Statement from FDA Commissioner Robert Califf on the release of the final individual patient expanded access form

2 June 2016 - Today, the U.S. FDA finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients.

As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.

Access to investigational treatments requires the active cooperation of the FDA, industry, and health care professionals in order to be successful. But we know that navigating that process can be challenging and time consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible.

One way we hope to make things simpler for physicians is to reduce the amount of time they spend filling out a request for access to an investigational drug. That’s why today we are releasing the final Individual Patient Expanded Access Investigational New Drug Application - Form FDA 3926. The new form can be used by physicians to request expanded access to investigational drugs for individual patients who suffer from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative therapy is available. It is much shorter than the form previously used for individual patient expanded access requests and is designed specifically for these requests. It should take about 45 minutes for a physician to complete the new form. Along with the new form we are also releasing step-by-step instructions on how to complete it.

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Michael Wonder

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Michael Wonder