FDA reaches "tipping point" after high-level departures

Driving the news: The latest uproar surrounds the unexpected departure of Richard Pazdur, a respected oncologist who just three weeks ago became the fourth person to direct the FDA's drug center this year.

• Pazdur's appointment had helped calm nerves to some degree within industry after months of turmoil. But now, executives and even former FDA commissioners are publicly questioning the agency's direction.
• Health Secretary Robert F. Kennedy Jr. inserted himself in the personnel drama and met with Pazdur on Wednesday, Axios' Caitlin Owens reported. A Health and Human Services official said the meeting was to thank Pazdur for his service.
• Tracy Beth Høeg, a sports medicine doctor and critic of the COVID-19 response, will be acting director of the drug center.

What they're saying: John Crowley, CEO of the industry group the Biotechnology Innovation Organization, said the FDA is at a "tipping point."

• "This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China," he said in a statement.
• Twelve former FDA commissioners from Republican and Democratic administrations took the highly unusual step of publicly airing their concerns on Wednesday, writing in the New England Journal of Medicine that the upheaval "could diminish both the FDA's strength and Americans' health and safety."

The persistent complaint from former FDA officials and industry leaders is that political appointees are shutting out career agency scientists from decision-making, and that the departure of many agency veterans will jeopardize the drug review process.

• On Wednesday, agency leaders removed the longtime director of the office of over-the-counter drugs from her position, Stat reported.
• The group No Patient Left Behind, which represents biotech investors, warned commissioner Marty Makary last month about missed deadlines for reviews and canceled meeting with regulators, saying the turmoil is making it harder to plan for clinical trials.
• "We're all patients, and we all know somebody who's sick — parents, kids, peers — and so this really matters in the sense that you really want a forward-thinking FDA," Peter Rubin, the group's executive director, said in an interview.
• HHS didn't respond to a request for comment.

Between the lines: The morale at the agency has plummeted amid concerns about meddling from higher-ups, one former FDA staffer told Axios.

• "They don't talk to each other," the former staffer, speaking on the condition of anonymity because of the sensitivity of the subject, said of current employees. "They go to the bathroom, they come [back], they shut their door."

One area of concern is a new program Makary set up to award expedited reviews of certain drugs deemed to align with Trump administration priorities.

• Some drug industry and regulatory experts have questioned what they say is vague criteria, and whether FDA has the legal authority to implement the effort.
• Top vaccine regulator Vinay Prasad has been at the center of much of the controversy, including an email he wrote to agency employees last week signaling a crackdown on the vaccine approval process and linking COVID-19 vaccines with the deaths of 10 children, without providing details.
• That memo drew pushback from the former FDA commissioners, who wrote that it's time to rebuild confidence and not "toss aside the basic rules of science, stifle argument and oversight, or supplant expert scientific inquiry for the unilateral decision making of a few individuals."