This week, President Obama signed an Executive Order directing key Federal departments and agencies to take action to combat the rise of antibiotic-resistant bacteria. The Administration also released its National Strategy on Combating Antibiotic-Resistant Bacteria. In addition, the President’s Council of Advisors on Science and Technology (PCAST) is releasing a related report on Combating Antibiotic Resistance. The Administration also announced a $20 million prize, co-sponsored by the National Institutes of Health and the Biomedical Advanced Research and Development Authority, to facilitate the development of rapid, point-of-care diagnostic tests for healthcare providers to identify highly resistant bacterial infections.
The Executive Order signed Sept. 18 by President Obama directs Federal departments and agencies to implement the National Strategy and address the PCAST report. The National Strategy provides a five-year plan for enhancing domestic and international capacity to: prevent and contain outbreaks of antibiotic-resistant infections; maintain the efficacy of current and new antibiotics; and develop and deploy next-generation diagnostics, antibiotics, vaccines, and other therapeutics. The PCAST report provides actionable recommendations from the President’s Council, in consultation with experts from the public and private sectors, for combating antibiotic resistance.
The Executive Order signed by President Obama:
Establishes a New Task Force for Combating Antibiotic-Resistant Bacteria
· The Executive Order directs establishment of the Task Force for Combating Antibiotic-Resistant Bacteria, co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services (HHS). It also instructs the Task Force to submit a National Action Plan to the President outlining specific Federal actions to implement the Strategy and address the recommendations made by the PCAST.
Establishes the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
· The Executive Order directs the Secretary of HHS, in consultation with the Secretary of Agriculture, to establish a Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, to be composed of leading non-governmental experts.
· The Presidential Advisory Council will provide advice, information, and recommendations regarding programs and policies intended to: preserve antibiotic effectiveness; strengthen surveillance of antibiotic-resistant infections; advance the development of rapid, point-of-care diagnostics for use in human healthcare and agriculture; advance research on new treatments for bacterial infections; develop alternatives to the use of antibiotics for some agricultural purposes; and improve international coordination of efforts to combat antibiotic resistance.
Improves Antibiotic Stewardship
· The Executive Order directs the Departments of HHS, Defense, and Veterans Affairs to review existing regulations governing antibiotic stewardship in hospitals and other inpatient healthcare delivery facilities and to propose new regulations and other actions to improve antibiotic stewardship programs in accordance with the best practices, including those defined by the Centers for Disease Control and Prevention.
· The Executive Order requires Federal departments and agencies to lead by example through defining, communicating, and implementing stewardship programs in office-based practices, outpatient settings, emergency departments, and institutional and long-term care facilities such as nursing homes, pharmacies, and correctional facilities.
· The Food and Drug Administration is directed to continue taking steps to eliminate agricultural use of medically important antibiotics for growth-promotion purposes. These and other improvements in antibiotic use will be tracked through the National Healthcare Safety Network.
Strengthens National-Surveillance Efforts for Resistant Bacteria
· The Executive Order requires the Task Force to develop procedures for creating and integrating surveillance systems and laboratory networks to provide timely, high-quality data in healthcare and agricultural settings, including detailed genomic data to adequately track resistant bacteria across diverse settings.
· It further directs Task Force agencies to, as appropriate, link data from Federal repositories for bacterial strains to an integrated surveillance system. Where feasible, the repositories shall integrate their sample collections and further interoperable data systems with national surveillance efforts.
Promotes the Development of New and Next-Generation Antibiotics and Diagnostics
· The Executive Order requires the Task Force to describe steps that departments and agencies should take to encourage the development of new and next-generation antibiotics, diagnostics, and alternatives to traditional antibiotics. This includes steps to strengthen infrastructure for clinical trials, such as the Antibacterial Resistance Leadership Group (ARLG), to reduce obstacles faced by drug companies who are developing new antibiotics as well as develop options for attracting greater private investment in the development of new antibiotics and rapid, point-of-care diagnostics.
· The Executive Order also directs the Biomedical Advanced Research Development Authority in HHS to develop new and next generation countermeasures to antibiotic resistant bacteria that present a serious or urgent threat to public health.
Strengthens International Cooperation
· The Executive Order directs the Secretaries of HHS and State to designate representatives to engage with the World Health Organization (WHO) and member states on the development of the WHO Global Action Plan for Antimicrobial Resistance.
· The Executive Order complements the Global Health Security Agenda, which was launched to accelerate action to prevent, detect, and respond to threats posed by antibiotic-resistant bacteria and other disease threats.
National Strategy on Combating Antibiotic-Resistant Bacteria
The National Strategy provides detailed actions for five interrelated national goals to be achieved by 2020 in collaboration with partners in healthcare, public health, veterinary medicine, agriculture, and food safety, as well as in academic, Federal, and industrial research and development. The goals are:
1. Slow the emergence and prevent the spread of resistant bacteria.
2. Strengthen national efforts to identify and report cases of antibiotic resistance.
3. Advance the development and use of rapid diagnostic tests for the identification and characterization of antibiotic-resistant bacteria.
4. Accelerate basic and applied research and development for new antibiotics as well as other therapeutics and vaccines.
5. Improve international collaboration, capacities for antibiotic-resistance prevention, surveillance, control, and antibiotic research and development.
Collectively, the actions outlined in the National Strategy will enhance antibiotic stewardship; strengthen national-surveillance capabilities; and expand the arsenal of diagnostics, antibiotics, and other countermeasures available to combat resistant bacteria.
PCAST Report on Combating Antibiotic Resistance
At the request of the President, the PCAST, working with U.S. government and non-government experts, developed a set of practical and actionable steps that the Federal government could take to address the rise of antibiotic resistance through focused efforts in three areas:
1. Improved surveillance of antibiotic-resistant bacteria to enable effective response, stop outbreaks, and limit the spread of antibiotic-resistant organisms.
2. Increased longevity of current and new antibiotics, by promoting appropriate use, preventing the spread of antibiotic-resistant bacteria, and scaling up proven interventions to decrease the rate at which microbes develop resistance.
3. Increased rates of discovery and development of new antibiotics.
Launch of a $20 Million Prize for New Rapid, Point-of-Care Diagnostic Tests
The National Institutes of Health and Biomedical Advanced Research and Development Authority will co-sponsor a prize for the development of a rapid, point-of-care diagnostic test for healthcare providers to use to identify highly resistant bacterial infections. In the near future, HHS agencies will host a public meeting that will engage stakeholders to ensure that this competition focuses on the type of diagnostic most needed by the medical and public health communities for recognizing and treating antibiotic-resistant bacterial infections.