FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer - Drug Information Update

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer - Drug Information Update

Today, the U.S. 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.

Expanded Access is a pathway for a patient with an immediately life-threatening or serious disease or condition to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory alternative therapy options available. Because investigational medical products have not yet been approved or cleared by the FDA and have therefore not been found safe and effective for their specific use, part of the FDA’s role in granting Expanded Access requests is helping weigh whether the potential benefit of the investigational treatment justifies the potential risks. To make a request, the patient’s physician will contact the pharmaceutical company to ask for its agreement that it will provide the medical product. The company has the right to approve or disapprove the physician’s request. The FDA authorizes the vast majority of these requests. This process can be perceived as complex to navigate, particularly for oncologists who don’t have experience working with clinical trials or these types of requests.

The Project Facilitate phone number is 240-402-0004 and the email address isOncProjectFacilitate@fda.hhs.gov. Health care professionals may call during regular business hours, 9 a.m. to 5 p.m., Eastern Standard Time, Monday through Friday. Patients and families with questions can call 301-796-3400 or email druginfo@fda.hhs.gov.

To learn more, please visit: Project Facilitate.