New meaning to vet oversight in FDA plan

Dec 16, 2013

It appears that the U.S. Food and Drug Administration (FDA) is jumping on the “no antibiotic” bandwagon, with its plan to implement new regulations. Citing a potential threat to public health, the FDA is hoping to phase out the use of antibiotics in meat production, using a voluntary approach.

FDA announced last week that it will ask pharmaceutical companies to voluntarily stop labeling drugs important for treating human infection as acceptable for growth promotion in animals.

If the drug companies sign on, using those antibiotics to promote growth in animals could become illegal. Prescriptions would be required to use the drugs for animal illnesses, hence requiring a vet erinarian for basic animal care that producers have been doing for decades.

According to reports, both Zoetis and Elanco have shared plans to support the new regulations.

The proposed changes focus on the Veterinary Feed Directive (VFD) regulation, which mandates the rules and responsibilities of licensed veterinarians in prescribing and administering medically important antibiotics in feed.

FDA has two key pieces to its new veterinary plan:

• The use of medically important antimicrobial drugs in food-producing animals should be limited to uses that are considered necessary for assuring animal health.

• The use of medically important antimicrobial drugs in food producing animals should include veterinary oversight or consultation.

In addition, FDA wants to phase out growth promotants and establish therapeutic treatment indications for the use of medically important antimicrobial drugs in food producing animals. “This would mean a change from Overthe-Counter (OTC) to VFD regulation status for medicated feed products containing medically important antimicrobial drugs. It also would mean a change from OTC to prescription (Rx) status for medicated drinking water products containing these same antimicrobial drugs,” according to a Zoetis press release.

“We believe that veterinarians should be involved in decisions regarding antibiotic use in food animals for the health of the animal and for the safety of the food supply. We support the revisions to the VFD regulation to guide veterinarians and farmers as they manage the health and welfare of animals,” the company said.

Zoetis expects to complete and implement plans to remove growth promotion uses of medically important antibiotics once the VFD regulation is finalized.

“This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” said Bernadette Dunham, DVM, Ph.D., director of the FDA’s Center for Veterinary Medicine. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working—and will continue to work—to make this transition as seamless as possible.”

FDA officials said the move is designed to limit antibiotic-resistant diseases in humans as antibiotic resistance has become a growing public health problem.

In September, the Centers for Disease Control and Prevention released estimates that more than 23,000 people a year are dying from drug-resistant infections.

The new guidance will give the companies three years to comply, and is based on a voluntary procedure.

In FDA’s plan, companies would voluntarily revise the FDA-approved use conditions on the labels of products to remove production indications. The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight.

“Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs can no longer be used for production purposes, and their use to treat, control or prevent disease in animals will require veterinary oversight,” FDA said.

The FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months. These companies would then have a threeyear transition process.

“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,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor. “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”

These changes were originally proposed by the FDA in 2012, and representatives from the meat industry were not completely surprised following the announcement.

While producers stand by the fact that they are already administering antibiotics responsibly, stakeholders have agreed to comply with FDA rules, despite belief that a link between antibiotic use in animals and antimicrobial resistance in inconclusive.

“[W]e realize that there are strong emotions and conflicting views on the issue of antibiotic resistance— an issue that is very complex, and not black and white. For that reason, NCC has supported and will continue to support FDA’s Guidance 213 and VFD process and we will continue to work with our members and the agency on implementing this policy,” said Ashley Peterson, Vice President for Science and Regulatory Affairs for the National Chicken Council.

“American Meat Institute’s Betsy Booren said, “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 [FDA’s policy] adheres to these principles.”

“The pork industry has been bracing itself for this and preparing itself for the fact that we’re going to eventually lose the use of these antibiotics,” said Ron Birkenholz, a spokesman with the Iowa Pork Producers Association. “We don’t necessarily agree with it, but we’re going to live with it.”

And while producers will work toward following the guidelines, others will continue to push for more regulations. Rep. Louise Slaughter (D-NY) said the FDA guidance “falls woefully short of what is needed to address a public health crisis.”

The guidance for animal pharmaceutical companies is now in final form, and the proposed VFD rule is open for public comment for 90 days starting Dec. 12, 2013. To electronically submit comments on the proposed VFD rule, go to and insert docket FDA-2010-N-0155. Send written comments to the Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852. — Traci Eatherton, WLJ Editor