The UCSF professor and frequent YouTube poster has criticized COVID-19 vaccine mandates as well as the accelerated approval pathway and other FDA practices. Predictions of what his tenure might achieve are scattershot.
Vinay Prasad is an oncologist and hematologist at the University of California, San Francisco, as well as a frequent health policy critic on his YouTube channel and various podcasts. Now, he can add chief of the FDA’s Center for Biologics Evaluation and Research to his resume, becoming just the third person to lead the relatively new division, which reviews biological drugs, including cell and gene therapies and vaccines.
He is replacing Scott Steele, who stepped in as interim director after the ousting of Peter Marks, a long-tenured FDA official who reportedly refused to give Health and Human Services Secretary Robert F Kennedy Jr. access to the Vaccines Adverse Event Reporting System.
Since news broke of Prasad’s appointment on Wednesday, the biotech stock index XBI has fallen about 7%.
Audrey Greenberg, an executive with experience in the cell and gene therapy space, summed up the mixed response to Prasad’s appointment.
“A longtime critic of FDA policies and an outspoken voice from UCSF on drug approvals and regulatory standards, Prasad is anything but a status quo appointment,” she wrote on LinkedIn.
Prasad has been critical of vaccine mandates and drug approval policies, referring to COVID-19 as “now a common cold respiratory virus” on his YouTube channel. Whether Prasad’s status as a commentator and critic of FDA policies will serve him now that he’s in the driver’s seat at CBER seems to be still up in the air, according to observers and analysts.“When outsiders become insiders, they take on responsibilities that did not burden their prior opinions,” policy and regulatory consultant Steven Grossman told BioSpace in an email.
“CBER will be different under Dr. Prasad, but it doesn’t mean that all the decisions will be different,” he added. “Stakeholders who project a straight line from past comments to future actions do so at their own risk.”
Commentators in the medical field were not all pleased. “An oncologist with ZERO training in Infectious Diseases or vaccinology and with open contempt for infection control joins the roster of other fringe antivax physicians who are now running this country,” physician Michael Patmas wrote on LinkedIn. “He is openly contemptuous of healthcare administrators many of whom are his physician colleagues.”
Prasad does not have previous government experience. Marks started out as a clinician scientist before spending a few years in the pharmaceutical industry (helping to get the first oral iron chelator approved in the U.S.) before joining CBER as deputy director in 2012. Karen Midthun, Marks’ predecessor, started at the FDA as a medical officer before joining the Office of Vaccines Research and Review and later moving to CBER.
Reactions from Wall Street have been measured. “Prasad has been notably critical of Marks and the prior administration of FDA,” BMO Capital Markets analysts Evan Seigerman and Kostas Biliouris wrote in an investor note Wednesday, highlighting Prasad’s previous criticism of COVID-19 vaccines for patients who are neither elderly nor immunocompromised and clinical trials for oncology drugs or gene therapies that don’t use placebos. He also directly criticized Marks’ decision to approve Sarepta’s Duchenne muscular dystrophy drug despite FDA advisors recommending the agency reject the application.
While noting that “Prasad appears accepting of the value of vaccines broadly,” the BMO analysts went on to say that they “they view this decision as a net negative for the BioPharma sector. While Prasad’s positions are not anti-innovation, they are seemingly more restrictive and cautious for therapies that may have more nuanced risk/reward for patients.”
William Blair took a more muted stance, noting that CBER does not oversee small molecules or even biologic-like drugs such as antibodies or enzymes. This falls to CBER’s sister division, the Center for Drug Evaluation and Research (CDER). “Therefore, we believe the sharp sell-off in several of our oncology companies under coverage . . . is overdone.”
Jefferies analysts took a similar tone, and, like BMO, focused on Prasad’s more cautious approach to approvals. “We see some increased uncertainty in biotech space (at a macro level), given his relatively conservative stance towards FDA approvals,” especially his past criticism of the accelerated approval pathway.
“We believe Dr. Prasad thinks more rationally (and conservatively) around FDA approvals, and we suspect he will require sponsors to produce more supporting clinical evidence (taking less ‘shortcuts),’” Jefferies continued.
“Some will cheer his focus on data rigor and skepticism of accelerated pathways. Others will worry about delays and roadblocks in advancing urgently needed therapies,” Greenberg said. “What’s clear is that [Prasad’s] appointment will force tough conversations about standards, speed, and how we balance urgency with rigor.”
