future use of the antibiotics in question would need to be approved by licensed veterinarians for the purpose of preventing, treating or controlling disease in food-producing animals, the FDA explained.

The plan consists of two components, dubbed Guidance 213 and the Veterinary Feed Directives (VFD), which the FDA says explain “how animal pharmaceutical companies can work with the agency to voluntarily remove growth enhancement and feed efficiency indications from the approved uses of their medically important antimicrobial drug products, and move the therapeutic uses of these products from over-the-counter (OTC) availability to marketing status requiring veterinary oversight.”

David Warner, a spokesman for the National Pork Producers Council, said that the FDA’s plan will “mean real change for how antibiotics are used on farms and how veterinarians are involved,” echoing the sentiments of other industry groups that support the voluntary plan.

“As for the withdrawal of antibiotics, which also are used in human medicine, that are labeled only for feed efficiency/growth promotion being voluntary, it's voluntary until it isn't,” Warner explained. “In other words, if drug companies don't voluntarily withdraw those antibiotic uses over the next three years, FDA will make the withdrawal mandatory.”

But Avinash Kar, of the National Resources Defense Council, is highly critical of the voluntary nature of the guidelines and expressed pessimism that they will eventually be made mandatory.

“As I have blogged about before, the guidance is voluntary. It asks drug manufacturers to voluntarily stop selling antibiotics to speed up animal growth,” Kar wrote. “The livestock industry accounts for 80 percent of their antibiotic sales. Do we really think the pharmaceutical industry is going to voluntarily walk away from such a big chunk of its customer base? I don’t see that happening.”

Pam Eisele, a spokeswoman for the major pharmaceutical company Merck, which manufactures drugs used in animal production, said the company supports the FDA plan.

“Merck Animal Health firmly believes in the responsible use of antibiotics and is committed to working with governments, veterinarians and producers to help ensure these products remain an important tool in improving and maintaining the health and welfare of animals now and in the future,” she said.

Food safety and public health advocates expressed support for the goals of the new plan, though they criticized the fact that it is voluntary, adding that they will monitor the rollout closely to ensure that companies effectively implement the guidelines.

“Unfortunately it requires the drug companies who profit from sales of their drugs to initiate the process,” Caroline Smith DeWaal, director of Center for Science in the Public Interest, said in a statement. “The good news is that the agency has pledged to evaluate levels of compliance and inform the public after 90 days if the drug industry is cooperating with the relabeling effort.”

Laura Rogers, a spokeswoman for the Pew Charitable Trust’s human health and industrial farming division, told the Associated Press that the new FDA initiative is a “promising” development for consumers concerned with the use of drugs in food production.

“We commend FDA for taking the first steps since 1977 to broadly reduce antibiotic overuse in livestock,” Rogers said. “There is more work to do, but this is a promising start, especially after decades of inaction.”

The U.S. Government Accountability Office reported in 2011 that even a plan like the one introduced by the FDA on Wednesday could be less effective than many health-conscious consumers would like.

“One veterinarian told us that if FDA withdrew an antibiotic’s approval for growth promotion, he could continue to give the antibiotic to the animals under his care at higher doses for prevention of a disease commonly found in this species,” the GAO wrote. “The veterinarian stated that there is an incentive to do so because using an animal antibiotic can help the producers he serves use less feed, resulting in cost savings.”

Scott George, president of the National Cattlemen’s Beef Association, a trade group that represents American cattle producers, was not as strong in his endorsement of the guidelines as some other trade groups were, saying in a statement that cattle producers already work with veterinarians to ensure that they use antibiotics properly.

“Through multiple industry-led initiatives, including the Beef Quality Assurance (BQA) program and the Producer Guidelines for Judicious Use of Antimicrobials, cattle farmers and ranchers work with veterinarians to select and use antibiotics appropriately and as needed,” George said, adding, “Only by carefully evaluating antimicrobial resistance in a comprehensive manner that [looks at] all of the peer-reviewed science related to all animal and human use will we effectively address this important issue.”

William Flynn, of the FDA’s Center for Veterinary Medicine, described the new guidance as a positive step toward curbing the overuse of antibiotics in the food supply.

“We need to be selective about the drugs we use in animals and when we use them,” Flynn said in a Wednesday statement. “Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.”

The FDA’s announcement comes a month after former FDA commissioners David Kessler and Donald Kennedy submitted an open letter to the White House urging the Obama administration to take steps to curb the use of medically important antibiotics in animals in order to help slow the potential arrival of a “post-antibiotic” era of rampant untreatable infections.

“We have more than enough scientific evidence to justify curbing the rampant use of antibiotics for livestock,” they wrote. “Action by the Obama administration would be an initial – and long-awaited – step to encourage livestock producers to stop relying on massive overuse of antibiotics to compensate for overcrowding, poor hygiene and lax animal health management.”