On December 11, 2013, the FDA announced the implementation of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes. As part of this plan, FDA asked the animal pharmaceutical industry to seek withdrawal of animal drug approvals relating to any production uses and transfer the remaining therapeutic uses of these drugs under the oversight of a veterinarian. FDA asked affected sponsors to notify the agency in writing within three months, or by March 12, 2014, of their intent to engage with FDA as defined in Guidance for Industry (GFI) #213.
FDA is encouraged by the response thus far and will continue to monitor ongoing participation and provide public updates on a periodic basis. Following is a summary of the responses FDA received from the affected sponsors:
- The number of affected sponsors is 26.
- 25 sponsors confirmed in writing their intent to engage with FDA as defined in Guidance #213 and have given FDA consent to list their names in this update.
- These 25 sponsors hold 99.6 percent of the applications affected by Guidance #213.
- These applications represent 99.95 percent of the total sales of products affected by Guidance #213, based on 2011 data. (Because the majority of sponsors indicated their intent to engage in this process, publicly releasing the total volume of sales of all products affected by GFI #213 would indirectly reveal the sales data of sponsors that did not notify FDA of their intent to engage or did not wish to make their intent public. FDA is legally prohibited from sharing confidential business information, including the sales data of individual sponsors.)
FDA will update its listing of Applications Affected by GFI #213 to indicate what actions have been finalized regarding individual drug applications (e.g., removal of production indications, change to veterinary oversight). Some sponsors may opt to voluntarily withdraw their approved applications for certain products. After an application is voluntarily withdrawn, those product(s) can no longer be marketed or sold in the United States.
As of March 26, the following sponsors have agreed in writing that they intend to engage in the judicious use strategy by seeking withdrawal of approvals relating to any production uses and changing the marketing status of their products from over-the-counter to use by Veterinary Feed Directive or prescription, and have consented to allow FDA to publicly acknowledge their participation:
Wednesday March 26, 2014/ FDA/ United States.