Media Statement on U.S. FDA Guidance #209, #213 and the Draft Veterinary Feed Directive
Public Company Information:
- Today the U.S. Food and Drug Administration finalized Guidance #213 establishing the procedures for voluntarily phasing out growth promotion indications for medically important antibiotics in alignment with Guidance #209 and published proposed changes to the Veterinary Feed Directive (VFD) regulation.
- The VFD regulation mandates the rules and responsibilities of licensed veterinarians in prescribing and administering medically important antibiotics in feed.
- Guidance #209 establishes two voluntary principles:
- The use of medically important antimicrobial drugs in food-producing animals should be limited to uses that are considered necessary for assuring animal health.
- The use of medically important antimicrobial drugs in food-producing animals should include veterinary oversight or consultation.
- Guidance #213 provides the procedures for voluntarily phasing out growth promotion indications and establishing therapeutic treatment indications for the use of medically important antimicrobial drugs in food producing animals. This would mean a change from Over-the-Counter (OTC) to VFD regulation status for medicated feed products containing medically important antimicrobial drugs. It also would mean a change from OTC to prescription (Rx) status for medicated drinking water products containing these same antimicrobial drugs.
- Zoetis supports the FDA’s efforts to voluntarily phase-out growth promotion indications for medically important antibiotics in food producing animals. Zoetis plans to implement Guidances #209 and #213 and has already taken action. This reflects our continued commitment to antibiotic stewardship and represents the many ways that Zoetis promotes the responsible use of antimicrobial drugs in animals.
- We believe that veterinarians should be involved in decisions regarding antibiotic use in food animals for the health of the animal and for the safety of the food supply. We support the revisions to the Veterinary Feed Directive (VFD) regulation to guide veterinarians and farmers as they manage the health and welfare of animals.
- Zoetis has been a leader in providing ongoing education to veterinarians and livestock producers on the proper use of antimicrobial drugs to treat, control, and prevent infection and disease in livestock animals. We affirm our commitment to this important educational service. Zoetis offers veterinary and livestock producer customers a range of educational programs such as animal husbandry, the Individual Pig Care™ program to help train animal caregivers to identify sick pigs early, and Residue Free Guarantees that promote the use of antimicrobial drugs according to label specifications which minimizes the inappropriate use of antimicrobial medicines.
- Zoetis expects to complete and implement plans to remove growth promotion uses of medically important antibiotics once the Veterinary Feed Directive (VFD) regulation is finalized. We are committed to supporting our veterinary and livestock producer customers to make a successful transition to the new procedures outlined in the VFD.
- As the new policies move forward, we remain committed to researching and developing new therapeutic products and strategies to help veterinarians treat illness in livestock animals and to help farmers protect the health and wellness of livestock animals.
- With the removal of growth promotion indications, use of medically important antibiotics in animals is intended for therapeutic purposes at therapeutic doses and under the supervision of a veterinarian.
Zoetis (zō-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on a 60-year history as the animal health business of Pfizer, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, with a focus on both farm and companion animals. In 2012, the company generated annual revenues of $4.3 billion. With approximately 9,300 employees worldwide at the beginning of 2013, Zoetis has a local presence in approximately 70 countries, including 29 manufacturing facilities in 11 countries. Its products serve veterinarians, livestock producers and people who raise and care for farm and companion animals in 120 countries. For more information on the company, visit www.zoetis.com.
Zoetis is the proud sponsor with the Smithsonian Institution Traveling Exhibition Service and the American Veterinary Medical Association of the mobile educational exhibit Animal Connections: Our Journey Together. Families visiting the exhibit will explore the vast bonds between people and animals and learn about the important role veterinarians play in protecting animal and human health. For more information, visit www.zoetis.com/animal-connections-tour/.