Pfizer CEO Albert Bourla levels criticism of CBER's Vinay Prasad - Fierce Pharma

One of the most powerful voices in the biopharma industry, Pfizer CEO Albert Bourla, Ph.D., has weighed in with sharp criticism of the FDA’s Vinay Prasad, M.D., and his performance as the chief of the Center for Biologics Evaluation and Research (CBER), which regulates vaccines in the U.S.

“We have a problem with the leadership of CBER,” Bourla said Monday at the TD Cowen healthcare conference. “I think the current director is not following the recommendations of his staff.”

The rebuke came in response to a question about Pfizer’s interactions with the FDA on vaccines. The company is one of the world’s most prolific manufacturers of vaccines, recording sales of more than $11 billion for its shots last year.

Bourla added that “differentiation” must be made when speaking about the leadership of the CBER and the “career scientists” Pfizer has interacted with for decades.

“With them we are having very productive professional collaborations,” Bourla said of the staff. “Most of them are renowned regulators that when they publish something, regulators around the world, they listen to them. So that hasn’t changed.”

Bourla added that the company is not rethinking its vaccine strategy nor adjusting its long-term investment plans based on the decisions made recently by Prasad and other regulators.

Last month, the FDA first declined to review Moderna’s application for approval of a flu shot but then accepted it a week later after the company adjusted its submission. With the original decision on Moderna’s application, Prasad overruled reviewers in signing off on a refuse-to-file letter, according to a report from Stat.

In December, the Centers for Disease Control and Prevention overhauled its vaccine schedule, removing seven childhood shots from its universal recommendation list while presenting little if any scientific justification for the decision.

Monday, Bourla characterized the recent regulatory decisions as “an anomaly that will correct itself.”

“We are not going to go back to the period before Pasteur discovered the rabies vaccine, right? So, vaccines will be extremely important as a result,” Bourla added.

While most industry leaders have been mum on U.S. healthcare policy under the new administration of President Donald Trump, Bourla has been an outspoken critic, calling Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. “anti-science.”

In January, at a Wall Street Journal event during the World Economic Forum in Switzerland, Bourla said that he and the HHS leadership had “very productive discussions when it comes to cancer cures.”

“It’s a different world when you start discussing vaccines, there’s almost like a religion there,” Bourla added.