Vital Directions for Health and Health Care: Priorities From a National Academy of Medicine Initiative.

Importance: Recent discussion has focused on questions related to the repeal and replacement of portions of the Affordable Care Act (ACA). However, issues central to the future of health and health care in the United States transcend the ACA provisions receiving the greatest attention. Initiatives directed to certain strategic and infrastructure priorities are vital to achieve better health at lower cost. Objectives: To review the most salient health challenges and opportunities facing the United States, to identify practical and achievable priorities essential to health progress, and to present policy initiatives critical to the nation's health and fiscal integrity. Evidence Review: Qualitative synthesis of 19 National Academy of Medicine-commissioned white papers, with supplemental review and analysis of publicly available data and published research findings. Findings: The US health system faces major challenges. Health care costs remain high at $3.2 trillion spent annually, of which an estimated 30% is related to waste, inefficiencies, and excessive prices; health disparities are persistent and worsening; and the health and financial burdens of chronic illness and disability are straining families and communities. Concurrently, promising opportunities and knowledge to achieve change exist. Across the 19 discussion papers examined, 8 crosscutting policy directions were identified as vital to the nation's health and fiscal future, including 4 action priorities and 4 essential infrastructure needs. The action priorities-pay for value, empower people, activate communities, and connect care-recurred across the articles as direct and strategic opportunities to advance a more efficient, equitable, and patient- and community-focused health system. The essential infrastructure needs-measure what matters most, modernize skills, accelerate real-world evidence, and advance science-were the most commonly cited foundational elements to ensure progress. Conclusions and Relevance: The action priorities and essential infrastructure needs represent major opportunities to improve health outcomes and increase efficiency and value in the health system. As the new US administration and Congress chart the future of health and health care for the United States, and as health leaders across the country contemplate future directions for their programs and initiatives, their leadership and strategic investment in these priorities will be essential for achieving significant progress.

Advancing global health through regulatory science research: summary of the Global Summit on Regulatory Science Research and Innovation.

As a first step in the implementation of the Food and Drug Administration's (FDA) Pathway to Global Product Safety and Quality (Anonymous, 2011), FDA's Office of International Programs (OIP) and the National Center for Toxicological Research (NCTR) sponsored a Global Summit on Regulatory Science Research and Innovation. Through a series of presentations and panel discussions, the Global Summit participants explored how research could be used more effectively as a tool for advancing regulatory science, food safety, medical technologies, and public health. Speakers provided an overview of each of the components in the global regulatory-science research initiative, including scientific innovation and modernizing toxicology; and discussed how the integration of these components is needed to achieve the promise of regulatory science at the global level. All participants agreed with the formation of a Global Coalition of Regulatory Research Scientists who will work collaboratively to build knowledge, promote the development of regulatory science, discover novel ways to clearly define research needs, and improve public health.

Transparency practices at the FDA: A barrier to global health.

Data sharing among regulators must be "business as usual".

Considerations for infectious disease research and practice.

As the 21st century unfolds, strategies to prevent and control infectious diseases remain an area of vital interest and concern. The burden of disease, disability, and death caused by infectious diseases is felt around the world in both developed and developing nations. Moreover, the ability of infectious agents to destabilize populations, economies, and governments is strikingly apparent. To an unprecedented degree, infectious disease-related issues are high on the agendas of world leaders, philanthropists, policymakers, and the public. This enhanced focus, combined with recent scientific and technological advances, creates new opportunities and challenges for infectious disease research and practice. This paper examines these issues in the context of three countries: China, India, and the United States.

Bioterrorism: responding to an emerging threat.

Only a few years ago bioterrorism was considered a remote concern but few today are complacent about the possibility of biological agents being intentionally used to cause widespread panic, disruption, disease and death. By its very nature, the biological weapons threat - with its close links to naturally occurring infectious agents and disease - requires a different paradigm than that for conventional terrorism, military strikes or attacks caused by other weapons of mass destruction. This evolving threat presents the medical, public health and scientific communities (importantly including biotechnology) with a set of difficult and pressing challenges. This article provides a brief overview of the threat from biological weapons, the nature of a bioterrorist attack and some of the issues that need to be addressed if we are to make meaningful progress to prevent or contain this disturbing and potentially catastrophic danger.

Creating a space for innovative device development.

The FDA announces a partnership with a new nonprofit organization--the Medical Device Innovation Consortium--to advance regulatory science in the medical technology arena.