The power afforded to the administrative state is heavily reliant on public trust and the perception of evidence-based agency decision-making. Organizational reputation is key to preserving regulatory power. However, recent investigations reveal that existing scientific integrity policies may not be sufficient to preserve the credibility of many federal agencies. In fact, a significant number of career scientists across various entities – including the FDA – have observed unreported incidents of political interference. While political influence exerted by the executive branch to set policy goals and determine agency priorities can be beneficial, political pressures must not undermine public trust in scientific agencies. Recently, public perception regarding the FDA’s COVID-19 response threatened to weaken the agency’s longstanding reputation as the gold standard of review. The COVID-19 pandemic publicized vulnerabilities that exist across agencies, as well as those that are unique to the FDA. The FDA’s evolution as an increasingly public health-focused agency that must function in the landscape of politicized science exposes the agency to a greater risk of political interference. After all, the FDA’s involvement in public health requires increased participation in non-ideal, value-based decision-making. Throughout its history, the FDA has managed to maintain its reputation through its firm responses to scandal. The COVID-19 pandemic provides a platform for the FDA to – once again – look introspectively and institute safeguards addressing vulnerabilities that plagued the agency’s pandemic response. This Article examines the FDA’s early COVID-19 response to propose reforms that promote meaningful transparency, public accountability, and scientific integrity.

Why are COVID-19 mitigation strategies successful in reducing infections in some cases but not in others? Existing studies of individual policies tend to neglect the many interaction effects that arise when multiple policies are enacted simultaneously. Particularly, if a socially undesirable behavior has a close (and equally problematic) substitute, then a prohibition of that behavior will simply cause people to switch to the substitute, resulting in no effect on infections. However, joint policies that prohibit both the targeted behavior and the substitute will create a positive interaction effect, which closes the loophole. Respectively, behaviors that are complements (rather than substitutes) can be discouraged by prohibiting one behavior because this discourages complementary behaviors as well.

We provide a new argument for why COVID-19 policies can fail and why the evaluation of such policies may be incorrect: policies are effective only when they reduce infections as a general equilibrium, accounting not only for the targeted behavior but also for interaction effects.

We illustrate our arguments by applying insights from traditional and behavioral law and economics to several examples. Thereby, we highlight regulators’ challenge when facing interaction effects and factors such as social norms and time preferences.

In this Article, I explore how nearly continuous public rhetorical challenges to abortion in the political realm first led the public and the courts to turn away from a particular abortion procedure (intact dilation and extraction, also known as partial-birth abortion) which political agitators labeled as “barbaric” and then to view physicians who performed abortions not as legitimate professionals, but simply as “abortionists,” and sometimes as evil “Frankensteins.” “Abortionists” use no “medical judgment” and are unworthy of deference by state legislatures, Congress, or the courts when deciding how or when to perform an abortion. The concentration on the welfare of fetuses and the actions of physicians permitted the abortion debate to bypass discussion of both the rights and welfare of pregnant patients, including their right to health, and to virtually never mention that abortion restrictions primarily affect people in poverty who cannot afford to seek reproductive health care, including an abortion, by traveling to a nonrestrictive state. Understanding the power of extreme rhetoric, including the use of social media in political campaigns and the use and misuse of concrete terms such as murder, infanticide, brutality, and dismemberment, and abstract concepts such as “human dignity,” can help us plot a post-Dobbs way forward. Perhaps the demise of Roe can lead to a birth of a new rhetoric on abortion, one that concentrates on the right to health of everyone, including the right to make reproductive decisions, and requires moving abortion back into the realm of contemporary medicine, complete with a meaningful doctor-patient relationship protected by privacy and financed in a way that is accessible to all pregnant patients.

Diet is the number one risk factor for deaths in the United States. Members of marginalized and impoverished communities particularly struggle to afford nutritious food. Poor diets result in health disparities along socio-economic, age, racial, ethnic, indigenous, rural, and urban lines. Despite the ever-growing social and financial burden of diet-related chronic diseases, the U.S. has failed to invest in health care-related dietary policy. This Article proposes produce prescriptions as a national dietary preventive medicine program through Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).

