FDA Plans Next Moves on Antimicrobials

CVM plans to bring non-feed dosage forms for medically important antibiotics used in livestock under the oversight of veterinarians. ( John Maday )

Editor’s note: We’ll have a series of articles summarizing highlights from the recent Bovine Respiratory Disease Symposium and Academy of Veterinary Consultants Conference on this site over the rest of this month. Check back often.

Veterinarians and livestock producers have adapted to significant changes in antimicrobial regulations over the last two years, and change will continue as the FDA works through its five-year plan for antimicrobial stewardship.

During the recent Bovine Respiratory Disease Symposium in Denver, Mike Murphy, DVM, a veterinary officer with the FDA’s Center for Veterinary Medicine (CVM) outlined progress and future plans for advancing antimicrobial stewardship in food-animal production.

In 2017, FDA completed implementation of Guidance for Industry (GFI) 213, which effectively removed label claims for performance or production enhancement from medically important antibiotics used in feed, and increased veterinary oversight for use of most medicated feeds under the veterinary feed directive (VFD).

Those changes have helped reduce sales of medically important antibiotics used in feed by 28%, Murphy says. FDA acknowledges though, that antibiotic sales alone do not provide a reliable measure of progress toward the ultimate goal of reducing the prevalence of antimicrobial-resistant pathogens. “A reduction in use indicates awareness of the regulations,” Murphy says, “but is not a full mesure of success.”

In its five-year plan (2019 through 2023) CVM’s lists three primary goals:

1. Align antimicrobial drug product use with the principles of antimicrobial stewardship.

2. Foster stewardship of antimicrobials in veterinary settings.

3. Enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals.

Timeline for FDA Actions

In terms of compliance with VFD rules, FDA has, so far, focused more on education than enforcement. By the end of this month, (August 2019) FDA plans to publish a summary report on VFD inspections and compliance. Murphy suggested that overall compliance has been good, and violations generally have involved honest mistakes or misinterpretations of the regulations rather than intentional.

Also in the short term, CVM plans to bring remaining dosage forms for medically important antibiotics used in livestock, such as injections or intra-mammary applications, under the oversight of veterinarians. Many of those products remain available for over-the-counter (OTC) purchase. FDA/CVM plans to release a draft GFI next month, September 2019, outlining plans for these new rules.

Also, by the end of this year, FDA/CVM plans to update its list of “medically important” antimicrobials used in livestock, currently listed in GFI 152.

Currently, the labels for some medications delivered in feed or water do not specify duration of use. Murphy says FDA/CVM plans to issue a draft strategy to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use by September 2020.

Access the full five-year plan for antimicrobial stewardship online from the FDA.

For more about FDA efforts toward antimicrobial stewardship, see these articles from BovineVetOnline:

VFD Audits: What to Expect

FDA Draft Guidance Updates VFD Q&A

Antibiotic Stewardship: FDA Cites Progress