Drugs

FDA ‘Not Serious’ About Mifepristone Review: GOP Senators

Some Republican senators left a closed-door briefing by FDA commissioner Marty Makary on the agency’s review of the abortion drug mifepristone convinced that FDA is not taking the review seriously and Congress needs to act to ban the drug. Politico quotes Sen. Josh Hawley (R-MO) as complaining that Makary failed to give a timeline for completing the review, explain what the audit will involve, and disclose whether it was even underway.

“I think that this safety study is a dead end,” Hawley told Politico. “I just think that FDA is not serious about it. I don’t think they’re proceeding with any sense of urgency whatsoever, if they’re really proceeding at all. I frankly can’t tell.”

Also complaining was Senate HELP Committee chair Sen. Bill Cassidy (R-LA), who organized the briefing for some of his colleagues. In a statement, he cited the “lack of progress on HHS and FDA’s promised safety study on these dangerous drugs.” He said the review was “moving too slowly” and found that “disappointing.”

Politico says it’s hard to tell what comes next since congressional Republicans have tried and failed to impose restrictions on the use of mifepristone. Hawley said he hadn’t decided whether to attempt to control the drug through the next appropriations process or through a standalone bill. “I don’t have confidence [the FDA review] is going to amount to anything,” he said. “My view is Congress now needs to get involved.”

HHS referred Politico to an earlier statement that said FDA “is taking care to do this study properly and in the right way. We are planning to complete the study as soon as possible while ensuring we are not cutting any corners from a scientific research standpoint,” the statement said, adding that such reviews often can take a year.

Conservative anti-abortion activists have expressed disappointment in the Trump administration for retaining Biden-era rules that expanded access to abortion drugs via mail and telemedicine and for approving a new generic version of mifepristone.

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