Posted June 09, 2022 | By
The compromised proposal to reauthorize the Medical Device User Fee Amendments (MDUFA V) could put stress on the US Food and Drug Administration’s (FDA) ability to recruit and retain expert personnel and fails to fund critical postmarketing surveillance programs, four medical device policy experts wrote in the New England Journal of Medicine.
The final MDUFA V proposal, which was released on 22 March 2022 after a two-month delay, faces a deadline of 30 September 2022 for reauthorization through the US Congress.
“The FDA is at a crossroads as it emerges from the Covid-19 crisis amid growing calls to better promote safety and innovation. MDUFA has historically focused on expediting premarketing review rather than understanding device risks and benefits through the product life cycle. We believe now is the time to look ahead,” wrote Vinay K. Rathi, MD, of the Massachusetts Eye and Ear Infirmary in Boston, Joseph S. Ross, MD, of the Center for Outcomes Research and Evaluation at Yale, and Rita F Redberg, MD and Sanket S. Dhruva, MD, both of the University of California, San Francisco.
The perspective focuses on elements of the MDUFA V proposal that the authors assert could have unintended consequences or fall short of the goal of enhancing safety throughout the medical device life cycle, including the introduction of performance-based incentives for FDA, a “manufacturer-centric ” approach to the Total Product Life Cycle Advisor Program (TAP), and a failure to provide user fee funding for postmarketing surveillance of medical devices (RELATED: MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and moreRegulatory Focus March 23, 2022).
The MDUFA V proposal sent to Congress includes a set of performance-based incentives that would allow FDA to collect up to $120 million in additional user fee revenue for meeting review time goals and would trigger reductions in registration fees if the agency misses certain hiring targets. The review time goals do not account for increases in application volume, potentially overwhelming FDA staff and resulting in the authorization of unsafe devices, according to Rathi and colleagues. The financial penalties in the agreement could also prove counterproductive to the agency’s ability to hire expert reviewers.
“Alternatively, overburdened FDA staff may not authorize potentially beneficial devices or may postpone deadlines by requiring manufacturers to answer questions that suspend the agency’s review clock,” the authors wrote.
The authors were also critical of a compromise on the TAP program, which would allow FDA to fund the TAP pilot with unused MDUFA IV funds. The pilot would cover one device area with up to 15 products initially and be expanded in later years. Products would be enrolled on a first-come, first-served basis and be initially restricted to devices with a breakthrough designation. Independent assessment, starting in fiscal year 2024, would focus on agency response times, device-development and review times, and manufacturer satisfaction, the authors wrote. “This manufacturer-centric definition of success overlooks a key purpose of both the TAP and the FDA in general: promoting patients’ access to safe and effective devices of public health importance,” Rathi and colleagues wrote.
The proposal’s failure to provide user fee funding for postmarking surveillance is also problematic, the perspective authors wrote. FDA had been seeking funding to improve detection and communication of postmarket safety signals through real-world data and analytics and a public repository of patient-related device information. However, industry pushed for congressional – not user fee – funding for those priorities.
“Although the FDA has attempted to develop additional surveillance methods, health systems’ slow adoption of unique device identifiers and challenges inherent in using real-world data have impeded program,” the authors wrote. “To help protect patients, the FDA could be authorized to invest its carryover balance in strengthening postmarketing surveillance.”
New England Journal of Medicine perspective
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