In a bid to stem the growing problem of antibiotic resistance in humans, the US Food and Drug Administration has announced it is taking steps to phase out non-medicinal use of antibiotics in animals used for food production.
Many livestock growers add antibiotics to the food and water they give their cattle, poultry, hogs and other food animals, not just in order to control disease, but also to boost growth and reduce the amount of feed required.
However, some of these antibiotics are important for human health, and their use in food-producing animals – for whatever purpose – allows resistant bacteria and resistance genes to develop and spread from those animals to humans through the food chain.
In this latest step toward tightening up use of antibiotics in food animals, the Food and Drug Administration (FDA) is asking pharmaceutical companies to voluntarily change their drug labels so as to remove indications aimed at animal production – as opposed to disease control.
The federal agency has issued new guidance that gives the drug companies a road map of how to achieve these changes.
The FDA is also calling for a revision to the status of over-the-counter (OTC) drugs to ensure that their only remaining therapeutic uses are supervised by veterinarians.
Effectively, if the drug companies sign up to these changes, then any antibiotics they make that are “important for human health” can no longer be used to boost production – they can only be used to “treat, control, or prevent disease in animals,” and even then, only by prescription and under veterinary supervision.
This is not the first step the FDA has taken recently on this issue. For example:
- In June 2010, the agency started drafting guidance urging farmers and veterinarians to reduce use of antibiotics in boosting growth of food-producing animals. The document outlined the agency’s current thinking on why antibiotics that are important for medicinal use in humans should be used sparingly in livestock. The final guidance for the industry was issued in 2012.
- In April 2012, the FDA banned certain uses of antibiotics in food-producing animals. The ban was introduced to stop the use of “extra label” – that is unapproved use – of cephalosporins in major species of food-producing animals such as cattle, pigs (swine), chickens and turkeys.
The regulatory authority has also come under pressure from concerned groups. In May 2011, a consortium of health and consumer groups filed a lawsuit against the FDA, demanding it act on its own safety findings, which they allege emerged in 1977, namely that adding low-dose antibiotics used in human medicine to animal feed raised the risk of antibiotic-resistant bacteria.
The FDA has asked the drug companies to let it know their reaction – whether they intend to sign up to the plan – within the next 3 months. They would then have 3 years to implement it.
Michael Taylor, the FDA Deputy Commissioner for Foods and Veterinary Medicine, says:
“The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal.”
He says the FDA has every reason to believe the drug companies will sign up to the plan.
To help phase in veterinary supervision of antibiotics in food animals, the agency has also issued a proposal to update the existing regulations surrounding the role of veterinarians as covered by the Veterinary Feed Directive (VFD).
The update should help ease the transition of OTC drugs to VFD status, says the FDA.
The guidance for the pharmaceutical companies is now in its final form, and the proposed VFD ruling is open for public comment for 90 days, with effect from December 12th, says the FDA.