The US Food and Drug Administration (FDA) yesterday released new draft guidance that aims to close the loop on the use of medically important antibiotics in livestock and companion animals
Draft guidance for industry (GFI) #263 will bring the roughly 5% of medically important antibiotics that can still be bought over-the-counter for use in livestock and companion animals under the oversight of licensed veterinarians. It builds on a previous guidance (GFI #213) that brought all medically important antibiotics used in food-animal water and feed under veterinary supervision and eliminated the use of medically important antibiotics for growth promotion.
Prior to the implementation of GFI #213 in 2017, antibiotics used to treat human infections and also approved for use in animal feed and water could be purchased by farmers over the counter, without a prescription from a veterinarian. The FDA called the policy a "significant milestone" in national efforts to promote more judicious use of medically important antibiotics in food-animal production.
The policy, however, did not cover a handful of products, mainly injectable antibiotics. The new guidance, once finalized, means that all medically important antibiotics used in food-producing animals and companion animals will require veterinary oversight going forward and can be administered for therapeutic uses only.
"When Draft GFI #263 has been finalized and fully implemented, all dosage forms of all approved medically important antimicrobials for all animal species can only be administered under the supervision of a licensed veterinarian and only when necessary for the treatment, control or prevention of specific diseases," the FDA said in a statement announcing the draft guidance.
The agency says the draft guidance, issued by the Center for Veterinary Medicine, is part of its 5-year plan for supporting antimicrobial stewardship in veterinary medicine. That plan was released in September 2018.
Critics say FDA needs to do more
Matt Wellington, antibiotics campaign director for US PIRG (Public Interest Research Groups), said that while the draft guidance is an important step forward, he believes the FDA still has a lot of work to do to limit the use of medically important antibiotics in livestock.
The FDA maintains that medically important antibiotics should be used only when necessary to treat, control, or prevent disease. But Wellington and other stewardship advocates argue that medically important antibiotics should be used only to treat sick animals or to control a verified disease outbreak on farms, and that use of these drugs for disease prevention in healthy animals is unnecessary and contributes to rising levels antibiotic resistance.
"The FDA continues to miss the mark on what's truly needed to address this public health crisis, which is eliminating all routine use of medically important antibiotics," Wellington said. "We do not think we should be throwing life-saving medicines away to compensate for industrial farming conditions."
Among the immediate steps Wellington would like to see the FDA take is setting duration limits for use of medically important antibiotics in animals.
"About a third of the medically important antibiotics used in food-animal production have either no defined duration or really vague and open-ended durations," he said. "When you look at human medicine, there's really very few comparisons where it would be acceptable to use antibiotics in that way."
The FDA said in its 5-year plan said that it's gathering information on duration limits and that it intends develop and implement a strategy to ensure that all medically important antibiotics use in food animals are labeled with "an appropriately targeted duration of use."
Like GFI #213, the new guidance is asking companies that sell medically important antibiotics for use in animals to voluntarily change the marketing status on product labels from over-the-counter to prescription. The FDA is proposing a 2-year implementation period for the new rule after it receives comment on the draft guidance and issues the final guidance, and it says it will monitor progress to assess whether the changes are being implemented.
The public comment period ends on Dec 24, 2019.
Sep 23 FDA statement
Sep 23 FDA Draft GFI #263
Sep 14, 2018, CIDRAP News story "FDA plan focuses on antibiotic development, stewardship"