The US Food and Drug Administration (FDA) released the new draft guidance on Monday [September 23].
The proposed guidance is looking to both address the remaining antimicrobial drugs that are available over-the-counter and that can be used in livestock production but are medically important for humans, as part of its five-year antimicrobial stewardship plan.
Comments will be allowed on the proposed guidance for the next 90 days.
The guidance seeks to establish a process to voluntarily bring the remaining medically important drugs under the oversight of veterinarians by switching their marketing status from over-the-counter to prescription.
“The use of medically important antimicrobial drugs in animals should be under the oversight of licensed veterinarians that have the scientific and clinical training and knowledge to ensure that these important drugs are used judiciously,” said Steven Solomon, director of the FDA’s Center for Veterinary Medicine.
“Once the final version of this guidance is implemented, all medically important antimicrobial drugs for animals will need to be provided by licensed veterinarians,” he said. “The FDA is committed to working with affected stakeholders on the implementation of this and other critical parts of our five-year plan to support antimicrobial stewardship and combat antimicrobial resistance.”
The proposed guidance builds off of work started by the FDA’s guidance for industry 213, which took effect in 2017, and addressed many of the over-the-counter, medically important antimicrobials used in livestock production.
'Encouraging that FDA is taking the initiative'
The new guidance is a positive step towards the goal of judicious use of antibiotics that are medically important for human use, said Karin Hoelzer, senior officer in health programs with Pew Charitable Trusts.
“The FDA brought most of the antibiotics that are important for human medicine under veterinary oversight in 2017, and they saw a pretty dramatic decrease in the sales of antibiotics the following year, which is encouraging,” she told FeedNavigator.
“But there are still products that are available over-the-counter [and] that includes some antibiotics that the World Heath Organization (WHO) considers critically important for human health.”
The antibiotics covered by the proposed guidance are a relatively small percentage of the products available, but a fairly big volume has been sold every year, she said. And some of the use patterns suggested by data collected indicate that they could be widely used among an animal population.
“There is a need to ensure that these products are used judiciously, and we’re encouraged that FDA is taking the initiative,” she said.
The proposed guidance asks pharmaceutical companies to weigh in, within three months of the guidance being finalized, on whether they are voluntarily willing to change the designation of their products, said Hoelzer.
A similar process was used in the initial shift of products from over-the-counter to prescription use.
"The FDA has good precedent for taking a voluntary approach, but there’s always a question of how willing pharmaceutical companies will be to make these changes,” she said. “It’s encouraging that FDA asked them to report back within three months and kind of make a decision.”
The Trust is concerned, though, about the implementation timeline. The FDA is proposing a two-year implementation period that would begin after the agency considers comments on the draft guidance and issues the final guidance
“We understand that there are some logistics involved in changing the approval of a product, but it means that these products are available without veterinary oversight for at least two more years and that’s a concern for us – we’d like to see a more expeditious action from the industry.”
Ensuring judicious use of antibiotics
Pew is also looking for additional progress on judicious use of antibiotics in feed, water and with animal agriculture, said Hoelzer.
“FDA has outlined an ambitious five-year plan and it’s good to see progress in reaching some of these near-term goals but it will be important to keep the momentum going and to continue to work to achieve the goals that were outset in the plan,” she said.
The organization always wants changes to be made around duration of use for antibiotic products, she said. “At the moment, one in three antibiotics that are important for human medicine and marketed for animals doesn’t have a clearly defined duration of use – that clearly is a big obstacle to stewardship,” she added.