Guidance for Industry #213, the FDA document released today that outlines the new guidelines, asks drug companies to voluntarily withdraw approvals to use antibiotics in food animals for "growth promotion," while keeping approvals to use these drugs for "disease prevention." In both cases, antibiotics are fed to animals at low doses, often throughout their lives, making bacteria resistant to drugs used to treat infections.
"Problems can arise whenever antibiotics are fed to animals at low doses for long periods of time," said Keeve Nachman, PhD, MHS, a CLF scientist with the Johns Hopkins Bloomberg School of Public Health's departments of Environmental Health Sciences and Health Policy and Management. "Whether you call it growth promotion or disease prevention, this makes antibiotics less effective for treating sick people."
Many antibiotics are approved for both growth promotion and disease prevention at similarly low doses and without limits on how long they may be used. This means that even if all growth promotion approvals were withdrawn voluntarily, many antibiotics could still be used in similar ways. Under the guidelines, drug companies and the food animal industry could label such use "disease prevention."
"The FDA may care whether companies call it growth promotion or disease prevention, but the bacteria do not," said Nachman. "If antibiotics are used in the same ways, they will have the same effects."
"The widespread misuse of antibiotics in food animal production reduces the effectiveness of drugs we heavily rely on to keep the public and our families safe," said Robert Lawrence, MD, director of CLF and a professor with the Bloomberg School's Department of Environmental Health Sciences. "An infection that is now considered relatively easy to treat could once again prove fatal should antibiotics continue to be misused in food animal production and exacerbate this growing public health crisis."
"The agency needs to change how antibiotics are used, but these guidelines will only change how they are labeled," adds Nachman. "Instead of issuing voluntary guidelines, the FDA should use its regulatory authority to protect public health by withdrawing all approvals to use antibiotics for disease prevention and growth promotion."