30 May 2018 - For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access products through clinical trials. 

This is the mission of our expanded access program. The agency is dedicated to these purposes, and it has been for more than three decades.

We’ve taken many steps to improve our process through which patients can access promising investigational drugs. We understand that treatment decisions for those facing terminal illnesses are best made by patients and families, with the support of their treating physicians. When appropriate, those suffering from a terminal illness who’ve exhausted available options should be able to access promising treatments being studied in clinical trials, or products under active review by the FDA. The agency is faithfully committed to these goals, to protecting patients, and to making sure they’re able to make informed decisions.

Read FDA Statement