- Federal Register Notice: New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Re: Docket No. FDA–2008–N–0326
The American Society for Microbiology (ASM) supports the recently issued Food and Drug Administration (FDA) rule on prudent use of antimicrobial drugs in food animals, FDA-2008-N-0326, announced by the Agency on January 4 and effective April 5, 2012. The rule correctly prohibits certain uses of cephalosporin drugs in cattle, swine, chickens and turkeys, a positive step towards preserving the effectiveness of antimicrobials against infectious diseases and reducing the risk of drug resistance among certain pathogenic bacteria.
Antimicrobial resistance among pathogens has been steadily rising in recent years, resulting in human and economic costs to Society. The ASM has consistently called for coordinated, science-based initiatives to sustain the usefulness of current drugs, as well as increased investments in drug discovery to replenish our dwindling pipeline of future new antimicrobials.
The ASM understands the potential impact of pathogen resistance among commonly prescribed drugs, including the cephalosporins that are standard treatment for many life-threatening infections. Cephalosporins serve as significant treatments for a large number of childhood infections and for secondary infections in patients with oncologic diseases, HIV/AIDS, or those in the post-organ transplantation period. They also are the drug of choice in treating invasive bloodstream infections that can occur as a consequence of severe foodborne illness caused by Salmonella found on meat and poultry, but unfortunately are increasingly less effective as the bacteria have become more drug resistant.
The ASM concurs with the FDA prohibition of specific extralabel or unapproved uses in the major species of food producing animals, including:
- 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); and
- using cephalosporin drugs for disease prevention.
The new FDA rule marks a significant advance in the global campaign against rising drug resistance. We appreciate the opportunity to comment and urge FDA to take steps to review extralabel use of antimicrobials that, like the cephalosporins, are critical in treating infectious diseases and maintaining human and animal health. While ASM believes that the proposed changes in the FDA rule will help, we believe strongly that the FDA should take a leadership role (either independently or in collaboration with other relevant US agencies) to encourage other countries, especially those from which we import food products, to adopt similar policies. Thank you for the opportunity to comment.
David C. Hooper, M.D., President, ASM
Gail H. Cassell, Ph.D., Chair, Committee on Biomedical Research