Health Law and Policy Commons^™

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …

Disability, Race, And Health Beyond The Carceral State, Benjamin A. Barsky, Craig Konnoth, Michael Ashley Stein

Michigan Law Review

A review of Embodied Injustice: Race, Disability, and Health. By Mary Crossley.

Personal Data And Vaccination Hesitancy: Covid-19’S Lessons For Public Health Federalism, Charles D. Curran

Catholic University Law Review

During the COVID-19 vaccination campaign, the federal government adopted a more centralized approach to the collection of public health data. Although the states previously had controlled the storage of vaccination information, the federal government’s Operation Warp Speed plan required the reporting of recipients’ personal information on the grounds that it was needed to monitor the safety of novel vaccines and ensure correct administration of their multi-dose regimens.

Over the course of the pandemic response, this more centralized federal approach to data collection added a new dimension to pre-existing vaccination hesitancy. Requirements that recipients furnish individual information deterred vaccination among undocumented …

News You Need, David Foe Ma

The Journal of the Michigan Dental Association

The upcoming Annual Session in Lansing, from April 17-20, offers opportunities for dental professionals to access quality continuing education, explore the expansive exhibit hall, and engage in special events like the Sparkling Smiles Celebration. The MDA Board of Trustees discussed the proposed new ADA Tripartite Membership Model, aiming to enhance engagement and offer targeted benefits. Additionally, volunteers are still needed for the Mission of Mercy program, and the MDA emphasizes the importance of dentists as mandated reporters for child abuse or neglect.

Ada Report: Ada Board Discusses New Services, Ce Changes, And Dental School Issues, Michele Tulak-Gorecki Dds

The Journal of the Michigan Dental Association

Michele Gulak-Gorecki, DDS, 9th District Trustee for the ADA, highlights discussions from the winter ADA Board meeting. Key points include the emphasis on ADA values, expansion of member services such as financial offerings, updates on revenue and membership models, collaboration with new dentists, improvements in continuing education programs, and insights from dental school deans on reducing education costs.

Mda At Your Service: What Is The Beneficial Ownership Information Report?, Kristin Johnson Dds

The Journal of the Michigan Dental Association

MDA Staff, with input from Kristin Johnson, DDS, explains the Beneficial Ownership Information Report required by the Corporate Transparency Act. Dental practices with fewer than 20 full-time employees and <$5M in annual sales must file by Jan. 1, 2025. They also address MIOSHA regulations, dental assistant duties, and access to MDA resources like the Delegation of Duties Chart and educational videos on infant oral health.

Dentistry And The Law: Why Dentists Must Pay Attend To Antitrust Law, Dan Schulte Jd

The Journal of the Michigan Dental Association

In this month’s Dentistry and the Law column, Dan Schulte, JD, MDA Legal Counsel, emphasizes the importance of understanding antitrust laws for dentists. He explains that agreements between competitors that restrain trade are illegal and highlights the risks of price-fixing and group boycotts. Dentists should avoid any activities that may be construed as anticompetitive. Enforcement of antitrust laws can lead to criminal or civil actions, making awareness crucial.

Mda Foundation: Supporting Your Foundation Helps Those With The Greatest Need!, Anne Berquist

The Journal of the Michigan Dental Association

MDA Foundation aids the underserved through grants, scholarships, and events like Mission of Mercy (MOM). Mirlo Real Estate Partners, inspired by MOM's impact and aligned with the Foundation's mission, became its largest corporate donor. Mirlo's Nick Zagar and Remy Isdaner recognized dentists' needs and pledged substantial support. Their commitment mirrors the Foundation's ethos: helping those in need. Dental community support, volunteering, donations, and charitable distributions are vital for the Foundation's success in serving the community.

The Back Page Commentary: Care For Special Needs Patients: We Must Do Better, Craig C. Spangler Dds, Fscda

The Journal of the Michigan Dental Association

Despite strides in providing resources for neurodivergent and geriatric patients, access to suitable dental care remains a challenge. A survey revealed finding capable dentists as the primary barrier to care for special needs individuals. Transitioning from pediatric to adult care lacks continuity, highlighting gaps in predoctoral dental education. Challenges include inadequate training, limited opportunities for continuing education, and reimbursement issues. Collaboration between medical and dental leaders is crucial for addressing these pressing issues and ensuring equitable access to care.

The Mda’S Michigan Donated Dental Services (Dds) Program: How To Serve The Elderly And Disabled In Your Community And Build Your Team (Without Leaving Your Office!), April Stopczynski

The Journal of the Michigan Dental Association

April Stopczynski, MDA Manager of Access and Prevention, sheds light on the Michigan Donated Dental Services (DDS) program, elucidating its impact on individuals through poignant patient narratives and dentist testimonials. The article illustrates how DDS bridges the gap in dental care for the elderly, disabled, and financially compromised individuals in Michigan. The program not only restores smiles but also transforms lives by providing much-needed dental treatment through volunteer dentists and labs. This article presents the value of DDS for patients, providers, dental team members and the greater community. Information is provided on how to participate in this transformative program.

