ARTICLE SUMMARY:
FDA and industry met behind closed doors in October to start negotiations to reauthorize device user fees. The agency hinted at the prospect of refining the fee program to selectively support US-based businesses, and it pushed against the current performance-based framework for adjusting fees, according to meeting minutes posted this week.
FDA signaled interest in a device user fee structure that favors US businesses, and it pushed to remove the link between fee adjustments and the agency’s success in meeting review/hiring targets during its first MDUFA VI reauthorization negotiation meeting with industry groups held last month.
The agency said during the October 29 session that device user fee increases, overall, “should be nominal” and that it “would like to explore ways this could be accomplished without increasing user fees on American businesses operating in the United States,” according to minutes of the meeting posted online by FDA November 24. Per the minutes, FDA “conveyed the agency’s intention to negotiate the user fee structure and certain other aspects of MDUFA’s statutory framework, to align with agency and broader administration priorities for simplicity, programmatic alignment, and to advance certain aims such as promoting American business, and particularly small business.”
The comments align with the “America first” focus of the Trump administration and prior remarksby FDA officials about potentially leveraging the user fee programs to help shift more manufacturing back to the US. No other substantive details on FDA’s proposed fee structure were included in the summary of the meeting. It was the first of what is expected to be dozens of sessions scheduled between agency and industry officials over the coming months to hash out an agreement to reauthorize user fees, transitioning from MDUFA V, which expires September 30, 2027, to MDUFA VI.
