Drugs

Major Staff Losses at CDER and CBER Amid Shake-up

FDA has posted hiring data showing steep declines in staffing at its two key centers, CDER and CBER, responsible for drug and biologics regulation. The figures come amid a sweeping reorganization earlier this year at HHS and mounting concerns that the agency may be losing capacity to keep up with its regulatory responsibilities.

In its latest quarterly net-hiring tables (as of 9/30), FDA reports that the number of employees onboard at CDER dropped from 6,044 at the beginning of fiscal year 2025 to 4,951 by the end of the fourth quarter — a net loss of 1,093. Notably, the second quarter showed a net loss of 121, third quarter a loss of 246, and the fourth quarter alone a loss of 740. At CBER, the data show that its workforce shrank from 1,373 to 1,149 over the same period — a net loss of 224 — with its fourth quarter net loss alone showing 190.

The staffing shrinkage comes in the context of a broad reorganization at HHS announced in March, under which FDA was slated to cut around 3,500 employees (about 20% of its workforce) as part of a larger plan to cut 10,000 HHS jobs (see earlier story). FDA watchers have been warning that staff reductions were beginning to erode the drug-review program. With fewer reviewers and support staff, the pace of evaluating new therapies and biosimilars may slow — one early indicator: the agency’s drug-approval rate recently fell to 73% in the third quarter, down from an 87% average in prior quarters. There has also been a recent unexpected rise in rejected marketing applications to 15% and an 11% rate of delayed reviews, both higher than their historical averages.

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