BRIEF—FDA debuts pilot program to assist physician access to unapproved therapies

Today, the US Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.

A new call center called Project Facilitate will be a single point of contact where FDA oncology staff will help physicians treating patients with cancer through the process to submit an Expanded Access request for an individual patient, including follow-up of patient outcomes.

The FDA recently issued guidances encouraging companies to broaden their eligibility criteria to allow more patients with cancer to participate in clinical trials.

But in those cases where patients do not fit the trial requirements or live too far from a trial site, health care professionals can request permission from the FDA to treat a patient with an investigational medical product through Expanded Access.