FDA Policy/General

RFK Jr. reportedly Mulled Limiting Makary’s Authority

Health and Human Services secretary Robert F. Kennedy Jr. has privately discussed plans to scale back the operational role of FDA commissioner Marty Makary, 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, according to reporting by the Wall Street Journal and Reuters.

The Wall Street Journal (WSJ) first reported that senior HHS and White House officials weighed reassigning key day-to-day responsibilities away from Makary amid concerns about infighting among the commissioner’s deputies and recent high-level departures at the agency.

CBER director Vinay Prasad and then-CDER director George Tidmarsh reportedly had been locked in an extended internal dispute, culminating in Tidmarsh’s resignation earlier this month after an alleged extortion scheme surfaced, according to WSJ reporting. The turbulence drew attention from senior officials at HHS and the White House. In the days after Tidmarsh’s departure, Kennedy held a series of meetings to review concerns about Makary’s management. According to those familiar with the discussions, senior FDA staff told Kennedy that Makary was often difficult to reach and had avoided emails and meetings with several division heads.

Reuters corroborated the core reporting and added that the idea was ultimately set aside to give Makary more time to address leadership issues. The White House told Reuters it had “total confidence” in the HHS and FDA teams.

Entertaining the move, even if not implemented, signals friction at the leadership's top and raises questions about how political appointees at HHS may try to influence or reorganize FDA operations. Any changes to who runs daily operations can affect review timelines, internal morale, and the agency’s scientific independence. Reporting over the last several months has documented low morale inside FDA about political pressure and departures of senior scientific staff, and any senior-level reassignments would further worry career staff and outside experts.

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