HHS, USDA, DOD SECRETARIES DISCUSS COMBATING ANTIBIOTIC-RESISTANT BACTERIA

FROM:  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Our Plan to Combat and Prevent Antibiotic-Resistant Bacteria
Mar 27, 2015
By: Sylvia Mathews Burwell, HHS Secretary
Co-Authored by: USDA Secretary Tom Vilsack, Defense Secretary Ash Carter.

Antibiotics save millions of lives every year. Today, however, the emergence of drug resistance in bacteria is undermining the effectiveness of current antibiotics and our ability to treat and prevent disease. The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone. Antibiotic resistance also limits our ability to perform a range of modern medical procedures, such as chemotherapy, surgery, and organ transplants. That’s why fighting antibiotic resistance is a national priority.

Over the past year, the Administration has taken important steps to address the threat of antibiotic resistance. In September 2014, the President issued Executive Order (EO) 13676: Combating Antibiotic-Resistant Bacteria, which outlines steps for implementing the National Strategy on Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology (PCAST)’s report on Combating Antibiotic Resistance. Furthermore, the President’s FY 2016 Budget released earlier this year proposed nearly doubling the amount of Federal funding for combating and preventing antibiotic resistance to more than $1.2 billion.

Combating and preventing antibiotic resistance, however, will be a long-term effort. That’s why, today, the Administration is releasing the National Action Plan for Combating Antibiotic Resistant Bacteria (NAP). The NAP outlines a whole-of-government approach over the next five years targeted at addressing this threat:

1. Slow the emergence of resistant bacteria and prevent the spread of resistant infections

The judicious use of antibiotics in health care and agriculture settings is essential to combating the rise in antibiotic resistance. We can help slow the emergence of resistant bacteria by being smarter about prescribing practices across all human and animal health care settings, and by continuing to eliminate the use of medically-important antibiotics for growth promotion in animals.

2. Strengthen national "One-Health" surveillance efforts

A “One-Health” approach to disease surveillance will improve detection and control of antibiotic resistance by integrating data from multiple monitoring networks, and by providing high-quality information, such as detailed genomic data, necessary to tracking resistant bacteria in diverse settings in a timely fashion.

3. Advance development and use of rapid and innovative diagnostic tests
The development of rapid “point-of-need” diagnostic tests could significantly reduce unnecessary antibiotic use by allowing health care providers to distinguish between viral and bacterial infections, and identify bacterial drug susceptibilities during a single health care visit making it easier for providers to recommend appropriate, targeted treatment.

4. Accelerate basic and applied research and development

New antibiotics and alternative treatments for both humans and animals are critical to maintaining our capacity to treat and prevent disease. This involves supporting and streamlining the drug development process, as well as increasing the number of candidate drugs at all stages of the development pipeline. Additionally, boosting basic research to better understand the ecology of antibiotic resistance will help us develop effective mitigation strategies.
5. Improve international collaboration and capacities

Antibiotic resistance is a global problem that requires global solutions. The United States will engage with foreign ministries and institutions to strengthen national and international capacities to detect, monitor, analyze, and report antibiotic resistance; provide resources and incentives to spur the development of therapeutics and diagnostics for use in humans and animals; and strengthen regional networks and global partnerships that help prevent and control the emergence and spread of resistance.

The NAP is a comprehensive effort that will require the coordinated and complementary efforts of individuals and groups around the world, including public- and private-sector partners, health care providers, health care leaders, veterinarians, agriculture industry leaders, manufacturers, policymakers, and patients. Working together, we can turn the tide against the rise in antibiotic resistance and make the world a healthier and safer place for the next generation.
Sylvia Mathews Burwell is the Secretary of the Department of Health and Human Services. Tom Vilsack is the Secretary of the Department of Agriculture. Ash Carter is the Secretary of the Department of Defense.

WHITE HOUSE ANNOUNCES ACTION TO COMBAT ANTIBIOTIC-RESISTANT BACTERIA

FROM:   THE WHITE HOUSE 

September 18, 2014

FACT SHEET: Obama Administration Takes Actions to Combat Antibiotic-Resistant Bacteria

Today, 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.

According to the Centers for Disease Control and Prevention (CDC), antibiotic-resistant infections are associated with 23,000 deaths and 2 million illnesses in the United States each year.  Estimates of annual impact of antibiotic-resistant infections on the U.S. economy vary but have ranged as high as $20 billion in excess direct health care costs, and as much as $35 billion in lost productivity from hospitalizations and sick days.  And the problem is worsening.  Some bacterial infections are almost, or entirely, untreatable because the causal agents have acquired resistance to all of the antibiotics that can be deployed against them.  Without effective antibiotics, we will no longer be able to treat bacterial infections reliably and rapidly. Antibiotics are critically important for many modern medical interventions, including chemotherapy, complex surgery, and organ transplantation.

The Executive Order signed today 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.

Controlling the development and spread of antibiotic resistance is a top national security and public health priority for the Obama Administration.  Taken together, the Executive Order, National Strategy, and PCAST report will significantly help the Federal government curb the rise of antibiotic-resistant bacteria, potentially saving thousands of lives.

President Obama’s Executive Order

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:

Slow the emergence and prevent the spread of resistant bacteria.
Strengthen National efforts to identify and report cases of antibiotic resistance.
Advance the development and use of rapid diagnostic tests for the identification and characterization of antibiotic-resistant bacteria.
Accelerate basic and applied research and development for new antibiotics as well as other therapeutics and vaccines.
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:

Improved surveillance of antibiotic-resistant bacteria to enable effective response, stop outbreaks, and limit the spread of antibiotic-resistant organisms.
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.
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.