Antibiotic resistance is one of the most pressing public health issues facing the world today.  The Centers for Disease Control and Prevention (CDC) estimates that each year at least two million illnesses and 23,000 deaths are caused by antibiotic-resistant bacteria in the United States alone.  Antibiotic resistance limits our ability to quickly and reliably treat bacterial infections, and the rise of resistance could hamper our ability to perform a range of modern medical procedures from joint replacements to organ transplants, the safety of which depends on our ability to treat bacterial infections that can arise as post-surgical complications.

Antibiotic-resistant bacteria also pose economic threats.  The CDC reports that antibiotic-resistant infections account for at least $20 billion in excess direct health care costs and up to $35 billion in lost productivity due to hospitalizations and sick days each year.

Given the clear need for action on this issue, in September 2014 President Obama signed an Executive Order launching Federal efforts to combat the rise in antibiotic-resistant bacteria.  The Administration also issued its National Strategy on Combating Antibiotic-Resistant Bacteria, which outlines steps the U.S. government will take to improve prevention, detection, and control of resistant pathogens.  In addition, the President’s Council of Advisors on Science and Technology released a report with recommendations for addressing the antibiotic-resistance crisis.

The President’s FY 2016 Budget builds on these recent efforts by nearly doubling the amount of Federal funding for combating and preventing antibiotic resistance to more than $1.2 billion.  The funding will improve antibiotic stewardship; strengthen antibiotic resistance risk assessment, surveillance, and reporting capabilities; and drive research innovation in the human health and agricultural sectors.

This $1.2 billion investment increases funding for antibiotic resistance across the government in FY 2016.  For example, the Budget:

• Proposes an almost $1 billion investment in FY 2016 – nearly double the 2015 funding level –  for the Department of Health and Human Services (HHS), including:

• Nearly quadruples antibiotic research and surveillance funding at the Department of Agriculture (USDA) to $77 million.
• Increases funding at the Departments of Veterans Affairs (VA) and Defense (DoD) to $85 and $75 million, respectively, to address issues related to antibiotic resistance in healthcare settings. 

Improving Antibiotic Stewardship

Judicious use of antibiotics is essential to slow the emergence of antibiotic resistance in bacteria and extend the useful lifetime of effective antibiotics.  Preserving the usefulness of antibiotic resources without compromising human or animal health requires coordination, cooperation, and engagement of healthcare providers, healthcare leaders, pharmaceutical companies, veterinarians, the agricultural and pet industries, and patients.

The President’s FY 2016 Budget supports several key efforts to address issues related to antibiotic stewardship, including:

• Enhancing collaborative efforts to improve antibiotic prescribing and prevent the spread of resistant bacteria.  Antibiotic-resistant bacteria can spread when infected patients move between hospitals, long-term care facilities, or other healthcare settings.  The President’s FY 2016 Budget includes investments that will help healthcare facilities work together, in close partnership with state health departments, to implement effective interventions that slow the regional spread of antibiotic-resistant bacteria.
• Strengthening education programs for medical professionals, veterinary professionals, food-animal producers, and members of the public.  Some antibiotics are overprescribed in a variety of human and animal settings. Investments in this area will be used to develop education and outreach programs to clarify and strengthen responsible, appropriate use of antibiotics in humans and animals.  Investments will also support programs that enhance relationships and support necessary linkages across the human and animal health communities.
• Improving antibiotic stewardship in animal agriculture.  FDA will continue to support the phasing out of medically important antibiotics in food-producing animals, and accelerate the evaluation of new antibacterial drugs and diagnostics for antibiotic-resistant organisms.
• Improving the health and well-being of veterans.  VA will improve the implementation and effectiveness of the VA Antimicrobial Stewardship Program.  This program fosters the judicious use of antimicrobials through education, direct provider-to-provider stewardship, and surveillance, and supports and expands ongoing efforts to prevent emergence of multidrug-resistant organisms.  All of these actions are focused on improving the health and well-being of our veteran population.
• Investing in advanced diagnostics.  Optimal, informed deployment of antibiotics relies on diagnostic tests that can quickly and accurately detect disease-causing bacteria, identify the presence of antibiotic-resistant bacteria, and characterize resistance patterns.  Currently, most diagnostic tests take 24 to 72 hours from specimen collection to results, with some tests taking up to weeks.  The President’s FY 2016 Budget will accelerate the development of new advanced diagnostic tests – including rapid point-of-care diagnostic tests suitable for use during a healthcare visit – that could significantly reduce unnecessary antibiotic use.  The Budget will also expand the availability and use of advanced diagnostics to improve treatment, enhance infection control, and improve responses to outbreaks of antibiotic-resistant bacteria in hospitals and in the community.
• Advancing research to make antibiotic stewardship more effective.  The President’s FY 2016 Budget supports research to develop improved methods and approaches for embracing good antibiotic stewardship practices and combating antibiotic resistance in a variety of health care settings.  In particular, improvements in antibiotic stewardship practices are important in the acute-care hospital setting and in ambulatory and long-term care settings, where stewardship efforts are not as well developed.  Investments in this area include translation of relevant research findings into useful tools for healthcare providers to prevent and control emergence and spread of antibiotic resistance, and support for DoD efforts to develop antimicrobial stewardship policy to foster judicious use of antimicrobials. 

