FDA Policy/General

House FDA Budget Bill Floor Vote Scrapped

House Republican leaders have scrapped a floor vote this week on FDA’s fiscal year 2025 budget. Capitol Hill reports indicate that Republican lawmakers are not in agreement on whether the funding measure should contain language that would have limited access to the abortion pill mifepristone. With no sure path to passing, it looks like the bill is on hold until lawmakers return from their August recess.

Earlier this month, the House Appropriations Committee marked up and approved its version of the agency’s FY 2025 spending bill (see earlier story). That measure calls for total funding at $6.75 billion, including user fees. The Alliance for a Stronger FDA said in response that the House action was disappointing. “It provides the FDA with about $20 million less in taxpayer money in FY 25 than is available to the agency in the current fiscal year,” the group said. When factoring new initiatives that have to be funded, program growth, mandatory salary increases, and building/facilities repairs, the “net loss for the agency is at least $150 million compared to the FY 24 final appropriations,” it added.

Meanwhile, the White House this week added its two cents on the bill’s fate, saying that it goes against an agreement President Biden and House Republican leaders reached last year on spending limits. “Rather than respecting their agreement and taking the opportunity to engage in a productive, bipartisan appropriations process to build on last year’s bills, House Republicans are again wasting time with partisan bills that would result in deep cuts …,” a White House statement says.

Indicating that the president would veto FDA’s spending bill in its present form, the statement had this to say regarding cuts in spending: “The administration is concerned that funding reductions contained in the bill compared to the FY 2025 budget request, including for essential staff, buildings and facilities, and other critical infrastructure investments to ensure food safety, personal care product safety, and a robust supply chain, would leave the FDA underprepared to address ongoing and emerging public health challenges in FY 2025.”

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