New CBER Leadership: The FDA Matters Analysis
The headline, “Dr. Prasad to succeed Peter Marks as CBER director,” spread like wildfire Tuesday night after Endpoints News broke the story.
Reactions ranged from “Omigod, he’ll destroy the industry and the hopes of patients” to “no big deal, staff do the product reviews regardless of who runs the Center.” Experience tells me his tenure is likely to be a little bit of “omigod” and a little bit of hands-off deference to reviewers….but mostly his time at CBER will be measured by how well he led the center during a time of great promise for products within its jurisdiction.
My three observations (below) were written before two further stories broke last night, recounting the results of Dr. Prasad’s incredibly positive first meeting with FDA staff. The stories are at Inside Medicine and STAT News. They more than vindicate my belief that Dr. Prasad’s prior and more recent statements should not pre-judge what he will do as the CBER director.
Observation 1: When outsiders become insiders, they take on responsibilities that did not burden their prior opinions.
It is easy to have an opinion when someone else will be making the decisions and bearing the consequences. It is quite a different matter when you have the power to decide, and your decision will directly affect the course of many people’s lives.
It is not so much that Dr. Prasad will change his mind, but rather personal responsibility and public accountability change your perspective. He may come to the same conclusion as when he was a commentator, but often he will see things differently.
I said this of Dr. Makary—and it is the universal experience of becoming a government official--nobody knows for certain how they will respond to a given situation until they actually have to make the decision that affects people’s lives.
Observation 2: Advocates would be well-advised to continue focusing on their medical and policy positions and not project a straight-line from Dr. Prasad’s past comments to his future actions.
I received a frantic note from a friend and former colleague asking how to block the appointment because Dr. Prasad was going to kill off research and investment in targeted cancer therapies. I could have gotten similar notes with any of a half-dozen other topics in the subject line.
I responded that there was no way (to my knowledge) to block the appointment. I added that while CBER will be different under Dr. Prasad, it doesn’t mean that all the decisions will be different from his predecessors. Some will be genuinely different, but some might be the same, perhaps with small tweaks and new names.
In light of this, I would advise advocates to focus on tightening the case for the policy they want. Show that the science is good and the unmet need serious and worthy of attention.
Rebutting past statements by Dr. Prasad just feels off by tying him to the past. Advocates should stick with positive positions that are deeply documented and convincingly presented.
Observation 3: Drs. Makary and Prasad appear to be aligned on vaccines (cautious support but also skeptical), but do not initially appear to be aligned on cell and gene therapy and orphan drugs.
Along with Dr. Makary, Dr. Prasad was part of a group of physicians who were loudly critical of much of the US public health response to COVID-19. There is a presumption (but no evidence yet) that the two are aligned on vaccines. The bigger question is likely to be how the two of them will handle Secretary Kennedy’s far more critical view of vaccines.
On orphan drugs (including cell and gene therapies), there is an initial misalignment that I do not expect to last. Dr. Makary has advocated for a new pathway for drugs for ultra-rare diseases (based on plausible mechanism)[1] and has acknowledged the difficulties of trials with small populations. Dr. Prasad has generally emphasized stronger trials that are designed to produce more definitive information.
Based on my own sense of the situation—reinforced by the Inside Medicine and STAT News articles on his first remarks to FDA staff—I see an easy transition for him to be more supportive of orphan drugs without backing down overall on seeking greater clinical trial rigor.