Aditya Narayan

Background: The 21st Century Cures Act (2017) was enacted during a period of evolving FDA flexibility in evidentiary standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024. Methods: We constructed a database of all novel FDA approvals from January 1, 2016, through December 31, 2024. Each study linked to an approved drug (N = 6,763) was cataloged by study number, sponsorship, and timing of results reporting relative to completion. Results: Since 2016, the number of studies supporting approval has steadily declined. Beginning in 2017, the modal number of studies per approval fell to one. Industry sponsorship increased while NIH-supported studies decreased. Average time to public posting of results exceeded the one-year statutory limit. Conclusions: In the post-2016 period, FDA approvals were supported by fewer studies and by a greater proportion of industry-sponsored studies. Although this may accelerate access to new therapies, it raises concerns about the strength of evidence for safety and effectiveness.

PURPOSE: Patients with GI cancers often face significant financial toxicity (FT) and health-related social risks (HRSRs), yet best practices for screening remain unclear. This study aimed to evaluate the prevalence of FT and HRSR and identify associated factors. METHODS: From June 2022 to August 2023, patients were screened using the Comprehensive Score for Financial Toxicity (COST), patient-reported HRSR (eg, housing, food insecurity), and quality of life (QOL). Multivariate regressions were used to assess predictors of FT and HRSR, adjusting for several variables. RESULTS: Among 8,335 patients with GI cancer, 45% had a COST score of P < .001), advanced disease (stage III [β, 1.33; P < .001]; IV [β, 1.56; P < .001]), recent treatment (β, 3.23; P < .001), and anal (β, 1.97; P = .003), esophageal (β, 1.66; P = .005), or hepatobiliary cancer (β, 1.05; P = .031). Older age (≥65 years [β, –5.17; P < .001]), higher income ($100,000-$200,000 [β, –1.81; P < .001]; >$200,000 [β, –3.80; P < .001]), and private insurance (β, –1.70; P < .001) were protective. Twenty-eight percent reported at least one HRSR. HRSRs were associated with minority status (odds ratio [OR], 2.14; P < .001), advanced disease (stage III [OR, 1.31; P = .001]; IV [OR, 1.24; P = .010]), recent treatment (OR, 1.20; P = .001), and gastric cancer (OR, 1.25; P = .027). Lower HRSR was associated with older age (OR, 0.59; P < .001), higher income ($100,000-$200,000 [OR, 0.66; P < .001]; >$200,000 [OR, 0.48; P < .001]), and private insurance (OR, 0.64; P < .001). Sex was not a predictor. Worst FT was associated with decreased QOL (β, –0.98; P < .001) and reduced medication adherence (β, 0.11; P < .001). CONCLUSION: High levels of FT and HRSR were observed in patients with GI cancer. Early intervention to address financial and social burdens may improve both disease and survivorship outcomes.

Background: The 21st Century Cures Act (2017) expanded FDA flexibility in applying methodological standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024. Methods: We constructed a database of all novel FDA approvals from January 1, 2016, through December 31, 2024. Each study linked to an approved drug (N=6,763) was cataloged by study number, sponsorship, and timing of results reporting relative to completion. Results: Since 2016, the number of studies supporting approval has steadily declined. Beginning in 2017, the modal number of studies per approval fell to one. Industry sponsorship increased while NIH-supported studies decreased. Average time to public posting of results exceeded the one-year statutory limit. Conclusions: After implementation of the Cures Act, FDA approvals have relied on fewer, increasingly industry-sponsored studies. Although this may accelerate access to new therapies, it raises concerns about the strength of evidence for safety and effectiveness.

CMS's new ACCESS payment model is a novel approach in how Medicare pays for chronic-disease management: recurring, condition-specific payments tied to clinical improvement, rather than billing for discrete encounters or tightly defined remote-monitoring activities. The promise is straightforward, more reimbursement for technology-enabled longitudinal care and more choice and competition for patient care. But ACCESS leaves many questions unanswered about payment levels, how quality is measured, risk adjusted, and how these patients' facing technology-enabled services coordinate care with the traditional delivery systems. Whether ACCESS strengthens primary care will depend on the details.

By 2040, more than 80 million Americans will be aged ≥65, yet contemporary senior living communities still operate on a hospitality-first model developed for healthier cohorts three decades ago. This commentary argues that the next generation of senior living must pivot from hotel-style amenities to person-centric health platforms that proactively coordinate medical, functional, and social support. We outline four mutually reinforcing pillars. (1) Data infrastructure that stitches together clinical, functional, and social determinants of health enables continuous risk stratification and early intervention. (2) Ambient and conversational artificial-intelligence tools can extend sparse caregiving workforces while preserving resident autonomy. (3) Value-based contractual arrangements—for example, Medicare Advantage special-needs plans embedded within senior living sites—can realign financial incentives toward prevention rather than occupancy. (4) Targeted policy levers, including low-income housing tax credits for the “forgotten middle” and outcomes-based regulatory frameworks, can catalyze adoption at scale. Ultimately, re-architecting senior living around integrated technology, value-based financing and supportive regulation can transform these communities into preventive-care hubs that delay nursing home entry, improve quality of life, and reduce total cost of care.

There are substantial financial incentives to develop orphan drugs for rare diseases, but concerns about the quality and volume of supporting evidence have emerged. We compare evidence used to evaluate orphan and nonorphan drugs approved by the Food and Drug Administration (FDA) between 2016 and 2023. This retrospective cross-sectional analysis utilizes FDA data on approvals and study information from ClinicalTrials.gov to compare characteristics of studies relevant to orphan and nonorphan drugs approved between 2016 and 2023. Of the 368 total drugs approved, 50% were orphan drugs. The FDA-approved drugs based on significantly fewer studies for orphan (1.5 studies/drug) compared to nonorphan (2.4 studies/drug). Additionally, a significantly lower proportion of studies were completed before FDA approval for orphan drugs (25% vs 41%). Orphan drugs were significantly less likely to be evaluated in randomized clinical trials (RCTs) (34% vs 63%). Of these RCTs, there were significantly fewer completed before approval (40% vs 54%) and that had results posted (35% vs 53%). There was a significant difference in the available evidence for orphan and nonorphan drugs. As new legislation like Cures 2.0 is developed, it is critical to examine the balance between an expedited approval timeline and the standard of clinical evidence.

The ongoing Russian war in Ukraine resulted in the displacement of vulnerable refugees and a catastrophic disruption in health care services within and beyond the nation’s borders, threatening the population’s right to care [1,2]. Within Ukraine, over 1000 health care facilities have been attacked since 24 February 2022, representing 15% of the country’s total health […]

India’s evolving digital health strategy leverages innovative technologies to enhance access to healthcare services. This paper explores the key components of India’s digital health transformation, including the Ayushman Bharat Digital Mission (ABDM) and India’s integration of biometric identification and digital infrastructure to improve healthcare delivery. The lessons learned from India’s large-scale implementation of digital health provide valuable insights for global health markets and digital transformations in healthcare systems.