Animal-health industry commits to FDA Guidance 213

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Members of the Animal Health Institute (AHI) and the Generic Animal Drug Alliance (GADA) today announced their written commitments to align all affected products with the Food and Drug Administration’s (FDA) policy on judicious use of antibiotics.  

Under the policy, the growth promotion uses of medically important compounds will be phased out and veterinary oversight of the use of therapeutic products will be phased in.

FDA stated it anticipates the new policy will be fully phased in over the next three years and originally asked companies to communicate their intentions to the agency within 90 days from December 12, 2013, when Final Guidance 213 was announced.

“FDA’s collaborative stakeholder process works,” said AHI President and CEO Alexander S. Mathews.  “By working cooperatively with stakeholders, FDA has achieved a significant change in the way antibiotics are to be used in animal agriculture that we believe will avoid unintended consequences.”

FDA still must issue a final rule on proposed changes to the veterinary feed directive, the mechanism used to ensure veterinary oversight of products used in feed. 

Successful implementation of this policy means that medically important antibiotics will only be used in food animals under the direction of a veterinarian when there is a specific disease challenge.

“We understand that consumers have concerns about medically important antibiotics being used to promote growth,” said Mathews.  “We hope this change in regulation and control will increase consumer confidence and lead to a more productive discussion about animal welfare, sustainability and public health.”

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