FDA Calls for Comments on Antibiotics Use Guidance
June 29th, 2010
On Monday June 28th, the US Food and Drug Administration (FDA) published a draft guidance entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” calling for public comment during the next 60 days.
The use of antimicrobials, including antibiotics, whether in people or animals, hastens the development of resistant microbes, including bacteria. Public health leaders call for caution in the use of medically important antibiotics (those antibiotics used in human medicine), in order to preserve the drugs’ effectiveness for future use.
Antimicrobials are used in animal agriculture for three purposes:
1) to treat diagnosed disease in an animal or a limited group of animals;
2) to promote growth; and
3) to prevent disease prophylatically.
The Union of Concerned Scientists estimates that 70 percent of all antimicrobials in the US are used as feed or water additives for pigs, poultry and cattle for the non-therapeutic purposes of growth promotion and prophylactic disease prevention.
Leading public health organizations around the country and around the world, including American Medical Association, American Public Health Association, American Academy of Pediatrics, Infectious Diseases Society of America, and World Health Organization have spoken out against the routine use of medically important antibiotics in animal agriculture for these non-therapeucitic purposes.
The FDA’s draft guidance states that growth promotion is not a judicious use of medically important antibiotics. It argues, however, that some feed and water administration of medically important antibiotics for disease prevention is “necessary for assuring the health of food-producing animals.” The agency observes correctly that “some may have concerns” with this conclusion.
Critics contend that whether the subjective intent is growth promotion or routine disease prevention, routinely providing medically important antibiotics to animals through feed or water is the very same practice. Moreover, critics note that non-therapeutic use of antibiotics offsets for overcrowded, stressful, and unsanitary conditions at large confined animal feeding operations (CAFOs). By contrast, animals raised in more appropriate conditions, such as those on pasture-based systems, rarely, if ever, require antibiotics.
The FDA seeks to address the potential for abuse by recommending greater veterinary involvement. It notes, however, that there is a shortage of large animal veterinarians, which can make consultation and oversight challenging. The agency therefore proposes a phased-in approach to including increased veterinary oversight, and asks for public comments on how such as phase-in would work. The agency states that it does not want to “disrupt the animal agriculture industry.”
Comments on Docket No. FDA2010D0094 can be submitted during the next 60 days through regulations.gov.