Last week, the Keep Antibiotics Working (KAW) coalition sent a letter to the U.S. Food and Drug Administration urging the agency to police efforts by drug companies to sidestep Guidance #213 on antibiotics in animal feed. Released last December, FDA announced its final plan to phase out the use of antibiotics to promote growth in food animals, and the agency gave industry 90 days to respond with their intentions to comply or not. By March, 25 of the affected 26 animal drug sponsors informed the agency that they intend to comply. But public health advocates are concerned that the change won’t do much to reduce the use of these drugs. They emphasize that manufacturers have stated that they don’t expect the change will affect their revenues. Some suggest that drug companies will opt to continue using the antibiotics under the label of disease prevention — prophylactic use involving low, sub-therapeutic doses that can cover much of an animal’s lifespan. Public health advocates think that would still be a significant factor contributing to overuse of antibiotics and the rise of antibiotic-resistant bacteria. Another concern is that companies could still continue extra-label marketing for growth promotion and other benefits. Steven Roach, director of the Food Animal Concerns Trust’s Food Safety Program, addressed this loophole in the KAW letter to Michael Taylor, FDA’s Deputy Commissioner for Food and Veterinary Medicine. “Companies intent on avoiding reductions in sales that are likely to result from the withdrawal of growth promotion claims have several avenues open to them,” Roach wrote. He used a drug made by Novartis to illustrate the concerns about marketing. The feed additive containing tiamulin hydrogen fumarate, in combination with chlortetracycline hydrochloride, was never approved for growth promotion but is included in the list of products affect by Guidance #213. It is approved for controlling dysentery and treating pneumonia and enteric disease in pigs, but the marketing materials emphasize benefits to production “in terms of daily gain, body weight achieved, feed to gain ratio, and return on investment.” The promotional materials speak more to production issues than animal health, Roach told Food Safety News. He uses it as a response to FDA’s claim that the antibiotics would not continue to be used in the same way sub-therapeutically because Guidance #213 would make it illegal: “You look at this case and they’re already doing it for a drug that’s not approved for growth promotion,” he says. As for veterinary oversight, Roach says that if a company is “already doing this type of marketing directly, unless FDA tells them not to do it, there’s no reason that they couldn’t give the promotional materials to a vet.” And FDA is “not going to be able to keep vets from saying, ‘Yeah, if you use this drug, you’ll get a growth-promoting effect.’ They can keep the drug companies from putting it on their website,” he says. The requests by KAW are that FDA require Novartis to stop promoting the production benefits of its tiamulin-chlortetracycline drug approved for disease prevention and control and to “send a general notice to all drug manufacturers that it will not tolerate the claims of production benefits in advertising associated with any medically important animal antibiotics.” Drug companies have three years to comply with the guidance, but Roach suggests that now is the best time to handle the issue with promotion. “This is actually the appropriate time to tell the companies to stop doing this — before they take them off the label — so that everyone knows what the rules are as we go forward,” he says. An FDA spokesperson told Food Safety News that the agency has responded to the coalition letter “and understand the concern that drug manufacturers may promote extralabel production uses for products approved only for therapeutic use, thereby undermining the spirit and intent of GFI #213.” In addition, FDA intends “to look for ways to reinforce the importance of the principles of judicious and appropriate use, including engaging animal drug manufacturers on the appropriate use of promotional materials. We are in the early stages of implementing this strategy. Important issues will arise along the way, and we are committed to addressing them.”