Tuesday, January 28, 2020

Tuesday, January 28, 2020

Project Facilitate will help physicians access unapproved therapies

A new pilot program, Project Facilitate, was announced last week by the Food and Drug Administration to help oncology health-care professionals access unapproved therapies for their cancer patients.

The FDA staff will help the health-care professionals through the process of submitting an Expanded Access request. This move comes after the FDA issued guidelines for companies to expand their eligibility criteria so more cancer patients could participate in clinical studies.

“For decades, the FDA has been deeply committed to helping facilitate access to investigational medical products for patients with serious or immediately life-threatening diseases, while also protecting patients and helping them to be able to make informed decisions with their physicians,” said acting FDA Commissioner Ned Sharpless.

“The first option for patients who have exhausted available treatments is to enroll in a clinical trial, but when that is not an option, we support Expanded Access and are exploring ways to make it easier for patients, their families and health care professionals to understand the process and how to access investigational therapies. 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. Today's launch of Project Facilitate is part of our continued commitment to Expanded Access and we hope that this pilot program will simplify the process for oncologists, and ultimately benefit patients."

The Expanded Access applications would allow a seriously ill patient to receive an investigational medical product for treatment when there are no other options available through approved products.

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US Food and Drug Administration

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