FDA Policy/General

FDA ‘Making Good Progress’ Hiring New Staff: Zeta

FDA acting chief of staff and deputy commissioner Lowell Zeta says the agency has secured 600 new employees and is looking to bring in another 1,600 as it works to recover from the massive staff cuts orchestrated in 2025 by the so-called Department of Government Efficiency. As reported by BioSpace, Zeta was among several top FDA officials speaking at an FDA Town Hall as part of the 6/23 BIO International Convention.

Acting CDER director Michael Davis said hiring picked up in the last month or so, following the departure of FDA commissioner Marty Makary and several other senior staff. He noted an increase in the number of staffers attending the agency’s bimonthly new employee orientations.

The speakers say the agency is also focusing on retaining existing employees. “Over a year of leadership turnover and political interference in agency decisions drove morale into the gutter, driving more employees to find the exit,” BioSpace says. “Now, the acting leaders are working to ensure their teams are heard, well supported, and empowered.”

Acting CBER director Karim Mikhail made the point that while FDA is hiring, “if we’re losing at the same pace of hiring for whatever reason, because people are dissatisfied with what they do, then it’s not working.”

Davis added that attrition rates are now back down to the historical rate. Commenting on the commitment of the agency’s current leadership to prioritize staff satisfaction, he said he makes an effort to listen to as many staff as he can, to have lunch with them, etc., “and I feel a lot of hope in people of things going forward. I think the attrition numbers would support that with data, but qualitatively I do feel like there’s been improvement in morale.”

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