Califf, BIO out of sync on accelerated approval, IRA

BIO CEO Rachel King asked FDA Commissioner Rob Califf about some of the industry’s most pressing concerns at the trade association’s convention on Wednesday. His responses weren’t comforting for an industry that is fighting to prevent FDA from increasing the hurdles to accelerated approval, has argued vehemently against attempts to reduce coverage and reimbursement for accelerated approval drugs, and dreads Medicare drug price regulation.

Beyond accelerated approval, Califf provided cold comfort for biopharma companies that are fighting tooth and nail against the Medicare drug price regulation provisions of the Inflation Reduction Act. ...