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

By Ameet SarpatwariBeatrice 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

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

By Ameet SarpatwariBeatrice 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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