Health Law and Policy Commons^™

The Fall Of Fda Review, Daniel G. Aaron

Utah Law Faculty Scholarship

The U.S. Food and Drug Administration (FDA) is in crisis. FDA can hardly go a single day without an investigation, negative news story, or scholarly critique of the agency’s work. We have increasingly entrusted FDA—today, to the tune of 25% of the U.S. economy—with vetting the products we put in and on our bodies. But the array of problems facing the agency raises questions about whether it is equipped to succeed in the 21st century.

FDA’s core function is to oversee a special legal regime called “premarket review.” Congress has prohibited all marketing of certain types of products (like drugs) …

Reevaluating Regional Law Reform Strategies After Dobbs, Jamie Abrams

Scholarly Articles in Law Reviews & Journals

This article studies the triad of 2016 social media campaigns known as “#AskDr.Kasich,” “#askbevinaboutmyvag,” and “#PeriodsforPence.” While these campaigns, each located in the regional mid-South, were motivated by restrictive state abortion bills, they uniquely positioned menstruation and women’s bodies at the center of their activism—not abortion alone. They leveraged, as a political fault line, the contradiction of these states’ governors’ perceived disgust relating to basic women’s reproductive health, relative to their patriarchal assuredness in regulating and controlling women’s bodies.

In so doing, they tapped into meaningful disruptions in the geographies, religiosities, and masculinities of abortion politics. These campaigns achieved regional …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

The Ripple Effects Of Dobbs On Health Care Beyond Wanted Abortion, Maya Manian

Scholarly Articles in Law Reviews & Journals

The Supreme Court’s momentous decision in Dobbs v. Jackson Women’s Health Organization to overturn fifty years of precedent on the constitutional right to abortion represents a sea of change, not only in constitutional law, but also in the public health landscape. Although state laws on abortion are still evolving after Dobbs, the decision almost immediately wreaked havoc on the delivery of medical care for both patients seeking abortion care and those not actively seeking to terminate a pregnancy.

This Article also argues that focusing the public’s attention on the deleterious consequences of abortion bans for health care beyond wanted abortion …

On The Appeal Of Drug Patent Challenges, Charles Duan

Scholarly Articles in Law Reviews & Journals

Administrative patent challenge proceedings, the most prominent form of which is inter partes review, have attracted much controversy. In particular, the pharmaceutical industry and its supporters have criticized the proceedings as unfairly biased toward canceling valuable drug patents. Yet there has been little study of the real-world, practical impact of these administrative proceedings on drug patents or pharmaceutical markets.

This Article reviews the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. The majority of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and, that administrative cancellation …

Ordered Liberty After Dobbs, Linda C. Mcclain, James E. Fleming

Faculty Scholarship

This Essay explores the implications of Dobbs v. Jackson Women’s Health Organization for the future of substantive due process (SDP) liberties protecting personal autonomy, bodily integrity, familial relationships (including marriage), sexuality, and reproduction. We situate Dobbs in the context of prior battles on the Supreme Court over the proper interpretive approach to deciding what basic liberties the Due Process Clause (DPC) protects. As a framing device, we refer to two competing approaches as “the party of [Justice] Harlan or Casey” versus “the party of Glucksberg.” In Dobbs, the dissent co-authored by Justices Breyer, Sotomayor, and Kagan represents the party of …

Approaches To Sea Level Rise And International Law: A Comparative View Of Emerging Policy Responses By The African And The Americas Regions, Charles Chernor Jalloh

Articles

No abstract provided.

Is There A Fundamental Right To Privacy When An Educational Institution Requires A Student To Disclose Proof Of His Or Her Vaccination Status?, Mary D. Fatscher

Touro Law Review

In 2020, the coronavirus disease (“COVID-19”) dominated the world. Although the public has progressively become more informed about the disease and how to safeguard itself, challenges persist as there is still much unknown. Aside from wearing masks, social distancing, and despite its undetermined consequences, the COVID-19 vaccination has emerged as a primary solution to substantially reducing the incidence and severity of the virus in our country. Many COVID-19 vaccine mandates were initiated once three pharmaceutical and biotechnology companies including Pfizer-BioNTech, Moderna, and Johnson & Johnson received Emergency Use Authorization from the Food and Drug Administration (“FDA”).

New York Mental Hygiene Law Article 81 Proceedings: A Proposal To Better Protect The Best Interests Of An Alleged Incapacitated Person, Casey Marsh

Touro Law Review

Guardianship proceedings under New York Mental Hygiene Law Article 81 are intended to protect the personal needs and property management of an alleged incapacitated person. A guardian appointed for a person is responsible for making decisions in line with the best interests and wishes of his or her ward. While guardians serve a very important purpose, the current procedures of guardianship proceedings allow too much room for family members to bring a proceeding without the alleged incapacitated person’s best interests in mind. Often, people bring guardianship proceedings to fish for information on family members or to circumvent a future Surrogate’s …

Advancing Racial Justice Through Civil And Criminal Academic Medical-Legal Partnerships, Yael Cannon, Vida Johnson

