USA – PDUFA VII: FDA, industry preview their reauthorization wish lists

At its first public meeting in the runup to the reauthorization of the Prescription Drug User Fee Act, the US Food and Drug Administration (FDA), industry and other stakeholders on Thursday shed light on their goals for what will be the agency’s seventh PDUFA program.

The meeting, held fully virtually for the first time due to the COVID-19 pandemic, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s new drug review program from FY2023-FY2027.

Going from VI to VII

FDA Commissioner Stephen Hahn opened the meeting by touting the successes of the current PDUFA program. “Since FY2016, nearly five years after our previous meeting, CDER and CBER have approved over 150 new molecular entities, new drug applications and biologics license applications,” Hahn said, nearly half of which have been for orphan indications.

Hahn added that in the most recent fiscal year, FDA, “Reached a new high for priority applications filed – 72 – and total applications filed – 166 – and again are on track to meet or exceed most of our review performance goals.”…