Drugs

High Court Backs Abortion Pill Access for Now

The U.S. Supreme Court on Thursday temporarily preserved nationwide access to the abortion pill mifepristone by mail, blocking a lower court ruling that would have reinstated in-person dispensing requirements while litigation continues.

In a 7-2 decision, the court granted emergency requests from manufacturers Danco Laboratories and GenBioPro after the 5th U.S. Circuit Court of Appeals moved to roll back a 2023 FDA rule allowing the drug to be prescribed through telehealth and shipped by mail. Justices Samuel Alito and Clarence Thomas dissented.

The case, Louisiana v. FDA, was brought by Louisiana and other anti-abortion states arguing that the FDA exceeded its authority by easing restrictions on mifepristone distribution and that mail-order access conflicts with state abortion bans and the federal Comstock Act.

The ruling leaves current FDA rules in place while the broader legal challenge proceeds through the courts. Mifepristone, used with misoprostol in medication abortions, accounts for roughly two-thirds of U.S. abortions, according to multiple reports.

The decision does not resolve the underlying case, which is expected to return to the Supreme Court for a full review at a later date. Abortion-rights groups called the ruling a temporary but significant victory for access to medication abortion, while opponents vowed to continue pressing legal challenges against the FDA’s policies.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome