FDA Policy/General

Makary Outlines ‘Mission Critical’ Ops Under Shutdown

As the government shutdown went into effect 10/1, FDA commissioner Marty Makary told employees that the agency will continue mission-critical activities necessary to protect public health until the budget impasse is resolved. This means the agency is directed to respond to foodborne illness outbreaks, manage high-risk food and medical product recalls, pursue civil and criminal investigations when imminent threats to human life are identified, and monitor safety concerns with medical devices and other medical products. The agency will also continue work funded by carryover user fees, allowing some ongoing therapeutic development activities to proceed, he says.

However, Makary noted that FDA will not be able to accept new user fee payments assessed for fiscal year 2026, meaning regulatory submissions that require fee payment cannot be processed until new budgetary funding is approved. “The FDA plays a critical role in safeguarding the food families feed their children and pets, and ensuring the effectiveness of medicines Americans rely on,” he says. “While all our work is important, only activities permitted by law will continue during a lapse in funding.”

An earlier HHS contingency plan (see earlier story) says 13,872 FDA employees — about 86% of the agency’s workforce — would continue working during a shutdown. Of these, 10,740 are considered “exempt” because their activities are supported by carryover user fees or other non-lapsing funds, and 3,132 are “excepted” because their work is deemed essential to protecting human life or property.

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