Senators Elizabeth Warren (D-MA), Kirsten Gillibrand (D-NY) and Dianne Feinstein (D-CA) sent a letter Tuesday to Secretaries Chuck Hagel, Tom Vilsack and Sylvia Burwell, co-chairs of the newly formed Interagency Task Force for Combating Antibiotic-Resistant Bacteria, to ask how this task force will address gaps in how the Food and Drug Administration (FDA) is currently addressing the public health threat posed by the overuse of antibiotics in food animals. “While the FDA’s policies are a step in the right direction, we are concerned that FDA may lack the authority to ensure veterinarians adhere to the criteria for determining an appropriate preventive use laid out in its guidance documents, that the FDA does not have a clear mechanism for collecting the data necessary to evaluate whether its policies effectively reduce the public health threat, and that the administration has no clear metrics or benchmarks that will be used to determine success or a need for future action,” the senators wrote. In September, the White House released a report on antibiotic resistance by the President’s Council of Advisors on Science and Technology (PCAST) and issued an Executive Order establishing an interagency task force for combating antibiotic-resistant bacteria. The governmental task force must submit an action plan to the president by February 2015 describing how to meet the administration’s National Strategy on Combating Antibiotic-Resistant Bacteria and address PCAST’s recommendations. The senators’ letter listed 11 questions they have about how the task force plans to address issues in enforcement, data collection, and policy evaluation while developing the National Action Plan:
- In light of the disagreements among stakeholders and their competing interests, what tools are available to the administration to encourage compliance with FDA criteria for determining an appropriate preventive use of antibiotics?
- Does the administration need additional authorities to ensure compliance?
- How will the administration measure the rate of adoption of the Guidance #213 guidelines among veterinarians?
- When does the administration plan to finalize the VFD (Veterinary Feed Directives) rule?
- USDA surveys are voluntary and depend on the participation of producers. Are these surveys an effective means of collecting the valid on-farm antibiotic use data — across all of the major food-producing species in the U.S. — necessary to evaluating current FDA policies? If not, what agency and department will be tasked with obtaining these data?
- We understand that USDA does not currently have the necessary resources to conduct comprehensive surveys of on-farm antibiotic use practices and that a large-scale study can cost up to $1.5 million. In its fiscal year 2016 budget request, does the administration plan to request additional funds to perform a study of on-farm antibiotic use practices within the budget caps?
- What is the first step toward developing a new data collection mechanism (as directed by the National Strategy) that will be included in the Feb. 15, 2015 Action Plan?
- If the FDA’s guidance documents succeed in reducing the continuous low-dose use of antibiotics in food animal production, what changes will you expect to see (in sales data, in VFDs, or any other currently collected data point) and when will you expect to see these changes?
- What additional metrics and benchmarks for evaluating the FDA policies will be published as a part of the Action Plan?
- What agencies and departments will be responsible for running the evaluation?
- If FDA policies are unsuccessful, what next steps will the administration consider to continue addressing the misuse and over-use of antiotics in animal agriculture?
Senators Warren, Gillibrand and Feinstein also wrote to FDA Commissioner Margaret Hamburg in July expressing their concerns about guidance documents #209 and #213 and the proposed rule on Veterinary Feed Directives and asking for more information about those efforts.