Drugs

Senator Hawley Urges FDA Action on Mifepristone Study

Senator Josh Hawley (R-Mo.) has sent a 4/28 letter to FDA commissioner Marty Makary asking that FDA review a new study allegedly revealing greater safety risks than the agency currently acknowledges for the abortion drug mifepristone. Hawley questioned Makary’s recent remarks about the agency having “no plans to take action” on mifepristone, and reminded him of his confirmation hearing and a pledge to “review the totality of the data and ongoing data” to inform action on the drug. “I urge you to follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone,” Hawley said in the letter. The study results were published by the conservative group Ethics and Public Policy Center.

Hawley’s letter asked FDA to respond to the following questions:

Will FDA now take action to restore longstanding, critical safeguards for mifepristone use? How quickly can we expect action?
What plans does the agency have to adjust the relevant drug safety label given this new information?
Going forward, how does FDA plan to appropriately evaluate the real-world health effects of mifepristone on American women?

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