MDUFA V: FDA proposes TPLC advisory panel, industry says ‘back to basics’

Regulatory NewsRegulatory News | 18 June 2021 |  By 

Minutes from the latest round of negotiations between the US Food and Drug Administration (FDA) and industry around the next iteration of the Medical Device User Fee Amendments (MDUFA V) have been released to the public and highlight how stakeholders are approaching the talks with different goals in mind.
Negotiations for MDUFA V began this year after months of delays due to the COVID-19 pandemic. Last year, a public kick-off meeting was pushed from April 2020 to October 2020. FDA and industry held a virtual meeting to begin negotiations on 24 February 2021. (RELATED: MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations, Regulatory Focus 20 April 2021)
Held virtually on 7 April, the latest FDA – Industry MDUFA V Reauthorization Meeting centered mainly around FDA and industry’s disparate goals for MDUFA V. The tension was between FDA’s focus on a proposed Total Product Life Cycle (TPLC) Advisory Program and industry’s preference to go “back to basics” and ensure existing commitments under MDUFA IV are being met.
The minutes echoed sentiment seen in the earlier October kick-off meeting where FDA’s attention was on expanding the MDUFA program and bringing its funding in line with its user fee programs for prescription and generic drugs. During that October meeting, industry’s desire for MDUFA V was for refining but not adding to MDUFA program. (RELATED: MDUFA V: Industry wants fine tuning while FDA seeks expansion, Regulatory Focus 27 October 2020)
While industry seems satisfied with the current MDUFA program, FDA said in October they are “seeing signs of strain” due to the COVID-19 pandemic and the agency indicated current MDUFA performance is not sustainable.
TPLC Advisory Committee
In the minutes for the April meeting, FDA outlined a proposal for a TPLC Advisory Committee (TAP) that would address declining investment and startup activity in the medical technology industry. The agency said TAP would accelerate patient access “efficiently and broadly while maintaining high standards of safety, effectiveness, and quality.”
FDA’s vision for the TPLC Advisory Program is one where “early, frequent, and strategic communications between FDA and sponsors could yield more rapid patient access to safe, effective, and innovative medical devices.”
“From the Agency’s perspective, the current MDUFA program has been optimizing a limited portion of the Total Product Lifecycle. By investing in earlier and more strategic coordination of stakeholder input, as well as more frequent FDA interactions and faster FDA responses, FDA believes the MDUFA program can continue to help nurture the MedTech ecosystem and help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come,” according to the minutes.
FDA also highlighted an increased number of pre-submissions and breakthrough interactions from industry, but these programs “are not resourced to provide rapid-response capacity or optimally engage FDA reviewers and other stakeholder experts across the full spectrum of device types.” The agency noted that a lack of dedicated funding for these programs would hinder them.
TAP aims to address issues with communication, early engagement, and coordination, and the program is designed to “leverage, scale, and enhance existing FDA programs and to support convening external stakeholders to provide early strategic input to sponsors.” FDA said it wants to start using TAP in its Breakthrough Devices Program and Safer Technologies Program (STeP).
‘Getting back to basics’ with MDUFA V
Industry’s presentation at the meeting focused on a “back to basics” approach and explained that user fee reauthorization should stay as an additive fee, with the bulk of FDA’s funding coming from Congressional appropriations.
The “back to basics” model proposed by industry included meeting existing MDUFA IV commitments as well as suggested premarket review changes such as “targeted” premarket review process improvements and reinvesting carryover balances “into areas of mutual agreement to enhance the premarket review program.” Industry also proposed addressing the submission and pre-submission request backlog and accountability for resource and staffing targets.
Citing specific action items, industry proposed a “full accounting and quarterly reporting” of hires and vacancies under MDUFA I through V, as well as annual specific hiring targets under MDUFA V. Industry also asked for specific vacancy percentage targets by year for all hires under MDUFA I through V, and that funds allocated for hiring that remain unused be put toward an offset of the last year of fees under MDUFA V. For financial accountability, industry proposed a third-party, independent audit of how MDUFA funds are being used.
Disagreements on the need for TAP
In the discussion portion of the meeting, industry questioned the need for a program like TAP, referring to their request to go “back to basics” and noted that current FDA programs “can provide the necessary early interaction and efficient review.” They also noted that industry stakeholders are not necessarily concerned with the “expediency of FDA review” as much as the “quality of the journey.” Further, industry said FDA’s initial targeting of programs under a proposed TAP initiative may not yield devices that “would justify the creation of a new program.”
FDA responded and explained they had received feedback from stakeholders in the pre-submission and pre-EUA process that suggested the need for an additional program like TAP. The agency said implementing TAP would not change any existing review goals and would “reinforce those fundamental goals of transparency, consistency, and predictability, while also building on lessons learned from COVID-19 pandemic response about outcomes from early communication and engagement and evaluating how to facilitate even more timely patient access to medical devices.”
MDUFA V minutes


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