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US FDA’s Unapproved Drug Initiative Nixed, But Without Agency Buy-In Demise May Be Short-Lived

 
• By Sarah Karlin-Smith

Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.

Conceptual hand writing showing FDA Approved.
HHS halts FDA program that encourages marketing approval of old drugs • Source: Shutterstock

The US Department of Health and Human Services is ending the Food and Drug Administration’s Unapproved Drugs Initiative in an effort to tackle the cost of prescription drugs, arguing the program has led to spikes in drug prices and shortages.

The administration is also considering whether more drugs should be exempt from FDA’s approval process – a move that could...

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Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
• By Sarah Karlin-Smith

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 
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Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 
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NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

More from Agency Leadership

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 
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HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
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A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.