Contacts: Jennifer Schleman Lisa Phelps
National Health Council National Organization for Rare Disorders
FOR IMMEDIATE RELEASE
The National Health Council and the National Organization for Rare Disorders Commend House Passage of FDA User Fee Reauthorization; Urge Senate to Follow Suit
Washington, DC, 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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