FDA to phase out non-therapeutic use of antibiotics in food animals

Date: Dec-12-2013In 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.

FDA asking drug companies to sign up voluntarily

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.

FDA has already taken measures on antibiotic use in food animals

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.

FDA confident that drug companies will sign up

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.

Written by Catharine Paddock PhD

Copyright: Medical News Today

Not to be reproduced without the permission of Medical News Today.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.