White House Seeks $1.2 Billion in Funding for Antibiotic-Resistant Initiatives


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-29-2015 07:39

  

President Barack Obama issued the Administration's fiscal year (FY) 2016 budget, which includes $1.2 billion in federal funding for combating and preventing antibiotic resistance. The amount nearly doubles the amount of federal funding and builds on other recent efforts announced in September 2014. The funding is targeted to improve antibiotic stewardship; strengthen antibiotic resistance risk assessment, surveillance, and reporting capabilities; and drive research innovation in the human health and agricultural sectors.

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 outlined steps the US 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 problem of antibiotic resistance. 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. The CDC also reports that antibiotic-resistant infections account for at least $20 billion in excess direct healthcare costs and up to $35 billion in lost productivity due to hospitalizations and sick days each year.

Highlights of the funding
The $1.2 billion budget request for the Department of Health and Human Services includes the following:

  • More than $650 million across the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) to expand investments in developing antibacterial and new rapid diagnostics and to launch a large-scale effort to characterize drug resistance. Earlier this year, NIH-supported scientists developed a new technique for extracting antibiotics from soil, including teixobactin. The FY 2016 budge request increases support for research and discovery.
  • More than $280 million at the CDC to support antibiotic stewardship, outbreak surveillance, antibiotic use and resistance monitoring, and research and development related to combating antibiotic resistance.
  • $47 million at the Food and Drug Administration (FDA) to support evaluation of new antibacterial drugs for patient treatments and antibiotic stewardship in animal agriculture.
  • 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 million and $75 million, respectively, to address issues related to antibiotic resistance in healthcare settings.

Specific initiatives
In making the budget request, the Administration pointed to collaboration among several sectors, including the pharmaceutical industry. "Judicious use of antibiotics is essential to slow the emergence of antibiotic resistance in bacteria and extend the useful lifetime of effective antibiotics," said the White House in a prepared statement. "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."

Among the items called for, the President’s FY 2016 budget seeks to accelerate the development of new advanced diagnostic tests, including rapid point-of-care diagnostic tests suitable for use during a healthcare visit, which could reduce unnecessary antibiotic use. The budget also expands 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.

The budget request also calls for the adoption of a “One-Health” approach that integrates human health, veterinary, and ecosystem surveillance to 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 the 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.
  • Supporting FDA activities related to integrated monitoring of bacterial antibiotic resistance via new collaborative approaches for the National Antimicrobial Resistance Monitoring System.
  • Enabling the DoD to collect ongoing and enhanced antibiotic use and resistance surveillance data.
  • Supporting HHS’s Office of Global Affairs to promote international communication and collaboration on combating antibiotic resistance, improve criteria for susceptibility reporting, and coordinate regulatory approaches with international agencies.
  • Expanding VA efforts to perform additional surveillance.
  • Establishing a Detect Network of Antibiotic Resistance Regional Laboratories to serve as a national resource to characterize emerging resistance and rapidly identify outbreaks of antibiotic-resistant organisms. Laboratories in the network will 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 the 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 calls for improving 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.


Advancing new antibiotic  development

The President's FY 2016 budgets also calls for funding for advancing antibiotic development and increasing the number of candidates in the drug-development pipeline by boosting basic scientific research, attracting greater private investment, and facilitating clinical trials of new antibiotics. It calls for the following:

  • Investment 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 technologies, including systems biology, rapid genome sequencing, metagenomics, and Big Data, to advance the study of antibiotic resistance.
  • Intensifying research and development of new therapeutics and vaccines. The budget supports activities that will advance the discovery and development of new antibiotics, non-traditional therapeutics, and vaccines by investing in basic and applied research by 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: an increase of $100 million within NIH’s existing research activities, including the development of an antibacterial resistance clinical trial network for rapid testing of new drugs to treat multi-drug resistant bacteria; an increase of over $100 million at BARDA for the development of new antibiotic therapies and diagnostics; support for FDA efforts to streamline the development pathway to facilitate treatment of patients with unmet medical needs; and support for DoD participation in primary and collaborative efforts to identify new small-molecule candidates and point-of-care diagnostics.
  • Developing alternatives to antibiotics in agriculture. The President’s FY 2016 budget nearly quadruples funding to $77 million for the 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.

Goals of the funding
The United States government has laid out an ambitious plan that aims to help dramatically curb the expansion of antibiotic-resistant bacterial infections," said the White House in a statement. "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 Administration hopes that these efforts will achieve the following:

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

Source: The White House

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