
WASHINGTON — The commissioner of the Food and Drug Administration sounded a note of alarm Wednesday over how hospitals are being paid for custom-built cancer treatments, suggesting that if a solution is not found soon, drug development could suffer.
“I’m extremely worried that if we don’t adapt the approach to reimbursement soon, we may foreclose the therapeutic opportunities,” Gottlieb said. One area, he said, is CAR-T, bespoke therapies that involve engineering an individual patient’s cells to fight against the cancer.
Gottlieb also suggested the FDA might have a role to play in that payment conversation.