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FDA Funding Debate Reframed By GAO Reports On Strategic Planning

 
• By Nielsen Hobbs

Republican senators argue reports show that FDA needs significant reform; discussion of Cures and User Fee legislation will now likely focus on what the plan should be.

Skeptics of the 21st Century Cures Act have made several tactical retreats during the debates on the legislation, even as they have influenced the shape of the legislation as it advanced in the House and Senate. Now Republican senators seem to be hoping that two reports from General Accounting Office can provide enough ammunition to break through the last primary roadblock – the argument that FDA needs more funding as much as it needs structural reforms.

As the Cures package progressed in the House last year and the Senate this year, sponsors have had to drop...

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More from United States

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• By Sarah Karlin-Smith

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340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
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Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

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Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

 
• By Cathy Kelly

Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.

More from North America

Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

 
• By Cathy Kelly

Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
• By Grace Moser

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.