WASHINGTON, D.C. –  Today, U.S. Senator Cory Booker (D-NJ) wrote a letter to Food and Drug Administration (FDA) Commissioner Robert M. Califf expressing concerns about the FDA’s proposed revisions to rules guiding antibiotic use in animal agriculture. If finalized, the agency’s changes would exacerbate antimicrobial resistance (AMR) by worsening the massive overuse of antibiotics in factory farms. 

Antimicrobial resistance is a severe threat, making routine medical procedures more dangerous and common illnesses more deadly for people with compromised or weakened immune systems. Annually, drug-resistant infections sicken three million people and kill at least 50,000 in the United States, costing the healthcare system $4.6 billion.

“A primary driver of the spread of antibiotic resistance is the misuse of antibiotics in industrial animal agriculture. About two-thirds of the sales of medically important antibiotics are for use in food-animal production. Concentrated animal feeding operations create a breeding ground for AMR, due to their crowded conditions and the overreliance on antibiotics to keep animals healthy in an unsanitary and disease-promoting environment,” Senator Booker wrote. 

Despite this threat to public health, the FDA’s proposed revisions “would undermine the safety standards applied to new animal drugs by allowing animal health concerns to be the determining factor in human safety decisions about drugs used in food-producing animals. This will set a dangerous precedent by prioritizing the needs of the regulated industry over the FDA’s primary mission to protect public health. I urge you to finalize Guidance for Industry that meaningfully protects medically important antibiotics from overuse,” the Senator continued. 

Current FDA policy restricts high and medium-risk drugs to no more than 21 days of use in groups of animals to ensure human health safety. The proposed draft GFI#152 removes this limit, allowing durations to be determined on a case-by-case basis, considering animal health factors. Draft GFI#273 focuses solely on animal health benefits without considering human safety data, “If finalized, these draft GFIs would worsen AMR. Further, the FDA has failed to use its existing authority to collect information on antibiotic use from feed mills and has not created any metrics to measure the progress of its efforts to combat AMR, including targets to reduce antibiotic overuse in animal agriculture.”

The Senator requested answers from the FDA by July 16, 2024 on their efforts to manage the growing crisis of AMR. 

“I strongly urge the FDA to prioritize protecting public health when making decisions about the safety of animal drugs, whether through guidance or regulation, and to not compromise the separation between drug safety reviews and the review of benefits of a drug approval to the regulated industry,” the Senator concluded. 

To read the full text of the letter, click here.