Recently, nonprofits, governments, and health care providers have designed innovative produce prescription programs to combat diet-related chronic diseases. In these programs, clinical providers can prescribe subsidized fruit and vegetables to patients. Produce prescriptions empower patients by making dietary change affordable and by motivating patients to improve their health. Numerous studies, pilot projects, and local programs demonstrate that produce prescriptions can improve health care outcomes for individuals from diverse communities. Most at-risk members of our society receive health coverage through Medicare, Medicaid, or CHIP. This Article analyzes how to scale up produce prescriptions within these programs using law and policy.

Recent advances in prenatal genetic testing have made testing for congenital disorders more accessible, with emerging technologies promising further expansion of available testing options. In particular, non-invasive prenatal testing (“NIPT”) has allowed women to identify more fetal disorders earlier in pregnancy than was possible only a decade ago. In addition to allowing women to prepare for the birth of a child with a disability, prenatal diagnoses give women the ability to terminate a pregnancy to avoid raising a child with a disability, a choice driven by myriad factors.

This Article tackles the critical problem of COVID-19 vaccine hesitancy and provides a normative framework for legal policies to address such hesitancy in the ongoing pandemic. The foundation of this Article rests in decision-making theories that allow policymakers to understand individual misperception of risk as compared to evidence-based assessment of risk. Vaccine-hesitant individuals assign a high risk to the COVID-19 vaccine and a low risk to the disease—a perception that is disconnected from the science. The backbone of this Article is the timeline of the COVID-19 pandemic and the underlying science of the disease and vaccines. The timeline provides a factual background to demonstrate how vaccine hesitancy to the COVID-19 vaccine emerged. The instant pandemic also demonstrates changes in how individuals see themselves in society, receive information, and are persuaded by economic forces. This Article combines the individual’s decision-making process with modern day variables to suggest interventions that can undo anti-vaccine damage. While the novelty of the normative framework provided herein is instructive for current COVID-19 vaccine hesitancy issues, this framework can be applied to other areas in which individual’s perceptions of risk are disconnected from evidence-based assessment of risk.

The American with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act have made little progress towards preventing disability-based discrimination within the organ transplant evaluation process. Intellectual and developmental disabilities (I/DD) pose a unique problem for transplant teams and transplant physicians because I/DDs can simultaneously be a legitimate contraindication for transplantation and a mechanism for invidious discrimination against intellectually disabled persons. A culprit for ongoing disability-based discrimination is a transplant center’s authority to develop its own eligibility criteria. While medical criteria for eligibility are generally well-settled, psychosocial criteria — an amorphous constellation of risk factors for post-transplant success — can serve as a facially neutral disguise for social worth determinations of individuals with I/DDs. Consequently, individuals with I/DDs are unjustifiably denied eligibility for organ transplantation and transplant-related services.

This Article begins by identifying the pitfalls of current federal antidiscrimination legislation. It then discusses the foreseen benefits and drawbacks of House Resolution (H.R.) 8981, a recently proposed federal bill, that expressly prohibits disability-based discrimination within the organ transplant evaluation process. The Article ends by offering potential solutions for professional organizations and transplant centers that aim to provide for equitable access to organ transplantation and transplant-related services for intellectually disabled individuals.

The state is increasingly criminalizing reproduction. While prosecutions of pregnant people for prenatal drug use began occurring several decades ago,1 this type of prosecution remained relatively rare for many years.2 But such prosecutions have increased dramatically—thousands have now occurred across the United States.3 In addition, the criminalization of reproduction is not limited to instances of prenatal drug use,4 but extends to a wide array of prosecutions in the reproductive space—including the criminalization of stillbirth,5 miscarriage,6 breastfeeding,7 home births,8 and c-section refusals.9 And, of course, recent changes in the Supreme Court have resulted in an almost certain change in the criminal regulation of abortion, as well.10 The criminalization of reproduction often occurs at an initial point of access to the health care system – at the hospital, the doctor’s office, the lactation consultant appointment, or the addiction treatment clinic. In this way, health care settings become gateways into the criminal justice system, and it is the attempt to access reproductive health care that results in criminal prosecution.11

