FDA Policy/General

Budget Compromise Gives FDA $160 Million Boost

Senate and House appropriators have released a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 million (2.4%) budget boost over last year. The bill proposes $6.7 billion for the agency, which includes $3.5 billion in discretionary spending and $3.2 billion in user fees, but it falls significantly short of the funding sought by the Biden Administration almost a year ago. The funding bill will need to be enacted by 3/8 to avoid an agency partial shutdown, or another stopgap measure would have to be signed to allow more time and avoid any government disruption.

Under the Biden budget proposed in March (see earlier story), the agency was seeking a $372 million (10%) boost above current spending levels and a $150 million increase in user fees. The total FDA funding being proposed was $7.2 billion — $500 million less than the proposed budget agreement.

A Senate Appropriations Committee summary of the bill says the legislation would provide “$7 million to conduct oversight of cosmetics for the first time ever and $1.5 million to reduce animal testing through alternative methods. It also includes $50 million for the 21st Century Cures Act.”

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