Tag: REMS

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Sorry, You Probably Cannot Get MDMA Through Telehealth

Vincent Joralemon Leave a comment

By Vincent Joralemon

The U.S. Food and Drug Administration’s recent acceptance of an MDMA-assisted therapy New Drug Application has experts buzzing over expanded access to the infamous substance commonly known as “ecstasy” or “molly.” 

Yet, once approved, FDA will put limits on the approved drug. If past psychedelics are any indication, this means that MDMA will probably need to be provided in a clinic under certain protocols. This means patients will need to wait for other MDMA products to complete clinical trials before we’ll see at-home, private use of the drug.

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Medical Caduceus Symbol as Scales with backlight over Wall in dark room.

Gender-Affirming Care, Abortion, and the Politics of Science: A Response to Wuest’s ‘Born this Way’

The Petrie-Flom Center Staff Leave a comment

By Aziza Ahmed

On August 21, 2023, the 11th Circuit issued a decision that allowed a ban on transgender care to go into effect in Alabama. The Alabama ban, formally called the Alabama Vulnerable Child Compassion and Protection Act, is one of the most extreme of the many bans on gender affirming care. The law defines sex as the “biological state of being female or male, based on sex organs, chromosomes and endogenous hormone profiles…genetically encoded into a person at the moment of conception…” and targets physicians who might undermine this notion of sex with criminal prosecution. Their punishment could be up to ten years in prison.

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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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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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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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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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 April. The selections feature topics ranging from the pre-market development times for innovative vaccines, to an assessment of FDA postmarketing requirements and commitments from 2009 to 2018, to an analysis of implementation challenges and potential effects of U.S. adoption of international reference pricing for prescription drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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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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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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