FDA Director Vaccines Research & Review, Deputy QUIT as Booster Conversation ‘Sidelines Agency Safety Regulatory Role’
Marion Gruber, the 32 year veteran office director was first sidelined in July to force the full authorization for Pfizer vaccine – NewsRescue
by Zachary Brennan
Two of the FDA’s most senior vaccine leaders are exiting from their positions, raising fresh questions about the Biden administration and the way that it’s sidelined the FDA.
Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, will leave at the end of October, and OVRR deputy director Phil Krause, who’s been at FDA for more than a decade, will leave in November. The news, first reported by BioCentury, is a massive blow to confidence in the agency’s ability to regulate vaccines.
The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of Sept. 20.
A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.
JUST IN – 2 top FDA officials Marion Gruber and Philip Krause resign. Reports say they resigned because Biden admin announced vaccine booster shots ahead of FDA.
— Insider Paper (@TheInsiderPaper) August 31, 2021
FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”
@US_FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service. https://t.co/hkLJPDo2HK
— Luciana Borio, MD (@llborio) August 31, 2021
“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”
Janet Woodcock told Endpoints that she wishes Gruber and Krause well and thanks them for their significant service.
Source: End Points
Related (from July 30th 2021): How Marion Gruber Was Sidelined To Rush FDA Pfizer Full Approval
“Under the FDA’s new plan, the director of FDA’s biologics center, Peter Marks, will largely oversee review of the Pfizer application, taking over for Marion Gruber, a 32-year veteran of the FDA who currently heads the office of vaccine research and review within the larger biologics center, according to a second FDA source. A third source familiar with the plan, who like the others spoke on condition of anonymity, said Marks was heavily involved in the review, but did not comment on whether he was formally replacing Gruber in the agency’s chain of command.”
Source: https://www.statnews.com/2021/07/30/fda-under-pressure-plans-sprint-to-accelerate-review-of-pfizers-covid-19-vaccine-for-full-approval/
Everything is Politics Including Science
The same “Peter Marks” appears slated to replace Veteran Gruber.
After announced departures of FDA vaccine research office head Marion Gruber & deputy Phil Krause, @DrWoodcockFDA sends memo saying plan in place to “continue prioritizing science, while meeting timelines that are important to ensuring the end of this devastating pandemic.” pic.twitter.com/G9FcgpMqQF
— Meg Tirrell (@megtirrell) August 31, 2021