The Food and Drug Administration (FDA) recently requested that producers and veterinarians voluntarily restrict use of antimicrobials in food-producing animals for growth promotion.
FDA says the approach is more prudent than attempting to regulate their use in the agency’s quest to stave off antibiotic resistance in humans.
Tom Burkgren, DVM, executive director of the American Association of Swine Veterinarians (AASV), says this request is nothing new. Over the last couple of years, the agency has been in conversation with AASV and other industry groups to encourage veterinarians to voluntarily restrict use of antimicrobials, and also to lobby drug company sponsors to change their labels to discourage routine growth promotion use.
“Frankly, we have been a little resistant to this idea because we believe FDA should be a science-based agency and fulfill their responsibility of drug approvals,” Burkgren says.
“The antimicrobials in question are legally approved by the FDA and they have been effective to use. Until the FDA proves they are not safe, we think that veterinarians are within their legal rights to use them,” he comments.
Burkgren says it appears FDA would prefer an across-the-board restriction on antimicrobials, but he doesn’t believe that translates into sound science. “We know that resistance involves specific bug-drug interactions, and a total reduction is an easy thing for the agency to do, but I don’t think it is good science,” he notes.
The other issue is that of asking drug companies to voluntarily drop label claims without providing them a clear framework to add new product claims, which is the agency’s regulatory responsibility, Burkgren says.
Animal Health Institute (AHI) member pharmaceutical companies are discussing with FDA ways in which they can move to voluntarily restrict antibiotic use without further limiting the tools available to producers and veterinarians, says Ron Phillips of AHI.
That discussion includes asking FDA about the details of what might be required.
“FDA has stated they intend to issue further, more specific guidance next year,” says Phillips.