FDA Guidelines for Antibiotics

The U.S. Food and Drug Administration (FDA) announced Wednesday new voluntary guidelines for drug manufacturers to scale back the use of antibiotics in humans and livestock.

But critics are quick to point out that the rule changes have no repercussions, and thus offer few incentives for manufacturers to fall in line.

The new guidelines call for a reduction in the use of antibiotics for non-medical reasons in livestock meant for human consumption. Antibiotics are often used on livestock because the drugs can help to bulk animals up.

However, research has shown that this practice has increased the incidence of antibiotic resistance. It has also helped to boost the prevalence of “superbugs”, which are able to defend against even the strongest antibiotics available. 

Guidelines Call for More Veterinarian Oversight

The guidelines call for pharmaceutical companies to voluntarily revise the use of antibiotics and their labeling. They call for many antibiotics to be removed from over-the-counter status and put under veterinary oversight. The aim is for these drugs to be used only to treat, control, and prevent disease in livestock.

“Implementing this strategy is an important step forward in addressing antimicrobial resistance. 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,” FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said in a statement. “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”

Antibiotic resistance is a major concern for many federal agencies, including the U.S. Centers for Disease Control and Prevention (CDC). CDC director Thomas Frieden said earlier this year that we’re buying time with our current antibiotics.

Read More About the CDC’s Stance on Antibiotic Resistance »

Critics Call the Changes 'Hollow'

Rep. Louise Slaughter (D-N.Y.) the only microbiologist serving in Congress, has long pushed for stricter legislation to curb antibiotic overuse. She called the FDA’s new guidelines “an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success.”

“Sadly, this guidance is the biggest step the FDA has taken in a generation to combat the overuse of antibiotics in corporate agriculture, and it falls woefully short of what is needed to address a public health crisis,” Slaughter said in a statement.

Avinash Kar, an attorney with the Natural Resources Defense Council, said the policy is “an early holiday gift to industry.”

“It is a hollow gesture that does little to tackle a widely recognized threat to human health,” he said.

Kar said that the policy is a continuation of the FDA’s 35-year history of asking for voluntary compliance. During this time, antibiotic use in animals has continued to rise.

“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,” he said. “FDA is failing the American people.”

The guidelines are available for public comment for 90 days, beginning Thursday. They can be found at Regulations.gov.

Learn More: Would Restricting Antibiotic Use in Livestock Lower MRSA Infections? »