Booker Urges FDA to Reverse Course on Guidelines That Will Worsen Antimicrobial Resistance

Letter

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.

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.

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.

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