Burr wants more FDA accountability in the new user fee agreements and questions whether they benefit patients. Generic approval modifications get attention at hearing.
Outgoing Sen. Richard Burr, R-N.C., continues to warn that the US Food and Drug Administration’s user fee revenue is increasing without the necessary accountability.
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The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.
Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.
