Todd Berner in Healthcare, Pharmacy, Hospital Directors Gene Therapy CNS Rare Diseases • Vice President, Head Global Medical Affairs Jun 19, 2019 · 1 min read · +500

FDA To Expand Patient Access

FDA To Expand Patient Access

Cancer patients may be empowered to try experimental treatments with a newly launched FDA program. Titled Project Facilitate, the FDA is aiming to provide patients that have exhausted all conventional treatment options with an easy route to their Expanded Access program, which allows them to make use of any medication, biologic, and medical device undergoing FDA testing.


This program is only available to cancer patients with life-threatening conditions and aims to help them bypass the lengthy wait times to go through the trials and approvals process to use any experimental medicine. Even so, the responsibility falls on the FDA to ensure that any investigational medicine access is conducted in a safe and ethical manner. Though the FDA has always supported giving patients access to potentially life-saving treatment options, they hope that Project Facilitate will both streamline the process and provide patients with the education necessary to make informed decisions.


Project Facilitate illustrates further the complicated relationship between patients, healthcare providers, pharmaceutical companies, and the FDA. Even with the new program, the process of gaining access to investigational treatments can be long during a trying time in a patient’s life. Healthcare providers are given the responsibility of informing patients about these options as well as making contact with the pharmaceutical companies that might provide them. Project Facilitate helps patients by helping providers make contact with these companies and expedite the approval process.


In addition, Project Facilitate will feature a call center staffed by oncology experts to best assist physicians and address possible concerns. Since a patient can’t initiate the process themselves, having trained medical staff on hand to help make physicians make informed decisions while keeping the patients involved in the process is a perfect marriage of efficiency and autonomy for all parties involved.


And it’s not just about education for patients. The new program will also encourage more communication with pharma companies with the intent of them broadening their eligibility criteria for cancer patients to participate in clinical trials. Project Facilitate will also cultivate new data from their call center regarding the Expanded Access program and its impact on patients. This includes information on patient rejection, acceptance, and success rates to help researchers streamline clinical trials in the future.


Though it can be challenging to provide patients with investigational medical products while still maintaining transparency and safety, the FDA is looking to clear some of the obscurity surrounding options that can potentially save lives.