Regulatory Focus™ > News Articles > FDA's New Veterinary Antibiotics Strategy Yields Early Results

FDA's New Veterinary Antibiotics Strategy Yields Early Results

Posted 09 April 2014 | By Alexander Gaffney, RAC

Several months after first launching a new regulatory approach intended to voluntarily limit the prescribing of non-essential antibiotics in food-producing animals, the US Food and Drug Administration (FDA) is already seeing success.

Background

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 intended to slow down rates of microbial resistance to antibiotics. 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.

But some outside groups said the measure was destined to fail, and called for the implementation of more rigorous regulatory approaches. "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 December 2013, FDA responded to that call by unveiling yet another regulatory approach, a revision to its Veterinary Feed Directive (VFD) requiring most, if not all, antibiotic veterinary drugs to be authorized by a licensed veterinarian.

At the same time, FDA asked companies to voluntarily revise their product labeling to remove indications that would cause them to be prescribed for reasons that would contribute to antibiotic resistance.

Early Successes for Program

So far, that voluntary approach seems to be working.

In March 2014, FDA provided an update regarding the initial success of the program, indicating that "all but one animal drug company have committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription."

And on 9 April 2014, FDA announced that 19 antimicrobials sponsored by five companies were being withdrawn from the market and could no longer be sold. The manufacturers of those drugs are: ADM Alliance Nutrition, Ridley Feed Ingredients, Micro Beef Technologies, Provimi North America, and Virbac AH.

"This action is being taken at the sponsors' request because these products are no longer manufactured or marketed," FDA said in an accompanying Federal Register notice.

The withdrawal order will go into effect on 20 April 2014, FDA said.


Federal Register Notice (2)


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