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The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
In a FDAVoiceblog post, dated July 24, 2017, FDA’s Deputy Center Director for Science Operations, Center for Drug Evaluation and Research, Richard A. Moscicki, MD, announced that the agency has launched the Expanded Access Navigator. The new online tool will guide patients with life-threatening diseases or conditions through the process of gaining access to investigational drugs not yet approved by FDA.
FDA’s Expanded Access process permits manufacturers, with FDA permission, to provide patients with life-threatening conditions investigational new drugs under FDA review. The agency receives approximately 1000 such requests a year through individual patient, intermediate, or large-size expanded access programs.
To streamline the process, FDA developed a simplified application for individual patient expanded access. The new Expanded Access Navigator will help patients and their families navigate the system. Information will be in one online location and include links to companies’ expanded access policies, criteria used by companies to determine whether to make a drug available through expanded access, and contact information. It will also provide patients and caregivers resources regarding clinical trials. A separate section for physicians will offer information on investigational treatment options, clinical trials, and how to engage with FDA and pharma companies.
“Using an investigational drug will always come with risk-and the expanded access process helps to assess whether the potential risks are appropriate for a patient. But the last thing a patient and their loved ones coping with serious or life-threating illness needs is an overly burdensome process for access to potential treatment options. The Navigator helps to reduce that burden,” Moscicki stated in the blog post.
The Navigator was developed by a team led by the Reagan-Udall Foundation consisting of patient advocacy groups, pharma, and FDA.