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At Pfizer, protecting human health is a top priority. This is why Pfizer plays an important role in ensuring a safe and sustainable global food supply with healthy livestock.
Pfizer works to responsibly develop medicines for food producing animals within stringent government guidelines. As food animals are reared, Pfizer supports and encourages responsible veterinary use of animal medicines. And, as meat and dairy products enter the food supply, Pfizer supports government efforts to monitor microbial and food safety.
Safe Antibiotic Use in Food Producing Animals
As the U.S. FDA reconsiders a proposed regulatory action to prohibit veterinarians from using a class of antibiotics – cephalosporins – extra-label or beyond FDA-approved label uses in food animals, the agency will be reviewing public comments from Pfizer and many others. The FDA posted these comments for all to see at their public website.
By law, veterinarians are permitted to prescribe and use any FDA-approved human or animal medicine extra-label for only therapeutic uses in food animals. The FDA is concerned that cephalosporin antibiotics used extra-label in food animals could contribute to microbial resistance.
In its public comments, Pfizer questioned whether a complete prohibition of all extra-label cephalosporin use in food animals is appropriate. Instead, Pfizer proposed that:
- Cephalosporins – particularly human cephalosporin medicines – should be banned for use in food animals, unless these medicines are FDA-approved for use in food animals;
- Extra-label use of FDA-approved veterinary cephalosporins should continue to be allowed only in the livestock species indicated on the FDA label; only at the approved dosage regimen via injectable or intramammary routes of administration; and only for treatment and control of diagnosed bacterial diseases in livestock;
- Any other extra-label use of cephalosporins should require a microbial safety risk assessment by the FDA before that extra-label use is allowed;
- Finally, appropriate veterinary oversight is needed when using any antimicrobial drug, not just cephalosporins.
Pfizer supports the efficacy and safety of its cephalosporin products – including its cefitofur formulations – when used according to FDA label instructions. Pfizer's Excede, Excenel, and Naxcel were expressly developed for livestock. Each was approved by the FDA to safely, effectively treat and control bacterial diseases in sick animals and in animals at known risk of infection.