Gottlieb: Supply, not FDA, limits pre-approval access

On Tuesday, FDA Commissioner Scott Gottlieb said limited supplies of unapproved drugs, not FDA actions, are the main barrier to patients receiving access to unapproved investigational products. Pending right-to-try legislation does not address supply constraints, he said at a House Energy & Commerce Committee hearing.

“I’m in favor of giving sick patients options,” Gottlieb said. “Patients still have trouble getting access to drugs they think could save their lives,” he added. “The biggest problem is supply.”...