The FDA and device makers have finally wrapped up what may be the most contentious set of negotiations in the history of the device user fee program. Despite industrial antipathy to a recurrent doubling of user fee volumes, the fifth device user fee deal will provide the FDA with as much as $1.9 billion in user fees, roughly double the fees collected under the current agreement.
The quinquennial user fee process for medical devices has always proven controversial, but the FDA and industry have missed a Jan. 15 deadline for an agreement to be presented to Congress. Recently, several members of the House and Senate inked a letter to the FDA about the missed deadline, a signal that the agency’s aspirations for a $2.5 billion user fee deal are in jeopardy.
Negotiations between the FDA’s device center and the med-tech industry over the next device user fee schedule are dragging on, but the gap between the two sides may have narrowed. The FDA had previously proposed a package that ran more than double the current total user fee volume, and industry has responded with a proposal that would provide the agency with $1.65 billion in user fees over five years, leaving the two sides with a gap of more than $800 million to bridge.
The least burdensome principle is a critical component in industry’s understanding of the proper role of government regulation, but this principle is the subject of considerable tension between the two sides. The latest report on the FDA’s performance under the fourth device user fee agreement noted that device makers raised the least burdensome flag in less than 0.5% of 510(k) submissions filed between February 2019 and April 2021, but the report gives the agency passing grades on its handling of those potentially controversial regulatory encounters.
Negotiations between the FDA and industry over the next device user fee are going on behind closed doors, but the agency’s summaries of these meetings suggest there are sharp disagreements. While the FDA continues to press industry on additional fees for the total product life cycle advisory program, industry’s dissatisfaction with the FDA’s fiscal management of the user fee program has prompted a demand for a one-off audit of the agency’s use of those user fees.
The FDA and industry are deep into the negotiations over the next device user fee, with the usual array of concerns such as premarket program performance and the volume of user fees. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), has once again given voice to a perceived need for a significant boost in user fee volumes in an interview with a major trade association, suggesting that device makers can expect a significant uptick in fees for PMAs and 510(k)s in the years ahead.
The negotiations for the next device user fee agreement are well underway, and there are signs that the FDA is looking for a significant boost in user fees from device makers. However, Rep. Anna Eshoo (D-Calif.) told members of the MDMA that no member of Congress should believe that user fees relieve Congress of its responsibility “for funding the agency in a robust way.”
The negotiations for the next medical device user fee agreement are well underway, but the FDA is pressing the case for a substantial increase in device user fees. While the controversy over the cost of each addition to the FDA staff has not gone away, the agency continues to compare device user fees to drug user fees even though the drug industry is populated by much larger companies, thus nullifying any such comparisons in the view of device makers.
The U.S. Centers for Medicare & Medicaid Services (CMS) had packaged a proposal to redefine the term “reasonable and necessary” along with the proposal to cover FDA-designated breakthrough devices, but ultimately punted on the definitional question until the end of this year. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that it may be just as well that the agency didn’t expeditiously push through the reasonable and necessary question because of the enormous complexity of the proposal.
The U.S. FDA’s device user fee schedule doubled for both the third and fourth user fee agreements over the prior iterations, but the pressure against another doubling for the fifth iteration of the user fee program is mounting. The Medical Imaging & Technology Alliance (MITA) said it sees a need to retain the user fee programs that are working and to jettison any underperforming programs, adding that user fees “should be stabilized around current funding levels.”
