For decades, FDA commissioners sought to insulate the agency’s professional staff from political interference with regulatory decisions.
Today, this guardrail appears to have been removed, two former agency officials said at a recent meeting of Friends of Cancer Research.
The Feb. 5 meeting, “Modernizing Endpoints: Pathways for Evidence and Policy,” featured a fireside discussion with Richard Pazdur, former director of the FDA Oncology Center of Excellence, and Janet Woodcock, a physician who served as director of the Center for Drug Evaluation and Research for over twenty years.
The meeting also focused sessions on ctDNA, AI-enabled tumor assessment tools, and the regulatory infrastructure needed to support endpoint modernization. Friends released a white paper, “Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors,”
“I’m very concerned about what has happened there in terms of the political influence that we have,” Pazdur said at the meeting. “With regards to HHS in general, when I interviewed people before to be medical officers, generally they would ask a question: ‘Is there any political influence in the agency?’ And my bottom line was ‘No.’ The commissioner generally never asked about any drug approval. They didn’t ask about what we were doing.
“We had a podcast last year in the fall where we had all of the former commissioners, and they felt that their job was to protect the staff from any political influence. And I really believe that that firewall has been transgressed here, and that’s going to have lasting implications,” Pazdur said.
Said Pazdur:
We’re already seeing that, with what has happened in the agency, with a large number of people that have left.
And although there are attempts to hire, I think it’s important to realize that it’s not just about hiring numbers of people.
It’s the qualifications and the type of people that have left the agency.
And that’s going to have a profound effect as we talk about novel endpoints and other issues, emerging science are the requisite people there with the requisite training, with the ability to take chances, for example.
That is what is, I think, a lasting legacy that is going to have to be addressed with other administrations as they come in to look at what the agency has become after this administration leaves…
I think the major problem that we’ve had is with the agency—and this has been reported in the trade press consistently—that there’s inconsistency and changes, in plans, etc., that the FDA has sprung upon a lot of people late in the development course or the review of drugs, etc. (The Cancer Letter, Feb. 13, 2026).
And I think it’s important to realize that if we keep on just changing administrations with different goals and aspirations, and we’re going to change with another administration that comes in, I think we really have to take a look at the FDA in general.
Should it be an apolitical body? With people that are recruited, that have basically gone through vetting processes based on scientific ability rather than political aspirations, etc., and that these people stay for eight years or whatever, and are outside of the political process here.
And that should go for not only the people in the commissioner’s office or the heads of the FDA, but also the center directors, office directors, and even the division directors. And I think that this will get away from complaints that there’s this quote, “Body of people that are making decisions for long periods of time that have political aspirations, etc.”
I know this is probably a reality that will not happen here with political environments, but I really think we should say this is a scientific organization. It should have scientists running this. They should not be approved by politicians. They should come and go at a particular time and point here, eight years terms or whatever one wants to have it, where they would come into the office, basically run the place, and then leave the place, so to speak.
But these people would be vetted for their scientific abilities, rather than other issues that may come into play.
Woodcock responded with her perspective.
Said Woodcock:
Well, it’s long been discussed: Should FDA be an independent agency with a different status, not under HHS? This goes back and forth.
I don’t consider it a huge problem. I feel this is a special time, and this administration, because as Rick said, over the years, for every administration, I have been subject to political pressure to do something.
But, you know, the center director, that level and the commissioner level, protected the staff from that. And I remember when Jane Haney was commissioner, she insisted: Only two political appointees in addition to her, or something.
But frankly, there has to be some interface between the political world.
Science doesn’t actually tell you the answers. It tells you the facts.