Negotiations are underway between the FDA and industry regarding MDUFA V, the fifth medical device user fee agreement, but there are still some issues with the current agreement. One of those, according to industry representatives, is that the agency still has not hired all the staff it had committed to under MDUFA IV, an omission they say must be corrected expeditiously.
According to the transcript for the Oct. 27, 2020, meeting for MDUFA V, Janet Trunzo, senior vice president for regulatory affairs at the Advanced Medical Technology Association (AdvaMed), said user fees promote rather than distract the FDA from fulfilling its mission of protecting public health. Trunzo also said user fees have allowed the FDA’s Center for Devices and Radiological Health to hire hundreds of scientists, engineers and medical officers, and that interactive reviews have enabled a faster, leaner resolution of issues encountered in premarket submissions.
Nonetheless, Trunzo recommended that the agency complete the hiring of all staff that were agreed to and funded by MDUFA IV “as soon as possible.”
That perspective was echoed by Mark Leahey, president and CEO of the Medical Device Manufacturers Association. Leahey expressed some concern about the ever-rising volumes of user fees with each agreement, but added that the agency has yet to make approximately 50 hires agreed upon under MUFA IV.
Leahey also questions the FDA’s method for calculating the cost of each full-time equivalent (FTE) employee. He said the agency’s practice is to divide the total device review budget by the number of FTEs to arrive at the cost per FTE. Device makers are waiting for some information from the agency about this calculation, Leahey said, adding that industry seeks to arrive at a more appropriate approach for making such calculations.
Fees Supplemental, not Primary Revenue Sources
MDMA’s Leahey said the primary responsibility for FDA’s funding sources is congressional appropriations, and that user fees were always seen as supplemental to appropriations. That perspective should be maintained as the negotiations grind on, he said.
The first device user fee program yielded $144 million and jumped to $312 million under MFUFA II. The volume of fees doubled in each of the following iterations and will amount to more than $1 billion under MDUFA IV when all is said and done. Leahey said user fees amounted to more than $200 million in fiscal year 2019 alone.
Peter Weems, senior director of policy and strategy at the Medical Imaging & Technology Alliance, did not specifically call out the dollar figure for the next user fee program, but did state that MITA does not anticipate any need for major new programmatic initiatives or major new commitments. The association’s position is that all programs assembled with the help of user fees should be revisited to determine which should be sustained going forward, and which should be halted if there is a determination that the need is no longer there.
FDA commissioner Stephen Hahn had no reservations about another expansion of total user fees. Hahn stated that the device user fee program and the associated resources “are only a fraction of the size of the programs for prescription and generic drug user fees.” This fact makes the success of the device user fee programs “all the more remarkable,” he stated.
Hahn said he is concerned about the long-term health of the device user fee program, given the pace of innovation in the device industry. The next user fee agreement will give stakeholders a chance “to see what investments we can make in human resources and programs” that enhance communication between sponsors and the agency, he said, a statement he applied to registries as well. Hahn more or less reiterated that view toward the end of his remarks, stating that the negotiations will also provide an opportunity “to consider how we can provide technological, programmatic and other resources to the device team,” including human resources.