June 22, 2018

Groups Criticize FDA Antibiotic Guidance

cows-grazing-arsThe FDA is announcing new steps it is taking to address antimicrobial resistance. The government has a plan to “ensure judicious use of antibiotics in farm animals”. Farmers use antibiotics to enhance growth, improve feed efficiency, and prevent disease under poor growing conditions. This sub therapeutic use of drugs is helping bacteria evolve to be resistant to many medically important antibiotics, threatening modern medicine.

The government is asking – asking – manufacturers of antibiotics used in farm animals to stop selling those drugs for growth promotion. One silver lining is that the FDA has issued a proposed rule to update the existing regulations that would require specific authorization of antibiotics by a licensed veterinarian.

This move is only a “guidance”. That means it is a recommendation from the FDA, and cannot be legally enforced. And that’s the problem, according to many food safety experts and consumer advocates.

The Natural Resources Defense Council is criticizing this move, saying the guidance “doesn’t do much, pretends to do more, and kicks the can significantly down the road.” Voluntary guidance simply asks drug manufacturers to stop selling antibiotics to speed up growth. And it allows much of the problematic use under a different name. Even if manufacturers actually stopped promoting antibiotics to speed growth, they can still use them to “prevent” disease under poor living conditions. And FDA has delayed action on this issue. The guidance took 1-1/2 years to develop. It gives manufacturers three years to adapt, starting from today, the finalized date.

A year and a half ago we told you about the federal court ruling that forced the FDA’s hand on this issue. Then, Judge Theodore Katz ruled that the FDA must rescind approvals for sub therapeutic uses of antibiotics in livestock and denied the FDA’s March 2012 appeal of this order. That court decision ordered the agency to withdraw approvals of medically important antibiotics unless drug manufacturers could show they were safe.

The experts at Johns Hopkins Center for a Livable Future also criticized the FDA move, as did Food & Water Watch. You can comment on the voluntary guidance, called Veterinary Feed Directive, at Regulations.gov. The Docket ID number is FDA-2010-N-0155.

 

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