The Food and Drug Administration on April 11 addressed antimicrobial resistance resulting from the use of antibiotics in food-producing animals by recommending that the farming industry phase out the use of "medically important" antibiotics and phase in their use only for therapeutic purposes under veterinary supervision.
The guidance for industry, titled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals," is a voluntary initiative under which "certain antibiotics would not be used for so-called ‘production’ purposes, such as to enhance growth or improve feed efficiency in an animal," while keeping the drugs available for preventing, controlling, or treating illnesses in these animals under the supervision of a veterinarian, according to the FDA statement.
A major shift is that farmers will now have to consult with a veterinarian regarding the use of these drugs in food-producing animals for targeted therapeutic purposes, for a specific duration of time, which includes preventive uses, Michael Tucker, the FDA’s deputy commissioner for foods, said during a press briefing. He said he expects that the changes will take about 3 years to be phased in.
The FDA also issued two draft documents, which are open for public comment: One is aimed at helping manufacturers remove production uses of their antibiotics from the FDA-approved product labels – voluntarily – and will add, "where appropriate, scientifically supported disease prevention, control, and treatment uses." The second document is a proposed regulation 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," according to the statement.
Mr. Tucker acknowledged that the voluntary nature of the program could be considered a possible limitation, but added that an outright ban would require a formal process that would include evidentiary hearings and would be an "intensive lawyer-driven process" that could take decades to complete, and that the voluntary program would achieve the goals of the program faster and more efficiently.
The Infectious Diseases Society of America is among the medical associations that have addressed the problems of inappropriate use of antibiotics in agriculture and animals used for food. IDSA has recommended "ending the use of antibiotics for growth promotion, feed efficiency, and routine disease prevention purposes in food animals; requiring prescriptions and veterinary oversight of all antibiotics given to animals; and ensuring that antibiotic use in all animals, similar to human medicine, is carried out under the supervision of a veterinarian," according to a statement on its Web site.
"The relationship between antibiotic-resistant infections in humans and antibiotic use in agriculture is complex, but well-documented," the statement says, referring to "a large and compelling body of scientific evidence" which demonstrates "that antibiotic use in agriculture contributes to the emergence of resistant bacteria and their spread to humans."
A statement issued by the Alliance for the Prudent Use of Antibiotics (APUA) applauded the release of the guidelines, which it said address "mounting scientific evidence of transfer of resistant genes in the environment to dangerous pathogens in humans and the role that food animal production plays in that process." The guidelines put the food animal industry "on a level playing field" with the human medical community in terms of requiring responsible use of antibiotics, the statement said, referring to the "long-standing irony" that antibiotic use in human medicine requires prescriptions, unlike in the animal industry. The guidelines also promote responsible food production practices already codified in many European countries, Kathy Young, APUA’s executive director, said in the statement. In the statement, Dr. Stuart Levy, APUA’s president and director of the Center for Adaptation Genetics and Drug Resistance, Tufts University, Boston, said that the organization will be involved in carefully monitoring compliance with the program, since it is voluntary.
A statement issued by the Center for Science in the Public Interest, however, described the program as "tragically flawed," and said that it relied "too heavily on the drug industry and animal producers to act voluntarily in the best interest of consumers."
The final guidance and draft documents are being published in the federal register and are available online.