Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program





Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program  

Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials. As a cancer survivor, I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. This is especially relevant when there’s no other FDA-approved treatment option available to a patient.

FDA is deeply committed to facilitating this access, while also protecting patients and helping them to be able to make informed decisions with their physicians. We also take steps to help make sure that such access doesn’t interfere or jeopardize investigational trials...