FDA Unveils Pilot Program to Expand Access to Investigational Oncology Drugs

The FDA has announced the launch of an oncology-specific pilot program for physicians and patients who need access to investigational therapies. The expanded access pilot program is a concierge service, said Richard Pazdur, MD, Director, FDA’s Oncology Center of Excellence, who spoke at a press conference at the 2019 American Society of Clinical Oncology Annual Meeting.

Project Facilitate is a 2-pronged program offered by the FDA’s Oncology Center of Excellence. It includes an online resource known as an expanded access navigator, which is provided by the Reagan-Udall Foundation for the FDA. The goal of expanded access programs is to locate investigational agents for patients who typically have exhausted all other treatment options and are not able to enroll in clinical trials of these newer therapies.

According to Dr Pazdur, the FDA receives approximately 1000 expanded access requests each year. Many of these requests come from patients who are in dire need of treatment and perceive investigational therapies are a last resort. Project Facilitate will streamline the process for patients and physicians to gain access to investigational agents as well as enable the FDA to gather data to improve the expanded access process and gain more knowledge about investigational agents, including outcomes and adverse events.

The Expanded Access Navigator is a searchable database that physicians and patients can use to identify clinical trials of investigational agents. The database will also provide information about expanded access oncology programs that will expedite an information search, said Ellen V. Sigal, PhD, Board Chair, Reagan-Udall Foundation, Washington, DC.

“For the first time, those who need quick access to drug availability and expanded access options will find it in one place without having to visit site by site or sift through thousands of studies that don’t [serve] their needs,” Dr Sigal explained.

The plan is to have physicians first visit the Reagan-Udall Foundation site and then go to Project Facilitate, which expedites the physicians’ process of applying for expanded access from drug companies. This process should be more streamlined than in the past, with the FDA focusing on broadening access and following up with physicians about outcomes.

“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 [facilitate] the process,” according to Dr Pazdur in a statement from the FDA Oncology Center of Excellence.

The FDA plans to share outcomes and adverse events of patients who have received investigational oncology drugs through the new expanded access process with the companies that provide the drug.

Expanded access depends on the drug company’s agreement to make an investigational therapy available outside of a clinical trial. A drug company may deny such requests because of limited drug supplies and other reasons that are beyond the control of the FDA, Dr Pazdur noted.

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