MDUFA V: Industry wants fine tuning while FDA seeks expansion

Regulatory NewsRegulatory News | 27 October 2020 |  By 

The US Food and Drug Administration (FDA) kicked off the negotiation process that will inform the fifth iteration of the Medical Device User Fee Amendments (MDUFA V) program via a virtual public meeting on Tuesday.
The meeting, initially scheduled to take place in April, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s medical device program from FY2023-FY2027.
During the meeting, FDA officials made the case for expanding the scope of the MDUFA program and bringing its funding in line with its user fee programs for prescription and generic drugs.
“As we enter the next cycle of MDUFA negotiations, it is imperative that we continue to build on the successes of the past few years, and look for opportunities that enable us to work smarter,” said FDA Commissioner Stephen Hahn, who praised Center for Devices and Radiological Health (CDRH) staff for their efforts to meet its performance goals and implement other MDUFA IV commitments while responding to the COVID-19 pandemic.
However, Hahn cautioned that the agency is operating at “a level of effort that cannot be sustained in perpetuity” absent new resources.
Hahn pointed out that the MDUFA program, “and the resources that come with it, are only a fraction of the size of the programs for prescription and generic drug user fees,” adding that this raises “concern for the long-term health of the program.”
Hahn said he hopes the reauthorization process provides a chance for FDA and industry to look into new investments in “human resources and programs that enhance opportunities for meaningful early and ongoing communication between FDA and device sponsors [and] further investments in the development and evaluation of real world data.”
CDRH Director Jeffrey Shuren echoed Hahn’s sentiment, noting the aging regulatory paradigm for medical devices and calling for “sound strategic investments in the FDA to modernize our regulatory program, to keep pace with the speed of device innovation and to build our infrastructure in ways that sustain the success of our program for years to come is absolutely critical.”
Despite FDA officials’ enthusiasm for expanding on MDUFA IV, representatives of industry, who were largely supportive of the agency’s current performance, sought to make refinements to the MDUFA program without adding to its scope.
“Now that we are well into the fourth year of the current MDFUA IV program, the investment of resources into the device program has yielded positive results,” said Janet Trunzo, senior executive vice president, technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed). Trunzo pointed to the addition of hundreds of CDRH staff, improvements to the presubmission process and the agency’s first-time commitment to de novo decision performance goals under MDUFA IV.
Trunzo also noted that FDA has not completed hiring of all MDUFA-funded full-time equivalent (FTE) employees and urged the agency to do so as soon as possible.
As for priorities for MDUFA V, Trunzo said, “We have the tools we need with the current infrastructure and now we just need to focus on sharpening those tools and maximizing their use. As we begin the MDUFA V discussions, we recommend continued improvement in MDUFA IV successes achieved thus far and focusing on review process basics.”
Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), agreed with Trunzo and downplayed the need for additional user fee funding for FDA. Leahey pointed out that user fee funding under MDUFA has ballooned from $144 million under the first agreement to more than $1 billion under MDUFA IV and said that Congressional appropriations should be the primary source of FDA funding.
“Before we go and work to create new initiatives or priorities, there are some foundational MDUFA IV commitments I think we should focus on,” Leahey said. Some of those commitments include providing device makers with citations and the agency’s rationale in deficiency letters and to make progress on finalizing guidance.
Leahey also called for improved methodology for calculating FTE costs under MDUFA V. “As we begin the MDUFA V negotiations, there’s a better methodology to calculate the cost for FTEs. The current methodology takes the total device review budget, divides by the number of FTEs, and that’s the cost per FTE. I don’t think anyone would agree that that’s a very scientific or precise methodology,” he said.
Similarly, Peter Weems, director of policy and strategy for the Medical Imaging & Technology Alliance (MITA), said the negotiations should focus on what MDUFA IV programs should continue and whether they should continue to be funded by user fees.
“Given the satisfactory performance the agency has achieved under MDUFA IV, at this time we do not anticipate any need for major new programmatic initiatives or major new commitments in MDUFA V,” he said.
Representing the clinical diagnostics industry, Thomas Sparkman, senior vice president for government affairs and policy at the American Clinical Laboratory Association, raised concerns about FDA’s past efforts to regulate laboratory developed tests (LDTs) and called “a clear and appropriate regulatory framework and market pathway” for both LDTs and in vitro diagnostics.
“We see a number of scenarios where user fees may be imposed or proposed for clinical laboratories developing and offering LDTs. The various scenarios, including a potential new statutory framework, make it necessary to outline various uncertainties impacting any proposed user fee allocation,” he said. Sparkman said that any framework would need to take into account the number and size of labs and the number of LDTs they offer, as well as the complexity and burden of oversight, criteria for premarket review or applications and the timeframe for implementing any new regime.


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