FDA issues voluntary antibiotics approach

FDA is addressing the use of “medically important” antibiotics in food-producing animals for production uses including enhancing growth or improving feed efficiency.

These drugs are deemed important because they are used to treat human disease and might not work if the bacteria become resistant to the drugs’ effects.

Because the use of antimicrobial drugs contribute to the development of antimicrobial resistance, it is important to use the drugs only when medically necessary, said the agency.

The policy, known as Guidance 213, was widely criticized when it was released in draft form in April 2012, because it failed to require any changes in the use of antibiotics. 

The drugs are usually added to feed or to the animals’ drinking water.

Antimicrobial resistance​

William Flynn, DVM, MS, deputy director for science policy at FDA’s Center for Veterinary Medicine (CVM) said there is a need to be selective about the drugs used in animals and when they are used.

“Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.”​

Flynn said that the final guidance document made participation voluntary because it is the fastest, most efficient way to make these changes.

'Early holiday gift'​

Avinash Kar, Natural Resources Defense Council (NRDC) health attorney described the move as an “​early holiday gift to industry”.

“It is a hollow gesture that does little to tackle a widely recognized threat to human health. FDA has essentially followed a voluntary approach for more than 35 years, but use of these drugs to raise animals has increased. ​

“There’s no reason why voluntary recommendations will make a difference now, especially when FDA’s policy covers only some of the many uses of antibiotics on animals that are not sick.”​

However, the American Meat Institute welcomed the proposed Veterinary Feed Directive (VFD) rule which establishes a three year timeframe for phasing out growth promotion uses of antibiotics important in human medicine and phasing in veterinary oversight of these products.

“AMI strongly supports the prudent and judicious use of antibiotics in food animal production under the care of a veterinarian, as defined by the American Veterinary Medical Association, which is consistent with protecting both animal and public health, ensuring the ability to medically treat animals, and maintaining the highest standard of animal welfare practices and we believe guidance 213 adheres to these principles.”​

CSPI concerns​

The Center for Science in the Public Interest (CSPI) said it brought good and bad news.

The good news was the pledge to evaluate levels of compliance and inform the public after 90 days if the drug industry is cooperating with the relabeling effort. The bad news was that it requires the drug companies who profit from sales of their drugs to initiate the process.

By volume, about three times the amount of antibiotics sold for treatment of humans are sold for use in animals, said the group.

Caroline Smith DeWaal, CSPI food safety director, said no one is advocating that sick animals should not be treated.  

“But just as our kids see a doctor to get antibiotics, farmers should call a veterinarian, who can assess whether and when treatment with an antibiotic is appropriate.  ​

“This simple step could save antibiotics as treatment options for future generations of consumers and farmers.”​