April 16, 2012
Dear International Colleague:
On April 11, the U.S. Food and Drug Administration (FDA) announced a new strategy and measures to address antimicrobial resistance. The need to limit the use of medically important antimicrobial drugs in food-producing animals has been recognized for many years by national and international scientific organizations, such as the Institute of Medicine and the World Health Organization. A number of countries have banned the use of antimicrobial drugs for agricultural production purposes (feed efficiency and growth promotion). Some large food companies in the United States, such as McDonalds and Kentucky Fried Chicken, have responded to this scientific consensus by imposing limits on their suppliers concerning the use of antimicrobials. In addition, a number of legislative proposals have been introduced that are aimed at curbing antimicrobial use in food-producing animals.
FDA’s newly-announced strategy encourages key stakeholders to work cooperatively with FDA to address this complex public health issue while minimizing impacts on animal health and disruption of the animal agriculture industry. The FDA’s strategy is embodied in three documents:
- A final “judicious use” guidance for industry (GFI #209) that establishes the framework for phasing out agricultural production uses of medically important antimicrobials and phasing in veterinary consultation or oversight of the therapeutic uses of such drugs in food-producing animals.
- A companion draft guidance for industry (GFI #213) that provides detailed guidance to the animal drug industry regarding how to change “conditions of use” for certain antimicrobial drugs in a way that would phase out the production use of those drugs and phase in veterinary consultation or oversight. The animal drug companies specifically requested this guidance from FDA.
- A draft of a proposed regulation to streamline and modernize the current veterinary feed directive (VFD) regulation which governs veterinary authorization of the use of certain animal drugs in feed. The animal pharmaceutical industry has made it clear that it needs a better understanding of FDA’s intentions for updating the VFD process in a manner that is both practical and feasible. FDA is inviting comment on this proposal from all stakeholders, including other regulatory agencies and relevant international organizations
All three documents are available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm299802.htm?utm_source=fda&utm_medium=website&utm_term=AMR&utm_content=f1&utm_campaign=HomePageSpotlight
The strategy will employ a phased-in approach which will allow animal drug and animal production industries time to adhere to the new guidance. The policy calls for the animal drug industry to voluntarily withdraw claims for production uses of medically important antimicrobials and to modify the marketing status of such products to include veterinary oversight. FDA will evaluate the rate of adoption of the proposed changes across effected products and will consider further action as warranted if adequate progress is not made through the voluntary process. FDA consulted with the U.S. Department of Agriculture on strategies for addressing the issue that would be sensitive to the needs of small-scale animal producers.
We would be happy to address any questions you may have on this initiative and we look forward to keeping you apprised of our progress.
Mary Lou Valdez, MSM
Associate Commissioner for International Programs