The FDA is finalizing steps to streamline the process used by physicians to request “compassionate use” access to investigational drugs and devices for their patients, according to FDA Commissioner Dr. Robert Califf.
Expanded access, often referred to as “compassionate use,” allows physicians to use investigational devices or drugs outside of a clinical trial to treat a patient suffering from a serious disease or condition with no alternative treatment option, according to the FDA.
“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,” Califf said in a press release.
The federal watchdog today released the final Individual Patient Expanded Access Investigational New Drug Application.
The form, FDA 3926, can be used to request expanded access to investigational drugs for patients who suffering from serious or life-threatening conditions without a comparable or satisfactory alternative therapy available.
The newly released form is significantly shorter than the previous form, Califf said, and should take approximately 45 minutes to fill out. The form also comes with step-by-step instructions for completion, and is designed specifically for individual patient expanded access requests.
The FDA also released 2 additional final guidance documents related to expanded access. The 1st is in a Q&A format and explains what expanded access is, how to use it and the type of information required, and the 2nd explains explains how patients would be charged for investigational drugs.
“The FDA has a long history of supporting patient access to investigational treatments and we hope the information released today will help health care professionals, patients, and industry to more easily navigate the expanded access process and help patients who qualify to gain access to potentially life-saving investigational treatments,” Califf said in prepared remarks.