This week, United States Senators Dianne Feinstein, D-Calif., Elizabeth Warren, D-Mass., and Kirsten Gillibrand, D-N.Y., sent a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg requesting more information about the FDA's efforts to “curb the overuse of antibiotics in food animal production.”
"The use of antibiotics in food-producing animals must be reduced as part of the effort to preserve the efficacy of antibiotics," the senators wrote in the letter, available here. "Research has shown that antibiotic resistant bacteria are most likely to develop when antibiotics are used continuously at low doses - the type of regimen used frequently in food animal production."
The trio of senators called Guidance #213, released in December 2013, and the proposed rule on Veterinary Feed Directives “important first steps” but were concerned that these efforts “may not be sufficient to curtail the routine use of dangerously low doses of antibiotics for the duration of an animal’s life.”
They don’t believe veterinary oversight alone will be able to solve the problem.
Guidance 213 calls for animal pharmaceutical companies to voluntarily revise the FDA-approved labels for these products to remove growth promotion labels. In June, the FDA announced all 26 drug manufacturers affected by Guidance 213 have agreed to fully engage in the strategy.
The senators called on the FDA to answer specific questions by Sept. 8:
- How do you intend to determine whether the non-judicious use of antibiotics in food animal production materially declines as a consequence of guidance documents #209 and #213, or simply continues under disease prevention or containment labels?
- If no change in overall usage is observed, what steps will the FDA take to address the public health threat of antibiotic overuse in food animal production?
- What actions does the FDA plan to take to make sure that approved labeling indications do not pose the same risks of fostering resistance as the production uses that are being voluntarily phased out in response to guidance documents #209 and #213?
- What is your plan for completing inspections of facilities to ensure proper collection and enforcement of VFDs? What, if any, additional resources or authorities are needed?
- How do you plan to collect and compile data from the VFDs to better track how specific antibiotics are being used in different types of animals?
The letter was sent just four days after a divided U.S. Second Circuit Court of Appeals overturned earlier district court rulings resulting from a lawsuit filed by activist groups seeking to end the use of antibiotics in livestock feed. The court ruled the FDA does not have to considering banning the practice of feeding antibiotics to healthy, food-producing livestock, clearing the way for the FDA to rely on voluntary guidelines. Click here for more.