FDA to ban popular industry antibiotic
The Food and Drug Administration (FDA) plans to ban on April 5 the agricultural use of cephalosporin, a popular antibiotic used primarily in swine, chickens and turkeys, but also cattle, to prevent the rise of drug-resistant bacteria that infect humans.
Cephalosporins are commonly used to treat people with pneumonia and skin and soft tissue infections, FDA said. Examples of cephalosporins are the human antibiotics Cefzil, which treats bronchitis, ear infections and skin infections, and Ceftriaxone, used to treat mild pneumonia, bacterial meningitis and gonorrhea.
“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 Michael Taylor, FDA’s deputy commissioner for foods.
According to FDA’s release, this new order takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008 but revoked before it went into affect.
EPA’s report didn’t discuss key information on the science behind the decision to ban the product. “The research supporting this ban is pretty thin,” according to NCBA Vice President of Communications Colin Woodall. Woodall anticipates at least two more ag antibiotic bans to follow.
In its order, FDA is prohibiting what are called “extra-label” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys. Specifically, the prohibited uses include:
• using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration; • using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals); • using cephalosporin drugs for disease prevention.
Last week’s announcement responding to public comment includes the following exceptions, which protect public health while considering animal health needs:
The order does not limit the use of cephapirin, an older cephalosporin drug that is not believed by FDA to contribute significantly to antimicrobial resistance.
Veterinarians will still be able to use or prescribe cephalosporins for limited extra-label use in cattle, swine, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.
Veterinarians may also use or prescribe cephalosporins for extra-label uses in minor species of food-producing animals such as ducks or rabbits.
“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 Michael R. Taylor, deputy commissioner for foods.
This new regulation follows on the heals of FDA’s Dec. 23 controversial withdrawal of a decades-old proposal to limit the use of antibiotics in animal feed.
Medical groups claim the common practice is decreasing the effectiveness of antibiotics in human medicine and increasing the threat of infections in humans.
In 2011, a lawsuit was filed against FDA that included recommendations from an advisory committee relating to penicillin and tetracycline. FDA was told to “immediately withdraw approval” for subtherapeutic uses of the drugs in livestock.
According to last week’s FDA notice, Congress stepped in before FDA could move forward, asking the agency to refrain from taking any action until there was more research on public health risks.
The new order of prohibition has a comment period from Jan. 6 to March 6, 2012. To comment on the order of prohibition, visit www.regulations.gov and enter FDA-2008-N-0326 in the keyword box. — Traci Eatherton, WLJ Editor