More from the STAT article just posted on Reddit
Reached for comment, Health and Human Services spokesperson Andrew Nixon said in an email: “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.”
On a hastily organized call with staff, Verdun said she had not been given an explanation.
“Rachael and I have been placed on administrative leave and told that we are being relieved of our duties, for now, and we were escorted out,” Verdun told staff on an emergency call convened around 5:30 pm, adding “That’s all we’ve been told. We don’t have any additional information.”
The news could raise new concerns among investors about the current head of CBER, Vinay Prasad, who was elevated Wednesday morning to also serve as the FDA’s chief scientific officer and chief medical officer. Previously, those had been separate roles. Before joining the FDA, Prasad had been a critic of the agency’s approval standards, but since becoming head of CBER, he has struck a more conciliatory tone with industry.
At a recent “Cell and Gene Therapy Roundtable” hosted by the FDA, Prasad seemed to articulate a willingness to speed gene therapies to market for severe diseases in the face of limited data — a stance that seemed in line with the kind Verdun has taken. Verdun was listed as an attendee of the meeting but did not speak.
“When Peter Marks left, all the companies I spoke with were encouraged that Nicole Verdun was remaining, hopeful that she’d provide needed continuity inside CBER,” said Baird biotech analyst Brian Skorney. “Now, there will definitely be concerns and questions about what this means for the division under Vinay Prasad.”
The CEO of another gene therapy company told STAT that he met recently with Verdun. The news of her exit from the FDA “is a surprise,” the CEO said, asking for anonymity to preserve his relationship with FDA officials.
Verdun had not always agreed with Marks. In fact, Marks had overruled her on a key decision that has proved controversial: to approve a gene therapy made by Sarepta Therapeutics to treat Duchenne muscular dystrophy in patients who can no longer walk, despite a lack of data proving the treatment would be beneficial. The death of a second patient in that group caused Sarepta stock to plummet this week.
Prasad had been openly critical of the Sarepta decision before joining the FDA.
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