ARTICLE SUMMARY:
FDA hopes to reach a tentative agreement with industry groups on a MDUFA VI user fee reauthorization this month, but the two sides still have multiple issues to resolve, according to public meeting minutes.
FDA wants to start crafting a formal commitment letter with industry groups this month detailing the structure of company fees and FDA commitments under a reauthorized device user fee agreement.
The agency directed negotiators “to hold March meeting dates in order to finalize MDUFA VI negotiations and begin the commitment letter writing process,” during a February 4 session, according to meeting minutes published by FDA. That plan would put the process about a month behind what the agency signaled last October when the talks began. At that time, the agency told patient and clinical groups that it wanted the core negotiations wrapped up in February followed by a six-month effort with industry to write the commitment letter agreement.
Under that timeline, if a preliminary agreement is reached in March, the commitment letter might be released by around September, giving the agency about three months to collect public feedback before the parties are supposed to submit the agreement to Congress in January. The goal is to give lawmakers enough time to pass necessary reauthorization before the current MDUFA V program expires in September 2027.
The two sides, where industry is represented by AdvaMed and the Medical Device Manufacturers Association, have made progress over four months of negotiations, but disagreement on certain issues has persisted. Information on the status of the talks is based on meeting minutes issued publicly by FDA on a delayed schedule. The most recently available minutes come from a February 11 meeting, but the parties have likely held at least three sessions since then—so the public details are not up to date. Still, what has been circulated helps paint a picture of core components that are likely to be in a deal and where the biggest points of contention remain.
Here’s a spotlight on select items of agreement, areas of ongoing discussion, and points of clear disagreement based on a Market Pathways analysis of the minutes that have been released as of March 3 from 10 negotiation meetings extending from the end of October to February 11.
