Drugs

ACLU Sues FDA for Records on Mifepristone Review

The ACLU has filed a lawsuit seeking to force FDA to release documents related to its ongoing safety review of mifepristone, accusing the agency of withholding information requested under a Freedom of Information Act filing submitted in August. The FOIA request seeks details on the scope of the agency’s review and any communications with anti-abortion groups, elected officials, or other entities pushing for tighter restrictions on medication abortion, according to an ACLU notice about the lawsuit.

The group argues that recent statements from Trump administration officials — including FDA commissioner Marty Makary — suggest the review is being driven by a non–peer-reviewed analysis authored by a Project 2025 cosponsor. More than 260 researchers have criticized the paper for methodological flaws and misrepresenting the medication’s safety record.

Advocates warn that the administration may be laying the groundwork for new barriers, such as limits on telemedicine prescribing for abortion care, which now accounts for about a quarter of U.S. medication abortions.

The lawsuit comes as a federal court ruling in Purcell v. Kennedy (see story) found the FDA has not adequately justified its existing restrictions on mifepristone. The decision requires the agency to consider the substantial peer-reviewed evidence on the drug’s safety as it conducts its current review.

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