Industry and rare disease groups call for more transparency in FDA voucher pilot

The pharmaceutical industry and rare‑disease advocacy groups have voiced concerns about the Commissioner's National Priority Voucher pilot program.

Stakeholders say the program lacks transparency and that the criteria for awarding vouchers appear unfair.

Uncertainty surrounds the program’s future after comments from former FDA Commissioner Marty Makary raised questions about its direction.

Both industry representatives and patient advocates are urging the FDA to provide clearer guidance and a more open process for voucher allocation.