As PDUFA VIII talks begin, FDA wants ‘America First’ on the table

The Trump administration appears to have set aside its long-standing unease with FDA user fees in favor of a pragmatic approach in FDA’s negotiations with biopharma industry representatives on PDUFA reauthorization. Talks have begun smoothly, but recent PDUFA reauthorizations have all taken unexpected turns. It’s hard to imagine the White House or Congress resisting the temptation to engage in brinkmanship or use must-pass legislation as a bargaining chip.

The agency and industry are working to meet a series of deadlines that culminate in a Sept. 30, 2027, enactment of PDUFA VIII reauthorization legislation...