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.

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.

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.

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.

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.

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.

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.

Infantile food products have been at the forefront of litigation in the recent year for unsafe standards set forth by their developing companies. This recent case development explores how the Court decided on a suit brought forth against Gerber for toxic levels of heavy metals in their food. Their opinion shines a light on how upcoming larger cases against Abbott Industries for unsafe milk products might be handled. The author urges the Courts and the FDA to work together to resolve these cases in the interest of pediatric public health.

As the opioid epidemic continues in the United States and ongoing litigation seeks to hold contributors responsible, state governments have initiated lawsuits against retail pharmacies for their role in contributing to the crisis. This article summarizes an action the State of West Virginia brought against CVS, which the parties recently settled in the fall of 2022. This article examines the unique position of retail pharmacies like CVS, which often serve as both distributors and dispensers, in contributing to the oversaturation and illicit diversion of opioid prescriptions. The article concludes by assessing the viability of potential causes of action against retail pharmacies in opioid litigation.

This RCD discusses a recent decision by the United States Court of Appeals for the First Circuit that struck down Puerto Rico’s Act 90-2019, which aimed to regulate pay structures for Medicare Advantage insurers in Puerto Rico. The court found that the provision in Act 90, known as the “Mandated Price Provision,” is preempted by federal law. However, the author argues that the court’s decision did not adequately consider the congressional intent of the Medicare Advantage Act in weighing the public health crisis in Puerto Rico. The RCD provides background on the Medicare Advantage program and Act 90 and explains how Act 90 aimed to eliminate insurers’ practice of paying providers at rates below the CMS’s minimum reimbursement rates under the traditional Medicare program. The article concludes that the court’s decision inadequately considered the larger purpose of the Medicare Advantage Act and the relevant public health crisis in Puerto Rico.