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Jul. 12, 2017

TOPIC: Advocacy, Featured News

The National Health Council and NORD Commend House Passage of FDA User Fee Reauthorization; Urge Senate to Follow Suit

Posted by Christina Jensen

Washington, D.C., July 12, 2017 – The National Health Council (NHC) and the National Organization for Rare Disorders (NORD) commend the House of Representatives for passing the FDA Reauthorization Act (FDARA) with overwhelming bipartisan approval.

Passing this bill is a crucial step in reauthorizing four user fee programs that ensure the Food and Drug Administration (FDA) has the tools it needs to deliver safe and effective treatments and cures to people with chronic and rare diseases. These agreements, which are the culmination of years of negotiation between the FDA and industry, also include many patient-supported improvements such as increasing the voice of the patient in product development, increasing transparency of biomarkers and surrogate endpoints, developing a process for using real-world evidence, and improving the rare disease program.

The NHC and NORD also call on the Senate to pass, and President Trump to sign, FDARA by the end of July. If the bill is not enacted by July 31, the FDA will be forced to send layoff notices to their staff, causing tremendous disruption at the agency. Delay in reauthorization in 2007 created a backlog of product reviews that lasted for years.

In May, more than 120 patient organizations called on Congress to reauthorize the user fees in a timely fashion. People with chronic and rare diseases and disabilities simply cannot wait.

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About the National Organization for Rare Disorders (NORD)®
The National Organization for Rare Disorders (NORD)® is the leading independent advocacy organization representing all patients and families affected by rare diseases. NORD is committed to the identification, treatment and cure of the 7,000 rare diseases that affect 30 million Americans, or 1 in every 10 people. NORD began as a small group of patient advocates that formed a coalition to unify and mobilize support to pass the Orphan Drug Act of 1983. For more than 30 years, NORD has led the way in voicing the needs of the rare disease community, driving supportive policies and education, advancing medical research, and providing patient and family services for those who need them most. NORD represents more than 260 disease-specific member organizations and their communities and collaborates with many other organizations in specific causes of importance to the rare disease patient community.

Media Contact for NORD:
Lisa Phelps
(203) 702-2872
lphelps@rarediseases.org

Media Contact for National Health Council:
Jennifer Schleman
(202) 973-0550
jschleman@nhcouncil.org

2 Responses to “The National Health Council and NORD Commend House Passage of FDA User Fee Reauthorization; Urge Senate to Follow Suit”

  1. Lara Stoller says:

    I think that what you are doing is great! I just wish that there was more that I could do. I have Moyamoya. I was also recently diagnosed with Gastroparesis as well. I am dealing with this one. LOL Not too well. I will get a handle on this one. I always sign the E-Mails urging Congress. All it takes is one more voice. As you say, alone we are rare, together we are strong! My dad was diagnosed a few years ago with Parsonage Turner Syndrome as well. Keep doing what you’re doing. You guys are great!

  2. I have a rare and painful disease called porphyria and I’m getting a lot of trouble from the pain clinic about my medications is there anyone who knows who can help me get these people to understand that I’m not going to get any better I’m getting worse and the pain is getting worse too at the same time they are reducing my pain meds if anyone knows anyone who advocates for people like us or anyone to call please let me know thank you very much I don’t have the money to hire a lawyer and I’m not sure what to do anymore they will reduce my meds again September 1st please help

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