Agricultural News
FDA Wants to Ban Many Extra-label Uses of Cephalosporin Drugs in Cattle, Swine, Chickens, and Turkeys
Thu, 05 Jan 2012 09:05:42 CST
The Food and Drug Administration is moving to ban many extra-label uses of cephalosporin drugs in cattle, swine, chickens, and turkeys, saying the drugs may cause failure of antibiotic treatment of life-threatening infections in humans. The industry says FDA has little evidence that a problem actually exists.
Tom Super with the National Chicken Council emailed us with a statement ""We share the concerns of others that FDA's rule on extralabel drug use will take medical decisions to treat animals out of the hands of veterinarians. We question any substantive link or scientific basis between veterinary use of cephalosporins and antibiotic resistance in humans." (His full statement is below)
FDA announced Wednesday that it will publish a notice in Friday's Federal Register prohibiting the use of cephalosporin drugs in food animals for disease prevention purposes. The agency said it would also restrict other uses of the drugs to the doses, frequencies, duration, or routes of administration that are already approved, and also to the species and production classes already approved.
In the news release- the FDA seems to contend that there is evidence of animal drug use and antibiotic effectiveness in humans. Quoting the release- "FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.
"Cephalosporins are commonly used in humans to treat pneumonia as well as to treat skin and soft tissue infections. In addition, they are used in the treatment of pelvic inflammatory disease, diabetic foot infections, and urinary tract infections. If cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects.
"In its order, FDA is prohibiting what are called "extralabel" or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys, the so-called major species of food-producing animals."
Click here for the full news release from FDA with details of the comment period.
Ron Phillips, vice president for public and legislative affairs at Animal Health Institute, says the evidence that the FDA is basing this proposal on is "thin.". His group, the AHI, issued the following statement on Wednesday in regards to this FDA proposal:
"The Food and Drug Administration's proposed rule on extralabel drug use (ELDU) will eliminate some current extralabel drug use practices while allowing others to continue with new restrictions placed on veterinarians. We are generally concerned about FDA taking medical decisions to treat animals out of the hands of veterinarians.
"Extra-label drug use is strictly limited by law. It can only be done by a licensed veterinarian in the existence of a valid veterinarian-client-patient relationship. It can only be used when no approved drug is available in the necessary dosage form. Extralabel use is an exception to the drug regulations that is not permitted for all approved drugs and is never permitted for any drug administered in feed."
Back to the National Chicken Council- here is the full statement provided to us by Tom Super, their Vice President for Communications.
"Antibiotics are a valuable tool in ensuring animal health and in producing wholesome food for the consuming public.
"Antibiotics are used sparingly in chicken production, and only if they are approved by the FDA. A majority of the antibiotics, such as Ceftiofur, are not used in human medicine meaning the threat of creating resistance is essentially reduced to zero.
"Consumers should know that chicken is safe, wholesome and that all chicken produced in the United States is inspected by the USDA. Inspectors test meat samples for chemical and antimicrobial residues poultry must be in compliance with USDA standards. When antibiotics are used in chicken production, strict withdrawal periods must be followed before the birds are processed for food. Chicken consistently has the best record of any product tested by USDA.
"We share the concerns of others that FDA's rule on extralabel drug use will take medical decisions to treat animals out of the hands of veterinarians. We question any substantive link or scientific basis between veterinary use of cephalosporins and antibiotic resistance in humans."
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