ARTICLE SUMMARY:
In this week’s roundup: FDA and industry finally complete MDUFA V user fee negotiations, a look ahead to the International Medical Device Regulators Forum’s next meet-up, new CPT codes, recalls guidance, Swiss database, omnibus bill, notified body group’s new member, and more.
Top Pick: User Fee Deal Done
FDA and industry finally come to terms on MDUFA V:
After more than a year of challenging negotiations, the two sides have reached a MDUFA V user fee agreement with a novel structure, according to sources close to the negotiations. It will include fee increases for industry, the potential for “add-on” payments to FDA, new, total time-to-decision performance goals, strict hiring targets, and a pilot launch of the agency’s hard-sought TPLC Advisory Program. At its base, the deal would deliver about $1.8 billion in industry fees to FDA (including some carryover money from the MDUFA IV program), which is about $650 million above the current five-year fee total. But FDA could collect up to up to $1.9 billion from FY 2023 to FY 2027 if it meets all of its premarket performance goals. FDA and industry groups are hatching out the formal commitment letter this week so Congress can move forward with its legislative process. (For more details on the yet-to-be-announced deal, see “MDUFA V Deal Features Add-On Payments, Hiring Targets, and FDA’s TAP,” Market Pathways, March 9, 2022.)
