Industry shifts FDA from punitive to reward-based America First PDUFA policy

The biopharmaceutical industry appears to have secured a key concession in PDUFA reauthorization negotiations, moving FDA away from a punitive approach and toward an incentive-based one for advancing the Trump administration’s “America First” agenda.

The agreement is not final and remains subject to further negotiation as PDUFA reauthorization discussions continue. FDA and industry are expected to finalize negotiations and submit a PDUFA VIII agreement to Congress in the coming weeks. The legal deadline is January 15, 2027, but agreements are typically transmitted to Congress in the first quarter of the year before PDUFA expires. PDUFA VIII must be reauthorized by Oct. 1, 2027 to avoid a funding lapse. ...