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The FDA Oncology Center of Excellence recently announced Project Facilitate, a pilot program seeking to streamline expanded access to investigational drugs in the era of Right to Try laws.
The project calls for a new call center, which will be a single point of contact for physicians seeking expanded access to investigational oncology drugs. FDA oncology staff will help physicians through the process of submitting the request for expanded access and follow-up as needed.
Jessica Boehmer, MBA, a regulatory scientist in the Office of Hematology and Oncology Products, outlined the benefits of the new approach at a recent FDA workshop. These include “IRB resource options,” she said.
“Project Facilitate staff will be equipped to provide step-by-step support geared toward community providers who need access to an IRB where they practice,” Boehmner said. “[FDA] will guide the caller to IRB resource options, pharma\biotech contact, and necessary information to complete the request as well as assistance in filling the form if needed.”
As with other expanded access requests, physicians will not need preapproval from an IRB, but will need to notify the IRB within five days of treatment initiation, an FDA spokesperson says.
The first option for patients is to enroll in a clinical trial, but if that is not possible, oncology patients can seek investigational treatments through the project facilitate pathway. “[The FDA is] exploring ways to make it easier for patients, their families, and healthcare professionals to understand the process and how to access investigational therapies,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.
The idea is to simplify the expanded access process, which Right to Try advocates have accused of being too cumbersome and bureaucratic, says Carolyn Riley Chapman, PhD, MS, a professor in the New York University Division of Medical Ethics.
“Oncologists can call and get guidance on how to submit the request. They can even call before they have gotten approval from a particular manufacturer about access,” she says. “The FDA is opening its doors as a resource.”
The pilot call center project will inform the FDA’s efforts to streamline the expanded access process in general. For example, the longstanding approach for expanded access for cancer patients saw requests forwarded separately to various points within the FDA, including to the separate divisions for oncology and hematology.
“The pilot program includes a central office for oncology requests so that the FDA can follow up on individual requests and gather data, such as how many patients received the investigational medical products, and if not, why the requests were denied,” the agency said in a statement. “The FDA can use this data to determine how the process is benefiting patients and healthcare professionals. In addition, the data could assist in encouraging sponsors to open clinical trials to study drugs for additional indications.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Leslie Coplin, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.