FDA Receives Strong Industry Commitment for its Antibiotic Resistance Strategy
For Immediate Release: March 26, 2014
Media Inquiries: Siobhan DeLancey, 202-510-4177, firstname.lastname@example.org
Trade Press Inquiries: Megan Bensette, 240-506-6818, email@example.com
Consumer and Industry Inquiries: AskCVM@fda.hhs.gov
The U.S. Food and Drug Administration is announcing today that since December 2013, when FDA announced final Guidance for Industry #213, all but one animal drug company have committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.
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. 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 #213.
FDA is encouraged by the strong response thus far and will continue to monitor ongoing participation and provide public updates on a periodic basis. A summary of the responses FDA received from the affected sponsors can be found on FDA’s Judicious Use of Antimicrobials page.