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The dust is beginning to settle on catastrophic cuts to the FDA's White Oak campus in Maryland, with sources saying as many as 800 in CDER were let go yesterday, and a new acting replacement for CBER chief Peter Marks was added. While HHS is aiming for 3,500 FDA cuts across the board, we're hearing of firings of not only senior leadership — like FDA's chief medical officer and director of the Office of New Drugs — but deep cuts to the offices of the chief scientist, manufacturing quality, drug
promotion (see more below), all three of the employees implementing Trump's Right to Try law, and many more on the media affairs, communications and policy sides of FDA. Be sure to stay in touch as we learn more — you can find me on Signal at zacharybrennan.20 or email me. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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by Zachary Brennan
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Mass firings and forced resignations swept through the FDA on Tuesday, as part of thousands of planned job cuts at federal health agencies being implemented by the Trump administration. Some employees who showed up to work at the FDA's main White Oak campus on Tuesday found out they had been fired when they attempted to check in at security, only to find out that
their badges no longer worked and their jobs were gone. They were then escorted by security to collect their belongings. The scenes were described to Endpoints News by several people who witnessed them, and requested anonymity. Others, such as CDER Office of New Drugs Director Peter Stein, were offered a new, hastily created role in a different department — or the choice to quit. |
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by Max Bayer
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WASHINGTON — The size and scope of the FDA that began Tuesday won’t be the same as the day nears a brutal conclusion for agency staffers that were laid off or forced to resign. Sitting in a corner office closer to the power brokers that crafted the restructuring, BIO CEO John Crowley tried not to catastrophize. “It’ll be a challenge,” he said in an exclusive interview with Endpoints News. “We take the FDA as we find it and this is the FDA we have today.” Few areas of the agency were spared as part of the Trump administration's sweeping cuts. Chief medical officer Hilary Marston was fired; the head of the Office of New Drugs, Peter Stein, was placed on administrative leave; and the
Office of Media Affairs was decimated by cuts. There were deep cuts at the FDA’s Office of Manufacturing Quality and immuno-oncology staff within CBER. |
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A Johnson & Johnson lab tech researches Covid-19 (AP Photo/Virginia Mayo) |
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by Ryan Cross
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On Tuesday, drug discoverer and biotech entrepreneur Alpha Lee told scientists at a chemistry meeting about a new molecule to combat the Zika virus. There are no treatments designed to stop the mosquito-borne infection, which can cause birth defects. After three years of work, Lee and a team of collaborators had made a compound that shut down an enzyme that’s essential for Zika virus
replication. But his excitement was short-lived. After the conference session ended, Lee checked his email and saw that the $67 million federal funding supporting the work and several other antiviral programs had been terminated. “The end of the pandemic provides cause to terminate COVID-related grant funds. These grant funds were issued for a limited purpose: to
ameliorate the effects of the pandemic. Now that the pandemic is over, the grant funds are no longer necessary,” said the email, which was reviewed by Endpoints News. |
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by Zachary Brennan
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A top official pushed out over vaccines. Senior staff heading for the exit. Thousands of workers targeted for firing. A new commissioner who has yet to visibly take charge. And an HHS secretary whose views on vaccines run counter to established science. After several tumultuous weeks at the FDA, many inside and outside the agency are wondering: What could come next? Center for Biologics Evaluation and Research Director Peter Marks' Friday exit was just the highest-profile of a number of key staff departures. Other top officials who have left in the past month include Lola Fashoyin-Aje, head of
cell and gene therapy clinical evaluation, Heather Lombardi, head of cell therapies, Heather Erdman, associate director of quality assurance, and Vaishali Popat, branch chief in cell and gene therapies, according to sources. |
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Peter Marks (Susan Walsh/Pool via AP Images) |
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by Drew Armstrong, Max Gelman, Kyle LaHucik
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The departure of one of the FDA’s highest-profile regulators, whose career was defined by advancing new technologies to patients, rattled investors and companies who were already feeling insecure. Friday’s shock exit of Peter Marks, the director of the Center for Biologics Evaluation and Research, was met by dismay across the industry. Marks was best known by the broader public for his work on Covid-19 vaccines during the pandemic — which made him a target for HHS
Secretary Robert F. Kennedy Jr., who has taken multiple steps to undermine vaccine research and trust. But as the head of the biologics center, Marks wa |
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