Congressman Markwayne Mullin (OK-02) discussed the importance of the Rare Pediatric Disease Priority Review Voucher (PRV) Program during an Energy and Commerce Health Subcommittee hearing today. Mullin is an original cosponsor of H.R. 4439, the Creating Hope Reauthorization Act, which permanently reauthorizes the PRV Program.

Full video of Mullin’s remarks can be found here.

“There’s a disconnect between adult care and pediatric care. What’s available to our children versus what is available to adults is disproportionate,” Mullin said. “We can invest in this without costing us anything because of the return on investment.”

Today, half of rare diseases affect children, and it is estimated 95 percent have no treatment options. The PRV Program creates an incentive for drug manufacturers to develop therapies for rare pediatric diseases by providing a voucher which can be used by a drug manufacturer to speed the FDA review timeline for another drug application from the usual 10-month review to 6 months.

Without Congressional action, the Rare Pediatric Disease Priority Review Voucher Program is set to expire at the end of the fiscal year. The elimination of the Rare Pediatric Disease PRV program could have devastating impacts on rare disease drug development moving forward. Additionally, the program does not cost any taxpayer funding and is budget neutral.