News & Analysis as of

Food and Drug Administration (FDA) Life Sciences Abortion

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

Jenner & Block

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

Jenner & Block on

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

Manatt, Phelps & Phillips, LLP

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more

Manatt, Phelps & Phillips, LLP

5th Circuit Rejects FDA Actions Expanding Access to Medication Abortion; Supreme Court Review Likely

On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills...more

Dinsmore & Shohl LLP

Contradictory Court Opinions Leave the Approval of Abortion Medication in Question

Dinsmore & Shohl LLP on

On April 7, 2023, two federal judges in Texas and Washington State issued dueling opinions about the abortion medication Mifepristone, just hours apart. These two decisions come in the midst of growing tension about abortion...more

Polsinelli

FDA Modifies Mifepristone REMS Program, Establishes Certification Process for Pharmacies

Polsinelli on

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

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

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

Polsinelli on

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

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