On February 5, 2026, Pharmaceutical Technology quoted Jeremiah Kelly on the Food and Drug Administration’s (FDA) rare pediatric disease priority review voucher (PRV) program returning to the pharmaceutical landscape. According to Pharmaceutical Technology this development follows a “lengthy period in regulatory limbo,” and is “a win for biopharma companies developing therapies for rare diseases in children.”
Pharmaceutical Technology noted that the program’s return is being authorized under the “Mikaela Naylon Give Kids a Chance Act,” which the publication described as “a bill that covers a range of regulatory frameworks to increase the speed at which children battling rare diseases and certain cancers can access therapies.”
“The reauthorization of the pediatric priority review voucher program will incentivize drug and biologics development for diseases that, otherwise due to low prevalence, lack the return-on-investment in the market to compel companies to undertake the costly risks associated with that development,” Kelly commented. “Thankfully, Congress has reauthorized this program, which should strengthen the pipeline of products on the way to help some of our most vulnerable children—this program shifts the balance more in favor of innovation in the pediatric drug development space.”
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