Georgetown Law Faculty Publications and Other Works

The medical-legal partnership (MLP) model, which brings attorneys and healthcare partners together to remove legal barriers to health, is a growing approach to addressing unmet civil legal needs. But MLPs are less prevalent in criminal defense settings, where they also have the potential to advance both health and legal justice. In fact, grave racial health inequities are deeply intertwined with both civil and criminal injustice. In both spheres, health justice is racial justice. Building on the experiences of the authors in their respective civil and criminal law school clinics at Georgetown University in Washington, D.C., this Article argues that academic …

Leveraging Academic-Medical Legal Partnerships To Advance Health Justice, Vicki W. Girard, Yael Cannon, Deborah F. Perry, Eileen S. Moore

Georgetown Law Faculty Publications and Other Works

Unmet legal needs contribute to housing, income, and food insecurity, along with other conditions that harm health and drive health inequity. Addressing health injustice requires new tools for the next generations of lawyers, doctors, and other healthcare professionals. An interprofessional group of co-authors argue that law and medical schools and other university partners should develop and cultivate Academic Medical-Legal Partnerships (A-MLPs), which are uniquely positioned to leverage service, education, and research resources, to advance health justice.

Training A Public Accommodations Lens On Vaccine Passports, Paul Diller

Lewis & Clark Law Review

The Covid pandemic and the rise of smartphone technology enabled the use of “vaccine passports”—that is, a requirement to show proof of vaccination against Covid—on a scale unmatched before in human history. In the United States, many public accommodations such as restaurants, coffee shops, stadiums, and movie theaters required patrons to show proof of vaccination in order to enter or consume food and drink on the premises. In approximately two dozen local jurisdictions as well as the District of Columbia and Puerto Rico, government mandated that public accommodations do this, with varied carveouts for religious objections and medical or age-based …

More Than The Minimum: Why States Should Enact Better Fmla Equivalents, Matt Heldt

Lewis & Clark Law Review

For many workers, taking time off from work for a serious health condition or to care for a family member’s serious health condition is complicated. Since 1993, the Family Medical Leave Act (FMLA) has provided job protection for workers who take leave. However, not all workers are covered. This Comment looks at where the FMLA comes up short, how some states are providing broader coverage and more robust benefits, and advocates for states to continue improving upon the FMLA baseline.

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel E. Sachs, W. Nicholson Price Ii

Faculty Scholarship

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (“IRA”) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

Increasing Compliance With International Pandemic Law: International Relations And New Global Health Agreements, Matthew M. Kavanagh, Clare Wenham, Elize Massard Da Fonseca, Laurence R. Helfer, Elvin Nyukuri, Allan Maleche, Sam F. Halabi, Adi Radhakrishnan, Attiya Waris

Faculty Scholarship

No abstract provided.

Sanitation: Reducing The Administrative State’S Control Over Public Health, Lauren R. Roth

Scholarly Works

On April 18, 2022, in Health Freedom Defense Fund, Inc. v. Biden, United States District Judge Kathryn Kimball Mizelle vacated the mask mandate issued by the Centers for Disease Control and Prevention. Following a framework laid out in other decisions restricting CDC actions in response to COVID-19, the court found that the agency lacked statutory authority to protect the public from the virus by requiring mask wearing during travel and at transit hubs because Congress did not intend such a broad grant of power. Countering decades of public health jurisprudence, the federal district court failed to defer to experts and …

The Future Of Ivf Post Dobbs, Rebecca Feinberg

Scholarly Works

No abstract provided.

Masking Vulnerability: Including Ppe As A Covered Service In Health Insurance, Mary Leto Pareja

Faculty Scholarship

The COVID-19 pandemic laid bare the shared vulnerability inherent in the human condition, prompting a collective recognition of our physical susceptibility to infectious diseases. While great strides have been made in combating COVID-19 through vaccinations and treatments, a portion of the population remains profoundly vulnerable due to health conditions that make the disease more dangerous, that limit vaccine efficacy, or that prevent vaccination altogether. This article explores a path forward by proposing a solution within health benefit plans—encompassing both private health insurance and public health benefits. Specifically, the article advocates for a coverage mandate for over-the-counter personal protective equipment (PPE) …

Ada Executive Director Dr. Ray Cohlmia: "We're Focused On The Future, Not The Past", Debra Peters Dds

The Journal of the Michigan Dental Association

In this interview, Dr. Raymond Cohlmia, the Executive Director of the American Dental Association (ADA), reflects on his first year in office and discusses the challenges of overcoming the decline of membership marketshare. He addresses the importance of strategic forecasting, nimbleness, and the role of the ADA team in shaping the future of dentistry. Dr. Cohlmia also highlights the significance of science and research in dentistry and the ADA's commitment to global presence. The interview offers insights into the ADA's evolving strategies and its dedication to serving its members and the dental community.

Ce Requirements For Michigan Dental Licensure, Andrea Sunderman

The Journal of the Michigan Dental Association

The distribution of mandated topics for the 60 hours of CE for dentists and 36 hours for RDHs and RDAs required for each three-year licensure period is presented in this graphic. The ADA, AGD, an accredited dental school, or the Michigan Board of Dentistry must approve courses. The Michigan Dental Association provides access to CE programs necessary for dentists and members of their teams to meet these requirements.