Ahead of the launch of a new pilot aimed at improving patient access to unapproved oncology drugs, dubbed Project Facilitate, the US Food and Drug Administration (FDA) held a public workshop on Thursday explaining its goals for the initiative and to discuss ongoing issues related to expanded access.
According to Richard Pazdur, director of FDA’s Oncology Center of Excellence, the pilot will be rolled out towards the end of May.
“Access to clinical trials and access to novel therapeutics for patients is still a problem. We know that not all oncologists or healthcare providers have the regulatory expertise or resources to navigate the single patient [investigational new drug] IND process, and I know many oncologists just assume the process is cumbersome without even trying it,” said Acting FDA Commissioner Ned Sharpless.
The goal of Project Facilitate is to address those issues by providing a single point of contact for oncology expanded access requests within FDA.
Under Project Facilitate, FDA staff will operate a call center for oncology expanded access requests that will help patients and healthcare providers find expanded access contacts at drug or biotechnology companies, complete the expanded access request form (Form 3296) and identify Institutional Review Board (IRB) resources.