In the wake of the high-profile departure of Peter Marks, M.D., Ph.D., the FDA has a new leader for its Center for Biologics Evaluation and Research (CBER).
FDA Commissioner Marty Makary, M.D., has named Vinay Prasad, M.D., to the post, he said in a post on X.
"Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER," Makary said in the post.
Endpoints News first reported the appointment Tuesday, citing an internal email from Makary to agency staffers.
A hematologist-oncologist with more than 500 published academic articles, Prasad most recently served as a professor at the University of California, San Francisco, according to an online biography. He authored books on the medical field in 2015 and 2020.
Last year, he publicly voiced concerns about an FDA proposal for additional regulatory flexibility in support of multiple myeloma drug approvals.
Like other healthcare leaders in the Trump administration, Prasad also criticized the healthcare system's response to the COVID-19 pandemic. In a 2022 op-ed in City Journal, he wrote that "public-health officials have omitted uncomfortable truths, made misleading statements, and advanced demonstrably false assertions" during the pandemic.
"In the information era, where what one says is easily accessible and anyone may read primary literature, these falsehoods will be increasingly recognized and severely damage the field’s credibility," Prasad continued in the op-ed.
Investors' immediate reaction to the appointment was negative, with the most prominent biotech index (XBI) turning sharply red at midday. As of 1:40 p.m. ET, the XBI index was down about 6%.
The nomination comes roughly a month after the high-profile exit of former CBER head Marks. The former CBER director turned in his resignation in late March after butting heads with Department of Health and Human Services Secretary Robert F. Kennedy Jr. on the subject of vaccines.
In his resignation letter, Marks wrote that "truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies."
As CBER leader, Prasad will be responsible for the agency's regulation of vaccines and biologics, including cell and gene therapies.