A new FDA program aims to simplify the process doctors use to offer non-approved cancer treatments to patients.
WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.
Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, said some patients can’t afford to wait for potential remedies as they undergo lengthy approval processes.
“I think it’s a step in the right direction,” Orient told FDA Reporter. “If a patient has a choice of no treatment and almost certain death over a certain period of time than it seems to us that patient has the right to choose to take more risks than they would if they were perfectly healthy. “
The program, announced June 3 by the FDA, will establish a call center known as Project Facilitate. It will serve as the go-to contact for physicans who need to reach FDA oncology staff. Staff will be available to help phyiscians file necessary paperwork to request access to experimental treatments, as well as answer any questions related to their patients' medical cases.
Before, there was no single source receiving requests from physicians seeking alternative treatments for cancer patients. Under the new FDA project, a central office will take requests, allowing officials to collect data on the number of patient requests that were approved or rejected. Such data could later be used to encourage clinical trials to study certain drugs.
Safety concerns exist regardless of whether drugs are FDA-approved, Orient said. Providing more choices can prove beneficial to patient care.
“I think anytime a physician has more options available to treat patients — especially those who are desperately ill and just don’t have any other chances — the doctors, in general, are in favor of anything that might help their patient,” Orient said. “I understand that it’s a risk and I think that they will certainly figure that into their decisions about whether or not to recommend the drug.”
Doctors request permission to treat patients with not-yet-approved medicines in cases where the patient does not fit the requirement for experimental trials or resides too far from the site.
“It’s giving them more options,” Orient said. “As a matter of philosophy for us, I think that patients really have the right to make their own medical decisions.”