Olivier J. Wouters, PhD, is an associate professor at Brown University's School of Public Health (Department of Health Services, Policy, and Practice) and a visiting faculty member at Harvard Medical School (Division of Pharmacoepidemiology and Pharmacoeconomics). He was previously an assistant professor at the London School of Economics. Olivier researches and teaches pharmaceutical policy and regulation. He has published in top health policy and medical journals, including Health Affairs, JAMA, The Lancet, and NEJM. In 2021, Olivier received the London School of Economics’ Excellence in Education Award for “outstanding teaching contribution and educational leadership.” Olivier has a master's degree in health economics and a PhD in health policy from the London School of Economics. He holds an undergraduate degree in international relations from Georgetown University’s School of Foreign Service.
Trade-related tensions between the United States and China have escalated dramatically in recent months. Despite a tentative agreement in May 2025 (extended in August 2025) to reduce the size of newly imposed tariffs on both sides, geopolitical frictions remain. Among other implications, these tensions threaten the cross-border trade of medicines. China has long been a major global supplier of generic drugs and active pharmaceutical ingredients. In recent years, it has also emerged as an important player in new drug development — a field traditionally dominated by the United States and European countries. This shift has implications for global access to promising new medicines and presents challenges for U.S. regulators and policymakers.
More than 75% of cancer drugs are approved by the US Food and Drug Administration (FDA) through expedited regulatory programs,(1) the use of which often leaves clinical uncertainties that may arise from issues related to trial design, conduct, analysis, or reporting—such as unvalidated end points, limited long-term data, or approval based on a single trial—about drug efficacy and safety.(2) Communicating these uncertainties is important, as clinicians may otherwise be unaware and overestimate a drug’s benefits and underestimate its risks.(3)
Although the FDA describes these uncertainties in detail in its benefit-risk assessments,(2) these documents are not widely read by clinicians. Instead, clinicians often rely on journal publications and guidelines. It is unclear whether clinical trial uncertainties about newly approved cancer drugs are reported in these sources.
Equitable access to essential medicines, which the World Health Organization (WHO) defines as those that meet the priority needs of the population,1 is key to achieving universal health care coverage.(2) However, it is estimated that essential medicines are unaffordable or unavailable to 1 in 4 people worldwide.(3) As governments strive to achieve universal access to essential medicines, it is important to understand how the prices and affordability of these medicines vary between countries. High drug prices strain both personal and government budgets, especially in low- and middle-income countries, where patients often face high out-of-pocket costs.
Although many national surveys of medicine prices and affordability have been conducted, fewer analyses have compared these variables internationally, with most research dating back to 2011 or earlier.(4-20) Many of these studies have focused on high-income countries. Of the studies that also included low- and middle-income nations, most compared the prices of 15 or fewer medicines or included a small number of countries, limiting the generalizability of those findings. Therefore, little is known about the relationship between national income and drug prices. The question remains whether some poor countries routinely pay more than rich countries for the same prescription drugs, possibly owing to weaker pharmaceutical pricing policies.
This cross-sectional study used global data on pharmaceutical sales to compare the list prices of 549 essential medicines in 72 high-, middle-, and low-income markets (covering 87 countries) in 2022, both in nominal and purchasing power–adjusted terms. We also evaluated the affordability of 8 essential medicines used to treat major causes of death and disability globally.
Uncertainties about the benefits and harms of new drugs are common at the time of drugs’ approval. It is unclear to what extent the Food and Drug Administration (FDA) communicates these uncertainties in the FDA-approved prescribing information (the drug label), which is the primary channel of communication between the FDA and physicians. Although physicians might not regularly consult the drug label for prescribing decisions, other information sources used by physicians either index or incorporate information from the label. We searched FDA review documents for uncertainties identified by FDA reviewers with new cancer drugs. We considered the subset of uncertainties highlighted in the FDA’s Benefit-Risk Framework as important to the FDA’s approval decision. During the period 2019–22, the FDA approved fifty-two new cancer drugs. In review documents, FDA reviewers identified a total of 213 clinical trial uncertainties with new cancer drugs, 50 percent of which were considered to be important uncertainties to the FDA’s approval decision. Labels for physicians reported information on 26 percent of all uncertainties and 48 percent of uncertainties that were important to the FDA’s approval decision. Communicating uncertainties about the evidence of drugs in the label is essential for informing physicians about drugs’ safe and effective use.
The Publication-of-the-Year Award recognizes the best and most relevant peer-reviewed, scientific work that the fields of health services research and health policy have produced and published in the prior calendar year.
Publication-of-the-Year Award
Differential Legal Protections for Biologics Vs Small-Molecule Drugs in the U.S.
Olivier J. Wouters, Ph.D.
In recent months, a new kind of partnership between telehealth companies and pharmaceutical manufacturers has come under scrutiny over concerns that such arrangements could lead to inappropriate prescriptions and poor care. Eli Lilly and Pfizer, along with five telehealth companies accessible through the pharma companies’ websites, have recently received letters from four senators echoing those concerns, asking questions about care, prescription volume, and the flow of data and money between the firms. The lawmakers want to determine whether pharma-telehealth deals may be violating the federal anti-kickback statute. That question has also piqued the interest of three health policy researchers at Brown University.
