Senators Elizabeth Warren (D-MA), Dianne Feinstein (D-CA) and Kirsten Gillibrand (D-NY) have sent a letter to Secretaries Chuck Hagel, Tom Vilsack and Sylvia Burwell of the Interagency Task Force for Combating Antibiotic-Resistant Bacteria to ask how gaps in the FDA’s plan to combat antibiotic-resistant bacteria will be addressed. President Obama issued an executive order on September 18, 2014 to set up that Task Force.
The first guiding principle of the national strategy is that “misuse and over-use of antibiotics in health care and food production continue to hasten the development of bacterial drug resistance, leading to the loss of efficacy of existing antibiotics.” But almost 75% of the antibiotics sold every year in this country are used in food animal production, in a way that poses a “clear threat to human health,” according to the letter.
When low doses of antibiotics are administered, antibiotic resistant bacteria evolve and grow. While the FDA released guidance documents 209 and 213 and the Veterinary Feed Directives (VFD) rule to address this problem, FDA may not have the authority to ensure veterinarians are adhering to the criteria. Many antibiotics that were used to prevent disease are still allowed for growth promotion in the same dosage range.
Data collection about the Veterinary Feed Directives (VFD) rule is also under question. The FDA may not have a clear mechanism for collecting data to evaluate whether the policies even work. USDA has the authority to conduct voluntary surveys, but those may not be an effective means to gather data.
Finally, the Senators want to know what policy evaluation will be used if “further action” called for in the National Strategy is needed. Neither the FDA nor the administration has given any indication of what success will look like and what problems trigger additional action. Clear metrics and benchmarks are needed to evaluate the issues.
