By Erika Miller, Senior Vice President and Counsel, CRD Associates
Building on the President’s commitment to address antibiotic resistance outlined in the National Strategy on Combating Antibiotic-Resistant Bacteria released last fall, the FY 2016 White House Budget request nearly doubles current federal funding for combating and preventing antibiotic resistance to more than $1.2 billion. The President’s proposal will stimulate the development of new antibiotics and diagnostics, promote appropriate antibiotic use, and improve surveillance and data collection of antibiotic use and resistance patterns.
The funding proposal outlined in the budget comes at a critical time. Over 2 million people contract antibiotic-resistant infections in this country, but the numbers may be far greater given the gaps in current surveillance capabilities. More than $20 billion in healthcare expenditures are attributed to these infections. If Congress fully funds the President’s proposal, it will provide an overdue investment to address this widespread and life threatening issue. The proposed funding would be spread across the Departments of Defense, Health and Human Services, and Veterans Affairs.
The bulk of the proposed funding will to agencies within the Department of Health and Human Services.
- The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response would see their funding increase by $108 million over FY2015 for a total of $192 million. BARDA is charged with developing innovative partnership with industry to develop novel antimicrobials and diagnostics. Part of the funding would be designated for a joint competition with the National Institutes of Health (NIH) for the accelerated development of an affordable, accurate, and rapid diagnostic test to be used by healthcare providers at the point of care to identify highly resistant bacterial infections.
- The Centers for Disease Control and Prevention (CDC) would receive $280 million, an increase of $264 million, to support its Antibiotic Resistance Solutions Initiative. Actions would be taken in all 50 states to stop the spread and protect citizens. The funds would allow the CDC to accelerate its work detecting outbreaks through the creation of AR Regional Labs and a new AR Isolate Bank. The funding would allow the CDC to double the number of sites in its Emerging Infections Program from 10 to 20. CDC would increase its research and development projects to combat antibiotic resistance.
- The Food and Drug Administration (FDA) would receive $47 million under the President’s budget to evaluate new antibacterial drugs for patient treatments and antibiotic stewardship in animal agriculture; streamline the pathway to facilitate treatment of patients with unmet medical needs; and integrate the monitoring of bacterial antibiotic resistance through new collaborative approaches for the National Antimicrobial Resistance Monitoring System.
- The budget requests $461 million, an increase of $100 million, for the National Institutes of Health (NIH). Besides the joint competition with BARDA, the funding will be used by the National Institute of Allergy and Infectious Diseases (NIAID) to fund basic, translational, and clinical research. These efforts include developing a national database of genomic sequence data of all reported human infections with antimicrobial-resistant microorganisms; launching a large-scale effort to characterize drug resistance; spurring the development of new, rapid diagnostics to ensure that antibiotics are prescribed appropriately; and creating a rapid response clinical trial network to test new antibiotics.
Department of Veterans Affairs (VA)
With $85 million requested, the VA would improve the implementation and effectiveness of the VA Antimicrobial Stewardship Program; foster the judicious use of antimicrobials through education, direct provider-to-provider stewardship, and surveillance; and support and expand ongoing efforts to prevent the emergence of multi-drug resistant organisms.
United States Department of Agriculture (USDA)
The President’s budget requests $77 million for the USDA’s efforts related to combating antibiotic resistance. These funds will be used to address antimicrobial resistance in pathogens found in humans and livestock; to seek answers to key questions about the relationships among microbes and livestock, the environment, and human health; and to develop alternatives to antibiotics in agriculture.