Scoop: Kennedy gets personally involved in FDA personnel drama
Add Axios as your preferred source to
see more of our stories on Google.
Health Secretary Robert F. Kennedy Jr., during a Cabinet meeting at the White House on December 2. Photo: Andrew Cabellero-Reynolds/ AFP via Getty Images
Health Secretary Robert F. Kennedy Jr. today met with the FDA's departing top drug regulator amid concerns the agency is in turmoil, two sources familiar with the situation told Axios.
Why it matters: The appointment of veteran cancer specialist Rick Pazdur to lead the agency's drug center mere weeks ago came as an enormous relief to the biopharmaceutical industry, and his pending retirement has reignited fears that the agency is imploding.
Between the lines: Pazdur takes issue with FDA Commissioner Marty Makary's performance in the role, according to the sources, speaking on the condition of anonymity because of the sensitivity of the subject.
- Kennedy's direct involvement signals the seriousness with which HHS is taking FDA's personnel chaos.
- Pazdur has filed papers to retire from the agency at the end of this month. STAT reported that Pazdur was concerned about the legality of a new drug review program and Makary and other officials' interference in drug review decisions and hiring.
- Pazdur succeeded George Tidmarsh, the previous director of the Center for Drug Evaluation and Research, who abruptly departed last month amid allegations that he used his position to get revenge against a former business associate. Tidmarsh has denied the charges and suggested he was retaliated against for raising concerns about speeding some drug approvals.
- It's unclear what will come of Pazdur's meeting with Kennedy. An HHS official said the meeting was to thank Pazdur for his service.
The big picture: Pazdur was widely viewed as a stabilizing force at the FDA during a particularly tumultuous time, especially in contrast to his counterpart in charge of FDA's vaccines and biologics center, Vinay Prasad.
- A memo Prasad wrote to staff last week attributing "at least" 10 children's death to COVID vaccines and threatening significant changes to how vaccines are regulated has drawn widespread criticism, including from a dozen former FDA commissioners and top health officials in the new New England Journal of Medicine.
- "We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most," write the officials, who include Scott Gottlieb, Brett Giroir and Norman Sharpless — all whom served in the first Trump administration.
