BETHESDA, Md., June 27, 2012 /PRNewswire-USNewswire/ -- The Cystic Fibrosis Foundation applauds passage of a bill in the United States Senate to expand cooperation between the Food and Drug Administration (FDA) and outside rare disease experts and patient advocates during the FDA drug approval process.
The bill, passed yesterday, is known as the Expanding and Promoting Expertise in Review of Rare Treatments Act (EXPERRT). Its passage in the Senate is the last hurdle before the bill goes to President Obama for his signature. He is expected to sign it into law.
Introduced by Sen. Sheldon Whitehouse (D-RI), EXPERRT is part of the FDA Safety and Innovation Act, which reauthorizes the FDA's user-fee program that funds its drug and device evaluation.
"The Cystic Fibrosis Foundation commends the Senate for its action on this issue, which is critical to the 30,000 Americans with cystic fibrosis and millions of others who struggle with complex conditions for which there are little or no available treatments," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "Senator Whitehouse has been an invaluable champion for the CF community, and we are grateful to him for his work on this critical legislation."
"I've heard from so many people with rare diseases who are frustrated with waiting for promising new treatments to gain approval, and who want to help speed up the process," said Whitehouse. "This bill accomplishes that goal by encouraging the FDA to take advantage of the wisdom and insights of rare disease experts and patient advocates in approving new treatments. It's an important step toward providing faster access to promising new therapies, and I thank everyone who supported this bill for helping me to push it across the finish line."
Passage of this legislation follows the recent approval of Kalydeco™, a cystic fibrosis drug developed by Vertex P
|SOURCE Cystic Fibrosis Foundation|
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