One pill on mint green background.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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.

Below are the citations for papers identified from the month of May. The selections feature topics ranging from a discussion of how the US Patent and Trademark Office could more closely scrutinize applications for drug patents whose siblings have been discontinued in other jurisdictions, to an evaluation of FDA advisory committee referrals for new drugs approved from 2010-2021, to an analysis of the patents and regulatory exclusivities on inhalers approved from 1986-2020. A full posting of abstracts/summaries of these articles may be found on our website.

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Washington, DC, USA, May 5, 2022: people protest the leaked draft Supreme Court opinion overturning Roe v. Wade and the right to abortion

Stemming Supreme Court Rights Reversals

By James G. Hodge, Jr.

Based on the May 2022 leak of an initial draft, most believe the Supreme Court will carry through some rescission of abortion rights later this month through its final opinion in Dobbs v. Jackson Women’s Health Organization.

Already, concerns have arisen over other freedoms the Court may seriously reconsider down the road, including rights to gay marriage, intimacy, contraception, and informational privacy.

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Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

A Brief History of Abortion Jurisprudence in the United States

By James R. Jolin

POLITICO’s leak of Supreme Court Justice Samuel Alito’s draft majority opinion in Dobbs v. Jackson Women’s Health Organization suggests that U.S. abortion rights are on the verge of a fundamental shift.

If the official decision, expected this month, hews closely to the draft, the constitutional right to abortion affirmed in Roe v. Wade (1973), Planned Parenthood v. Casey (1992), and other seminal Supreme Court rulings will disappear.

This brief history of abortion rights and jurisprudence in the United States aims to clarify just what is at stake in this case.

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hand opening white plastic pvc window at home.

It’s Time for the Federal Government to Get Back to Protecting the Nation Against COVID-19

By Jennifer S. Bard

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic.

These decisions are devastating, and likely signal a continued attack on government authority, but they are not a reason to give up.

The federal government can still use its vast resources to slow the spread and continued mutation of the virus, by telling people what it knows of the danger, and what it knows about how to mitigate it.

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Serving trays with delicious food on table. Concept of school lunch.

New Data Reveal Sparse Protections for Students Who Cannot Pay for Meals at School

By Temple University Center for Public Health Law Research

As a federal program to serve meals to all U.S. public school students during the COVID-19 pandemic ends on June 30, the consequences of unpaid school meal debt will resurface for the millions of students nationwide facing food insecurity.

New data released on LawAtlas.org capture details of state unpaid school meal policies and reveals sparse and variable protections for students who cannot pay for meals at school.

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Washington, DC, USA, May 5, 2022: people protest the leaked draft Supreme Court opinion overturning Roe v. Wade and the right to abortion

The Leaked Dobbs Opinion, Explained

By Chloe Reichel

On May 2, 2022, Politico published a leaked draft of the majority opinion in Dobbs v. Jackson Women’s Health Organization, which showed the Supreme Court’s intent to overturn the right to abortion as decided in Roe v. Wade.

In response to the leak, the Petrie-Flom Center hosted a discussion with legal historian and Daniel P.S. Paul Visiting Professor of Constitutional Law Mary Ziegler and Petrie-Flom Center Faculty Director, James A. Attwood and Leslie Williams Professor of Law, and Deputy Dean I. Glenn Cohen.

Together, Cohen and Ziegler explained the background of the case, the contents of the draft opinion, and its potential implications not just for abortion access, but also for other constitutionally-protected rights, and for access to reproductive technologies, such as in-vitro fertilization.

The highlights of the conversation have been edited and condensed below.

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People wearing masks on bus.

Flaws in the Textualist Argument Against the CDC Mask Mandate

By Stefan Th. Gries, Michael Kranzlein, Nathan Schneider, Brian Slocum, and Kevin Tobia

In Health Freedom Defense Fund, Inc. v. Biden, the United States District Court for the Middle District of Florida ruled that the U.S. Centers for Disease Control and Prevention’s transit mask order, which was issued to stem the spread of SARS-CoV-2, exceeds the agency’s statutory authority, and struck down the mandate through a nation-wide injunction.

The district court’s reasoning exemplifies modern textualism. It focuses on the text of the 1944 Public Health Services Act (PHSA), which the Biden Administration claims authorizes the CDC’s transit mask order. The court relied heavily on the statute’s “ordinary meaning” and especially one word: “sanitation.”

Does the evidence support the court’s linguistic conclusions? Our team — of linguists, social scientists, philosophers of language, and lawyers — took a second look. We conclude that the district court’s approach fails on its own textualist terms. It gives the impression of selective reading of the linguistic record, rather than the careful investigation of meaning that textualism claims to champion.

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Brooklyn, New York, United States - JUNE 13 2021: Protest in Brooklyn, NY for trans youth rights.

Misleading, Coercive Language in Bills Barring Trans Youth Access to Gender Affirming Care

By Arisa R. Marshall

On Friday, a federal judge temporarily enjoined part of a new Alabama law that would make it a felony for physicians to provide gender-affirming care to trans youth. The law had been in effect for less than a week.

This is only the most recent development relating to a raft of anti-trans legislation sweeping the country. More than twenty bills that would impose life-changing healthcare restrictions on transgender children have been introduced in statehouses nationwide over the past two years, threatening the wellbeing of transgender youth and communities. Most of these bills aim to entirely ban gender-affirming medical care for minors, including surgeries, prescription puberty blockers, and hormone replacement therapies.

These laws are detrimental to the mental, physical, and social health of children. They are dismissive of the experiences of transgender children and teenagers, misleading, and manipulative.

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gavel.

Adoptee Rights and Adoption Annulment

By Gregory Luce

Annulling or legally ending an adoption is not a new concept, but it has rarely applied to the benefit of adopted people. Instead, informal practices, as well as specific legal frameworks dating back more than 100 years, have long-supported a “right of return” policy for adoptive parents who no longer feel an adoption is beneficial or even desired.

Activists within today’s adoptee rights movement, however, are working to establish a right to end a person’s own adoption by building on what has long existed in the law for adoptive parents, but refocusing it on the specific demands for autonomy of adopted people, particularly those who do not view adoption to be in their best interests.

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