OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mitchell Chan, PharmD, BCPS, Regulatory Project Manager; Tamy Kim, PharmD, Associate Director of Regulatory Affairs; Jessica Boehmer, MBA, Regulatory Scientist; and Richard Pazdur, MD, Director, Oncology Center of Excellence, discuss Project Facilitate, an OCE initiative to provide personalized support to oncologists and health-care teams seeking the expanded access pathway for investigational drugs for individual patients.
Mitchell Chan, PharmD, BCPS
Tamy Kim, PharmD
Jessica Boehmer, MBA
Richard Pazdur, MD
Conception of Project Facilitate
How was the idea of OCE’s Project Facilitate conceived?
Dr. Pazdur conceived the idea of a call center to assist oncology health-care professionals with expanded access requests to the FDA. He had the idea for many years, and, in late 2018, with support from the FDA Commissioner, the team began working to set up the call center.
The idea was to have FDA oncology staff available by phone to walk oncology professionals step-by-step through the process of submitting expanded access requests to the FDA. To meet the needs of oncologists and their health-care team, Dr. Pazdur envisioned a streamlined approach where an oncology staff member can be reached immediately through one phone number. He wanted Project Facilitate to have FDA oncology staff on hand and ready to answer questions by phone or e-mail right away and to make the process of requesting expanded access through the FDA as streamlined and efficient as possible.
The call center has been staffed by a designated Team Leader and Regulatory Project Managers from the oncology divisions and the OCE who volunteer for the project. All staff members have experience processing expanded access requests and are equipped to guide callers through the process and assist with questions that might come up.
The FDA is committed to helping facilitate access to investigational drug products for patients with serious or immediately life-threatening diseases, when there is no satisfactory alternative therapy, potential patient benefits outweigh potential risks, and enrollment in a clinical trial is not possible.
Project Goals
What are the goals of Project Facilitate?
Our goals are to make expanded access equitable, to become a conduit for expanded access information and advice, to support oncology health-care professionals, and to improve efficiency and reduce FDA review process times. The FDA has diligently worked on streamlining and improving the expanded access framework, including an improved application form. Despite these improvements, we understand that, for many health-care professionals, especially those not familiar with the expanded access program, the process can appear burdensome and daunting.
To begin, we recognized there were challenges in obtaining expanded access. These challenges include lack of time, resources, and knowledge. Rural or small clinics generally do not have the resources of academic cancer centers, which may have regulatory offices to help manage expanded access submissions. Even large institutions sometimes do not know where to begin in submitting expanded access requests.
Often, oncologists and their teams do not have time to find the expanded access contact for a drug company or to research the steps for submitting such a request—some teams are not aware that treatment with an investigational drug is even an option. Some of the common challenges faced by oncologists are identifying an independent review board, obtaining and filling out Form FDA 3926, and determining who to contact when questions arise. Therefore, Project Facilitate offers one-on-one live assistance for all questions regarding the expanded access process.
Contact Information
Who can use Project Facilitate, and how can they reach you?
Project Facilitate is a resource for oncologists and their health-care team, including nurses, pharmacists, and other regulatory professionals. We work one-on-one with oncologists and their team to guide them through the expanded access process, regardless of their experience with it. We can be reached by e-mail at ONCProjectFacilitate@fda.hhs.gov or by phone at (240) 402-0004, during business hours Monday through Friday, 8:00 AM to 4:30 PM EST. For after-hours emergency requests, the FDA’s Emergency Call Center should be contacted at 1-800-300-4374.
Patients and their family and friends can contact the FDA’s Division of Drug Information at DrugInfo@fda.hhs.gov or (855) 543-DRUG.
Future Plans
What does Project Facilitate have planned in the future? Are there arranged phases?
The first phase of Project Facilitate started May 31, 2019. The purpose of the first phase was to establish an infrastructure for Project Facilitate. This structure includes ensuring that the call center is staffed during business hours, focusing on outreach to spread awareness, and triaging all oncology expanded access requests to their respective divisions or offices.
The second phase will involve centralizing the review of oncologic expanded access requests within Project Facilitate for products reviewed by the Office of Oncologic Diseases. Centralizing the intake and review of requests to Project Facilitate should improve efficiency and review times. The second phase is anticipated to occur toward the end of 2020.
“We saw a positive trend in 2019 compared with 2018, with more oncology expanded access requests being submitted to the FDA.”— Mitchell Chan, PharmD, BCPS; Tamy Kim, PharmD; Jessica Boehmer, MBA; and Richard Pazdur, MD
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Preliminary Data
Do you have any preliminary data to share?
We compared the number of Center for Drug Evaluation and Research oncology expanded access requests received between May 31 to August 31 of both 2018 and 2019. For 2018, a total of 133 requests (125 nonemergency, 8 emergency) were received by the FDA. For 2019, a total of 149 requests (142 nonemergency, 7 emergency) were received. For this period in 2019, Project Facilitate received 172 inbound phone calls and 1,007 e-mails. No applications were denied.
We saw a positive trend in 2019 compared with 2018, with more oncology expanded access requests being submitted to the FDA. We intend to continue outreach in the years ahead to reach more health-care teams and to gather information that can help adapt the program to the needs of the public.
Spreading the News
How is the FDA publicizing Project Facilitate?
The FDA held a public workshop on May 16, 2019, prior to the launch of Project Facilitate to obtain feedback from stakeholders to inform plans for the pilot. We continue to publicize Project Facilitate to oncologists and health-care and regulatory professionals by providing presentations about the program at different conferences, public meetings, and webinars. We currently have a dedicated web page for Project Facilitate as well as the available videos listed here:
- 2019 Public Workshop
- Project Facilitate Web Page
- Short introduction to Project Facilitate video
- Longer video on Project Facilitate and the Expanded Access process.
We held a press conference at ASCO on June 3, 2019, which was covered by several media outlets. Project Facilitate was also presented during the Drug Information Association and the Regulatory Affairs Professionals Society FDA Townhalls. We have also had several presentations at JADPRO Live, the annual meeting sponsored by the Journal of the Advanced Practitioner in Oncology and the Advanced Practitioner Society for Hematology and Oncology (APSHO), and plan to present at the 2020 Hematology/Oncology Pharmacy Association (HOPA) Annual Meeting in March. The OCE relays information about Project Facilitate on the @FDAOncology Twitter handle.
DISCLOSURE: Drs. Chan, Kim, and Pazdur and Ms. Boehmer reported no conflicts of interest.
