FDA Policy/General

FDA Mum on Hiring Freeze and Staff RIFs

FDA is facing new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal Supreme Court decision, both issued last week. Under a new executive order (Ensuring Accountability and Prioritizing Public Safety in Federal Hiring) signed by president Trump, a government-wide civilian hiring freeze is now in effect through 10/15, halting nearly all new federal hires — including at the FDA — unless explicitly approved by presidential appointees such as commissioner Marty Makary. Simultaneously, the Supreme Court cleared the way for the government to proceed with long-watched reduction-in-force (RIF) terminations, which could remove thousands of FDA employees whose positions were previously protected by legal injunctions.

“For FDA-regulated sectors — including pharmaceuticals, medical devices, food safety, and cosmetics—this convergence of executive and judicial action could have immediate and longer-term consequences such as regulatory delays or disruptions,” according to a post on FDALawBlog.com. “This large-scale personnel reduction at FDA could slow review timelines for applications, and already has in the case of one new drug application, and guidance issuance.”

FDA has not publicly addressed whether it will begin implementing these terminations or how it will navigate the hiring freeze. A request to HHS by FDA Webview on how the hiring freeze could affect FDA user fee-related hires was not returned by press time.

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