Biologics

Makary, RFK, Jr., Feuding Over Vaccines: Politico

Based on information from two anonymous senior administration officials, Politico is reporting that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are embroiled in a feud over vaccine policy and agency personnel. The article provides additional insight into earlier reporting on Kennedy having discussed plans to scale back the operational role of the commissioner, including the possibility of appointing another official to run day-to-day operations while leaving Makary as a more ceremonial figure — a move that administration officials later decided not to pursue for now.

One of the issues, Politico says, is that Kennedy wants FDA to quickly open new vaccine safety studies, while Makary believes the agency first needs to develop a new system for evaluating vaccine side effects. Makary’s hesitancy is reportedly annoying Kennedy.

An HHS statement to Politico said, “Secretary Kennedy has full confidence in Commissioner Makary. There has never been a time in history when an HHS secretary has been more aligned and had a closer working relationship with an FDA commissioner.”

But Politico says tensions over Makary’s management of the agency have simmered for months, and Makary has been unable to promote policy advisor Sanjula Jain-Nagpal (listed on the FDA directory as a health information specialist) to deputy chief of staff, because the White House, which reportedly was not consulted on the promotion, has not signed off. Jain-Nagpal announced her promotion on an 11/12 call with FDA stakeholders, the post says, but an HHS spokesperson told Politico that Sam Doran is the FDA deputy chief of staff.

The report says the notion of installing someone to run FDA daily operations was stopped when White House chief of staff Susie Wiles intervened on Makary’s behalf. It says Makary has started sending sensitive questions directly to the White House, given Wiles’ support, rather than to HHS. Wiles also reportedly intervened in August when the White House fired CBER director Vinay Prasad on the advice of Trump whisperer Laura Loomer. Makary and Kennedy had said, with Wiles’ apparent support, that Prasad was essential to the Make America Healthy Again movement, although his tendency to set a high bar for drug approvals reportedly has annoyed conservatives who favor a “right-to-try” philosophy that Trump espoused in his first term.

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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

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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