[Congressional Record Volume 162, Number 115 (Friday, July 15, 2016)]
[Extensions of Remarks]
[Page E1141]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             RARE PEDIATRIC PRIORITY REVIEW VOUCHER PROGRAM

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                         HON. G.K. BUTTERFIELD

                           of north carolina

                    in the house of representatives

                        Thursday, July 14, 2016

  Mr. BUTTERFIELD. Mr. Speaker, I rise today to express my hope that 
the House of Representatives will reauthorize the Rare Pediatric 
Priority Review Voucher (PRV) Program before its expiration deadline of 
September 30, 2016. I urge my colleagues to consider and pass H.R. 
1537, the Advancing Hope Act of 2015 which I introduced with 
Representative Michael McCaul (TX-10) and would permanently reauthorize 
the Rare Pediatric PRV Program.
  The Creating Hope Act, which was signed into law by President Obama 
in 2012 as part of the PDUFA reauthorization, expanded the cost-neutral 
Food and Drug Administration (FDA) priority review voucher (PRV) 
program, allowing pharmaceutical companies to expedite FDA review of 
more profitable drugs in return for developing treatments for rare 
diseases. The Creating Hope Act was reauthorized for Fiscal Year 2016 
through the budget agreement passed at the end of last year, but is 
scheduled to expire soon. The Butterfield-McCaul bill would reauthorize 
the program, clear the way for more treatments to reach the people that 
need them most, and clarify the scope of the program to include 
diseases like Sickle Cell Anemia.
  There are many pediatric disease spaces where treatments are woefully 
inadequate or nonexistent, and the Advancing Hope Act of 2015 would 
help encourage the private sector to help find solutions. An example of 
a condition that could benefit from the reauthorization of the Rare 
Pediatric PRV Program is Alternating Hemiplegia of Childhood, known as 
AHC, which leads to life-threatening temporary paralysis in 
approximately three hundred children nationwide. Duke Children's 
Hospital and Health Center, located in North Carolina's First 
Congressional District, assists North Carolinian children Matthew 
Wuchich, Madison Pino, and Marley Pino, manage their conditions. 
However, they often have to travel long distances for care or be pulled 
out of school, and there is no cure in sight.
  Mr. Speaker, I urge my colleagues to reauthorize the Rare Pediatric 
PRV Program before the program expires in September. Congress must do 
all it can to encourage the development of cures for children like 
Matthew, Madison, and Marley.

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