This may be a sign of things to come:

https://www.zerohedge.com/medical/fda-approves-therapy-rare-disease-without-randomized-trial-data

Article on the issue from Endpoints:

Makes me think of socialist purges in Russia when the Reds took over...

April 1, 2025 08:00 AM EDTUpdated 04:18 PM PeopleFDA+

Firings sweep across FDA as former leaders lament the gutting of drug agency

Zachary Brennan

Senior Editor

Mass firings and forced resignations swept through the FDA on Tuesday, as part of thousands of planned job cuts at federal health agencies being implemented by the Trump administration.

Some employees who showed up to work at the FDA’s main White Oak campus on Tuesday found out they had been fired when they attempted to check in at security, only to find out that their badges no longer worked and their jobs were gone. They were then escorted by security to collect their belongings. The scenes were described to Endpoints News by several people who witnessed them, and requested anonymity.

Others, such as CDER Office of New Drugs Director Peter Stein, were offered a new, hastily created role in a different department — or the choice to quit.

“I was offered a reassignment’ in ‘patient affairs’ (as they were required to do) or termination (after admin leave). I declined the offer (as ridiculous) so am on administrative leave,” Stein said in an email to Endpoints.

“The FDA as we’ve known it is finished,” said Robert Califf, the commissioner under the Biden administration who has emerged as a strident critic of the Trump administration’s efforts to gut the agency. “I will be glad if I’m proven wrong.”

And Scott Gottlieb, who served as commissioner under the previous Trump administration, warned that the cuts would lead to a return to a period of slower drug approvals and less access to new technology.

“The cumulative barrage on that drug-discovery enterprise, threatens to swiftly bring back those frustrating delays for American consumers, particularly affecting rare diseases and areas of significant unmet medical need,” said Gottlieb, who now serves as an investor and a board member at Pfizer and Illumina, in a post on X (formerly known as Twitter).

Biotech stocks fell for a second day in a row, with the S&P Biotech ETF $XBI down 1.3%, while the broader market was up.

Additional firings and unit changes Endpoints was able to confirm with sources include:

FDA chief medical officer Hilary Marston; the office of the chief medical officer was fired as well

Deep cuts at FDA’s Office of Prescription Drug Promotion, which regulates drug ads

Deep cuts at FDA’s Office of Manufacturing Quality, which protects the public from adulterated drugs and ensures compliance with good manufacturing practices

Cuts to CBER’s immuno-oncology staff

Communications, public affairs, policy and FOIA staff

Endpoints attempted to reach the FDA for comment, only to find out from sources that the agency’s office of media affairs and the office of communications had also suffered deep cuts.

The moves are part of a sweeping and sudden transformation of an agency that will see 3,500 FDA staffers — 19% of the agency — depart. Already, HHS Secretary Robert F. Kennedy, Jr. has pushed out one of the agency’s highest-profile leaders, biologics center chief Peter Marks. Other senior staff working in cancer drugs and biologics have left or been forced out as well, Endpoints reported Monday.

Kennedy announced the planned firings last week, describing them as an effort aimed at “streamlining HHS to make our agency more efficient and more effective.” But the staff eliminations are almost certain to be disruptive to healthcare product reviews, given the elimination of senior leaders at the FDA whose careers encompass decades of experience. On Tuesday, he posted on X that “The revolution begins today!” and officially announced the swearing-in of new FDA Commissioner Marty Makary.

Empty hallways, gutted divisions

FDA staff who spoke with Endpoints described the scene at the agency headquarters as a “bloodbath” that had left remaining employees in shock in the empty hallways. There were few, if any, communications from agency leadership — including Makary — about who had been cut and what the firings would mean for the agency’s operations moving forward.

The firings include whole offices at the regulator, multiple FDA sources told Endpoints, including leadership and administrative staff in several departments.

Similar firings were happening Tuesday across other federal health agencies, with some senior leaders given a choice to relocate to remote, rural offices with the Indian Health Service, or to Alaska, according to the Washington Post.

Reached for comment, an HHS spokesperson pointed Endpoints to a statement issued last week that contained few details, and didn’t respond to specific questions about the FDA cuts.

Editor’s note: This story has been updated throughout with new details on the cuts.