FDA Policy/General

Could HHS Mea Culpa Lead to FDA Rehires?

HHS secretary Robert F. Kennedy Jr. admitted 4/3 that many mistakes were made in cuts across HHS health agencies, including FDA, this week. He told the media that in the course of making cuts, “personnel that should have not been cut were cut,” and he said some have been reinstated and others will be. “We’re reinstating them, and that was always the plan,” he said.

Kennedy is referring to the Elon Musk-led Department of Government Efficiency (DOGE), which oversaw the cuts, and its operating plan that assumes 20% of cuts will be riddled with mistakes. “The part of that, DOGE — we talked about this from the beginning — is we’re going to do 80% cuts, but 20% of those are going to have to be reinstalled because we’ll make mistakes,” Kennedy said. FDA Webview requested HHS clarification on the rehires but no response has been received.

Potential FDA employees who could be rehired after being mistakenly cut are those supporting medical product reviewers and facility inspections. Earlier this week, former FDA commissioner Scott Gottlieb publicly complained (see story) about severe impacts to product reviews caused by the cuts. Many cuts to the review process were made by those who didn’t fully realize what role they played in actual drug reviews. Across the Office of New Drugs there were a number of “policy” offices eliminated and the staff in these would help “adjudicate cross-cutting scientific issues that transcended different drug reviews,” Gottlieb said.

Additionally, 170 support staff in FDA’s inspection cadre were let go, which will likely lead to significantly fewer inspections being conducted going forward. Many routine surveillance inspections will likely fall by the wayside as the agency prioritizes “for cause” inspections, such as those that examine a safety risk product recall, senior FDA officials said (see story). The layoffs also eliminated FDA’s travel operations staff who planned and booked investigators’ foreign and domestic travel plans. This ranged from booking flights to coordinating with the State Department to reserve translators and security needed for inspections abroad.

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