FDA Questions Antimicrobials
On June 28, the Food and Drug Administration (FDA) published draft guidance on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, which are not intended to serve as regulation, but rather outlines FDA’s current thinking on strategies to assure that antimicrobial drugs important for therapeutic uses in humans are used judiciously in animal agriculture.
The draft guidance concludes that using medically important antimicrobial drugs for “production” or “growth-enhancing” purposes (i.e. non-therapeutic or subtherapeutic uses) in food-producing animals is not in the interest of protecting and promoting public health and recommends phasing in measures to limit medically important antimicrobial drugs uses to those considered necessary for assuring animal health and that include veterinary oversight or consultation. Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine, was quoted in an FDA press release: “Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals.” The Agency invites the public to comment on this draft guidance for the next 60 days.