- PerspectiveAug 31, 202210.1056/NEJMp2211311
Intradermal JYNNEOS may safely provide populations that have been disproportionately affected by monkeypox with rapid access to a limited resource without sacrificing the level of immune response achieved.
- N Engl J Med 2022; 387:672-675
For the one in nine hospitalized U.S. adults who have SUD, hospital-based addiction care has critical health benefits. But most hospitals don’t offer such care.
- N Engl J Med 2022; 387:579-581
Tecovirimat might speed resolution of monkeypox illness and improve outcomes, but how can we manage compassionate access to a drug whose safety and efficacy in humans have not been established?
- N Engl J Med 2022; 387:491-493
A shortage of contrast material has made weighing value an urgent aspect of imaging decisions and provided a stark example of the consequences of low-value imaging for public health and health equity.
- N Engl J Med 2022; 387:481-483
Explicitly including race or ethnicity as a factor in government allocation of resources raises legal concerns. Litigation related to Covid-19 treatment guidance in New York highlights these issues.
- N Engl J Med 2022; 387:196-199
User fees are vital to FDA operations. But user-fee legislation has focused on expediting premarketing review rather than understanding device risks and benefits throughout the product life cycle.
- N Engl J Med 2022; 387:199-201
User-fee reauthorization creates new opportunities for the FDA to address issues with its accelerated-approval program, including the lack of evidence of clinical benefit for some products.
Physicians Spreading Misinformation on Social Media — Do Right and Wrong Answers Still Exist in Medicine?N Engl J Med 2022; 387:1-3
In light of widespread falsehoods about Covid-19 and its treatment and prevention, the American Board of Internal Medicine has informed doctors that disseminating misinformation is grounds for disciplinary sanctions.
- N Engl J Med 2022; 387:3-5
A new bill, the Dietary Supplement Listing Act of 2022, would create the impression of reform in the supplement industry while leaving the current lax regulatory framework largely untouched.
- N Engl J Med 2022; 386:2239-2242
In the face of a rapidly changing technology landscape, the National Academy of Medicine has formed the Committee on Emerging Science, Technology, and Innovation in health and medicine to convene diverse stakeholders to reenvision governance in health and medicine and drive collective action.
- N Engl J Med 2022; 386:2164-2167
The financial burden associated with orally administered anticancer drugs can be overwhelming for Medicare beneficiaries. Policies adding an out-of-pocket spending cap to Part D have been proposed, and Congress could permit price negotiation for anticancer drugs.
- N Engl J Med 2022; 386:2159-2161
An important challenge involves reaching people who are undecided about Covid-19 vaccination. The roadmap drawn by tobacco-control efforts shows that the public mindset can be tilted toward public health and social good.
- N Engl J Med 2022; 386:2064-2066
A decade after preexposure prophylaxis against HIV became available, less than a quarter of people in the United States who could benefit from PrEP are taking it. The failure is, in part, a perverse outcome of a system that relies on high drug prices to fund HIV prevention.
- N Engl J Med 2022; 386:1680-1682
Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.
- N Engl J Med 2022; 386:1677-1679
The Cures 2.0 Act represents an opportunity to advance policies that encourage the use of digital tools, incorporate more efficient and patient-centered research designs, and clarify expectations for evidence generation throughout the life cycle of medical products.
- N Engl J Med 2022; 386:1638-1645
Development and public acceptance of vaccines are crucial for disease control. This review covers the process of evaluating vaccines for safety and efficacy, authorization pathways, and factors that advisory bodies consider when establishing vaccine recommendations.
- N Engl J Med 2022; 386:1581-1583
Although restricting access to nontobacco flavors of e-cigarettes may reduce vaping among adolescents and mitigate associated risks, it could also impede smoking cessation among adults, thereby increasing smoking-attributable mortality. But policy solutions could exist.
Not Ready for the End Game — Why Ending Federal Covid-19 Emergency Declarations Will Harm Access to CareN Engl J Med 2022; 386:e40
Demands to “end the emergency” reflect understandable longing for normal life. But rushed terminations of federal emergency declarations will eliminate regulatory flexibility and financial supports for patients, providers, and the health care system.