Category: Health Law Policy

Denver, Colorado, USA 9-21-20 Amtrak Train crossing through the Colorado Rocky Mountains with peak Fall Colors in September.

Could Amtrak’s Quiet Car Be a Model for COVID-19 Travel Policies?

The Petrie-Flom Center Staff Leave a comment

By Terri Gerstein

Consider the quiet car. Some Amtrak trains have a designated car for people who want a hushed environment in which to work, read, or sleep. Passengers who want quiet choose the quiet car. People who don’t want quiet sit elsewhere. In short: people want different options for travel, and Amtrak threads the needle, accommodating varying needs.

Amid the ongoing COVID-19 pandemic, this same approach could be taken in relation to masking. While the science is clear that universal masking is the best way to reduce the virus’ spread, highly vocal opponents have made masks a thorny subject for political leaders. Mask mandates are gone, at least for now. As such, Amtrak, airlines, public transit, and other transportation companies should provide must-mask options for passengers who need or want them.

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U.S. Capitol Building at Night

Is Preemption the Cure for Healthcare Federalism’s Restrictions on Medication Abortion?

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This post is an adaptation of an article published in the Harvard Social Impact Review.

By Allison M. Whelan

On June 24, 2022, the U.S. Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization, overruling almost fifty years of precedent established by Roe v. Wade and reaffirmed by Planned Parenthood v. Casey. The tragic consequences of Dobbs are many, and all require urgent attention.

Post-Dobbs, states have complete control over the regulation of abortion, including medication abortion. Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. As a result, the question of whether states can restrict or ban pharmaceuticals approved by the U.S. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public

The consequences that result from state bans and restrictions on medication abortion reverberate across the U.S. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care.

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Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

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By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

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Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

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By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

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Woman with face mask getting vaccinated.

The Right Tool for the Job: Supporting Vaccination Rates with Universal Paid Sick Leave

Temple University Center for Public Health Law Research Leave a comment

By Alina Schnake-Mahl, Rebecca Finkel, and Jennifer Kolker

Policies like paid sick leave are key tools to prevent another “winter of death” and disruption, finds our recent study of U.S. cities’ sick leave and vaccination data. Further, universal paid sick leave policies are particularly effective at protecting the most vulnerable communities.

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UN United Nations general assembly building with world flags flying in front - First Avenue, New York City, NY, USA

The UN Must Take Steps To Be an Accountable Player in Public Health

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By Bailey Kennedy

If a government commits a tort, it can be sued — but the United Nations cannot be. That’s because it is generally understood that the UN has absolute immunity, meaning that no national court has jurisdiction over the UN. This immunity is justified on the basis that the UN cannot effectively fulfill its role in the world if it is constantly at risk of being hauled into court around the globe. Moreover, at the time the UN was founded, it was understood to be an organization that would promote peace, security, and health across the globe — and why would such an organization need to be sued? 

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see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

What Happened to the COVID-19 Vaccine Patent Waiver?

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By Sarah Gabriele

In June 2022, after almost two years of debate over a potential COVID-19 vaccine patent waiver, the World Trade Organization adopted the Ministerial Decision on the TRIPS Agreement (“WTO Decision”), which provided for a partial waiver of intellectual property rights.

More specifically, the WTO Decision waived patent rights on vaccines and allowed for the use of protected clinical trial data for regulatory approval of vaccines. However, after almost four months since the adoption of the WTO Decision, there is still a large gap in vaccination rates worldwide.

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Businessman's hands typing on laptop keyboard in morning light

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3

The Petrie-Flom Center Staff Leave a comment

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 and Part 2.

Part 3: What’s an IRB to do?

EA is considered treatment, not research. EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. But, once sponsors decide to capture/share EA-derived data above and beyond that needed to report SAEs, what should IRBs do when reviewing such plans: view this as research, and thus hold it to (higher) research standards, or continue to view this as treatment?  This distinction is important for patients’ rights and welfare.

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Pile of envelopes with overdue utility bills on the floor.

The Unfurling Crisis of Unfunded Isolation, Testing, and Treatment of Infectious Disease in the US

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By Steven W. Thrasher

For many politicians in the United States, the summer of 2022 was a time of trying not to think about the coronavirus pandemic—though, if they were concerned about the risk that they, their neighbors, and their constituents were facing, they should have been paying very close attention. By August, there were about 500 to 600 COVID deaths a day, accounting for more than a “9/11’s worth” every week, a level of death twice what it had been in the summer of 2021.

But for gay men in the United States, the summer of 2022 was a time of worrying about a whole new viral epidemic: monkeypox. The variant of the MPX orthopoxvirus circulating globally in 2022 has behaved very differently than it had in previous outbreak, acting as a sexually transmitted infection and moving almost exclusively through the bodies of gay men.

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SAINT LOUIS, MO. - August 2, 2021: A protestor holds a sign reading "Evictions Are Violence" at a protest held days after the federal eviction moratorium expired.

U.S. Eviction Policy is Harming Children: The Case for Sustainable Eviction Prevention to Promote Health Equity

The Petrie-Flom Center Staff Leave a comment

By Emily A. Benfer

Without a nationwide commitment to sustainable eviction prevention, the United States will fail the rising number of renter households at risk of eviction. Worse still, the country will set millions of children on the path of long-term scarring and health inequity.

A staggering 14.8% of all children and 28.9% of children in families living below the poverty line experience an eviction by the time they are 15. For children, eviction functions as a major life event that has damaging effects long after they are forced to leave their home. It negatively affects emotional and physical well-being; increases the likelihood of emotional trauma, lead poisoning, and food insecurity; leads to academic decline and delays; and could increase all-cause mortality risk.

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