Trump Signs Legislation to Reauthorize PRV Program

Rare Daily Staff

The Rare Pediatric Disease Priority Review Voucher program has been reauthorized through fiscal 2029 as part of a package of appropriations bills signed into law by President Donald Trump.

The priority review voucher (PRV) program incentivizes pharmaceutical companies to develop treatments for rare pediatric diseases. Before a treatment is approved, a company can obtain a rare pediatric disease designation from the Food and Drug Administration. To be eligible, the drug must qualify for priority review and represent the first approval for its active ingredient.

After the FDA approves an eligible treatment, the company is issued a PRV that can be used to obtain priority review for another treatment that wouldn’t otherwise qualify. Priority review means the FDA generally completes its review within six months rather than the standard 10-month period.

The vouchers are potentially lucrative because they are transferable. Most recently, Jazz Pharmaceuticals sold one for $200 million, as announced during the J.P. Morgan Healthcare Conference on Jan. 14, 2026.

In addition to reauthorizing the PRV program, the legislation expands the FDA’s authority over research on rare pediatric diseases by allowing the agency to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements, and by reauthorizing programs that support pediatric research.

The legislation also modifies requirements for molecularly targeted pediatric cancer investigations, permitting research on new drugs in combination with already approved active ingredients, provided certain conditions are met.

Additionally, the bill provides statutory authority for the FDA’s interpretation of orphan drug exclusivity. It specifies that the seven-year market exclusivity period for rare disease drugs prohibits the approval of the same drug for the same approved use or indication related to that disease or condition.