FDA Issues Guidance Recommending That Animal-Approved Over-The-Counter Medically Important Antimicrobial Drugs Are Required To Be Overseen By Veterinarians Before Sale And Use.

Fox Rothschild LLP

Fox Rothschild LLP

FDA recently published Guidance #263 titled, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter,” which builds on earlier provided guidance to limit medically important drugs in food-producing animals. (Guidance #209 and Guidance #213).

As explained in Guidance #263,

This plan builds upon the important steps the Center for Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in 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.

FDA wants to extend veterinary oversight for medically important antimicrobial drugs implemented for use in food-producing animals, to all animals, instead of those currently available over-the-counter.

FDA believes that requiring oversight by veterinarians should provide more judicious use of antimicrobials in all animals, since the following factors are considered by veterinarians prescribing such drugs to animal patients:

The decision by the veterinarian to use a specific approved drug is generally based on multiple factors , such as the mode of antibacterial action, drug distribution in specific tissues, the duration of effective drug levels at the site of infection, past treatment outcomes, local burden of illness information, and concurrent animal health issues. Other important factors veterinarians consider when determining the appropriateness of a given antimicrobial use include whether: (1) there is evidence of effectiveness, (2) such use is consistent with accepted veterinary practice, (3) the use is linked to a specific etiologic agent, (4) the use is appropriately targeted to animals with or at risk of developing a specific disease, and (5) no reasonable alternatives for intervention exist. FDA believes that veterinarians are uniquely qualified to make these decisions and to determine appropriately timed administration of the antimicrobial to treat, control, or prevent disease in animals.

FDA proposes a voluntary 2-year time frame for drug sponsors to submit revised labeling for approval and has published a list of affected drugs on its website. Guidance #263 includes instructions for such submission.

Anyone seeking additional guidance can contact us or FDA directly for assistance.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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