News & Analysis as of

Abortion Prescription Drugs Dobbs v. Jackson Women’s Health Organization

Shipman & Goodwin LLP

Shield Laws and the Battle to Provide Reproductive Health Services

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Following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization in 2022, which reverted the issue of abortion access back to the states, the landscape for access to reproductive care has become...more

Akerman LLP - Health Law Rx

What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of...

Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more

Fenwick & West LLP

SCOTUS Unanimously Preserves Access to Abortion Pill

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On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with misoprostol, was used in nearly two-thirds of all U.S. abortion and miscarriage treatments...more

Jenner & Block

Client Alert: The Supreme Court Signals That Access to Mifepristone Will Likely Remain Safe for Now

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On March 26, 2024, the Supreme Court heard arguments in the two consolidated cases concerning access to mifepristone pending before the Court, FDA v. Alliance for Hippocratic Medicine, Case No. 23-235 and Danco Laboratories,...more

Sheppard Mullin Richter & Hampton LLP

Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of...more

Sheppard Mullin Richter & Hampton LLP

Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...more

Sheppard Mullin Richter & Hampton LLP

Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more

BakerHostetler

Challenge to the FDA's Approval of Abortion Medication

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On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more

Goodwin

A Tale of Two Lawsuits: Federal Court in Texas Suspends FDA Approval of Medication Abortion Drug Mifepristone Nationwide, While...

Goodwin on

The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more

Polsinelli

FDA Modifies Mifepristone REMS Program, Establishes Certification Process for Pharmacies

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On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the requirement that mifepristone...more

Burr & Forman

Hot Topics in Health Care January 2023

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Court Remands Remedy for Unlawful 340B Rule to HHS - On January 10, 2023, the DC District Court remanded the issue of how to remedy five years of underpayments to 340B hospitals to the Department of Health and Human...more

Jenner & Block

Client Alert: New Year Brings New Guidance Related to Medication Abortion

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The federal government started 2023 by clarifying important legal issues surrounding the use of medications for abortions. These changes come after much uncertainty—and controversy—around the availability of medication...more

Quarles & Brady LLP

FDA REMS Protocol Modification Provides a Pathway for Pharmacies to Dispense Mifepristone

Quarles & Brady LLP on

On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to...more

Epstein Becker & Green

Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care

Epstein Becker & Green on

In the aftermath of the Dobbs v. Jackson Women’s Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been...more

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