FDA Policy/General

Leaked Budget Document Projects FDA Cuts: Report

An HHS leaked budget document circulating in Washington projects a 17% cut in FDA budget authority (BA) (non-user fee) expenditures in FY 2026 from the FY 2023 final consolidated appropriations act, according to an FDA Matters post by Steven Grossman. The post notes that the numbers are subject to negotiation and can change between now and the release of the president’s budget request.

Grossman reports that HHS says in the document that the FDA spending levels would be sufficient to meet maintenance of effort funding requirements, meaning that user fees could still be collected.

A table in the post shows that BA spending for drugs would drop from $760 million in FY 2023 to $576 million in FY 2026. Biologics spending would go from $272 million to $214 million, animal drugs and feed from $230 million to $183 million, medical devices/radiological health from $449 million to $450 million (slight increase), Office of the Commissioner from $225 million to $157 million, rent and facilities from $272 million to $241 million, and building and facility repairs from $13 million to $0. The total BA spending would drop from $3.543 billion in FY 2023 to $2.927 billion in FY 2026.

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