Apr 11, 2012 (CIDRAP News) – Saying a voluntary strategy is the best way to reduce the agricultural use of antibiotics and preserve the drugs' medical usefulness, the US Food and Drug Administration today released draft guidance designed to steer animal-drug producers, veterinarians, and farmers in that direction.
The FDA outlined a plan that calls for drug companies to voluntarily change their product labels to stop growth-promotion uses and that will require farmers to consult with veterinarians to use antibiotics in their animals. The agency plans to evaluate the success of the strategy after 3 years.
In announcing the plan at a press conference, Michael Taylor, JD, the FDA's associate commissioner for foods, said the causes of antibiotic resistance are complex and include overuse in human medicine, "but we know that use of medically important drugs in food production animals is a contributing factor."
"It is critical that we take action to protect public health," FDA Commissioner Margaret A. Hamburg, MD, said in a press release. "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 policy takes aim mainly at antibiotics that are used in farm animals to improve feed efficiency and growth, that are available without a prescription, and that were approved before October 2003, according to a fact sheet. That date was when the agency issued guidance on evaluating agricultural antibiotics in light of their possible effects on bacteria of human health concern.
Taylor was noncommittal today about the impact of a recent federal court ruling that directs the FDA to restart a process originally begun in 1977 to ban the use of penicillin and tetracycline in farm animals. The ruling was handed down in March in a lawsuit filed by several consumer and environmental groups.
"This initiative predates the litigation in that ruling," Taylor said. "The government is assessing the ruling and whether to appeal it. As we said earlier, we believe we can achieve the goal that seems to underlie that decision more expeditiously."
Three guidance documents released
The FDA announced the publication of three documents today in the Federal Register.
- 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 the drugs.
- A draft guidance, open for public comment, to help drug companies in voluntarily removing production uses of antibiotics from their product labels and in adding, where appropriate, scientifically supported disease prevention, control, and treatment uses. The guidance is also intended to help companies change "the marketing status" of drugs to include veterinary oversight.
- A proposed Veterinary Feed Directive regulation, open for public comment, that "outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient."
FDA officials insisted that trying to simply ban the growth-promotion uses of antibiotics in animals would not work because it would require a slow legal process.
"We can make changes more quickly [with a voluntary strategy] than if we had to rely solely on a cumbersome regulatory process that would require us to seek changes drug by drug and label-use by label-use," Taylor said. "Given that there are a couple hundred products involved here, it's decades of effort and million and millions [of dollars] in resources."
He also asserted that since the FDA first laid out its voluntary strategy in 2010, there has been a "sea change" in the understanding of the need to take action on the issue and in the ability of the government, the drug industry, and agriculture to collaborate on it. He spoke of a " very productive engagement" of the various players in dialog about the problem.
What's targeted, what's not
FDA officials said their plan, while targeting production uses of animal antibiotics, does not rule out using them to prevent disease in herds.
William Flynn, DVM., deputy director for science policy in the FDA Center for Veterinary Medicine, said growth-promotion and production uses of antibiotics generally means their "herd-wide or flock-wide" use on a long-term basis.
In response to questions, Taylor said there is a clear distinction between production and preventive uses of animal antibiotics. "In contrast, prevention is to prevent a specifically identified disease in animal at risk of developing that disease," he added. "Those uses are approved by the FDA and have to be shown safe and effective."
"A major shift is that in conjunction with removing production use, producers will now have to consult with a vet for use of that product," Taylor said. A veterinarian will have to assess the disease risk for the animals in question and use the appropriate drug, and not "simply put a drug in feed to cover whatever disease might come along," he explained.
FDA officials said they are sensitive to the concerns of small-scale farmers who live in remote areas with poor access to veterinary services.
Taylor said the agency's guidance provides for streamlining veterinary oversight procedures and making it "much more feasible for small-scale producers to get access to vets." The FDA is working with the veterinary groups and the US Department of Agriculture (USDA) to address the problem, he added.
FDA and USDA officials plan to hold some public meetings in the next few months to get input from producers and veterinarians on how to mitigate the impacts of the veterinary-oversight requirements, said Thomas J. Myers, VMD, PhD, associate deputy administrator of the USDA's Animal and Plant Health Inspection Service.
Officials at the press conference were wary of giving any specific assessments of the magnitude of ag antibiotic as a factor in antimicrobial resistance or how much of a dent the voluntary plan might make.
For example, they declined to say whether the farm sector is a bigger contributor to the resistance problem than human medicine is. "I think the fair thing to say is they're both contributors and we need to address the problem on both fronts," said Taylor.
Flynn said it's hard to predict what degree of reduction in usage to expect from the program, "but overall we feel confident it's going to have an effect not only in reducing use over time, but also in using the drugs in as smart a way as possible."
Once the draft guidance documents are finalized, the FDA will call for the animal health industry to report within 3 months their plans for responding to the guidance, Flynn said, commenting, "That'll give us an early indication of the engagement by the industry."
In a fact sheet, the FDA said it plans to evaluate the rate of voluntary adoption of the proposed changes after 3 years and will consider further actions at that time, if warranted.
Industry, advocacy groups react
Today's announcement triggered a range of reactions from industry and advocacy groups.
The Center for Science in the Public Interest (CSPI), one of the groups that had sued the FDA to force it to restrict animal-antibiotic use, called the FDA's policies "tragically flawed."
"They rely too heavily on the drug industry and animal producers to act voluntarily in the best interest of consumers," the group said in a statement. "Protecting public health is an authority and a responsibility that rests squarely with the FDA." However, today's step "at least indicates that the agency recognizes a 'public health imperative' to tackle this problem," it said.
In contrast, the Animal Health Institute, which represents producers of drugs and other health products for farm animals, expressed support for the FDA plan.
"Implementation of this policy means all medically-important antibiotics used in animal agriculture will be used only for therapeutic purposes—disease treatment, control and prevention—under the supervision of a licensed veterinarian," the institute said. "This policy will assure these medically important medicines are used in animal health in much the same way they are used in human health—under the supervision of a licensed professional and only to address disease challenges at various stages."
The institute said it agrees with the FDA's collaborative process but added that some details need to be address to make the approach practical and workable.
Rep. Louise Slaughter, D-N.Y., a microbiologist and veteran advocate for limiting ag antibiotic use, said the FDA is moving in the right direction, but hasn't done enough. She said the FDA is moving at a "glacial" pace.
"This is a step in the right direction, but much more must be done," Slaughter said in a statement. "Antibiotic-resistant diseases now kill more Americans than AIDS, and this issue needs to be treated with the seriousness it deserves. Of course if an animal is sick it should be treated, but the misuse of antibiotics in animal feed is destroying the effectiveness of antibiotics and limiting our ability to treat human illnesses.
"'Nonbinding recommendations' are not a strong enough antidote to the problem, particularly when we know that banned antibiotics are still being detected."
Apr 11 FDA press release with links to guidance documents
FDA questions and answers on its policy
Mar 23 CIDRAP News item on March court ruling
Nov 10, 2011, CIDRAP News story on FDA's denial of petitions to restrict animal antibiotic use
Animal Health Institute statement
Apr 11 CSPI statement