MDUFA VI Talks Resume With Foreign Fees, Funding Triggers and Staffing Still Open

Negotiations between the US Food and Drug Administration's device center and medical device industry groups over the next user fee agreement resumed in January with several large questions still open, including how fees should be split between US and foreign companies, the statutory conditions that let the FDA keep collecting fees, and the device center's staffing. MedTech Dive reported on January 14 that the FDA and industry meet multiple times per month behind closed doors, and that stakeholders expect an agreement to go to Congress this year.

The Medical Device User Fee Amendments, or MDUFA, set how much the FDA can raise from industry over five years to supplement taxpayer funding. The current program, MDUFA V, allows the Center for Devices and Radiological Health to receive $1.78 billion to $1.9 billion over five years, depending on whether the agency meets performance and hiring goals, MedTech Dive reported. It expires in September 2027.

Fees, triggers and the operating reserve

At a December 12 meeting, the FDA presented a mid-point assessment of the talks, according to the agency's minutes. "FDA emphasized that with modest fee structure revisions, any increase can be borne by foreign establishments such that entities operating within the United States should see flat or decreased user fees in MDUFA VI," the minutes say. Both sides agreed that major proposals were on the table and that later meetings would focus on refining them rather than introducing new ones.

Earlier, on December 2, the FDA proposed changes to the user fee "triggers", the appropriation and spending thresholds in the Federal Food, Drug, and Cosmetic Act that condition fee collection, including increasing both thresholds and enlarging the operating reserve to cover extended lapses in funding, according to minutes of that meeting. Industry agreed in principle that adjustments to the spending trigger would be appropriate, the minutes say.

At the next session on December 11, industry representatives supported reforming the operating reserve but opposed reforming the appropriations trigger, and opposed both parts of an FDA proposal on resource capacity planning, according to the December 11 minutes.

Staffing after last year's cuts

In the December 2 minutes, the FDA acknowledged that the device center "has recently experienced a reduction in staffing levels" while stressing active recruitment. Industry noted that MDUFA V funded net new hires and that the FDA is operating below that baseline, and on December 11 asked for confirmation that new hires funded under MDUFA V will be realized by the end of fiscal 2027, the minutes show.

MedTech Dive cited a ProPublica analysis from August that found the device center had lost more than 20% of its staff to cuts and attrition. Device lobbying groups AdvaMed and the Medical Device Manufacturers Association declined to comment to MedTech Dive on the negotiations.

Patient groups want more access

Patient groups told MedTech Dive they are excluded from the industry sessions and rely on minutes that are posted weeks after meetings. Diana Zuckerman, president of the National Center for Health Research, told the outlet that the FDA and industry aim to bring a commitment letter to Congress this year. "They seem to be moving quickly," she said.

Michael Abrams of Public Citizen called for more funding from Congress for postmarket reviews and recalls, MedTech Dive reported, while other advocates asked for easier adverse event reporting and stronger enforcement of malfunction and injury reporting.