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.
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.
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