The Need For Fentanyl-Specific Drug Education In Schools, Emma Guggenheimer

Cardozo Journal of Equal Rights & Social Justice

The note advocates for the implementation of state legislation requiring fentanyl-specific drug education in K-12 schools to combat the escalating opioid epidemic, particularly among teenagers. It emphasizes the critical role of schools in providing comprehensive education to raise awareness about the dangers of fentanyl and prevent overdose deaths. The proposal includes mandates for fentanyl-awareness campaigns, updated curricula, and the use of tools like fentanyl test strips and naloxone in schools.

What You Should Know About Michigan’S Revised Kindergarten Oral Health Assessment Law, Michele Kawabe Mph, Rd, Cdces

The Journal of the Michigan Dental Association

Starting from the 2024-25 academic year, Michigan mandates a pre-school oral health assessment for all incoming kindergarten students. Michele Kawabe, MPH, RD, CDCES, explains the legislative change, its implementation through the Kindergarten Oral Health Assessment (KOHA) program, and its potential impact on dental offices. This feature provides insights into frequently asked questions, covering assessment protocols, forms, patient records, reimbursement, and data tracking by the Michigan Department of Health and Human Services (MDHHS).

Staff Matters: Implementing A Painless Performance Evaluation Process, Jodi Schafer Sphr, Shrm-Scp

The Journal of the Michigan Dental Association

Jodi Schafer, HRM Services expert, addresses the common struggle of conducting employee evaluations. She emphasizes the importance of frequent, timely feedback and suggests breaking the review process into smaller, more manageable sessions to combat the "Recency Effect." Schafer also advises updating job descriptions, incorporating self-reviews, and simplifying evaluation forms for a more effective process.

Teaching Global Health Law: Preparing The Next Generation For Future Challenges, Lawrence O. Gostin, Sarah L. Bosha, Benjamin Mason Meier

Georgetown Law Faculty Publications and Other Works

Following from sweeping law reforms across the global health landscape, there is a need to prepare the next generation to advance global health law to ensure justice for a healthier world. Educational programs across disciplines have increasingly incorporated the field of global health law, with new courses examining the law and policy frameworks that apply to the new set of public health threats, non-state actors, and regulatory instruments that structure global health. Such interdisciplinary training must be expanded throughout the world to prepare future practitioners to strengthen global health law — ensuring a foundation for global health in legal studies …

The Persistent Public Health Emergency, Yael Zakai Cannon

Georgetown Law Faculty Publications and Other Works

May 11, 2023 was ostensibly a day of celebration. With infections and deaths from COVID-19 down, the federal government announced the end of the official Public Health Emergency three years after its initial declaration. But the conclusion of the Public Health Emergency also signaled the termination of unprecedented health protection measures—outside the realm of healthcare—such as eviction and utility shutoff moratoria and emergency rental and utility assistance. These COVID-era measures successfully cut eviction filings nationally by more than half and provided people in many jurisdictions with the protections and assistance needed to maintain their electricity, heat, water, and gas. Now …

Public Health Consequences Of Appellate Standards For Hostile Work Environment Claims, Lauren Krumholz

Washington Journal of Social & Environmental Justice

No abstract provided.

Forced To Bear The Burden And Now The Children: The Dobbs Decision And Environmental Justice Communities, Mia Petrucci

Washington Journal of Social & Environmental Justice

No abstract provided.

Pursuing The Exemption: The Makah's White Whale, Sarah Van Voorhis

Washington Journal of Social & Environmental Justice

No abstract provided.

Brief For Amici Curiae Legal Scholars Supporting Respondent, Nicole Huberfeld, Timothy S. Jost, Linda C. Mcclain, Wendy E. Parmet, Erwin Chemerinsky, Elizabeth Mccuskey, Danielle Pelfrey Duryea, Gabriel Scheffler, George J. Annas

Faculty Scholarship

QUESTION PRESENTED: Whether the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd, preempts Idaho law in the narrow but important circumstance where terminating a pregnancy is required to stabilize an emergency medical condition that would otherwise threaten serious harm to the pregnant woman’s health but the State prohibits an emergency-room physician from providing that care.

Financing Reforms To Meet A Pivotal Moment In Global Health, Kevin A. Klock, Alexandra Finch, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

2024 will be the most important moment for global health since the World Health Organization’s founding in 1948, but only if states give major reforms their full political and financial backing. Bold new commitments in disease surveillance, capacity building, and more equitable access to health products cannot be achieved without ample and sustainable funding. In this essay, we discuss major reforms found in the emerging pandemic agreement and reformed International Health Regulations and then explore the significant challenges and opportunities for financing them.