FDA Launches Expanded Access Pilot ‘Project Facilitate’

Regulatory NewsRegulatory News | 03 June 2019 | By

The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.
“The FDA has been working diligently to improve the Expanded Access framework, including development of an updated and more streamlined application form, but despite recent improvements, we understand that for many patients or health care professionals, especially those not familiar with the Expanded Access program, the process may appear confusing or burdensome,” said Acting FDA Commissioner Ned Sharpless.
Under Project Facilitate, FDA has set up a call center to serve as a single point of contact for oncologists to reach out to for assistance with completing and submitting expanded access requests for single patient investigational new drug (IND) applications.
“Through this pilot program, experienced FDA oncology staff will be available to support physicians and other healthcare professionals with their questions, assist in filling out the appropriate paperwork and acting as a facilitator for the process,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence.
Before the launch of the program, FDA said that expanded access requests for oncology treatments were received at multiple points within the agency before being routed to the appropriate oncology and hematology divisions.
Now, physicians looking for assistance with expanded access requests can call or email FDA at (240) 402-0004 or OncProjectFacilitate@fda.hhs.gov to speak with FDA oncology staff.
With Project Facilitate, FDA said it will gather better data on expanded access requests and treatments, including why requests were denied and how many patients receive the investigational drugs.
FDA said this data can help “determine how the process is benefiting patients and health care professionals” and could encourage sponsors to conduct clinical trials for new indications.
However, FDA stressed that improving its expanded access program is only part of its effort to increase access to investigational drugs and noted that the it recently issued five guidances aimed at expanding clinical trial eligibility criteria for oncology clinical trials.
In a separate announcement, the Reagan-Udall Foundation for the FDA on Monday said it has enhanced its Expanded Access Navigator to include expanded access programs registered with ClinicalTrials.gov.
“For the first time, those who need quick access to drug availability and expanded access options can find it all in one place, without having to visit site after site or sift through thousands of studies that don’t meet their needs,” said Amar Bhat, interim executive director at the Reagan-Udall Foundation.


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