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User Fee Package Offers FDA Reforms From A House Wary Of FDA Power

 
• By Derrick Gingery

House drafters’ dissatisfaction with FDA’s performance is evident in several provisions of draft user fee legislation. The agency would be required to finalize some guidances within a year of issuing a draft, which likely would provide more predictability for industry.

What a difference five years makes. The last round of use feer reauthorization, in 2007, gave FDA powers – the REMS safety program – that it wasn’t particularly asking for and had a hard time wielding at first.

In this round, the agency is asking for some specific authorities, but it may not get them, at least if...

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

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