Strengthening Antibiotic Resistance Risk Assessment, Surveillance, and Reporting Capabilities

Resistance can arise in bacterial pathogens affecting humans, animals, and the environment.  The adoption of a “One-Health” approach that integrates human health, veterinary, and ecosystem surveillance will help strengthen detection and control of antibiotic resistance.  Improved surveillance will be achieved through enhancement, expansion, and linkage of existing systems that monitor human and animal pathogens, including the National Healthcare Safety Network (NHSN), the Emerging Infections Program (EIP), the National Antimicrobial Resistance Monitoring System (NARMS), the National Animal Health Monitoring System (NAHMS), and animal health laboratories.

To improve national and international capabilities for surveillance and reporting of antibiotic resistance, the President’s FY 2016 Budget proposes expansion of existing capabilities and establishment of new supporting networks and programs.  Efforts in this area include:

• Bolstering monitoring and reporting of antibiotic-resistant bacteria.  The number of CDC’s Emerging Infections Program (EIP) sites will be doubled from 10 to 20 across the United States.  The EIP focuses on improving national estimates related to healthcare and community antibiotic resistant infections and expanding antibiotic resistant bacteria surveillance.  Investments in this area also:

• Understanding new types of antibiotic resistance.  A Detect Network of Antibiotic Resistance Regional Laboratories will be established, serving as a national resource to characterize emerging resistance and rapidly identify outbreaks of antibiotic-resistant organisms.  Laboratories in the network will use state-of-the-art methods to characterize known resistance patterns in real time and more quickly identify clusters of resistant organisms.  In addition, a new Antibiotic Resistance Isolate Bank will provide a complete collection of current antibiotic-resistant bacteria, help keep pace with mutations, and provide information to guide FDA approval of new tests, antibiotics, and related products.
• Increasing surveillance for antibiotic-resistant zoonotic and animal pathogens.  Surveillance for antibiotic-resistant zoonotic and animal pathogens nationwide is essential to understanding what bacteria may ultimately generate outbreaks that impact human and animal health.  The President’s FY 2016 Budget will improve existing surveillance capabilities by enhancing the NAHMS and expanding capacity among existing animal health networks.
• Supporting the National Healthcare Safety Network, a web-based system to monitor antimicrobial resistance and antimicrobial use. 

Driving Research Innovation in the Human Health and Agricultural Sectors

Antibiotics for treating human disease that lose their effectiveness due to the emergence of resistance must be replaced with new drugs.  Alternatives to antibiotics are also needed in animal agriculture and veterinary medicine.  Advancing antibiotic development and increasing the number of candidates in the drug-development pipeline requires intensified efforts to boost basic scientific research, attract greater private investment, and facilitate clinical trials of new antibiotics.  The President’s FY 2016 Budget will:

• Invest in basic life sciences research.  Understanding environmental factors that facilitate development and spread of antibiotic resistance common to human and animal pathogens is essential for ensuring that newly-developed drugs and vaccines remain effective.  Basic research in this area will exploit powerful new technologies – including systems biology, rapid genome sequencing, metagenomics, and Big Data – to advance the study of antibiotic resistance.
• Intensify research and development of new therapeutics and vaccines.  Despite the urgent need for new antibacterial drugs, the pipeline of antibiotics in development is inadequate, and commercial interest in antibiotic development remains limited.  The Budget directly supports activities that will advance the discovery and development of new antibiotics, non-traditional therapeutics, and vaccines by investing in basic and applied research, providing researchers with scientific support services (e.g., specimens, sequence data, and regulatory guidance), and fostering public-private partnerships that reduce the risks, uncertainty, and obstacles faced by companies developing new antibiotics.  Investments in this area include:

• Develop alternatives to antibiotics in agriculture.  The President’s FY 2016 Budget nearly quadruples funding to $77 million for USDA efforts to combat antimicrobial resistance.  This funding supports USDA development of alternatives to antibiotics, including improved management and animal care practices and other tools.

The United States government has laid out an ambitious plan that aims to help dramatically curb the expansion of antibiotic-resistant bacterial infections.  Over the next five years, the Administration’s efforts to combat antibiotic resistance will enhance national capabilities for antibiotic stewardship, outbreak surveillance, and research in the human healthcare and agricultural sectors.  This effort holds the potential to:

• Reduce the incidence of carbapenem-resistant Enterobacteriaceae (CRE) infections by 60 percent.
• Reduce the incidence of Clostridium difficile infection (CDI) and methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections by 50 percent.
• Reduce the incidence of multidrug-resistant Pseudomonas infections acquired during hospitalization by 35 percent.
• Spur at least a 25 percent reduction in the rate of multi-drug resistant Salmonella infections and pediatric and geriatric antibiotic-resistant invasive pneumococcal disease. 

Together, the Administration’s proposed investments of more than $1.2 billion to combat and prevent antibiotic resistance that will lead to critical new developments that could fundamentally transform how public health prevents the transmission and emergence of antibiotic-resistant infections.