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Another Chance to Make Priority Review Vouchers Work

 
• By Michael McCaughan

One of the “innovation” pieces of the FDA Safety & Innovation Act is a priority review voucher program for drugs to treat pediatric rare diseases. The new PRV is designed to avoid some of the glitches that have complicated the value of the program in tropical diseases—but it can’t avoid the core problem inherent in trying to capture the value of a priority review by legislative fiat.

Section 908 of the FDA Safety & Innovation Act is, in the words of Nancy Goodman, a “historic” provision. Goodman, who founded the Kids v. Cancer advocacy organization to encourage more research into pediatric cancers, hailed the provision (known as the “Creating Hope Act”) as “the first time Congress has passed legislation to address the dire need for new drugs developed expressly for children with cancer and other life threatening diseases.”

The goal of the program is to encourage more research into therapeutics focused on rare pediatric diseases and especially pediatric...

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