Drugs

FDA Changes Mifepristone REMS

FDA has modified the mifepristone REMS program to allow Mifeprex (commonly referred to as an abortion drug) and its approved generic to be dispensed by certified pharmacies or by or under the supervision of a certified prescriber. An agency question-and-answer notice says the change was made in response to supplemental applications, as amended, submitted by the applicant for Mifeprex and the approved generic tablets to remove the in-person dispensing requirement and add pharmacy certification. The supplemental applications were submitted after FDA sent 12/16/21 REMS modification notifications to the applicants.

The notice says the REMS modification was not in response to the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health that overturned the Roe v Wade precedent. Rather, it says, the 2021 REMS review that led to the change was related to the litigation in Chelius v. Becerra that involved the single, shared system REMS for Mifeprex and its generic. A stay in that litigation was granted 5/7/21 and under that stay and in conjunction with regular periodic assessments of the REMS, the agency reviewed the REMS in 2021 and approved the supplemental applications 1/3.

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