CHICAGO – The Food and Drug Administration launched a new call center project to assist physicians seeking to help cancer patients access unapproved therapies.
MDedge/Neil Osterweil
Dr. Richard Pazdur
Entitled “Project Facilitate,” the program aims to create a single point of contact with FDA oncology staff who can guide physicians through the process of submitting Expanded Access (EA) requests on behalf of individual patients.
“This is a pilot program to provide continuous support to health care professionals throughout the entire Expanded Access process,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products said during the unveiling of the project during a press briefing at the annual meeting of the American Society of Clinical Oncology.
Physicians utilizing Project Facilitate can expect a “concierge service” experience including advice on the information needed to complete requests, assistance completing forms, pharma/biotech contact information, independent review board resource options, and follow-up on patient outcomes.
The project will work in synergy with the Reagan-Udall EA Navigator website, an “online road map” for physicians and patients that was launched 2 years ago “to facilitate and coordinate and collaborate with the FDA to advance the science mission of FDA,” and which has been expanded in conjunction with Project Facilitate, Ellen V. Sigal, PhD, chair of the board of the Reagan-Udall Foundation for the FDA, said at the press briefing.
“EA Navigator delivers transparent, concise, and searchable information provided by companies about their Expanded Access policies,” Dr. Sigal said. “Today I’m pleased to announce that the Navigator now features Expanded Access opportunities listed in ClinicalTrials.gov for companies in the directory.
“For the first time, those who need quick access to drug availability and Expanded Access options will find it in one place without having to visit site by site by site, or sift through thousands of studies that don’t merit their needs,” she added, noting that EA Navigator will often be the first step for physicians before they engage with Project Facilitate.
Project Facilitate can be reached Monday-Friday, 9 a.m.-5 p.m. ET at 240-402-0004, or by email at OncProjectFacilitate@fda.hhs.gov.