- May 16, 2019
4:01 PM ET
Event LocationWhite Oak Campus: The Great Room
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
Norman E. "Ned" Sharpless,
Leadership RoleCommissioner of Food and Drugs - Food and Drug Administration
White Oak, MD
(Remarks as prepared for delivery)
Good afternoon, and thank you all for being at this meeting today.
I am pleased to be here to speak about Project Facilitate.
I believe this is an issue that gets to the very essence of some of our work at the Agency—making sure patients can get access to oncology products in the pre-market setting, when they are left without other options.
As an oncologist it was a large part of my work to find potential treatments for patients that are out of options.
In fact, one of the main reasons I switched from a largely clinical practice of medicine to a largely research setting was because of my disappointment in the lack of treatment options for patients.
That’s why I dedicated my work to focus on just that, finding new and treatments for patients with cancer.
We have come so far in the years since I’ve been an oncologist, and I am pleased and very optimistic about the progress we are making.
But access to clinical trials for patients remains a problem in cancer research.
We know that not all oncologists or healthcare providers have the regulatory expertise or resources to navigate the single patient IND process; and I know many oncologists who just assume the process is too burdensome to even try.
As NCI Director, I spent many hours in meetings trying to figure out ways to provide greater access to clinical trials for patients, as accrual is a key concern for modern cancer research.
Finding better ways to do clinical trials matching was a key research question at NCI
And Expanded Access (EA) has also been an important part of that conversation.
In order to help oncologists and patients obtain access to investigational drugs for treatment use, and to help ensure that patients don’t miss out on potential opportunities, Dr. Rick Pazdur envisioned and developed Project Facilitate.
This pilot project will ensure that healthcare providers have one single point of contact for all oncology EA requests.
FDA’s dedicated staff will be available during business hours to assist oncology healthcare providers to:
•Locate IRB resources
•Find the Expanded Access contact from the drug/biotech company
•Complete form FDA 3926
•And provide advice on other necessary information to complete their request.
Project Facilitate will also aim to gain insight on whether the drug manufacturer provides access to the investigational drug, and if not, the reason.
Additionally, there are plans to implement reminders to healthcare providers of required follow-up submissions (e.g. safety reporting, annual reporting) as sponsors of an EA IND.
I am confident that Project Facilitate will clarify the single patient IND process and will help facilitate access to investigational oncology drugs in a more streamlined manner.
I am also pleased that Project Facilitate will leverage The Reagan Udall Foundation’s Patient Navigator Website, which includes diseases beyond just oncology, which connects patients, caregivers and physicians with expanded access programs.
Project Facilitate and Reagan Udall’s Patient Navigator are complementary to each other.
Reagan Udall’s Navigator can help guide patients through the different clinical trial and expanded access options to discuss with their physician – physicians may also use the Navigator for this service as well.
Project Facilitate at the OCE will help the physician request access to an investigational drug after the drug is selected as an appropriate option by the patient and physician.
As many of you know, not all manufacturers provide expanded access programs for various reasons, but this is an effort to provide clarity and transparency around FDA’s EA process.
It is paramount that we make the effort to optimize and clarify the EA process to mitigate potential communications or administrative burdens patients and physicians may be facing during a critical time in their patients’ treatment.
The objective is for these programs to complement each other and we hope this will encourage more transparency around EA and more manufacturers offering these EA programs.
Thank you all for being here to engage in this important discussion.