This Article is the first to offer a comprehensive case against using racial quotas in pharmaceutical studies by providing a detailed examination of the arguments for and against the practice. It begins by discussing the current racial classification system, calls for racial quotas in pharmaceutical trials, and the troubling history of combining race and scientific investigation. It next examines the cautionary tale of BiDil, the first drug authorized by the U.S. Food and Drug Administration (FDA) for use in only Black people. The third part of the Article sets forth the arguments against racial quotas. The fourth part provides legal analysis of these arguments, concluding that racial quotas in pharmaceutical trials likely would not satisfy the strict scrutiny standard for two independent reasons. The fifth part evaluates the alleged benefits of racial quotas and demonstrates that when properly understood they are insignificant in comparison to the disadvantages. The final part weighs the evidence to arrive at a conclusion and considers future implications.

Ultimately, this Article provides a valuable framework for assessing the legal and pragmatic implications not just for pharmaceutical trial quotas but also for other racial-classification issues in health care. For example, while it presents a cumulative case against the proposed practice of racial quotas in pharmaceutical trials, many of the same arguments presented are also applicable to the currently mandated practice of acquiring and reporting racial data of pharmaceutical trial participants. It will serve as a valuable resource not only for opponents of racial quotas but also for advocates. For example, this Article provides numerous race-neutral alternatives for consideration. And the strong case against racial quotas helps facilitate a refocus of efforts away from merely ameliorating the end results of health care disparities and instead targeting the root causes. Evidence suggests that this redirected focus on root causes is more effective at producing positive change. In this way, rejecting these quotas is not in conflict with addressing health disparities; rather, it is beneficial to it. This Article will hopefully serve as a catalyst for future research regarding best practices on how pragmatic; legal; and diversity, equity, and inclusion considerations can synergistically exist.

During the emergence of SARS-CoV-2 and the COVID-19 pandemic, public health officials exercised their police powers to combat the spread of the virus. The pandemic-related legal interventions adopted throughout the United States included lockdown orders and mask mandates. However, these policies and interventions meant to promote the general welfare of the public, in defense of common good, were met with legal challenges, especially in opposition to interventions’ impact on the exercise of religion. This article provides a legal analysis of the policies meant to curb the COVID-19 pandemic with a focus on legislative and judiciary actions and their implications for religious freedom. Ultimately, we hope this article will help inform future legal analyses on conflicts between public health and religious freedom in the context of pandemic legal preparedness efforts.

Expanding on previous industry guidance relative to increased clinical trial diversity, while honing more exacting treatments and better ways to fight diseases that have often disproportionately impacted people of color, is a topic being discussed by multidisciplinary public health experts across the nation.

This writing draws attention to the African American demographic, which is continually subject to health care disparities. Any glimpses of knowledge or medical discovery that could potentially help to redress harm or reinforce a weakened familial-cultural infrastructure should be emphasized for sanative restoration of the impacted communities. The focus of this writing is the African American cohort and its nexus to Benign Ethnic Neutropenia as the diverse target population of discussion, hoping to convey a harmonized approach in the examination of (1) the African American Benign Ethnic Neutropenia cohort within the context of basic scientific understanding, (2) the interplay of applicable governing regulatory protections, and (3) increased clinical trial participation to enlarge the pathway for increased diversity in clinical trials.

This Note examines the effects of Title IX’s equal treatment framework on female collegiate athletes in the context of the female athlete triad. It describes the shortcomings of Title IX’s equal treatment approach and its deleterious effects on the health of female student athletes. It argues for the adoption of the special treatment approach as a remedy.

Eating disorders are one of the most common chronic illnesses among adolescents. Yet, our current framework for mental health care provides limited education, access to care, and support for adolescents suffering from this disease. The enactment of key legislation and federal guidance such as the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) is evidence that there are steps being taken to ensure the removal of barriers to care. However, eating disorders are often overlooked as a category of behavioral disorders. This paper analyzes the current legal and social framework for providing care and support to adolescents suffering from eating disorders. In doing so, it offers recommendations to develop stronger protective and responsive measures to ensure access, support, and care to these individuals.

This RCD discusses the recent development in Lange v Houston County. In this case, the United States District Court for The Middle District Of Georgia Macon Division found that an Exclusion Policy, prohibiting health insurance coverage of gender-affirming surgery for an employee, Anna Lange, violated Title VII of the Civil Rights Act. On appeal, the Defendants argued that the District Court erred in its decision and relied on the cost burden of gender-affirming surgery as one of their defenses. This RCD highlights that cost is a common defense tactic used by defendants in these cases. However, the author argues that these concerns are unfounded and meritless given the cost-effectiveness of including gender-affirming surgeries in health insurance plans, as highlighted in the RCD.

This article discusses how in March of 2023 a District Court in Texas enjoined the U.S. government from enforcing certain preventive care requirements under the ACA for private health insurers. The current order by the Court enjoined enforcement of the ACA preventive care requirements based on those recommendations made on or after the date of March 23, 2010, by the U.S. Preventive Services Task Force. This article discusses the Court’s analysis and the remedy the Court decided on after finding violations under the RFRA and Appointments Clause. The article also discusses the implications and effects of this decision on whether previously covered services that the ACA didn’t allow cost sharing for will now have cost sharing by private health insurers and how that will affect consumers. The article concludes that despite lack of enforcement, private health insurers should not require cost sharing for previously covered services that the ACA didn’t allow cost sharing for before this most recent decision. Cost sharing for previously covered services would increase costs for those enrolled in private health insurance plans and could lead to a reduction in access to preventive services and healthcare.

For over a decade and for the foreseeable future, federal agencies have made efforts to promote value-based care through various incentive schemes, such as the recent “Regulatory Sprint to Coordinated Care.” Federal incentive schemes and other “macro tailwinds” have brought in private equity investors, especially in the context of primary care for Medicare beneficiaries. Oak Street Health and its private equity backers were pioneers in this space, applying buy-and-build strategies to create “next-generation” primary care networks “that focus largely or entirely on Medicare Advantage enrollees.” Although Oak Street Health persuasively established a workable “playbook” for private equity investment in value-based care, and forecasts have been favorable, the ultimate market viability of this value-based playbook hinges on whether or not private equity investors can locate corporate buyers. The market viability of such a strategy has now been reconfirmed by the acquisition of Oak Street Health by CVS Health (“CVS”), announced February 8, 2023, and closed May 2, 2023, especially given that the incentives and the efficiencies associated with this deal are likely to be applicable to large-scale vertically integrated “payvider” corporations more generally. This Recent Transaction Comment examines CVS’s acquisition of Oak Street Health to consider what factors might lead vertically integrated health care corporations to acquire value-based primary care networks in the future, and what knock on effects such acquisitions might have on future private equity buyouts in health care.

This RCD analyzes the Alabama Supreme Court’s recent answer to two certified questions sent to the court from the Eleventh Circuit. The questions involved whether a pharmaceutical company’s duty to warn included a duty to provide instructions about how to properly mitigate for warned of risks, and if the pharmaceutical company had such a duty could a plaintiff recover if their physician would have prescribed the same drug but just changed their monitoring scheme. The Alabama Supreme Court answered both questions in the affirmative, expanding the causation standard in failure to warn claims.