FDA Restricts Use of Cephalosporin in Livestock
The U.S. Food and Drug Administration (FDA) has issued a final rule prohibiting the extra-label use of cephalosporin antimicrobial drugs in livestock. Citing “evidence that certain extralabel uses… will likely cause an adverse event in humans,” the agency has specifically barred using cephalosporins (i) “at unapproved dose levels, frequencies, durations, or routes of administration”; (ii) “in cattle, swine, chickens, or turkeys that are not approved for use in that species (e.g., cephalosporin intended for humans or companion animals)”; and (iii) “for disease prevention.”
The final rule, however, still permits the use of an older drug, cephapirin, while
allowing veterinarians to oversee limited extra-label cephalosporin use “in
cattle, swine, chicken, or turkeys as long as they follow the dose, frequency,
duration, and route of administration that is on the label.”
“We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals,” said FDA Deputy Commissioner of Foods Michael Taylor in a January 4, 2012, press release. The move has already drawn support from groups such as the Keep Antibiotics Working (KAW) coalition and the Pew Campaign on Human Health and Industrial Farming, which in a January 4 press release praised the final rule as “a victory for human health, as it will help ensure we can still rely on cephalosporins to treat life-threatening infections today and in the future.”
Nevertheless, KAW has continued to criticize FDA’s December 22, 2011, decision to withdraw two 1977 notices of opportunity for a hearing (NOOHs) on penicillin and tetracycline in animal feed. According to FDA, the agency closed the two dockets because it is already engaged in “other regulatory strategies” designed to address microbial food safety and needs to “prioritize any withdraw proceedings (for example, take into account which withdrawal(s) would likely have the most significant impact on the public health).” But KAW member Steven Roach argued that since FDA first proposed the withdrawals, “data connecting antibiotic resistance with overuse in animals has only gotten stronger. Yet the FDA refuses to fulfill its mandate to protect the public health and withdraw drugs that have been shown to be unsafe,” Roach said. See KAW Press Release, December 22, 2011, and January 6, 2012.
