The US Food and Drug Administration (FDA) is starting a program to facilitate requests for cancer patients to access drugs that have not been approved yet. The program is part of a wider effort to make its expanded-access program more accessible, according to the Washington Post.
The FDA already allows cancer patients that have exhausted other treatment options to request access to unapproved treatments.
But the agency’s “expanded access” program typically requires three stages of approval for a doctor to get unapproved drugs for a patient. First, they must ask a drug company to provide the treatment, then bring their request to an institutional review board (IRB) that ensures the patient understands the risks, and finally, to the FDA for final approval. After these other stages of scrutiny, the FDA almost always approves the requests.
However, drug companies often hesitate to approve these requests due to cost or limited supply of the treatments. And patients in hospitals with fewer resources to work on the request are often at a disadvantage in earning approval from companies. These hospitals are often in rural or disadvantaged urban areas.
But with the new program, the first step for doctors would be to contact the agency itself, which would handle the paperwork and make the request directly to the drug company, giving it added legitimacy. They’ll also help to find an IRB and the right contacts at the drug company.
For some oncologists new to the program, the process to request access may also still seem confusing, said the FDA’s Oncology Center for Excellence director, Richard Pazdur.
The program’s new “concierge service” will help doctors navigate the process through Project Facilitate, a call center meant to serve as a hub for requests. And by filing these requests through the agency, it could provide a more level playing field for patients’ requests to drug companies.
“We do not want to have the situation where somebody who screams loudest gets the drug,” Padzur said. “We are here to help. We are not here to make a drug company give a specific drug to a patient. We don’t have that authority.”
The project will specifically facilitate access to cancer treatments, and not drugs for other diseases. It was announced at a meeting of the American Society of Clinical Oncology in Chicago on Monday.