The FDA has a new CBER Director Dr. Vinay Prasad.
CBER is the FDA’s biologics branch that handles things like cell therapies and vaccines. The branch has been in near-constant upheaval this year.
For a time, Scott Steele was acting CBER Director. It wasn’t clear if he was there in a temporary capacity or would transition to become the permanent director.
So what does Prasad’s appointment mean for the fields of cell and gene therapy? Regenerative medicine?
There are reasons for concern.
Who is Vinay Prasad, the new CBER Director?
Prasad is an epidemiology professor at UCSF and is an oncologist.
Unlike Steele, Prasad has voiced controversial opinions including on precision oncology, which he referred to as an illusion, and Covid. Maybe that makes him more attractive as a leader in the new FDA we have under Marty Makary and RFK Jr.?
He’s been very critical of both the FDA and specifically CBER. Overall, it’s not clear to me that he has the kind of experience to run CBER.
A new STAT News article provides useful information on Prasad. The quote at the end from two anonymous FDA employees suggests internal skepticism of the new leader:
“Two employees told STAT they were alarmed by the decision to hire Prasad, who lacks regulatory experience and has more explicitly political views than center directors in the past.
“It’s very bad,” one employee said. “Another completely unqualified person who has no idea what regulation is running an important center.”
How can CBER function this way?
Note that the previous permanent CBER Director Dr. Peter Marks was forced out and temporarily replaced with Steele. On his way out, Marks noted many troubling issues with how Kennedy was operating.
Any unproven stem cell or clinic connections for Vinay Prasad?
Prasad also has some strong views on Covid including masking and vaccines for kids, although he doesn’t seem as controversial as Kennedy.
It does bring to mind Makary’s relatively new aide at the FDA Dr. Tracy Hoeg, who also was skeptical of many Covid measures and co-authored papers with Makary in that area. Hoeg also has offered unproven stem cell and regenerative medicine procedures at a clinic here in California.
I don’t see any obvious connection between Prasad and unproven stem cells like those sold at clinics. He has written academic papers that mention stem cells, but mainly related to transplantation for cancer patients.
It’s hard right now to predict how he might impact the area of cell and gene therapies.
Overall impact on biologics?
From the STAT piece:
“Robert Califf, who served as FDA commissioner during the Obama and Biden administrations, called Prasad an “unusual” choice.
“Previous center directors have been career civil servants with deep expertise in the full spectrum of the organization and significant managerial responsibilities,” Califf said. “But the Commissioner has the right to make the pick.”
Not a confidence booster. “Unusual” here is kind of like when someone says your views or your taste in clothes are “interesting.”
So will Prasad be more like a politician at the helm of CBER? Weaken regs despite some past articles suggesting rigorous ethical standards are important?
Could there be some group think inside CBER now too? In that regard, Prasad was also a co-author with Hoeg and Makary on two Covid-related articles. So did Makary in part pick him because he knows him and likes his vaccine views?
Remember that Kennedy is not only anti-vax, but he has also seemed upbeat about unproven stem cells.
Will Prasad stand up to Kennedy? I have wondered the same thing about Makary. What if Kennedy wants to approve not-ready-for-primetime, risky cell injections? Re-classify them as not being drugs at all?
My general sense is that both the FDA in general and CBER specifically are going to be dominated by politics and ideology for years to come, which will be bad for academics and biotechs working on cell and gene therapies. The importance of data might get lost in the shuffle.