Comment on FDA Plan for Human Drugs Used in Food Animal Production
March 15th, 2013
For many years, the Keep Antibiotics Working Campaign – a coalition of health, consumer, agricultural, environmental, humane, and other advocacy groups — has worked to eliminate the inappropriate use of antimicrobials, including antibiotics, in food animals. This use has been flagged as a major cause of resistance in numerous pathogens to antibiotics that are important in the treatment of disease in humans.
One major area of concern is the routine, sub-therapeutic use of antimicrobials in the feed and water of animals in confined animal feeding operations. According to Pew Charitable Trusts, a record high 29.9 million pounds of antibiotics were sold for meat production in 2011. In the same period of time, only 7.7 million pounds were sold for human use. That means for every one pound of antibiotics used to treat infections in humans, four pounds of antibiotics were given to already healthy animals.
After years of foot-dragging and litigation to avoid adequate oversight and regulation of antibiotic use in animal production, the U.S. Food and Drug Administration (FDA) is taking a modest first step to increase oversight on the use of antibiotics in food animals. The agency is proposing to change the marketing status of certain antimicrobial drugs to require the involvement of a licensed veterinarian. Under the proposal, the selected drugs will change from over-the-counter (OTC) status to Rx or Veterinary Feed Directive status. Animal producers will no longer be able to purchase the animal drug or medicated feed product directly from suppliers without a valid prescription or order from a licensed veterinarian.
Last week, FDA announced that it has scheduled five meetings to provide the public with the opportunity to discuss and provide feedback on the agency’s plan to phase-in veterinary oversight of the use of these drugs. FDA is joining with USDA’s Animal and Plant Health Inspection Service (APHIS) to sponsor these meetings. According to the Federal Register announcement, FDA and APHIS have planned meetings in the following locations:
- April 9, 2013, Bowling Green, KY
- April 23, 2013, Olympia, WA
- May 8, 2013, Fort Collins, CO
- May 21, 2013, Pierre, SD
- June 4, 2013, College Station, TX
More specific information on the meetings is provided in the Federal Register announcement. The FDA has also provided information on the agency’s approach to the use of antimicrobials in food animal production on its Animal and Veterinary webpage.
Those who wish to attend or comment at these meetings are not required to register but FDA recommends that if you wish to make comments at a meeting, you notify the contact person for the meeting. Comments also may be submitted at the website: www.regulations.gov. Use FDA Docket Number – FDA-2012-N-1046 – to find the website to submit the comments. Comments must be submitted by May 6, 2013.