Navigation Links
Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in the U.S. Senate
Date:6/27/2012

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 Pharmaceuticals with financial, scientific and clinical support from the Cystic Fibrosis Foundation.  Kalydeco's swift approval, announced by the FDA just three months after it was submitted for review, demonstrates how a well-informed, collaborative FDA review process involving reviewers, industry partners, patients and cystic fibrosis experts can efficiently move lifesaving therapies to market.  Kalydeco is the first CF drug to address the underlying cause of the disease in select CF patient groups.

About the Cystic Fibrosis Foundation
The Cystic Fibrosis Foundation is the world's leader in the search for a cure for cystic fibrosis. The Foundation funds more cystic fibrosis research than any other organization, and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. The Cystic Fibrosis Foundation is a donor-supported nonprofit organization. For more information, go to www.cff.org.


'/>"/>
SOURCE Cystic Fibrosis Foundation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Icahn Issues Statement Regarding Amylin Pharmaceuticals
2. American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
3. American Society of Hematology Statement on House Passage of Prescription Drug User Fee Act (PDUFA)
4. Millennium Laboratories Wins Lawsuit: Ameritox Advertisements Regarding Rx Guardian and Rx Guardian CD Contain Literally False Statements
5. Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in House of Representatives
6. Lilly Statement on PDUFA Vote by Senate
7. Synteract and Rempex Partner in "Great Strides" Walk to Support Cystic Fibrosis Cure
8. Insmed Incorporated Announces Lifting of Clinical Hold by U.S. Food and Drug Administration on ARIKACE® in Cystic Fibrosis Patients With Pseudomonas Lung Infections
9. Top-line Data From Phase 3 Trial of Ataluren in Patients with Nonsense Mutation Cystic Fibrosis Show Promising Results
10. Savara Pharmaceuticals Completes Phase I Clinical Study of AeroVanc in Cystic Fibrosis Patients
11. Cell Therapeutics to Host Investor and Analyst Meeting to Discuss Targeted Agents in Myelofibrosis and High-Risk Myelodysplastic Syndrome/Acute Myeloid Leukemia on Sunday, June 3, 2012, in Chicago
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , Net Sales of $1.90 billion represent an increase of ... and an increase of 1.2% on an adjusted pro forma, ... quarter were $0.52 reported, a decrease of 47.5% from the ... over the prior year period , The Company increases ... Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today ...
(Date:4/28/2016)... 28, 2016 TapImmune,Inc. (TPIV), ... peptide and gene-based immunotherapeutics and vaccines for the treatment of ... at the 3rd Annual Growth Capital Expo to ... 2016 at Caesars Palace in Las Vegas, Nevada.  The ... May 4 th by Dr. John N. Bonfiglio ...
(Date:4/27/2016)... 2016   , ... Recurring Consumable Sales  Clinical sales grow 16% ... (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary ... the first quarter ended March 31, 2016 and provided ... its commercial strategy. First Quarter 2016 Revenue ...
Breaking Medicine Technology:
(Date:5/2/2016)... ... May 02, 2016 , ... MedPro Waste Disposal, LLC ... service. MedPro now offers its mail back service for an all-inclusive rate. MedPro ... now able to provide service to all of the clients in the country who ...
(Date:5/2/2016)... Veendam, The Netherlands (PRWEB) , ... May 02, 2016 , ... ... Products is honored to announce that the new WHIMZEES Variety Value Boxes were selected ... EXPO 2016 New Product Showcase Award. , WHIMZEES natural dental chews for dogs ...
(Date:5/2/2016)... ... 02, 2016 , ... Dr. Rassouli, dentist in Orange County, CA ... the research, which was published in the “Journal of the American Geriatrics Society,” more ... million Americans have Alzheimer’s disease. The study found that dental problems may increase the ...
(Date:5/2/2016)... ... ... 2016 World Ultimate & Guts Championship (WUGC) Mixed roster was announced in February and Chris ... is being held in London, England this year from June 18-25. At the last WUGC ... in the women’s masters division, and a silver in the women’s division, so Mazur hopes ...
(Date:5/2/2016)... ... , ... According to an American Psychological Association article, the Centers ... the age of 18. Of those who survive, many still face effects as they ... In her new book, Lyah! Lyah! Pants on Fyah!, she shares stories from women ...
Breaking Medicine News(10 mins):