As the United States grapples with the complex issue of escalating prescription drug prices, policymakers are increasingly considering international pricing benchmarks as a tool to curb costs. Central to this discourse is the widely held belief that the U.S. offers patients faster access to new medications primarily because its regulatory agency, the Food and Drug Administration (FDA), operates more swiftly than counterparts abroad. However, a groundbreaking study from Brown University’s School of Public Health challenges this assumption by demonstrating that the timing of pharmaceutical company submissions and drug characteristics, more than regulatory speed, dictate the U.S.’s perceived advantage in drug availability.
This comprehensive analysis, published in the prestigious journal Health Affairs, meticulously examined every new prescription drug approved between 2014 and 2018 across five high-income countries: the United States, Europe, Canada, Japan, and Australia. The researchers tracked the delays associated with submissions for regulatory review alongside the actual duration of the evaluation processes across these jurisdictions up through 2022. Their goal was to unravel the factors influencing approval speed and availability, especially distinguishing between drugs offering substantial therapeutic value and those providing minimal additional benefit over existing treatments.
Historically, advocates for faster drug access in the U.S. argued that its regulatory infrastructure enabled patients to receive novel therapies ahead of their counterparts abroad, contributing to better health outcomes. This study, however, reframes the debate by revealing that the FDA’s review process is only marginally—often just a few weeks or a month—faster than similar agencies in other wealthy nations. Instead, the more critical factor is when pharmaceutical companies elect to submit their applications. Drugs deemed to offer minimal therapeutic improvements—a category the study terms “low-value” medications—are often submitted for U.S. approval months or even years prior to being presented to foreign regulatory bodies, resulting in earlier and broader patient access stateside despite questionable medical benefit.
Lead author Irene Papanicolas, a professor at Brown University, emphasizes the nuance in these findings. She acknowledges that while speedy access to genuinely innovative medicines remains crucial, not all newly approved medications confer meaningful improvements in patient care. This distinction is essential for policymakers who seek to balance encouraging innovation with ensuring that healthcare spending delivers tangible value. The study found pharmaceutical companies are motivated by distinct business incentives when choosing when and where to seek regulatory authorization, especially for products that may struggle to gain favorable pricing or reimbursement internationally.
The divergent regulatory landscapes underscore these corporate strategies. The U.S. market, being the largest globally, allows manufacturers considerable freedom to set drug prices upon launch without mandatory health cost assessments. Contrastingly, health authorities in Canada, Europe, Japan, and Australia rigorously evaluate a drug’s therapeutic incremental benefit relative to existing alternatives—a process that heavily influences price negotiations and coverage decisions. Olivier Wouters, co-author and associate professor at Brown, explains that this regulatory rigor abroad likely spurs companies to prioritize U.S. submissions for lower-value drugs where pricing and reimbursement hurdles are comparatively lighter.
Intriguingly, the analysis also demonstrates that for drugs with clear, demonstrable clinical advantages over current standards of care, pharmaceutical companies typically synchronize submissions across all major markets, thereby equalizing the timing of approvals. In these instances, the FDA’s reviews proceed slightly faster but not to an extent that would justify attributing the U.S.’s overall drug access lead to regulatory expediency alone. This suggests a more collaborative global approach for introducing high-impact medications, contrasting sharply with the staggered U.S.-first approach for lower-value products.
These insights bear significant implications for ongoing policy debates in Washington, notably surrounding proposals such as the “most favored nation” rule, which aims to tether U.S. drug prices to those negotiated by peer countries. Papanicolas cautions that implementing such policies is fraught with complexities, especially considering the opaque nature of international drug availability and submission timing. She raises critical questions about the handling of products not yet introduced abroad and the potential unintended consequences for pharmaceutical companies’ global approval strategies, which could, paradoxically, delay patient access or distort market behaviors.
The study’s revelations resonate profoundly in the broader context of America’s disproportionate prescription drug spending, which far surpasses that of other high-income nations without consistently correlating to superior health outcomes. By demonstrating that earlier U.S. access predominantly favors medications with limited additional medical benefit, the research challenges simplistic narratives that regulatory responsiveness alone drives innovation uptake and expenditure patterns. Instead, it highlights the strategic interplay between market incentives, regulatory frameworks, and clinical value assessments that collectively shape drug availability.
Moreover, these findings invite a more discerning public dialogue on pharmaceutical pricing reform, emphasizing the importance of aligning drug approval timing and pricing strategies with the true therapeutic value offered. The nuanced picture painted by this research calls for policies that incentivize the timely introduction of transformative medicines while scrutinizing and potentially restraining expedited U.S. access to high-cost, low-value drugs that contribute disproportionately to healthcare inflation.
The Brown University-led study also exemplifies the critical role of health services research in dissecting complex systems and informing evidence-based policymaking. By integrating cross-country regulatory data with drug characteristic analyses, the research provides a sophisticated lens through which stakeholders can evaluate the multifaceted drivers of drug market dynamics and formulate interventions that optimize patient outcomes and system sustainability.
Ultimately, this investigation reframes longstanding assumptions regarding drug approval timelines and market strategies. It portrays a pharmaceutical landscape in which the nominal speed of U.S. government review is less determinative of drug availability than the strategic submission decisions by companies navigating disparate international regulatory terrains. These insights bear profound implications as the U.S. confronts mounting pressures to enhance prescription drug affordability, access, and value in an era characterized by rapid biomedical innovation and complex global health economics.
Subject of Research: International comparison of drug approval submission timing and review durations among the FDA and four international regulatory agencies, with an emphasis on therapeutic value differentiation.
Article Title: Review Times For New Drugs And Submission Delays Among The FDA And 4 International Regulators, 2014–22
News Publication Date: 2-Feb-2026
Web References:
- Health Affairs article: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2025.00595
References:
- Papanicolas, I., Wouters, O., Sawaya, T., et al. (2026). Review Times For New Drugs And Submission Delays Among The FDA And 4 International Regulators, 2014–22. Health Affairs. DOI: 10.1377/hlthaff.2025.00595
Keywords: Pharmaceuticals, Drug Costs, Pharmaceutical Industry, Prescription Drug Prices, Drug Approval, Regulatory Review, Therapeutic Value, FDA, International Drug Markets, Health Policy, Drug Pricing Reform.