Women with opioid use disorder (“OUD”) are more likely than other women to experience sexual assault, unintentional pregnancy, transactional sex and coercion regarding reproductive health care choices than women without OUD. Laws described as family friendly may be punitive rather than helpful to women and rarely apply to men. Laws regarding reproductive health and OUD are unevenly enforced and therefore biased against poor, minority women. As part of a larger study oriented toward strengthening systems of care related to the intersection of HIV and OUD, we conducted an analysis of state laws related to pregnant and postpartum women with OUD. Data on disparities in child removals and pregnant women’s use of evidence-based treatment for OUD by income and race were captured for the five states with the most restrictive laws in both categories. Laws that were purportedly designed to improve reproductive health outcomes for women with OUD and/or their children often have the opposite of the expressed intended outcome. There is a relationship between restrictive reproductive choice and coercive OUD treatment policy for women. Restrictive state regulations for pregnant women with OUD persist despite negative outcomes for maternal and child health. Altering coercive and/or criminalizing regulation and redefining ‘family friendly’ may improve outcomes for individuals and families.

Laws regulating patient care are an essential component of protecting patients and doctors alike. No studies have previously examined what laws exist regarding pelvic examinations in the United States (US). This study systematically reviews and compares regulation and legislation of pelvic examinations in the U.S. and provides a comprehensive resource to educate clinicians, patients, and lawmakers. Each of the fifty States in the U.S. was included. The primary outcome was existence of any pelvic or rectal exam laws. Data was obtained for the type of examination defined within the law, exceptions to the law, to whom the law applied to, the type of consent required, and to whom the consent applied to. Laws were identified from each of the individual state legislative websites. All sections of each law pertaining to pelvic examination were reviewed and organized by state. Descriptive statistics were performed for each of the variables, including frequencies of each amongst the fifty states. State regulation for pelvic examinations varied from no law or regulation to laws pertaining to pelvic, rectal, prostate, and breast examination performed in any context. As of November 22, 2022, there are twenty states (40%) with pelvic examination laws applying to anesthetized or unconscious patients. Thirteen additional states (26%) have proposed pelvic exam laws. Seventeen states (34%) do not have any laws regarding pelvic examinations. Regulation of pelvic examinations has become an increasingly important issue over the past few years in response to growing concerns of patient autonomy and the ethical issues raised by such sensitive examinations. While pelvic examination laws that balance protection for patient autonomy and the needs of caregivers and educators exist in much of the U.S., more work needs to continue in consultation with physicians and health care providers to ensure that all states have reasonable laws protecting the autonomy of patients while also maintaining quality of care.

For years, the federal government has failed to uphold its promises to provide health care to Native Americans. These promises are echoed in treaties, the Constitution, and judicially-created law. As a result of this breach of promise and chronically underfunding, there are significant health disparities between indigenous populations and other Americans. In a recent 2020 case, McGirt v. Oklahoma, the U.S. Supreme Court held that both the federal government and individual states must follow the terms of a treaty made with a tribe, encouraging the possibility of direct health care funding. This reform, however, means little without tribal sovereignty and self-determination, which give dignity and decisionmaking capabilities back to a group that has long been without them. This Note explores two examples of self-determination in Native American health care, the Alaskan Native health care system and the recent vaccine rollout, proposing a framework for increasing self-determination in health care to provide support for funding reform, which becomes increasingly necessary as Native Americans continue to struggle to access health care.

As the United States’ largest public health insurance program, Medicaid has since 1965 played a crucial role in the struggle for equitable health care access. It has the potential to be a powerful instrument of reproductive justice, yet discriminatory policies that deny coverage for vital sexual, reproductive, or other health services, or exclude entire populations of people with low incomes from coverage altogether, constrain peoples’ health and reproductive futures. Resulting discrimination in Medicaid law and policy thwart the program’s ability to promote intergenerational health equity and reproductive justice for underserved communities.

