Drugs

FDA Staff Exodus Deepens as CBER Deputy Witten Quits

CBER deputy director Celia M. Witten has left the agency, the latest high-ranking FDA official to depart as staff morale plunges in the wake of Trump Administration firings of probationary employees that began earlier this week (see story). According to a just-posted organization chart, Witten was one of two deputies serving under Center director Peter Marks, with deputy director Julie C. Tierney remaining and no replacement for Witten having been named. Tierney has been in her current role for a year, having previously served as CBER chief of staff from 1/2021 to 12/2023.

Between 2005 and 2016, Witten served as CBER Office of Cellular, Tissue and Gene Therapy. Between 1996 and 2005 she served as CDRH Division of General, Restorative, and Neurological Devices director. Previous to FDA, she worked for over 10 years as a practicing physician at the National Rehabilitation Hospital in Washington, D.C. She earned her PhD from Stanford University, and a medical degree from the University of Miami School of Medicine.

Many FDA watchers are concerned about the loss of talent at the agency with recent voluntary departures and Trump-ordered cuts likely to have a negative impact on product applications under review. CDRH saw a substantial number of terminations of those working on artificial intelligence-related submissions and digital health programs, and CVM lost up to 20 reviewers who ensure that drugs for pets and livestock are safe and effective, according to an NPR report.

Meanwhile on Friday, the entire Senate Democratic caucus sent a letter demanding answers from HHS secretary Robert F. Kennedy Jr. for firing more than 5,000 HHS workers and undermining Americans’ health and safety. The lawmakers say they are worried the staff cuts would block the development of new treatments and cures. “FDA and NIH nonpartisan staff research and develop life-saving treatments,” they wrote. “Firing them may delay medical breakthroughs and will weaken America’s biomedical science leadership for years to come.”

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