FDA's Oncology Center of Excellence (OCE) on Monday announced a new pilot program that aims to bolster patients' access to experimental cancer treatments.
The pilot program will focus on FDA's Expanded Access pathway, also known as FDA's "compassionate use" program. The pathway allows health care professionals to request access to unapproved, experimental cancer treatments for patients with serious or life-threatening diseases if they have no comparable alternatives.
But OCE said the pathway "can be perceived as complex to navigate, particularly for oncologists who don't have experience working with clinical trials or these types of requests."
About the pilot program
To help simplify the process, OCE said it will launch a new call center, called Project Facilitate, that will serve as a single point of contact for oncology health care professionals to get help with submitting Expanded Access applications and following-up on patient outcomes.
Under Project Facilitate, FDA oncology staff will help oncology professionals with the entire Expanded Access process, including identifying necessary institutional review boards and appropriate contacts at pharmaceutical companies. OCE said it also will contact drugmakers that reject patients' access to drugs and ask why they denied the request.
According to OCE, the pilot project also will help FDA centralize and compile data on Expanded Access requests and their outcomes. The agency then can use that data "to determine how the process is benefiting patients and health care professionals" and potentially "encourage[e] sponsors to open clinical trials to study drugs for additional indications," OCE said.
Richard Pazdur, director of OCE and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said, "The new Project Facilitate call center aims to help in making these requests as streamlined and efficient as possible for physicians who would like to request access to investigational therapies for their patients with cancer." He continued, "Through this pilot program, experienced FDA oncology staff will be available to support physicians and other health care professionals with their questions, assist in filling out the appropriate paperwork, and acting as a facilitator for the process."
Acting FDA Commissioner Ned Sharpless said the pilot program "is part of [the agency's] continued commitment to Expanded Access." He added, "We hope that this pilot program will simplify the process for oncologists, and ultimately benefit patients."
According to the Journal, Pazdur said FDA is testing the pilot program first with cancer drugs, and later could expand the program to treatments for other diseases (Loftus, Wall Street Journal, 6/3; FDA release, 6/3; McGinley, Washington Post, 6/3; Paavola, Becker's Hospital Review, 6/3).
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