Most-favoured-nation pricing for brand-name medicines in Medicare was projected to decrease net spending. Potential reductions in net Medicare spending would be substantially greater than sales in the...

Sean Tu and Aaron Kesselheim argue that sidestepping established administrative processes to announce major regulatory policies undermines transparency, public participation and trust, and regulatory ...

BACKGROUND AND OBJECTIVES. Leucovorin, or folinic acid (vitamin B9), is approved by the Food and Drug Administration (FDA) to reduce adverse effects from antifolate cancer treatments including methotr...

The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited review program. But Health and Human Services Secretary Robert F. Kennedy Jr....

Marty Makary's legacy will be that he undercut many of the key principles that had made the agency one of the most important public health institutions in the world.

2026 bracket Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Explore groundbreaking innovations from

2026 bracket Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Explore groundbreaking innovations from

2026 bracket Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Explore groundbreaking innovations from

This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.

The US Food and Drug Administration@s (FDA) increasing reliance on holding expert panels, rather than advisory committees, for external expert advice may violate the Federal Advisory Committee Act (FA...

This study examines how chronic pain advocates in Canada navigated fraught relationships with pharmaceutical companies amid escalating concerns about the adverse public health impacts of opioids. Dra...

“FDA decision-making may be reduced to a sequence of ‘make-a-deals’ with Trump, his FDA, or even political allies,” experts warn.

Got questions about the FDA’s new plans around pharmaceutical ads? We’ve got answers.

The Administration's order and what can actually be done

ALT: homer simpson says that 's bad in front of a bookshelf

In his first term, Trump made a lot of noise about lowering drug prices but accomplished little of consequence. The noise continues, but it is now accompanied by new ill-conceived initiatives, includi...

New faculty members, the ORPHAN Cures Act, “hyaluronidase hopping,” and more from PORTAL

A US Department of Veterans Affairs dataset compiling veteran health-care use in 2021 was quietly amended on March 5, 2025. A column titled gender was renamed sex, and the words were also switched in ...

Expansion of the Medicare drug price negotiation rare disease drug carve-out would unnecessarily limit the number of drugs eligible for negotiation, allow for continued high drug prices for products that earn billions of dollars in Medicare, and introduce a new set of misaligned incentives.

This Perspective offers an analysis of the legal foundations in the context of these and other challenges to the role of the Advisory Committee on Immunization Practices.

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Some clarity for this wildly confusing topic.

So far, what’s been released is little more than tactics in pursuit of Kennedy’s own agenda.

This cohort study assesses health care costs after initiating sacubitril-valsartan compared to an angiotensin-converting enzyme inhibitor or an angiotensin II receptor-blocker in Medicare patients bei...

The FDA often exercises flexibility in deciding whether to approve highly promising drugs for patients in desperate need of treatment options. But it doesn’t consider a drug’s likely financial toxi...

This survey study examines physician-prescriber experiences with and perspectives on the clozapine risk evaluation and mitigation strategy.

Ally Memedovich and colleagues report on patent challenges within the first year of eligibility among small-molecule drugs approved by the FDA from 2007-2018 and investigate the extent to which market...

ALT: a philadelphia eagles logo with the words " it 's a win " below it

Protecting health agency independence, drug repurposing, academic detailing, and more from the PORTAL team.

Health care payers often use cost-effectiveness analyses (CEA) using the quality-adjusted life-year (QALY), as the measure of benefit, to inform reimb…

This cross-sectional study explores US prescription fills, retail spending, and prices of low-dose doxepin for insomnia and the possible cost savings to patients had they used liquid doxepin, a less e...

A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US - Volume 52 Issue 4

When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts and inflict lasting damage on institutional credibility.

This cross-sectional study reports on the study design characteristics of clinical trials for novel psychiatric drugs approved by the US Food and Drug Administration.

The article had to be pulled even though HHS Office of Research Integrity officials gave a public talk on the topic last fall

The article had to be pulled even though HHS Office of Research Integrity officials gave a public talk on the topic last fall

Repurposing off-patent drugs can be a potential source of low-cost treatments for patients with unmet medical needs. Here, we review the proposed new European Union (EU) pharmaceutical legislation in ...

U.S. shortages of critical drugs are a worsening problem, and the FDA has been too slow to authorize temporary importation of drugs from other well-regulated markets to meet pressing U.S. needs.

Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler,...

Bishal Gyawali: The case of cancer drug Xtandi / Aaron S. Kesselheim, Bishal Gyawali, cancer, Cancer Policy, Emily H. Jung, Helen Mooney, JAMA Oncology, Jerry

The US Food and Drug Administration on Monday approved a generic version of the daily injectable GLP-1 medicine liraglutide for people with type 2 diabetes, opening the door for lower-priced options t...