Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 11 December 2013 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA), bowing to decades of pressure, has agreed to "significant steps" it says will limit the prescribing of antibiotics to food-producing animals in an attempt to limit the spread of antibiotic-resistant bacteria.
FDA's antibiotic use policy first began to take shape in the 1970s, and in recent years has been subject to intense scrutiny from outside advocates, former FDA officials, government investigators, and even judges.
In April 2012, FDA released three guidance documents which sought to phase out the "injudicious use" of antibiotics through a voluntary scheme.
"The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective," Margaret Hamburg, commissioner of FDA, said at the time. "We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available."
While the guidance documents did not ban the use of antibiotics in food-producing animals, they did discourage their use. At the time of the announcement, three major companies-Pfizer, Eli Lilly and Merck-had all signed on to voluntarily change the labeling of their products to reflect restricted indications.
Still, some outside groups said the measure was destined to fail. "This is an ineffective response to the real and sobering threat of rising antibiotic resistance, which threatens human health," said Avinash Kar of the Natural Resources Defense Council (NRDC), whose organization successfully sued FDA to force the agency to ban antibiotics in animal feed.
In a statement on NRDC's website, Kar further called the guidances an "empty gesture," saying they do not meet the standards for compliance set by the group's earlier court victory over FDA. "Once again, FDA is pretending to act while barely acting at all," concluded Kar.
But in a notable shift, FDA appears to now be willing, ready and able to further restrict the use of antibiotics in food-producing animals. In an 11 December 2013 statement, FDA announced that it had finalized one of the three aforementioned guidance documents (#213) and proposed a new rule updating the Veterinary Feed Directive (VFD), a set of regulations which require that particular veterinary drugs be authorized by a licensed veterinarian through a specific process.
With respect to the guidance, FDA has outlined what it calls a "road map" by which pharmaceutical companies can revise the labeling on their products to remove indications that would cause them to contribute to antibiotic resistance.
"Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight," FDA noted.
Regulators are asking that companies notify them of their intent to comply with the strategy within the next 90 days. ""Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort," Michael Taylor, deputy commissioner of Foods and Veterinary Medicine at FDA, said in a statement.
However, the question that remains to be answered is whether every company will support the effort. Presumably even a handful of small pharmaceutical manufacturers could meet the demand for antibiotics if cattle ranchers or other producers of food animals still want to obtain the drugs.
FDA also said it was in the process of expanding its oversight over drugs contained within the guidance, as some are regulated under over-the-counter monographs.
"The VFD proposed rule is intended to update the existing VFD process and facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs," FDA wrote. "Such updates to the VFD process will assist in the transition of OTC products to their new VFD status.
Industry and the public have 90 days in which to submit comments on FDA's proposed rule.
Final Guidance Document (FR)
VFD Proposed Rule
Tags: Antimicrobial Resistance, antibiotics
Regulatory Focus newsletters
All the biggest regulatory news and happenings.