A guidance document issued by the FDA in December aims to phase out the use of medically important antimicrobial drugs for food production purposes. The document asks companies that make animal pharmaceuticals to voluntarily revise the labels of these products to remove production uses—such as enhancing animal growth or improving feed efficiency—and restrict these antimicrobials to therapeutic uses under veterinary oversight.
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“Implementing this strategy is an important step forward in addressing antimicrobial resistance,” says Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, in a statement issued December 13 at the time of publication of the guidance. “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”
Some antimicrobial drugs that have been traditionally used in agriculture to promote animal weight gain or other production purposes are also important for human medical uses, such as treating infections. Concerns have been raised that use in agricultural production may increase bacterial resistance to these medically important drugs. The aim of the FDA’s action is to limit agricultural uses of these drugs to therapeutic purposes under veterinary care.
“The voluntary guidelines seek to reduce the use of antibiotics for growth promotion purposes. Animals still get sick, and when they do, they deserve treatment, including the use of antibiotics,” says Jennifer McEntire, PhD, vice president and chief science officer at the Acheson Group, a Washington-based food safety consulting firm.
Critics of the document, known as Guidance 213, note that it asks pharmaceutical companies that profit from the sales of these drugs to voluntarily comply. However, the FDA is also asking these companies to notify the agency of their intent to comply within three months.
“Although the document was termed a ‘guidance,’ FDA was pretty clear that if companies don’t voluntarily comply within a few years, FDA will reconsider the ‘voluntary’ aspect of the guidance,” says Dr. McEntire.
“While I’m skeptical that this guidance will move the needle, clearly there should be judicious use of antibiotics—in humans and animals,” continues Dr. McEntire.
Guidance 213 is a follow-up to Guidance 209, which was published in April 2012. That document provided “a framework for the voluntary adoption of practices to ensure the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals.” Guidance 213 lays out the specifics of how drugs should be (voluntarily) relabeled to achieve that goal.