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FDA releases plan for supporting antimicrobial stewardship

The Food & Drug Administration’s Center for Veterinary Medicine has unveiled its five-year action plan for supporting antimicrobial stewardship in veterinary settings.

The Food & Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) unveiled Sept. 14 its five-year action plan for supporting antimicrobial stewardship in veterinary settings. The plan builds upon the important steps CVM has taken to eliminate production uses of medically important antimicrobials (i.e., antimicrobials important for treating human disease) and to bring all remaining therapeutic uses of these drugs under the oversight of licensed veterinarians. It also supports the judicious use of antimicrobials in food-producing animals and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control or prevention of specific diseases.

As part of its regulatory mission, CVM is responsible for ensuring the safety and effectiveness of animal drugs, including antimicrobials, and coordinates the development and implementation of regulations and policies pertaining to antimicrobial drugs intended for use in animals.

"Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023" is CVM’s blueprint for guiding its activities over the next five years to combat antimicrobial resistance and preserve the effectiveness of antimicrobial drugs. This includes applying a risk-based approach to evaluate new and currently approved antimicrobial products for animals, collaborating with key stakeholders to support stewardship of these products by end users and collecting data on resistance and antimicrobial use to monitor the effectiveness of these actions to slow the development of resistance.

CVM said it plans to initiate the actions outlined in the document in phases over the next five fiscal years. This phased approach will allow for adjustments based on critical, science-based analysis, public health impact and feedback from stakeholders.

In the coming years, CVM said it will further engage stakeholders and the public as it develops and implements the strategies for addressing individual actions identified in this plan.

FDA Commissioner Scott Gottlieb, M.D., said in remarks announcing the plan that it is part of a broader agency-wide strategy for combating antimicrobial resistance in both veterinary and human health care settings, including efforts to facilitate product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms.

Richard Sellers, senior vice president of public policy and education at the American Feed Industry Assn. (AFIA), said in its initial review of the plan is positive. “The FDA is to be applauded for developing this comprehensive, multi-year plan. The major portion impacting the feed industry was the 2017 change to veterinarian oversight of all medically-important approved animal drugs used in feed via the veterinary feed directive regulatory scheme. The next steps to bring oral dosage and injectable (including intramammary) drugs into the prescription scheme by a veterinarian is a natural progression that AFIA supports.  Finally, the other change proposed in the plan is to put duration limits on drugs approved for animal feed by working with animal drug sponsors to develop the data and based on sound science without comprising the animal’s health."  

AFIA said it will work with its members and others that distribute these affected products through farm stores, dealer networks and others to train and educate affected personnel on the importance of these changes.

Click here to view the plan.

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