FDA to Make Compassionate Use Applications Easier
The FDA is creating a simple, one-step process for physicians to gain access to experimental drugs for patients facing terminal, untreatable conditions.
Drugmakers will still have control over who receives investigational drugs, but the streamlined process outlined in draft guidance released last week will let a physician apply for patients to access a drugmaker’s compassionate use program in about 45 minutes, a process that currently takes 100 hours.
The centerpiece of the process is a new Form 3926 that requires just eight questions be answered providing information about the patient, their condition and prior treatments, and the name and treatment plan of the investigational drug.
In addition, physicians applying for compassionate use for a patient must request a letter of authorization from the drug’s sponsor to attach to the form, guaranteeing the drug will be made available and granting the FDA permission to refer to information in the sponsor’s commercial IND to review the request.
The FDA will review the application and the related IND to ensure that the patient is not eligible for access to ongoing trials, and approve use of the drug.
Once approved, the physician will be able to provide the medication to the patient without needing to satisfy other requirements in study protocols for the IND beyond those necessary to treat the one patient.
Under current FDA processes, physicians are required to complete the same form used for enrolling subjects in a trial to access compassionate use programs, which requires 26 pieces of information and at least seven attachments.
Industry will have 60 days to comment on the draft after notice of it is formally published in the Federal Register, which could be as soon as today.
View Individual Patient Expanded Access Applications: Form FDA 3926 at www.fdanews.com/02-04-15-expandedaccess.pdf. — Lena Freund