News & Analysis as of

Pregnancy Food and Drug Administration (FDA) Prescription Drugs

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

Sheppard Mullin Richter & Hampton LLP

Supreme Court Unanimously Preserves Access to Mifepristone

In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across...more

Fenwick & West LLP

SCOTUS Unanimously Preserves Access to Abortion Pill

Fenwick & West LLP on

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

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

Sheppard Mullin Richter & Hampton LLP

Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the...more

Epstein Becker & Green

The Legal Battle Over Mifepristone

Epstein Becker & Green on

During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific...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

Foley Hoag LLP

Mifepristone Update: Texas Judge Probes Extent to Which Court Can Affect the FDA’s Approval

Foley Hoag LLP on

Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge’s questions, as reported...more

Foley Hoag LLP

Preparing for Impact: The Mifepristone Case in Texas Nears a Decision

Foley Hoag LLP on

The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more

Faegre Drinker Biddle & Reath LLP

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...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

Console and Associates, P.C.

The Use of Depakote by Pregnancy Women Linked to Serious Birth Defects

Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more

Jones Day

FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials

Jones Day on

The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses. The Development: The U.S. Food and Drug...more

Pillsbury - Internet & Social Media Law Blog

The FDA Takes the Kardashian Endorsement Machine to Task

When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a...more

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