The U.S. Food and Drug Administration (FDA) introduced a more streamlined form for requesting permission for patient access to investigational drugs outside of clinical trials.
The new form is available for comment in a draft guidance for industry entitled “Individual Patient Expanded Access Applications: Form FDA 3926.” This draft guidance introduces and describes draft Form FDA 3926 – Individual Patient Expanded Access-Investigational New Drug Application (IND). When finalized, the form will be available for physicians to use for expanded access requests for individual patient INDs.
FDA invites comments on the draft form in its Federal Register notice.
Expanded access allows for the use of an investigational drug outside of a clinical trial for an individual patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Draft Form FDA 3926 provides a streamlined alternative to Form FDA 1571 (Investigational New Drug Application) for requesting individual patient expanded access.
In a post on the FDA Voice Blog, Peter Lurie MD, MPH, associate FDA commissioner for public health strategy and analysis, wrote that the agency developed the new form in response to concerns from physicians and patients that the current form was too difficult, requiring 26 types of information and seven attachments, and taking physicians about 100 hours to fill out. The new form requires only eight elements of information and a single attachment, and should take physicians about 45 minutes to complete.
“The revised process, when finalized, will not change the agency’s rigorous requirement that all medical products on the market be studied in clinical trials in order to be FDA-approved as safe and effective,” Dr. Lurie wrote. “As before, expanded access to an investigational medication may be available when there is no other product that can diagnose, monitor, or treat the patient’s disease or condition, and the patient is not and cannot be enrolled in a clinical study testing it.”
The agency also redesigned the Expanded Access section of its website to better explain the proposed process and make it easier to navigate.
