Gottlieb Highlights Agency’s Commitment to Expanded Access to Trials

Commissioner Scott Gottlieb unveiled a redesigned FDA website on expanded access to clinical trials and said the agency is “deeply committed” to helping critically ill patients with no other treatment options to join trials.

The FDA has granted 9,000 patients access to trial drugs over the past five years and has greenlighted more than 99 percent of the applications it has received, he said.

An independent assessment of the expanded access program showed that stakeholders support it, but also identified areas in need of improvement, he said. The most common reported challenges included difficulty navigating the program, multi-stakeholder coordination and administrative burdens.