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Gottlieb's Parting Words For US FDA: 'Be Willing To Push' For Major Policy Changes

 
• By Derrick Gingery

Outgoing Commissioner tells staff, “No phrase bothered me more than when I heard people say to me they didn’t want to do something important because they wanted to ‘preserve their political capital.’” FDA should not to worry about spending political capital, Gottlieb argued, because it is replenished upon accomplishing important things.

Gottlieb speaking
Outgoing FDA Commissioner Scott Gottlieb addresses employees during the final all-hands meeting of his tenure. • Source: HHS photo

Outgoing Commissioner Scott Gottlieb exited the US FDA proud and unapologetic about the sometimes contentious issues he took on during his tenure, telling staff that the commissioner must be willing to challenge "powerful interests and policy makers."

In a farewell speech to employees on April 4, Gottlieb said an agency head must seek support, but also "assert...

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More from US FDA

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

More from Agency Leadership

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.