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Defining 'Substantial Efficacy': Post Hoc Analysis OK (When FDA Does It)

 
• By Sue Sutter

Agency's interpretation of four unsuccessful trials of Fabre-Kramer's antidepressant seems like 'cherry picking' and could create an uneven playing field for sponsors, some advisory committee members say; nevertheless, panel overwhelmingly concludes efficacy was lacking.

FDA's approach to weighing "non-positive" efficacy data against results from two successful clinical trials for Fabre-Kramer Pharmaceuticals Inc.'s antidepressant Travivo (gepirone extended-release) drew protests from some members of the Psychopharmacologic Drugs Advisory Committee Dec. 1.

Agency reviewers conducted a post hoc analysis of four unsuccessful, active-controlled, gepirone trials using an endpoint that was not the studies' primary outcome. Some FDA staff suggested this analysis reduced...

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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.