Comparing the new Commissioner's National Priority Voucher Program review timeline with existing pathways and designations - not too dissimilar from real-time and rolling review mechanisms already in place, but with a much quicker decision date.

Excerpt from the Energy and Commerce Committee Subcommittee on Health hearing titled ‘The Fiscal Year 2026 Department of Health and Human Services Budget.’

Now disclosed via FTC posting, $REGN Regeneron Pharmaceuticals was the purchaser of $ABEO Abeona Therapeutics PRV.

Four Bills were introduced in Feb/March to reauthorize the Medical Countermeasure PRV and Rare Pediatric PRV Programs. No hearings are currently scheduled to progress the Bills....

Q2 2025 Priority Review Voucher (PRV) Summary: 🏛️FDA announced a new Commissioner’s National Priority Voucher program 📝 $NVS Novartis redeemed a PRV for the remibrutinib NDA 📝 $REGN Regeneron redeemed a PRV for an EYLEA HD sBLA 📝 $NOVO Novo Nordisk likely (unconfirmed)

🎙️Summary of todays FDA Direct - first 100 days: 📝FDA Commissioner Dr. Marty Makary initial Goals: - Streamline agency - More cures and other meaningful treatments for Americans - More powerful diagnostics - Better processes - Better food for children - Streamlined inspections -

Marty Makary FDA Commissioner discusses the Commissioner's National Priority Voucher Program on CNBC: What qualifies as a national priority? 🔹Large unmet public health need. Would like to see: - cure for T1 diabetes - more cancer therapies for stage 4 metastatic disease -

Marty Makary FDA Commissioner on Bloomberg TV (due to air at 6pm ET): FDA may issue Voucher for companies promising to equalize the price with other OECD countries and the U.S. even with products the company already has. Want to incentivise good behaviour in the market.

FDA updated their novel drug and biologic approvals dataset. In 2024…. · 50 novel drugs / biologics were approved · 34 drugs / 16 biologics · 21 with standard review / 29 with priority review (1 with a priority review voucher) · 26 had Orphan Drug Designation · 18 had

Complementary words on todays FDA Direct from Dr. Marty Makary and Vinay Prasad for acting CDER head Jacqueline Corrigan-Curay and that the FDA is close to confirming the new head of CDER.

Leaders from RDCC member companies, including @Neurocrine, BridgeBio Pharma, and @Stoketx, were on Capitol Hill this week, advocating for the reauthorization of the PRV program. The PRV program is a proven policy - Congress must act now to pass the Give Kids a Chance Act.

Summary of what we know so far about the FDA Commissioner’s National Priority Voucher (CNPV) Program: 1. The CNPV: > shortens the FDA review from 10–12m to 1–2m > allows sponsors to submit the majority of the application before the clinical trial is complete > will be reviewed

I found this quite funny…. ‘Don’t call us, we’ll call you’

Commissioner's National Priority Voucher program now accepting applications: 🔹Only one application per company (max 350 words) 🔹5 vouchers to be awarded in 2025 🔹Submissions will be reviewed by a committee led by Vinay Prasad (in Chief Medical/Scientific Officer capacity)

Updated FDA review timelines graphic w/ the latest information for the Commissioner's National Priority Voucher Pilot Program, shown alongside current pathways and designations.

The Give Kids a Chance Act, introduced in Feb 2025 by Michael McCaul to extend the FDA Rare Pediatric Disease Priority Review Voucher program through 2029, now has 226 cosponsors - over half the House. Still, no hearing has been scheduled to discuss the bill.