This Article provides an account of why reproductive justice is a necessary framework for examining, reimagining, and reforming Medicaid coverage law and policy. Part I gives a brief history and overview of reproductive justice, which serves as “an open source code that people have used to pursue fresh critical thinking regarding power and powerlessness.” Part II argues that we should utilize that open source code in Medicaid coverage reform. Using some of the reproductive justice movement’s critiques as a starting point, it explores how reproductive oppression has shaped Medicaid coverage law, policy, and mainstream reproductive and health care reform movements’ proposals, and to what effect. It argues that examining Medicaid law, policy, and proposed reforms through this lens and in collaboration with the reproductive justice movement can enable health advocates and policymakers to more fully understand, disrupt, and dismantle reproductive injustices that drive health inequities. Ultimately, it can empower reformers to build a more equitable public health insurance safety net that brings us closer to reproductive justice for all.

SmileDirectClub markets, manufactures, and delivers clear plastic dental aligners directly to the consumer: no dental office necessary. This well-known business strategy—cut costs by cutting out the middleman—has in several instances caught the attention of state dental regulators. While the dental boards consider some of SmileDirectClub’s practices to be violative of state dental practice law, the corporation has fought back in federal court, charging dental regulators with antitrust violations and with denying SmileDirectClub its constitutional rights.

The Supreme Court, as noted by SmileDirectClub, has insisted that a self-regulating state professional board is not itself the state, so a board’s actions might be subject to federal antitrust law. In the SmileDirectClub cases, however, state regulators have acted as required by state legislatures and as expressed in state dental practice acts. The boards’ activities here are therefore cloaked in the states’ immunity to antitrust litigation and should be treated deferentially by federal courts. Furthermore, judicial review of the substance of every regulation to which SmileDirectClub objects is inappropriate under principles of constitutional law. In the interest of public safety, courts should permit state dental regulators to fulfill their mandates and ensure that all dental providers comply with state health regulations.

In early June 2021, the U.S. Food and Drug Administration (“FDA”) granted Accelerated Approval to Aducanumab (“Aduhelm”) for treating Alzheimer’s disease. The decision was immediately engulfed in controversy because the agency ignored the Scientific Drugs Advisory Committee’s unanimous recommendation not to approve the drug. The FDA granted the approval based on Aduhelm’s ability to lower beta-amyloid levels. However, the agency had not previously indicated this as a surrogate clinical end for the trial, and its own scientific analysis failed to show that amyloid changes correlate with cognitive or functional changes for Alzheimer’s patients. This decision sets dangerous precedent and has the potential to transform the approval process for new drugs including, but not limited to, those meant to treat Alzheimer’s.

This Note details and proposes a solution to the deficit in access to justice and to care faced by the LGBTQ+ community due to historical and ongoing homophobia and transphobia in both the legal and medical fields. The proposed solution is the integration of medical-legal partnerships (“MLPs”) into LGBTQ+ resource organizations. These organizations already serve and have the trust of the queer community, which lowers one barrier to access medical and legal services for the LGBTQ+ community: mistrust and negative past experiences. MLPs are the ideal solution to this problem because they would not only allow LGBTQ+ individuals to access medical and legal services, but to receive holistic services that account for their personal circumstances as well as their physical health. Underlying this premise is the concept of social determinants of health, which are environmental and social factors that create systemic roadblocks to wellness. By creating an integrated MLP, professionals can address these social determinants head on and remedy the underlying causes of poor health. This is especially important for LGBTQ+ people whose minoritized identities often lead them to have multiple negative social determinants of health. The integration of MLPs into LGBTQ+ resource organizations would allow queer individuals to get the care they need—not just physically, but socially and environmentally.

