President Obama, on September 18th, signed an Executive Order (EO) directing Federal Government departments and agencies to take action at home and with international partners to combat this national security threat. The White House also issued its five-year National Strategy for Combatting Antibiotic Resistance and the President’s Council on of Advisor’s on Science and Technology (PCAST) also issued a related technical advisory report on Combating Antibiotic Resistance. In press briefings, senior administration officials cited the risks of political instability, crushing economic costs and erosion of other security capabilities from potential superbug health epidemics, and warned that a $35 billion per year estimate of annual direct and indirect costs (and 23,000 deaths) in the U.S. alone from superbugs is extremely conservative. 

Against that backdrop, as one of the economic incentives for innovation, the EO announced a $20 million prize co-sponsored by the National Institutes of Health and Biomedical Advanced Research and Development Authority for the development of rapid, point-of-care diagnostics to identify highly-resistant bacterial infections. The U.S. Department of Health and Human Services (HHS) will soon hold a public meeting to help ensure the competition’s focus on priority needs.  Senior officials hoped that the prize might help mobilize far higher investment levels and awareness of the issue, as other such prizes have.  

The EO establishes a new interagency Task Force co-chaired by the Secretaries of Defense, Agriculture and HHS to submit (by February 2015, according to senior officials) a National Action Plan to the President with specific steps recommended to implement his Strategy and to address PCAST recommendations, including on how best to promote new and next generation antibiotics and diagnostics.   

The key role of industry is clearly acknowledged in this “major upgrade”  in White House efforts to fight what one official referred to as a “permanent battle” against antibiotic resistance.  That battle will require an “enduring arsenal of effective antibiotics.”  A Presidential Advisory Council on Combatting Antibiotic Resistant Bacteria” made up of non-government experts will be established and co-chaired by the Secretaries of HHS and the Department of Agriculture to provide advice, information and recommendations on all elements of the National Strategy.   Both the Advisory Council and the new Task Force will consider a wide range of economic incentives (e.g. user fees, higher reimbursements, faster clinical trials, etc.) to improve the returns to R&D on antibiotics and diagnostics.         

The EO also emphasizes intensive efforts to improve the stewardship of existing antibiotics.  HHS, Defense and Veteran’s Affairs are charged with reviewing existing regulations and practices at hospitals and inpatient facilities, and to propose new regulations and approaches.   FDA is also directed to continue working to eliminate the use of medically-important antibiotics for agricultural growth promotion purposes.  Recognizing that superbugs know no borders, the EO also directs the Secretaries of HHS and the State Department to engage the World Health Organization and its Member States (190-plus) to develop WHO’s Global Action Plan on antimicrobial resistance (AMR GAP).  That Action Plan is set for completion in 2015.

The White House Fact Sheet on its ramped up efforts makes clear the intent to mobilize U.S. industry and expertise to help contain superbugs and to “expand the arsenal of diagnostics, antibiotics, and other countermeasures available to combat resistant bacteria.”  Next week, the White House will host an international meeting of over 30 countries on the Global Health Security Agenda (GHSA) and yesterday’s announcements positions the U.S. and its industry to help lead the way forward.