Judicial interference with mifepristone.

In the days since Texas federal judge Matthew J. Kacsmaryk invalidated the approval by the US Food and Drug Administration (FDA) of mifepristone, a medication used to terminate pregnancy, a shock wave of concern has swept through many people, organizations, and companies that work closely with the agency. The strong opposition reflects the high stakes not only for pregnant persons and for the FDA, but also for the scientific process of drug development and public access to safe and effective medications. Twists and turns in the case are already happening. A federal appeals court stayed the full suspension of mifepristone, but permitted multiple restrictions on its availability. Then the Supreme Court, which recently overturned the constitutional right to abortion, kept the status quo in place for a few days while considering the government's appeal. The results of the legal battle will be enormously consequential for reproductive health care-and far beyond, for innovation, science, and health.

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

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

Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency.

Seven former commissioners of the Food and Drug Administration (FDA) from both sides of the political aisle recommend that the FDA be moved out of the Department of Health and Human Services and reconfigured as an independent federal agency. We believe that such a reengineering would promote reliance on consistent science-based regulation and ensure that the American public has access to the best that science and industry can offer.

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.