FDA puts cephalosporin ban in abeyance

Veterinary medicine credited by some for pushing last-minute change

December 11, 2008 (published)
By Jennifer Fiala

Rockville, Md. — The Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) reversed a ban of the extralabel use of cephalosporin in food-producing animals just five days before its Nov. 30 enactment, and veterinary medicine is being credited for the rollback.

This summer, FDA published notice in the Federal Register linking cephalosporin’s overuse in food animals to the emergence of antibiotic-resistant bacteria that could impact public health. “Given the importance of the cephalosporin class of drugs for treating disease in humans, FDA believes that preserving the effectiveness of such drugs is critical,” an agency news release stated.

Insiders say the turnaround, spelled out in a Nov. 25 news release, most likely reflects grassroots pressure from DVMs, specifically the American Veterinary Medical Association (AVMA). The reluctance of organized veterinary medicine to let cephalosporin go quietly hints at the drugs’ importance to animal health; it’s often used to fight respiratory disease and pathogens not on the label. In the FDA-issued statement, regulators explain that “many substantive comments” opposing the restriction led to the ban’s re-review and revocation.

Steven Vaughn, DVM, director of CVM’s Office of New Animal Drug Evaluation explains that the agency’s concern about the off-label use of cephalosporin mounted following reports of increasingly resistant strains of bacteria, particularly Salmonella in cattle and other species.

“First and foremost, we have to take into consideration public health; that’s our primary concern,” Vaughn tells the VIN News Service. “Drug availability comes second. The fact that we revoked the order does not mean someone changed our minds on this.”

Mounting pressure?

Still, rumors circulate that the agency’s recent about-face concerning the ban is a product of Big-Pharma pressure (Pfizer is the only company that markets cephalosporin products in the United States, although Shering-Plough Animal Health currently seeks FDA approval for its version of the drug, intended for cattle).

Ron Phillips, spokesman for the Animal Health Institute, which represents major drug companies, refutes that suggestion. He points to concern regarding the data on which FDA used to base its restriction, science AVMA calls “confusing” and “lacking” in a 14-page letter to the regulatory agency.

Dr. Tom Burkgren, head of the American Association of Swine Veterinarians (AASV), also submitted comment to FDA, urging the agency to revoke its stance. He surmises that FDA officials were surprised by the number and quality of the comments received. “It wasn’t just, ‘Boo hoo, don’t do this.’ These letters were well-researched and serious.”

AVMA speaks up

Signed by the Executive Vice President Dr. Ron DeHaven, AVMA’s Oct. 30 letter to FDA pokes holes in data gleaned from the National Antimicrobial Resistance Monitoring System reports and European studies on which the ban was based. It also highlights “unintended consequences on animal health and welfare, on food safety and on the practice of veterinary medicine.”

“The AVMA supports the preservation of effective treatments for critically important human infections; however, our analysis demonstrates neither significant risk nor causality, between the extralabel use of cephalosporins in food animals and the effectiveness of human therapy.” The drug’s off-label use is “medially necessary to relieve animal pain and suffering,” the letter adds.

“Although reasonable federal oversight is rational, the AVMA believes veterinarians adequately and responsibly provide the safeguards to protect both human and animal health.”

Call for introspection

Public health and welfare advocates like Steven Roach, director of the Chicago-based Food Animal Concerns Trust, don’t doubt veterinarians act conscientiously when it comes to antibiotics. Still, he criticizes FDA’s latest move and hopes the agency reinstates the ban following a re-review period.

“It’s hard to figure out exactly why FDA did this, and we consider it a mistake,” he says. “Even we would acknowledge that these are important drugs for veterinarians; we just want to find alternatives to them.”

Roach hopes the cephalosporin issue sparks a dialogue within the profession focused on lessening the use of antibiotics by promoting the development of clinical practice guidelines and preemptive health practices.

“We would like veterinarians to work together to determine what have they been using cephalosporin for and what you can do to address these pathogens without putting the public’s health at risk,” he says. “There is just no doubt that antibiotic use in food animals has human-health impacts, including resistance.”

(Visit and type in docket number 2008-N-0326 to view all comments submitted in relationship to the cephalosporin ban)

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