Written Comment on Re-Authorization of the Animal Drug User Fee Act

December 19, 2022

Robert M. Califf, M.D.

Commissioner of the U.S. Food and Drug Administration 

My name is Louis Sokolow and I’m a Public Health Campaigns Associate with PIRG, a non-profit, nonpartisan consumer advocacy group. I appreciate the opportunity to comment publicly on the Animal Drug User Fee Act reauthorization and provide PIRG’s big-picture perspective. 

In a recent article, the London-based Bureau of Investigative Journalism used unpublished USDA data to chronicle the use of antibiotic classes considered highest priority critically important by the World Health Organization in the beef supply chains of significant purchasers like McDonald’s, Taco Bell and Walmart. Sales of medically important antibiotics to food animal producers have risen roughly 8% since 2017, which underscores the continued overuse of life-saving medicines in animal agriculture. 

About a year ago, PIRG launched the Coalition to Preserve Antibiotics, a multi-stakeholder group of 75 farmers, physicians and veterinarians dedicated to reducing antibiotic use in agriculture. As we continue our efforts to keep these life-saving medicines effective, ADUFA is a critical vehicle to encourage antibiotic stewardship in animal agriculture and address drug-resistant bacteria coming from our food supply. 

The vital and publicly available antibiotic sales data already collected by the FDA paint a broad picture of antibiotic overuse in animal agriculture. Gathering antibiotic use data from farms through ADUFA will allow a more detailed assessment of both this overuse and what, if any, recent progress the FDA has made on reducing it. 

The FDA has been dragging its feet on duration limits for antibiotics used in animal agriculture since 2016, and action is long overdue. As of April 2022, 93 medically important antibiotics that are approved for use in animal feed still lacked duration limits, leaving the length of use up to a veterinarian’s discretion. Setting duration limits would be a big step toward eliminating the routine feeding of medically important antibiotics to animals that aren’t even sick. 

In its ADUFA recommendations to Congress, the FDA should: 

• Request funding to collect veterinary feed directives (VFDs) and issue public reports on the antibiotic use data they contain. 
• Request additional support to finalize and implement guidance that sets duration limits on all medically important antibiotics approved for use in food animal production. 

Sincerely, 

Louis Sokolow 

Public Health Campaigns Associate, PIRG