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Gottlieb's "Right To Try" Sentiment: Law Fails To Address Difficulties Faced By Drugmakers

 
• By Michael Cipriano

US FDA Commissioner suggests Congress may need to explore incentives for drugmakers to make investigational products available in the pre-approval phase. 

Capitol House

US FDA Commissioner Scott Gottlieb did not shy away from addressing the limitations of the right to try legislation in its ability to facilitate access to investigational treatments when it was still a bill being debated in Congress. He reiterated that sentiment once again months after it was enshrined into law, asserting that the main barrier to access lies with the drugmakers.

Testifying at a House Energy and Commerce Health Subcommittee hearing about implementation of a different piece of legislation (the CURES Act), Gottlieb said, "The challenge still remains, the difficulty –...

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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.

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
• By Derrick Gingery

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

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