FDA Policy/General

Senate Gives FDA $170 Million Boost for FY 2025

The Senate Appropriations Committee 7/11 unanimously (27 to 0) marked up and approved FDA’s fiscal year (FY) 2025 budget, which provides $6.87 billion in total funding for the agency, which is about a $170 million (2.5%) boost over the FY 2024 spending measure. It includes $3.544 billion in discretionary funding — a $22 million increase over 2024. The bill also provides an increase of $1 million to conduct oversight of cosmetics; an increase of $15 million for food safety; an increase of $3 million for the neurology drug program; $2 million in new funding for the recently announced Tobacco Task Force; and $1 million more for antimicrobial research. It also includes $55 million for the 21st Century Cures Act.

Meanwhile, the House Appropriations Committee late 7/10 marked up and approved its version of the agency’s FY 2025 spending bill. That measure calls for total funding at $6.75 billion, including user fees.

In contrast, President Biden in March proposed a $500 million increase in FDA’s spending in FY 2025, which is 7.4% more than the current $6.7 billion spending level. The FY 2025 Biden budget proposal said the president is requesting $7.2 billion for the agency to “enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities.”

In reaction to the latest Capitol Hill movements, the Alliance for a Stronger FDA says 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 says in a release. 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 adds.

Regarding the Senate action, the Alliance says the funding bill is an improvement, “but it still leaves the agency with significantly less money than it will need in FY 25. After factoring the increased spending needs cited above, the net loss for the agency is at least $100 million compared to the FY 24 final appropriations. “We will continue to press Congress to recognize and fund FDA’s vital work,” it says.

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