In July 2020, a federal district court lifted the U.S. Food & Drug Administration’s (“FDA”) restriction requiring patients to pick up the first drug of a medication abortion—mifepristone—at a healthcare facility. Soon after, an ongoing experiment with remote care for abortion expanded, as telemedicine did in other areas, and virtual clinics began offering no-touch abortions. Growth of virtual care stalled in January 2021 when the Supreme Court stayed a district court’s order pending the appeals process. But in April 2022, persuaded by the evidence of remote abortion’s safety and efficacy, the FDA suspended enforcement of the in-person rule for the course of the pandemic. On December 16, 2021, the FDA lifted the requirement that patients pick up mifepristone at a healthcare facility, clearing the way for supervised mail delivery and pharmacy dispensation.

The expansion of virtual clinics, however, is not without significant limitations. First, questions remain about how to implement the new FDA regulation, specifically regarding certified pharmacies, and several FDA restrictions on mifepristone remain in place. Second, about half the country prohibits telehealth for abortion by either banning all abortion or by requiring the physical presence of a healthcare professional. Third, participation in telemedicine depends on various forms of privilege. Patients must have a stable internet connection or smartphone as well as an uncomplicated pregnancy, which, in part because of U.S. health disparities, is more likely for wealthier and white people. Even with the expansion of remote care, the need for clinical spaces will not disappear; in fact, it will come under increasing pressure.

This Article maps the emergence of virtual abortion care and analyzes the potential trajectory of medication abortion access, given that the Supreme Court has overturned constitutional protections for abortion. It considers the limits of telehealth for abortion—who telehealth can reach and who it cannot. Those living in states that permit abortion will have new options for ending early pregnancies. Those residing in states hostile to abortion will have to seek cross-border care, carry pregnancies to term, or find other avenues to end pregnancies. But the portability of abortion pills, when mailed by prescribers or dispensed by certified pharmacies, will test how closely states officials (or anyone else) can police or impede access to medication abortion.

Traditional methods to prevent and respond to domestic violence include criminal laws, national hotlines, and community programming to promote healthy relationships. Despite these methods, domestic violence continues to be a prevalent public health issue. In recent years, some states began to focus prevention and intervention efforts on the beauty industry. States including Arkansas, Illinois, Tennessee and Washington enacted laws that mandate domestic violence training for salon workers and other beauty professionals. The laws largely require salon workers to attend an informational training on domestic violence before obtaining or renewing their license. However, they do not require any affirmative action on the part of the salon worker if the client discloses that he or she is experiencing domestic violence. This paper investigates how the legislation uses the historically close relationship between hairdressers and their clients in order to achieve a unique way of reaching domestic violence victims, as well as the drawbacks to the legislative structure and atypical public health approach.

The ability of pluripotent stem to develop into any of the cell types in the human body has meant that it was only a matter of time before scientists would try to transform them into human gametes. Up to now though it has not been possible to do so. Nevertheless a 2016 book written by Henry Greely speculated that in twenty to forty years most people in developed countries will cease reproduction through sex, using sex exclusively for pleasure, and instead will rely on reproduction through pluripotent stem cell-derived gametes. This paper will offer a different perspective. After describing the process through which human pluripotent stem cells might eventually be coaxed into gametes, it will show why the use of pluripotent stem cell-derived gametes for reproductive purposes would present significant safety, ethical, and regulatory challenges.

Synthetic biology is an emerging, interdisciplinary research field with much promise for biomedicine. Broadly defined as “the design and construction of new biological systems to perform specific tasks,” researchers and clinicians are using synthetic biology to develop targeted treatments for cancer, coronaviruses, and so forth. Because of the experimental nature of synthetic biology, regulation is necessary. Current federal frameworks, such as the Food, Drug, and Cosmetics Act, The Toxic Substances Act of 1976, Institutional Review Boards, and self-regulation are not enough. As a result, states have a unique opportunity to develop statutory and regulatory frameworks to develop a pathway for regulating synthetic biology. In developing legislation, state lawmakers should look to build a comprehensive framework that addresses businesses selling technology for synthesizing DNA codes, monitors orders for synthetic DNA, and develops statewide documentation systems. Additionally, public health information on treatments using synthetic biology can help to educate the public and reduce the prevalence of misconceptions about the technology. In the absence of federal regulation, states should step into the synthetic biology regulatory space to ensure that their citizens are not harmed by therapies developed using synthetic biology.