“Hubris Squared”: What SCOTUS Decision Gutting Deference to Public Agencies Means for Health Care Protections

The Petrie-Flom Center Staff Leave a comment

This post originally appeared on Health Care in Motion, published by the Center for Health Law and Policy Innovation.

The last days of the Supreme Court of the United States’ (SCOTUS) term brought some blockbuster decisions with far reaching implications for federal agencies charged with regulating health care. In an expected but still monumental move, SCOTUS issued a decision in Loper Bright vs. Raimondo overruling decades of precedent under which courts gave deference to agency interpretation of federal statutes the agency was charged with enforcing.

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Moderna’s U.K. Vaccine Patent Pledge Cut Short by Boilerplate

Jorge Contreras Leave a comment

By Jorge L. Contreras

On July 2, 2024, the High Court of the United Kingdom issued a decision in Moderna’s mRNA vaccine patent litigation against Pfizer and BioNTech. As I previously discussed in October of 2020, Moderna pledged not to enforce its patents against makers of COVID-19 vaccines during the pandemic. Then, in 2022, Moderna sued competing vaccine makers Pfizer and BioNTech.  Pfizer/BioNTech responded that Moderna’s pledge authorized them to practice the asserted patents, at least until the end of the World Health Organization (WHO)-declared pandemic, which occurred in May 2023. Last week, however, the U.K. court found that the “forward-looking statement” boilerplate routinely appended to press releases of U.S. public companies permitted Moderna to revoke its pledge before the end of the pandemic, and that Moderna successfully did so in March 2022.

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Unseen Scars: The Devastating Impact of Corruption on Mental Health Systems in Low and Middle-Income Countries

The Petrie-Flom Center Staff Leave a comment

by Daniela Cepeda Cuadrado

There is a wealth of research demonstrating that corruption — the abuse of entrusted power for private gain — has contributed to weakening health systems and worsening public health globally. Corruption is associated with a higher infant mortality rate, the rise of antimicrobial resistance, and the diversion of key resources to invest in strengthening health systems. Corruption’s impact on health systems is well documented – that is if we see health systems only as the structures in place to cater to people’s physical health needs.

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Going to New Orleans? You may need to leave your ulcer medication behind

Leslie Francis Leave a comment

by Leslie P. Francis

That’s correct: unless your prescription for misoprostol meets strict new conditions, possession of the drug is now illegal in Louisiana.  In late May 2024, Louisiana governor Jeff Landry signed a bill making misoprostol and mifepristone schedule IV drugs, the most highly regulated controlled substances.  Violating the law may result in jail sentences or fines.

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Artificial Intelligence Plus Data Democratization Requires New Health Care Framework

The Petrie-Flom Center Staff Leave a comment

By Michael L. Millenson

The latest draft government strategic plan for health information technology pledges to support health information sharing among individuals, health care providers and others “so that they can make informed decisions and create better health outcomes.”

Those good intentions notwithstanding, the current health data landscape is dramatically different from when the organizational author of the plan, the Office of the National Coordinator for Health IT, formed two decades ago. As Price and Cohen have pointed out, entities subject to federal Health Insurance Portability and Accountability Act (HIPAA) requirements represent just the tip of the informational iceberg. Looming larger are health information generated by non-HIPAA-covered entities, user-generated health information, and non-health information being used to generate inferences about treatment and health improvement.

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The Impetus for a Neutered Chevron

Barbara Pfeffer Billauer Leave a comment

by Barbara Pfeffer Billauer

Legal pundits are predicting the imminent demise (or at least substantial enfeeblement) of the Chevron doctrine. Until recently, that case afforded substantial judicial deference to decisions made by administrative agencies if a statutory provision under its purview was ambiguous. Now two cases are before the Supreme Court challenging an agency interpretation regarding funding of statutorily required monitors on fishing boats. This development signals a “sea-change” is in sight for agency autonomy, as deference to agency decisions is being threatened.

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Q&A: George Church on Genomics of Cognitive Enhancement

The Petrie-Flom Center Staff Leave a comment

Interviewed by William Leonard Pickard

George Church, PhD, is the Robert Winthrop Professor of Genetics at Harvard Medical School, Professor of Health Sciences and Technology at Harvard University and the Massachusetts Institute of Technology. He is a founding member of the Wyss Institute for Biologically Inspired Engineering at Harvard.

His research efforts include the first direct genome sequencing method, collaborating in initiating the Human Genome Project, and creating the Personal Genome Project. He co-founded over 50 biotechnology companies as spin-offs from the Church Lab, including Veritas Genetics, Rejuvenate Bio, and Nebula Genomics. Church began Colossal Biosciences to de-extinct the woolly mammoth.

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New Portable MRI Revolutionizing Brain Research Demands Ethical and Legal Innovation

The Petrie-Flom Center Staff Leave a comment

by Francis X. Shen, Susan M. Wolf, and Frances Lawrenz

The advent of highly portable MRI will transform brain research, but urgently requires ethical and legal guidance.

Rather than participants traveling to the MRI scanner, now the scanner can travel to them. This advance could enable research with remote and marginalized communities that have not previously been able to participate, and in doing so address the lack of representativeness and diversity in human neuroscience research.

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What You Need to Know About Marijuana Rescheduling

The Petrie-Flom Center Staff Leave a comment

by Victoria Litman, M.Div., J.D., LL.M.

On May 21, 2024, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) signed by Attorney General Merrick Garland in the Federal Register. This publication kicks off a 62-day comment period on a rule that would move marijuana to Schedule 3 of the Controlled Substances Act (CSA), classifying it as a substance with “a moderate to low potential for physical and psychological dependence.” The process of rescheduling may be long and is unlikely to create a pathway to federal compliance for state-legal marijuana businesses without further federal legislation. Ultimately, Congress likely will need to clarify the division of federal and state regulatory powers over cannabis.

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From Regulation to Innovation: The Impact of the EU AI Act on XR and AI in Healthcare

Marcelo Corrales Leave a comment

By Marcelo Corrales Compagnucci

Extended Reality (XR) technologies like Virtual Reality (VR), Augmented Reality (AR), and Mixed Reality (MR), are revolutionizing healthcare. These tools, powered by artificial intelligence (AI), are enhancing how medical professionals work across various specialties such as cardiology, pharmacy, and neuroscience, improving precision and efficiency in ways previously unimaginable. Tools like IBM Watson and DeepMind are already in use, with current applications in diagnosis, predictive analytics, and personalized treatment. Near-future advancements include AI in surgical robotics and real-time patient monitoring through wearables.

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