MDUFA V negotiations press on with breakdown over TPLC proposal

Regulatory NewsRegulatory News | 07 July 2021 |  By 

In the latest negotiation session for the upcoming Medical Device User Fee Amendments (MDUFA V) program, the US Food and Drug Administration (FDA) and industry groups diverged over the agency’s ambitions for the next five-year program and the industry’s desire to lock-in gains from past programs.
TPLC Advisory Program
During the previous meeting on 7 April, FDA presented its vision for a Total Product Lifecycle (TPLC) Advisory Program (TAP) to a skeptical industry. FDA’s goal for the program would be to address declining investment and startup activity in the medical technology sector by investing in earlier and more frequent FDA interaction and faster responses. (RELATED: MDUFA V: FDA proposes TPLC advisory panel, industry says ‘back to basics’, Regulatory Focus 18 June 2021)
Industry remained unimpressed with the proposal. “Each of the Industry groups’ membership does not support the proposal as described during the 7 April meeting and Industry has a fundamentally different view of the MDUFA program and its purposes,” FDA wrote in its summary of the 28 April meeting.
Industry said it believes the proposal would not only extend beyond the scope of MDUFA but would require statutory changes to implement and would lead to costlier, more complex premarket reviews.
FDA pressed on and presented additional details on the proposed program. In addition to building on experience from the agency’s breakthrough devices and pre-submission programs, FDA said TAP “would also respond to industry feedback that FDA has received through its interactions with companies, requesting more frequent, high-quality, rapid-response interaction.”
FDA explained “the need to build capacity and expertise to support this new engagement model. In particular, the proposal reflects the addition of review staff, increasing clinical and technical expertise, additional training and professional development, expanding capabilities of existing stakeholder programs, and strengthening the infrastructure that supports program outcomes.”
Still facing opposition from industry, FDA further explained that TAP might serve industry’s underlying goal of focusing on program fundamentals in MDUFA V by ultimately facilitating higher quality premarket submissions and fewer review cycles; however, industry was unmoved by the agency’s presentation.
Industry goals
During the meeting, industry reiterated its core objectives for MDUFA V, which include supporting timely patient access to safe and effective medical devices; maintaining the US review process as the global “gold standard” for patient safety; ensuring that Congressional appropriations remain CDRH’s primary source of funding; and that user fees are used “solely” for the premarket review process and “mutually shared goals and process improvements.”
In addition to establishing an “accurate baseline” using revised lower per-FTE costs, industry called for a review of MDUFA IV one-time costs, “maintaining some, not renewing others that were completed, and potentially identify[ing] other one-time costs for funding.” Some of the programs industry said it would support continued funding for include initiatives for patient engagement, staff recruitment and retention, and the program’s independent assessment. Industry also called to cut one-time costs for standing up time reporting and IT investment to support digital health from the program, while indicating it would like to further discuss funding for IT enhancements for premarket reviews, real world evidence, standards conformity assessments, and third-party review. The only new one-time cost industry proposed would cover an independent audit of MDUFA financials.
As for goals and commitments under MDUFA, industry pushed to maintain the status quo for the next five-year agreement. “Many of the MDUFA IV goals themselves were continuations of MDUFA III goals, and some of the current goals are not particularly aggressive based on past results. However, maintaining the current goals and goal structure will ensure stability and continuity at a time when it will be difficult to evaluate current performance against goals, given that the Agency will be working to adjust to the ongoing effects of the COVID-19 public health emergency,” industry said.
Industry also called for FDA to set specific annual numerical hiring targets in MDUFA V: “Industry recommends more formality to the establishment of hiring targets in MDUFA V to ensure there is transparency as well as prioritization within the agency to meet those goals.” Additionally, industry said it would like FDA to set “vacancy percentage targets” for MDUFA hires and apply unused staffing funds to offset user fees in the program’s fifth year.
Industry said it would like to see the return of the 5th year offset from overcollections that was present in MDUFA I-III but shed for MDUFA IV. “The carryover balance has grown to a much more significant level than had been contemplated when Industry initially agreed to rescind the 5th year offset,” the industry groups said.
FDA goals and feedback
FDA reiterated its three overarching goals for MDUFA V. While somewhat overlapping with industry’s stated goals, the agency envisions a somewhat different route to achieving them.
The goals include enhancing operational success, reducing device development time, accelerating patient access, improving device safety throughout the TPLC, and optimizing FDA infrastructure, staffing and resources.
FDA also seems to have been taken aback at industry’s proposal to reinstate or expand the 5th year offset in fees, “given the negative effects that had caused FDA to seek and industry to support discontinuing the offset provision as part of MDUFA IV,” and asked that industry provide details of how it would like carryover funds to be allocated.


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