> This guidance lays a line in the sand and will remove some of the reviewer-to-reviewer variance present in the current FDA staff.

https://www.statnews.com/2026/01/13/richard-pazdur-jpm-fda-c...

Recent comments during JPM don't have me hopeful for smooth sailing at the FDA any time soon.

> He said he was also deeply troubled by agency staff “being trampled on.” He referred to one individual who was “writing inflammatory emails using the F bomb,” telling center directors and deputy center directors that “they will go after them, that they were going to lose their jobs if they did not play ball.”

> He would also not name this person. STAT has reported that employees have been fearful under Vinay Prasad, director of the Center for Biologics Evaluation and Research.

> “It’s terrible to see 25 years of work dismantled,” said Pazdur, who founded the FDA’s oncology center. He later added, “I did not leave because I wanted to leave.”

> “I think I have been consistently critical of parts of the FDA regardless of administration, but what’s emerged over the past few months is just reflective of complete and total disarray and a complete lack of functional leadership,” said Brian Skorney, an analyst at the investment bank Baird.

Horrific stuff seeing the level of expertise leaving the building at FDA. Some of the program managers I’ve dealt with in the past have taken the payout with their roles left vacant. Just absolutely abhorrent levels of leadership, the 30 day response timeframes for submissions is starting to produce some sloppy work on their side.