The bill would require the Food and Drug Administration (FDA) to withdraw its approval of medically-important antibiotics used for disease prevention or control that are at high risk of abuse, unless the producer of the drug can demonstrate that its use in agriculture does not pose a risk to human health. Antibiotics that meet the standard for prevention and control uses would be issued a revised label that supports prudent antibiotic use.The bill addresses a gap in the guidelines issued by FDA in December 2013, which called on the industry to eliminate the use of antibiotics for the purpose of making animals gain weight.
FDA estimates that 107 antibiotics used for therapeutic purposes, including disease prevention or control, do not have a defined duration of therapy or are labeled for continuous use. An analysis by the Pew Charitable Trusts estimates that 83 antibiotics used for disease prevention or control have an overlapping dose with a production use. These antibiotics are at high risk of being inappropriately administered, which could pose a risk to human health.
“Antibiotic resistance is one of the biggest public health threats we face and we need a comprehensive response to preserve the effectiveness of antibiotics,” said Senator Feinstein. “While FDA took an important step to reduce antibiotic overuse in agriculture, we need to do more. Our bill would ensure that antibiotics approved to treat disease are not used inappropriately. I am pleased that farmers and veterinarians are working to adopt FDA rules and I hope they will collaborate on this important piece of legislation.”
“Antibiotic-resistant bacteria remains a dangerous risk to human health and efforts to ensure that antibiotics are used appropriately in food animals to protect public health remain important,” said Senator Collins. “Our bill would build on efforts by the FDA to reduce antibiotic overuse in food animals, through the voluntary policy to eliminate approved growth-promoting uses and improving veterinary oversight, by helping to ensure the appropriate use of antibiotics for preventing and controlling disease in food animal production.”
The Prevention of Antibiotic Resistance Act is endorsed by the American Public Health Association, the Infectious Disease Society of America, Trust for America’s Health, the American College of Preventive Medicine and the Pew Charitable Trusts.
