FDA Policy/General

FDA Staff Given $25,000 Buyout Offers

As many as 80,000 federal employees at HHS, including FDA, are being offered up to a $25,000 buyout to retire or leave their government employment as part of a new Trump Administration tactic to cut costs. The buyouts have some exclusions, such as FDA inspectors, product reviewers (paid by user fees), and certain employees working on cybersecurity matters, according to several media outlets. The employees are being given until Friday (5:00 pm) to opt in and submit a response for the voluntary separation offer, the Associated Press says.

The mass buyout email coincides with the next wave of potential government staff cuts under a 2/26 memo asking agencies like FDA to “undertake preparations to initiate large-scale reductions in force (RIFs), consistent with applicable law.” They are ordered to develop and submit by 3/13 agency reorganization plans. The memo also appears to exclude staff under the user fee programs (see earlier story).

Currently, it is estimated that about 1,000 FDA staff have left the agency after accepting an earlier buyout that promised their salaries through September including probationary employees terminated since Trump took office. Outside of the latest buyout offer, there are thousands of FDA employees that are not funded by user fees and whose jobs could be in jeopardy. The memo says agencies should seek to “consolidate areas of the agency organization chart that are duplicative; consolidate management layers where unnecessary layers exist; seek reductions in components and positions that are non-critical; implement technological solutions that automate routine tasks while enabling staff to focus on higher-value activities; close and/or consolidate regional field offices to the extent consistent with efficient service delivery; and maximally reduce the use of outside consultants and contractors.”

The two staff reduction efforts are presumably being conducted without the concurrence of the likely next commissioner, Marty Makary. In fact, during his Senate confirmation hearing last week, he pledged to do his own “independent assessment on personnel” before recommending if any additional staff cuts are warranted at the agency (see story).

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