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?

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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red and green silhouette illustration of women having a conversation.

The Not-So-Sacred Human Genome: What South Africans Think About Heritable Human Genome Editing

By Donrich Thaldar

South Africans have issued a clarion call for research to move ahead on health-related applications of heritable human genome editing (HHGE), finds my research group’s new public engagement study — the first of its kind in Africa.

The study engaged a diverse group of 30 South Africans in three evenings of deliberations on the governance of HHGE. The methodology entailed (a) facilitated deliberation between the participants with the aim of finding consensus, although consensus was not forced; and (b) ensuring well-informed deliberations by providing participants with balanced, internationally peer-reviewed information about HHGE and the ethical arguments relating to it. The results of these deliberations are summarized briefly below.

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U.S. Capitol Building at Night

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

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

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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Genetic engineering and digital technology concept.

The ‘Res Nullius’ Construction of Human Genomic Data

By Donrich Thaldar

No one domain of the law holds exclusive sway over human genomic data. Instead, genomic data have a multidimensional legal nature, meaning that multiple legal domains — including property law, privacy law, contract law, and intellectual property law — are all applicable. This opens the door for different persons to have rights originating in different legal domains with respect to the same genomic data.

To determine who has rights with respect to a particular person’s genomic data, the rules of each relevant legal domain must be applied. The application of these rules to genomic data may be relatively straightforward in some domains, but in property law — which is relevant in determining ownership of genomic data — it is often more complicated. Only a handful of jurisdictions have specifically legislated on the ownership of genomic data. In the absence of such specific legislation that provides who owns genomic data, general property law rules must be applied. (In common law legal systems, and some mixed legal systems where legislation is absent, this would entail resorting to the jurisdiction’s common law.) However, given the novelty of applying property law rules to genomic data, it is not always obvious which of the general rules would apply. In this post, I will share some of my research group’s thinking in this regard. Although our thinking is based in South African law, many of the principles are shared with other legal systems.

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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’

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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Bill of Health - American currency (50, 100, 20) on a wooden table next to pills and spilling bottle of pharmaceuticals

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariAviva WangLiam Bendicksen, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of October. The selections feature topics ranging from newly enacted incentives for increasing diversity in clinical trials, to an analysis of how patients’ out of pocket costs changed after biosimilar versions of infliximab entered the US market, to an evaluation of how manufacturers have navigated postmarket requirements for drugs recently approved by the FDA. A full posting of abstracts/summaries of these articles may be found on our website.

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Woman with face mask getting vaccinated.

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

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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Black and white photo of a woman with phone in hand; phone has color retouched image of her face on it.

The Filter Effect: What Does Comparing Our Bodies on Social Media Do to Our Health?

By Sarah Gabriele

Filters on social media apps such as Instagram and TikTok are great to take silly pictures alone and with friends, and they often give us a good laugh. However, as Dr. Christine Stabler from Penn Medicine writes, they also create an illusion, a perfection that we struggle to live up to every day. This is the case even if almost everyone is well aware that pictures are filtered and carefully selected, and that pictures do not always represent reality.

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