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Dec. 20, 2018

TOPIC: Advocacy

NORD Issues Statement on FDA’s Impending Expanded Access Call Center

Posted by Christina Jensen

Washington, D.C., December 20, 2018 – The National Organization for Rare Disorders (NORD), the leading independent nonprofit organization representing the 30 million Americans with rare diseases, issued the following statement on FDA’s impending expanded access call center:

“Late last week, the Food and Drug Administration (FDA) announced it will soon be launching a call center specifically for patients and physicians seeking access to investigational therapies through expanded access. The program will initially focus on oncology but intends to soon expand to all conditions. NORD has advocated for several years for a central location within FDA for expanded access information and inquiries.

Currently, each review division within FDA handles single-patient expanded access requests, and it can often be difficult for patients to navigate. Consequently, we are thrilled that FDA has taken a step toward addressing this obstacle. NORD strongly believes that rare disease patients should be given every opportunity to access promising investigational therapies through expanded access, and this new project will go a long way toward facilitating that goal. We eagerly await the implementation of this new program, and we stand ready to assist FDA with this effort.”