Tag: Mifepristone

Rows of gold post office boxes with one open mail box.

Plan to See ‘Plan C’ This Year

Joelle Boxer Leave a comment

By Joelle Boxer

Tracy Droz Tragos’ new documentary, “Plan C,” follows the work of a grassroots organization dedicated to improving access to the abortion pill by mail in the U.S., while navigating an increasingly restrictive legal landscape.

There is no better time to hear the perspectives of these patients, providers, and activists. Just last month, the U.S. Supreme Court took on a case to determine the legal status of the pill, also called mifepristone. With a decision expected in June 2024, Tragos’ film shows us what’s at stake.

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Supreme Court of the United States.

The Federal Judiciary Is Broken — But Not for the Reason You Think

Jennifer S. Bard Leave a comment

By Jennifer Bard

Recent events, including the discovery that Justice Thomas has been accepting luxury vacations from and selling real estate to a billionaire, and the Fifth Circuit’s finding in Alliance for Hippocratic Medicine v. FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. But they’re not. Both involve a threat to our constitutional government and both highlight the need to shield all federal decision makers from entities with billions at stake and a fiduciary interest in increasing the value of their company for the benefit of shareholders. And while issues of influence affecting Supreme Court Justices attract the most attention, the factors that make Justices targets extend across the entire federal judiciary.

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U.S. Capitol Building at Night

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

The Petrie-Flom Center Staff Leave a comment

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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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

Chloe Reichel Leave a comment

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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Large pile of amber prescription pill bottles

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Alexander Egilman, Beatrice Brown, 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 January. The selections feature topics ranging from a discussion of why state laws restricting mifepristone access may be subject to federal preemption, to an analysis of patents impacting the availability of biosimilars, to an evaluation of the hypothetical out-of-pocket costs of guideline-recommended medications for the treatment of older adults with multiple chronic diseases. A full posting of abstracts/summaries of these articles may be found on our website.

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Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

How Social Movements Have Facilitated Access to Abortion During the Pandemic

The Petrie-Flom Center Staff Leave a comment

By Rachel Rebouché

Before the end of 2021, the U.S. Food and Drug Administration (FDA) will reconsider its restrictions on medication abortion. The FDA’s decision could make a critical difference to the availability of medication abortion, especially if the Supreme Court abandons or continues to erode constitutional abortion rights.

Under that scenario of hostile judicial precedents, a broad movement for abortion access — including providers, researchers, advocates, and lawyers — will be immensely important to securing the availability of remote, early abortion care.

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Person typing on computer.

COVID-19 and the New Reproductive Justice Movement

The Petrie-Flom Center Staff Leave a comment

By Mary Ziegler

The COVID-19 pandemic has transformed advocacy for reproductive rights and reproductive justice in what previously had been called an endless, unchanging, and intractable abortion conflict.

The pandemic — and the stay-at-home orders it required — finally shifted the movement’s focus to abortion access, rather than abortion rights, as exemplified by its emphasis on medication and telehealth abortion.

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Rows of gold post office boxes with one open mail box.

FDA Expands Medication Abortion Access During Pandemic, but State Barriers Remain

Temple University Center for Public Health Law Research Leave a comment

By Adrienne R. Ghorashi, Esq.

Last week, the Food and Drug Administration (FDA) suspended an in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic, allowing patients to access medication abortion by mail.

Previously, the FDA REMS requirement mandated that mifepristone must be dispensed in person, forcing patients to travel to a clinic in order to pick up the medication. In light of the pandemic, the requirement would lead to unnecessary risks of COVID exposure for patients and providers, in addition to imposing logistical and financial burdens.

This FDA decision is the latest development in a battle that made its way to the U.S. Supreme Court earlier this year. In its first abortion decision since Justice Amy Coney Barrett joined the bench, the Supreme Court reinstated the in-person dispensing requirement after it had previously been blocked by a federal district court in Maryland due to the risks of COVID-19.

Advocates for abortion access are celebrating the FDA decision as a win for science and evidence-based policy rooted in a growing body of research on the benefits of medication abortion and telemedicine for abortion.

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books

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, 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 October. The selections feature topics ranging from a commentary calling for reconsideration of the FDA’s risk evaluation and mitigation strategy (REMS) program for mifepristone, to an analysis of clinical development times for biosimilars seeking FDA approval, to an editorial describing the challenges of using the Defense Production Act to address drug shortages. A full posting of abstracts/summaries of these articles may be found on our website.

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