Proposed Legislation Highlight
What it would do: This bill will permanently authorize the Pediatric Priority Review Voucher (PRV) program. It will allow further opportunity to spur innovation in rare and neglected diseases that disproportionately impact children.
Why it is important: Since 2012, this program provides incentives for pharmaceutical companies to develop treatments for rare pediatric diseases by providing them with a priority review voucher that entitles the company to receive a 6-month review that would normally be reviewed under FDA’s standard 10-month review period. The Priority Review Voucher provides critical incentives to rare disorder product developers.
Why it is important to the Cure CMD community: The PRV may help future treatments for CMD when they are ready for FDA review and approval. This bill would make the PRV permanent so it is guaranteed to be available if and when we need it in the future.