The Food and Drug Administration (FDA) has launched Project Facilitate, a pilot program which offers assistance to physicians requesting access to investigational medicines for patients with cancer.

The core of the program is a new call center where FDA oncology staff will guide clinicians through the Expanded Access submission process; Expanded Access is a pathway for those with life-threatening diseases to gain access to investigational treatments outside of clinical trials when alternative therapies are unavailable.

Prior to the initiation of this program, requests for Expanded Access were received at multiple places within the FDA. A central office will now streamline the process by allowing a dedicated staff to track and follow up on requests, in addition to gathering data (ie, number of patient requests, reasons for denied requests). In a statement, the FDA indicated that they will “use this data to determine how the process is benefiting patients and healthcare professionals.” Furthermore, the data may encourage sponsors to open clinical trials to study drugs for additional indications.

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“Ultimately, a patient cannot submit an application for an investigational medical product; only a qualified physician is able to officially make the request,” said acting FDA Commissioner Ned Sharpless, MD. “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.”

The non-profit, Reagan-Udall Foundation for the FDA, recently updated its Expanded Access Navigator web resource to educate patients and healthcare professionals about the FDA’s Expanded Access process.

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