ARTICLE SUMMARY:
MDUFA VI talks between FDA and industry advance, with some snags. Excerpted from Pathways’ Picks Febraury 11: User Fee Sticking Points, AdvaMed Hire, China Clinical Trial Policy.
AdvaMed and the Medical Device Manufacturers Association oppose FDA’s push for more flexibility to charge device user fees in the face of funding and spending variance, according to recent meeting minutes released from the ongoing user fee negotiations. As part of the reauthorization that must take place next year, FDA is proposing updates to statutory trigger mechanisms that allow it to collect fees from companies only when Congress appropriates and the agency spends more than pre-set minimum amounts. The current MDUFA V appropriations trigger is tied to the amount lawmakers distribute specifically to the device program, but under MDUFA VI the agency wants to change the structure so it is based on FDA-wide appropriations, irrespective of device-specific funding. It is also seeking more wiggle room on the spending trigger. However, “industry remained opposed to all aspects of the proposal except for the technical corrections,” according to minutes from a January 14 session posted last week. The triggers are intended to ensure industry fees remain a supplement rather than replacement for government funding.