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US FDA Pediatric Priority Review Voucher Renewal May Come With Strings Attached

 
• By Michael McCaughan

Legislation to allow the US FDA to continue awarding pediatric rare disease PRVs is moving forward, but has become the subject of partisan disagreements amid calls for new mandatory study authorities to “balance” the program.

House Energy and Commerce Committee
Will Democrats eventually agree on a package to renew the rare pediatric disease PRV program? • Source: Shutterstock

The US Food and Drug Administration’s authority to issue priority review voucher incentives for new drugs to treat rare pediatric diseases may hinge on whether Republicans in the House of Representatives are willing to tie the program’s reauthorization to new authorities for the agency to mandate studies in children.

Key Takeaways

  • House Democrats support the PRV program extension, but want another bill added to the package.

  • The disagreement with Republicans comes as the 30 September sunset is approaching

While there appears to be broad bipartisan support for reauthorizing the PRV program, Democratic members on the House Energy and Commerce Committee made clear during a 16 May

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