President Obama Orders Plan for Combating Antibiotic-Resistant Bacteria


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-19-2014 20:02

  

US President Barack Obama issued an Executive Order to set up the organizational structures and policy focus to combat antibiotic-resistant bacteria. The White House issued a statement outlining, among several items, the establishment of the Task Force for Combating Antibiotic-Resistant Bacteria, to be co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services (HHS), which will be charged with the responsibility of developing a national strategy and action plan, including ways to facilitate development of new drugs and diagnostics.

"Detecting, preventing, and controlling antibiotic resistance requires a strategic, coordinated, and sustained effort. It also depends on the engagement of governments, academia, industry, healthcare providers, the general public, and the agricultural community, as well as international partners," said the President in the Executive Order. "Success in this effort will require significant efforts to: minimize the emergence of antibiotic-resistant bacteria; preserve the efficacy of new and existing antibacterial drugs; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance efforts in public health and agriculture; develop and promote the use of new, rapid diagnostic technologies; accelerate scientific research and facilitate the development of new antibacterial drugs, vaccines, diagnostics, and other novel therapeutics; maximize the dissemination of the most up-to-date information on the appropriate and proper use of antibiotics to the general public and healthcare providers; work with the pharmaceutical industry to include information on the proper use of over-the-counter and prescription antibiotic medications for humans and animals; and improve international collaboration and capabilities for prevention, surveillance, stewardship, basic research, and drug and diagnostics development.

The President said in the Executive Order that the federal government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.

In addition to the co-chairs of the newly created Task Force for Combating Antibiotic-Resistant Bacteria, the task force will consists of representatives for the Departments of State, Justice, Veterans Affairs and Homeland Security as well as representatives from the Environmental Protection Agency, the United States Agency for International Development, the Office of Management and Budget, the Domestic Policy Council, the National Security Council staff, the Office of Science and Technology Policy, and the National Science Foundation. The National Security Council staff, in collaboration with the Office of Science and Technology Policy, the Domestic Policy Council, and the Office of Management and Budget, will coordinate the development and implementation of federal government policies to combat antibiotic-resistant bacteria, including the activities, reports, and recommendations of the Task Force for Combating Antibiotic-Resistant Bacteria.

The task force is being charged with providing the facilitation and monitoring of implementation  of a national strategy for Combating Antibiotic-Resistant Bacteria. By February 15, 2015, the task force is required to submit a five-year National Action Plan to the President that outlines specific actions to be taken to implement the strategy. The action plan is to include goals, milestones, and metrics for measuring progress, as well as associated timelines for implementation as well as address recommendations made by the President's Council of Advisors on Science and Technology regarding combating antibiotic resistance and provide continual progress reports to this effort.

As part of the action plan, the task force is required to outline steps that agencies can take to encourage the development of new and next-generation antibacterial drugs, diagnostics, vaccines, and novel therapeutics for both the public and agricultural sectors, including steps to develop infrastructure for clinical trials and options for attracting greater private investment in the development of new antibiotics and rapid point-of-care diagnostics. The task force agency efforts are to focus on addressing areas of unmet medical need for individuals, including those antibiotic-resistant bacteria CDC has identified as public and agricultural health threats.

Additionally, the HHS Secretary, in consultation with the Secretaries of Defense and Agriculture, are to establish the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, which will be composed of not more than 30 members to be appointed or designated by the Secretary. The council shall provide advice, information, and recommendations to the Secretary regarding programs and policies intended to: preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance. The HHS Secretary will be required to provide the President with all written reports created by the Advisory Council.

Source: White House

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