The oncologist and former University of California, San Francisco, professor has long been critical of COVID-19 mandates and the accelerated approval of cancer drugs.
Five weeks after Peter Marks suddenly resigned as director of the FDA’s Center for Biologics Evaluation and Research, the division has a new boss. Tuesday, FDA Commissioner Marty Makary named Vinay Prasad as CBER’s next director, according to several news sources.
Prasad will take over for Scott Steele, who has been running CBER on an interim basis since Marks was reportedly given the choice to resign or be fired at the end of March.
William Blair analysts, in a note to investors Tuesday afternoon, said Prasad’s appointment “adds another round of FDA uncertainty.”
Prasad, an oncologist and former epidemiology professor at the University of California, San Francisco, has been critical of COVID-19 restrictions, according to Reuters, a distinction that brings him in line with his bosses, Marty Makary and Health and Human Services Secretary Robert F. Kennedy, Jr.
Makary announced Prasad’s hiring on X Tuesday afternoon. “With 500+ peer-reviewed publications and two books, Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward,” he wrote.
Prasad is hardly a stranger to his new boss. The pair published a 2022 essay in BMJ in which they called COVID booster mandates at universities “unethical.” In their paper, Makary and Prasad noted “a lack of evidence that booster doses provide a meaningful reduction in hospitalization risk among healthy adolescents and young adults” and claimed that “mandates have deleterious societal consequences and are eroding trust in scientific and government institutions.”
But while Makary has expressed an openness to accelerated approval, recently discussing a new pathway that would allow medicines for rare diseases to be approved based on what he called a “plausible mechanism,” Prasad has spoken out against the FDA’s frequent accelerated approval of cancer drugs. In a 2015 JAMA article, Prasad and his coauthor Chul Kim of the National Cancer Institute pointed to a 2009 Government Accountability Office report that criticized the FDA for failing to enforce postmarketing study commitments for such medicines. Notably, the FDA has attempted to address this concern in recent years, requiring that confirmatory trials be “well underway” before an accelerated approval can be granted. Prasad also cited the low overall survival numbers for cancer drugs—approved under both traditional and accelerated approval—between Jan. 1, 2008, and Dec. 31, 2012.
“We are surprised by the announcement, because it seems to be in stark contrast to themes and initiatives that have been laid out by Dr. Makary,” William Blair wrote.
In a Tuesday afternoon note, Jefferies analysts wrote that Prasad has been “historically critical of some gene therapy companies and big approvals in [Duchenne Muscular Dystrophy] and gene editing,” adding that this is having a particular impact on Beam Therapeutics and Verve Therapeutics, both of which are developing base editing therapies. Last August, Prasad penned a letter with co-author Timothée Olivier questioning the FDA’s approval of Sarepta Therapeutics’ Duchenne Muscular Dystrophy gene therapy Elevidys.
The analysts noted, however, that “Makary does not seem to want to disrupt oncology and rare disease approvals.”
The S&P Biotech ETF fell by more than 5% upon news of Prasad’s appointment, STAT News reported.
Prasad’s appointment comes on the heels of another announcement that experts fear could indicate possible delays for vaccines. Last Wednesday, HHS revealed a new policy requiring all new vaccines to be tested in placebo-controlled trials prior to approval in what the agency called a “radical departure” from past practices.
RFK Jr.’s healthcare team has sought to distance itself from the previous administration. In an interview last month with former Fox News journalist Megyn Kelly, Makary addressed what he called the “epidemic of distrust” toward the FDA, while calling for greater transparency in the agency’s actions. Meanwhile, the biotech industry has volleyed that accusation back at the new HHS, calling for “greater clarity” around cancelled and postponed vaccine advisory board meetings and the massive job cuts undertaken by RFK Jr. over the past couple of months.
