The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting.
Project Facilitate is essentially a call center that will be run by the FDA Oncology Center of Excellence. It’s a single point of contact where FDA oncology staff will help oncology providers submit an expanded access request for an individual patient.
Richard Pazdur, MD
“The new Project Facilitate call center aims to help in making these requests for expanded access as streamlined and efficient as possible for physicians who would like to request access to investigational therapies for their patients with cancer,” said Richard Pazdur, MD, Director of the Oncology Center of Excellence. From his perspective, it’s a “concierge service” that will operate throughout the expanded access experience, from the initial request for the drug to the completion of treatment.
Project Facilitate is being paired with Expanded Access (EA) Navigator, an “online road map” launched 2 years ago that is operated by the Reagan-Udall Foundation. EA Navigator, which can be used by providers or patients, links to a searchable database of current clinical trials, includes expanded access policy and program details, and is expected to be the initial step in the process.
EA Navigator delivers transparent, concise, and searchable information provided by companies about their expanded access policies.— Ellen V. Sigal, PhD
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“EA Navigator delivers transparent, concise, and searchable information provided by companies about their expanded access policies,” said Ellen V. Sigal, PhD, Chair of the Reagan-Udall Foundation. “I’m pleased to announce that the EA 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 company websites site by site by site or sift through thousands of studies that don’t meet their needs,” she added.
“Project Facilitate is not a patient portal, but EA Navigator is both for physicians and patients,” Dr. Pazdur explained. The provider (or patient) may search the EA Navigator for information to guide that choice and then the provider may contact Project Facilitate for help with the request.
Furthermore, the program should provide the FDA with much-needed information. “At the current time, the FDA doesn’t know the number of expanded access requests for patients,” Dr. Pazdur said. “And many times, the physician will go to the [drug] sponsor, and the FDA is not aware if the sponsor denies these requests. We also do not know the reasons for drug sponsors’ denying these requests.” The FDA would welcome this information, he added.
Information about patient outcomes will also be gathered during the process, and this may be shared with trial sponsors. “Frequently, we are unaware of patient outcomes such as benefits from the proposed therapy and adverse events associated with that therapy,” explained Dr. Pazdur.
Under the 21st Century Cures Act, companies were required to make information about their expanded access programs public. The Reagan-Udall Foundation component of this expanded access pilot helps, in part, to broadly disseminate that information. According to Dr. Sigal, Project Facilitate and EA Navigator are “necessary tools for patients and physicians.”
Project Facilitate can be reached Monday through Friday, 9:00 AM to 5:00 PM ET, at 240/402-0004 or by e-mail at OncProjectFacilitate@fda.hhs.gov. ■