FDA Policy/General

Poll Backs FDA Status Quo in Approving Products

On the heels of the U.S. Supreme Court’s 3/26 oral arguments in Danco Laboratories v. Alliance For Hippocratic Medicine that restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex), a new Axios/Ipsos poll finds that most Americans say they support FDA continuing to approve and regulate medications in the U.S. It also found that respondents trust FDA more than the Supreme Court when it comes to information about health topics.

The poll also found that regardless of affiliation, most Americans support women obtaining abortion medication from their doctor or a clinic. “In fact, most Americans across party lines agree that abortion issues should be managed between a woman and her doctor, not the government,” it says. “Given that the upcoming Supreme Court case around medication abortion may affect the way FDA approves and regulates drugs nationwide, it is important to consider that the overwhelming majority of Americans support the FDA continuing to take this regulatory role in the United States.”

During oral arguments, the majority of U.S. Supreme Court justices appeared skeptical whether there should be a ban or any new restrictions on mifepristone. The justices seemed likely to dismiss the dispute that challenged the drug’s labeling changes approved by FDA in 2016 and 2021 because the plaintiffs lack legal standing (see earlier story).

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