The US Food and Drug administration’s user fee programs took another step closer to renewal on 15 June, with legislation clearing the Senate’s Health, Education, Labor and Pensions Committee – but the tenor of the markup suggests the final steps to reauthorization could be increasingly less smooth.
User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments
Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.
More from User Fees
• By
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.
• By
FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.
• By
Republican congressional staffers could bring a wealth of experience and strong contacts with key legislators to the FDA ahead of the next user fee reauthorization process. But will Health and Human Services Department leadership interfere?
• By
Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.
More from Pathways & Standards
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
• By
US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.