The White House yesterday launched an ambitious multipronged attack on antibiotic-resistant bacteria that includes an executive order, a national strategy, and a detailed report from the President's Council of Advisors on Science and Technology (PCAST).
Federal agencies also announced a $20 million prize to speed the development of a rapid diagnostic test to be used by healthcare workers to identify highly resistant bacterial infections.
President Barack Obama's executive order establishes both an interagency Task Force for Combating Antibiotic-Resistant Bacteria and a Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. Experts on the advisory council will be appointed by Health and Human Services Secretary Sylvia Mathews Burwell, and the task force will comprise representatives from at least 11 federal agencies.
The task force will develop a 5-year plan for combatting resistant bacteria, which has been estimated by the Centers for Disease Control and Prevention (CDC) to cost the United States as much as $35 billion and 23,000 lives a year. The 5-year plan will incorporate initiatives from the national strategy and address recommendations in the PCAST report.
The White House push comes a year after a major report from the CDC highlighted the problem of antibiotic resistance in detail; in addition, the World Health Organization (WHO) recently warned that the world faces a "post-antibiotic" era if immediate steps aren't taken to curb overprescribing and other problems.
"Every day we don't act to better protect antibiotics will make it harder and more expensive to address drug resistance in the future," said CDC Director Tom Frieden, MD, MPH, in a statement in response to the White House efforts.
"We must be diligent stewards of antibiotics, protecting this precious resource in doctor's offices, homes, and farms, so that they are available to help us, and our children, in the future," he said.
Lauri Hicks, DO, a CDC medical epidemiologist, said, "As many as 5 out of 10 people who visit their doctor's office for an infection, like a cold, will walk out with an antibiotic even though it is completely ineffective."
Beth Bell, MD, MPH, director of the CDC's National Center for Emerging and Zoonotic Infectious Diseases, said, "The National Strategy for Combating Antibiotic-Resistant Bacteria is the President's serious response to the landmark CDC report sounding the alarm on the top antibiotic resistance threats to human health." She added that the strategy "opens a new chapter in the fight against resistance."
In his executive order, President Obama said, "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."
The task force will be co-chaired by Burwell, Secretary of Defense Chuck Hagel, and Secretary of Agriculture Tom Vilsack. Its 5-year plan must be completed by Feb 15, 2015, and include goals, milestones, and metrics for measuring progress, as well as timelines.
Within 6 months of completing the plan, the task force will provide an initial update to the president on progress toward national goals, followed by updates once a year after that.
The advisory council will provide advice to Burwell about programs and policies intended to optimize antibiotic stewardship, strengthen surveillance and prevent spread of antibiotic-resistant infections, improve point-of-care diagnostics, and promote research on new and next-generation antibiotics, among other steps. It will also work with the task force to assess the 5-year plan's progress.
The executive order specifies that, within 30 days, Burwell, Vilsack, and Secretary of State John Kerry will designate representatives "to engage in international action to combat antibiotic-resistant bacteria," including helping form the WHO's Global Action Plan for Antimicrobial Resistance now in development. Burwell, Vilsack, and Kerry will also review other international collaborative opportunities, the order states.
The national strategy "articulates national goals, priorities, and specific objectives that provide an overarching framework for federal investments aimed at combating antibiotic resistance," according to a White House Blog post yesterday by Lisa Monaco, assistant to the president for homeland security and counterterrorism, and John P. Holdren, PhD, assistant to the president for science and technology and director of the White House Office of Science and Technology Policy (OSTP).
Its five goals are to: (1) slow the emergence and prevent the spread of resistant bacteria; (2) strengthen national "one-health" surveillance efforts; (3) advance the development and use of innovative diagnostic tests; (4) accelerate basic and applied research and progress on new antibiotics, other therapeutics, and vaccines; and (5) improve international collaboration.
Some specifics include rapid detection and control of outbreaks (goal 1), enhanced data sharing across disciplines (goal 2), and strengthening of US and European collaboration (goal 5).
