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FDA announces Expanded Access pilot program for oncology
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CHICAGO — The FDA today announced a pilot project called OCE Project Facilitate aimed at allowing physicians to more easily navigate its Expanded Access program for investigational oncology treatments.
Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, unveiled the program during a press conference at ASCO Annual Meeting.
Project Facilitate will act as a single point of contact for physicians and their staff to navigate them through the entire expanded access process — from getting physicians in touch with the manufacturers of investigational oncology therapies to assisting in completion of required FDA documentation. The pilot program will also facilitate collection of follow-up data on patient outcomes and adverse events.
“Once a physician knows which product they want to use and proceeds with an Expanded Access request, then the OCE Project Facilitate would take over as a pilot program to provide continuous support to health care professionals throughout the entire expanded access process,” Pazdur said.
A lack of knowledge about how many physicians have been denied single-patient requests for investigational drugs and the reasons why those denials were given by the manufacturers, contributed to the need for this pilot program, Pazdur added. The Project Facilitate program will allow the FDA to track this information, along with patient outcomes.
“There is a potential for unequal access to the program due to a lack of information; most of the Expanded Access program requests we get at the FDA come from university programs or from the investigators who have had experience with the drug,” Pazdur said. “There is also a perception among physicians who have not utilized this program that it is a burdensome process; hence, we wanted a project that would facilitate the entire process.”
The Reagan-Udall navigator website for information on the expanded access program was previously available for both patients and physicians, but Project Facilitate will serve as what the FDA called a “concierge service” for physicians and their staff only.
“It will be available from the initial request through the completion of the therapy, and it is for oncology products only,” Pazdur explained.
The current expanded access program has indeed been a burdensome process, according to Lois Ramondetta, MD, professor in the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center. She said barriers have emerged at both the FDA level and with payers, with the major issues being the time commitment to navigate the process and general frustration among patients when they are denied access to the drugs.
Ramondetta, who was not involved with the project’s implementation, believes that Project Facilitate is a positive development that can help address one of the contributors to physician burnout.
“The number of opportunities for patients are amazing, yet the more technology we have available makes things more difficult, and physicians get pulled away from their primary jobs, which is to make clinical decisions and connections with patients,” she said. “Anything like this project is helpful.”
A program like Project Facilitate can free up time for physicians to have more important conversations about treatment risks vs. rewards instead of navigating administrative red tape to get access to experimental therapies, she explained.
“At our institution, patients come in for discussions about what they can do next, mostly because their physicians have said that they are out of options,” Ramondetta said. “Anything that allows us more time with patients is always valuable.” – by Drew Amorosi
For more information:
Providers interested in using Project Facilitate can email OncProjectFacilitate@fda.hhs.gov or call 240-402-0004.
Disclosure: HemOnc Today could not confirm relevant financial disclosures at the time of reporting.