Brand-name pharmaceutical firms increasingly use method of use patents and associated Orange Book “use codes” to delay generic entry, complicating the skinny labeling pathway that permits low-cost generics to omit patented indications from their labels and market their products for unpatented uses. Recent litigation, however, shows how overlapping use codes — targeting patient subgroups or biomarker thresholds rather than distinct conditions — can obstruct the skinny labeling pathway. Case studies of icosapent ethyl (Vascepa) and sacubitril-valsartan (Entresto) illustrate how overlapping use codes delay generic entry, inflate costs, and limit patient access. Reforms are needed to improve FDA and USPTO oversight of use code assignments and clarify legal standards for induced infringement, which would preserve the balance between rewarding innovation and ensuring timely access to affordable medicines.

The opioid overdose crisis has become a global public health emergency, claiming more than 100,000 lives each year. In North America, shifting opioid prescribing practices in response to the crisis have profoundly affected people living with chronic pain, who now face reduced access to prescription opioids. Against this backdrop, pain stakeholders have become increasingly active in policymaking arenas to shape how opioids and pain are understood. This study examines the Canadian Pain Task Force (CPTF) — a federal advisory body charged with creating a national pain strategy — by analyzing its reports, public and patient consultations, and internal documents. Through qualitative framing analysis, we find that stakeholders overwhelmingly depicted the overdose crisis as the result of illicit and irresponsible opioid use, while positioning stigma as both a driver and consequence of the crisis that compounded the challenges faced by people with chronic pain. From these problem definitions flowed policy proposals centered on expanding opioid access, reducing stigma, and advancing patient-centered care. These findings demonstrate how pain stakeholders shape, and are simultaneously shaped by, opioid policy debates — with consequences for both overdose prevention and chronic pain management.

Employers purchase health benefits for more than 60% of the nonelderly population, making employers both important custodians of employee well-being and important actors in the health care ecosystem. Because employers typically have unilateral control over health and retirement benefits, the federal Employee Retirement Income Security Act (ERISA), enacted in 1974, imposes fiduciary obligations on employers when they manage or administer benefits. We provide evidence, from a novel survey of respondents who administer or oversee health benefits for their companies, that many employers appear to neglect even the most basic of their fiduciary obligations to their employees. This neglect may help explain the poor performance of employer plans in controlling costs and providing access to health care, and it suggests that many employers may be vulnerable to liability from ERISA lawsuits.

People with HIV (PWH) often encounter health-harming legal needs that impede their access to care, including structural issues such as racism, discrimination, unstable housing, and stigma. Medical-Legal Partnerships (MLPs) have emerged as a promising strategy to address these challenges within HIV care settings. This study aimed to identify the characteristics and strategies of MLPs that are most effective in improving HIV care continuum outcomes. A mixed-methods analysis was conducted utilizing data from a cross-sectional survey of 60 providers in MLPs. Categorical features of MLPs, such as the personnel responsible for screening for health-harming legal needs (HHLN), the organizational structure (community-based vs. institutional), and the delivery of legal services, were examined. A multiple, variable linear regression analysis was conducted to explore the association between these variables and outcomes. Community health organizations were found to be associated with a greater number of patients achieving suppressed HIV viral load. Additionally, a higher number of on-site services were positively correlated with a greater percentage of PWH achieving decreased viral load and completing follow-up appointments. Findings underscore the significance of comprehensive care approaches within MLPs for enhancing positive patient outcomes in HIV care settings.

Current legislation guiding withdrawal of life-sustaining treatment and organ donation after circulatory death (DCD) leaves regulatory gaps that are not optimal for honoring the wishes of patient-donors. We describe these gaps, their consequences, and the need for revision to prevent harm to all parties.

After dispensing major precedents affecting the public’s health in each of its prior three terms, the 2024-2025 term of the US Supreme Court was arguably less impactful amid several unanimous decisions preserving existing jurisprudence (at least in part). However, this is an understatement. While the Court issued key decisions arguably favorable to communal health this prior year it also denied minors access to medical procedures sought by their doctors, diminished diversity, equity, and inclusion (DEI) initiatives in employment, allowed states to deny health providers access to Medicaid because they also provided abortions, disallowed rural hospitals from collecting specific costs for treating low-income patients, and provided a “script” of sorts for executive control of federal health advisory committees.