The report and recommendations resulted from consultation with a wide range of experts from public health and veterinary sectors, according to PCAST. It includes eight recommendations.
- Strengthen federal leadership on the issue. PCAST recommends that Obama appoint the National Security Council (NRC), OSTP, and Office of Management and Budget to coordinate federal efforts. It also says an NRC staffer should serve as White House Director for National Antibiotic Resistance Policy (DNARP), a new position.
- Enhance surveillance and response. This includes strengthening state and local public health infrastructure for surveillance and response via more CDC funding and establishing a national capacity for pathogen surveillance based on genome analysis.
- Bolster basic research. The report suggests expanding fundamental research that applies to developing new antibiotics and other therapeutics and developing alternatives to antibiotic use in agriculture.
- Foster clinical trials for new antibiotics. PCAST says the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) "should convene industry and other public and private stakeholders to define the requirements for an appropriate clinical trials infrastructure" to promote clinical trials. It also said the FDA should facilitate drug approval based on safety and efficacy in specific patients infected with antibiotic‐resistant bacteria while discouraging their use in other patients.
- Increase economic incentives for developing new antibiotics. The report advises the newly created DNARP to evaluate options for attracting private investment, and it says the White House should work with the Congress to fund incentives.
- Improve antibiotic stewardship. Recommendations include having the Centers for Medicare and Medicaid Services use reimbursement incentives and the federal government use funding requirements to drive stewardship. It also said the federal government should lead by example in its own healthcare facilities and suggested the prize for breakthrough diagnostics that was announced today.
- Limit agricultural use of antibiotics. PCAST said it strongly supports the FDA's new guidance 209 and 213 to promote the judicious use of antibiotics in agriculture.
- Ensure effective international collaboration. In addition to supporting the WHO's global action plan, the United States should continue to elevate the issue to a global priority, the report says.
As part of yesterday's rollout, the Obama administration announced that it will award a $20 million prize—sponsored by the NIH, Biomedical Advanced Research and Development Authority, and FDA—to facilitate the development of a rapid diagnostic test for use by healthcare workers to identify highly resistant bacteria in patients.
Public health agencies welcomed the high-level actions.
Barbara Murray, MD, president of the Infectious Diseases Society of America (IDSA) said in an IDSA news release that the initiative "adds to an impressive chorus of experts clamoring for substantial policies to address antibiotic resistance."
"Now it is time for action, and we are pleased to see the White House take critical initial steps to implement a well-coordinated plan, with clear timelines and benchmarks to measure progress, to address antibiotic resistance," she said.
In the news release, which contains her testimony before the US House Energy and Commerce Subcommittee on Health, she also advocated for bipartisan support of the Antibiotic Development to Advance Patient Treatment Act that was introduced in the House last December.
Jeffrey Levi, PhD, executive director of Trust for America's Health (TFAH), said in a TFAH press release, "TFAH commends the White House for the Executive Order and national strategy and PCAST for their new report on antibiotic resistance. Together, these actions recognize that antibiotic resistance is an urgent public health crisis."
He added, "It is not an exaggeration to say that antibiotic resistance presents one of the greatest and scariest threats to human health around the world."
Of the recommended federal measures, Levi emphasized four: having incentives for developing drugs, reducing the use of medically important antibiotics in agriculture, combatting overprescribing, and strengthening surveillance.
Regarding antibiotic use in agriculture, Rob Tauxe, MD, MPH, deputy director of the Division of Foodborne, Waterborne and Environmental Diseases at the CDC, said, "Antibiotics are commonly used in food animals to prevent, control, and treat disease, and to promote growth in food-producing animals. Farmers and veterinarians can play a role in the fight against resistance by using antibiotics only when they are needed to keep animals healthy."
Sep 18 executive order
Sep 18 national strategy
Sep 18 PCAST report
Sep 18 PCAST news release
Sep 18 White House Blog post
Sep 18 CDC media material
Sep 19 IDSA news release
Sep 18 TFAH press release
Sep 16, 2013, CIDRAP News story "CDC: Antibiotic-resistant bugs sicken 2 million a year"