FDA's Center for Veterinary Medicine ("CVM") announced last week that it was restricting the use of certain antibiotics in farm animals. On January 6, 2012, CVM published a final rule in the Federal Register that prohibits certain uses of cephalosporin drugs in food-producing animals. The rule is a modification of FDA's 2008 order banning all extralabel uses of cephalosporins in food producing animals. The roughly 170 comments in response to the 2008 proposal convinced FDA that the ban was too broad.
Specifically, the new rule prohibits certain extralabel uses of cephalosporin drugs in cattle, swine, chicken, and turkey. Included among the prohibitions are:
- Using cephalosporin drugs at unapproved dosage levels, frequencies, durations, or routes of administration;
- Using cephalosporin drugs in cattle, swine, chickens, or turkeys that are not approved for use in those species; and
- Using cephalosporin drugs for disease prevention.
- Extralabel use of approved cephapirin products in food-producing animals;
- Use to treat or control an extralabel disease indication, provided that the use adheres to a labeled dosage regimen approved for that particular species and production class; and
- Extralabel use in food-producing minor species (e.g. ducks and rabbits).
"Extralabel use" refers to "the actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling." 21 CFR ยง 530.3. This includes using the drug: (1) in species not in the labeling; (2) for indications not in the labeling; and (3) at dose levels, frequencies, or routes of administration not in the labeling. Under the Animal Medicinal Drug Use Clarification Act of 1994, extralabel drug use in animals is permitted when ordered by a licensed veterinarian who has a valid veterinarian-client-patient relationship. This means that the veterinarian has recently visited the animal and is personally familiar with how it is cared for.
21 CFR part 530 provides FDA with the authority to issue prohibition orders if the agency finds the extralabel use of a drug in animals presents a risk to public health. Here, FDA is concerned that the extralabel use of cephalosporins in food-animals will increase the number of cephalosporin-resistant strains of certain bacteria. Cephalosporin drugs are important in treating a number of human diseases, such as pneumonia, upper respiratory tract infections, skin and tissue infections, and pelvic inflammatory disease. Cephalosporins are especially important in treatments involving children because alternative treatments are often more toxic.
FDA drew heavy criticism last November when it denied two citizen petitions asking the agency to rescind its approval of the non-therapeutic use of human antibiotics in livestock (previously reported on by FDA Lawyers Blog here). For many, the restriction on cephalosporin drug use is viewed as a step in the right direction. According to Laura Rogers, project director for the Pew Campaign on Human Health and Industrial Farming, "this restriction is a victory for human health."
Others, though supporting the decision, appeared less enthusiastic. Congresswoman Louise Slaughter (D-NY) calls the move, "a modest first step." The Representative from New York states that we are facing a massive public health crisis and cannot afford for FDA to "ploddingly take half-measures."
Many in food production industry disagree. Members from the chicken, pork, and cattle industries are not convinced the ban was necessary. According to the industry, the science to require bans on antibiotics is not there yet, and moves to limit antibiotic use are taking important medical decisions out of veterinarians' hands.
For more information on final rule see CVM's website here. The rule is scheduled to go into effect on April 5, 2012, and those wishing to submit comments should direct them to Docket No. FDA-2008-N-0326 by March 6, 2012.
