The FDA's fifth Medical Devices User Fee Amendments (MDUFA V) agreement, which will set the agency's priorities for the next five years and the funding amount it can raise through fees on manufacturers, is making its way through Congress.
After a House subcommittee last week grilled the FDA over the long delays in reaching an agreement, the Senate health committee held its own hearing on Tuesday. Senators also took the opportunity to discuss user fees for prescription drugs, generics and biosimilars with industry groups.
Notably, there was no FDA representative present at the Senate hearing. Mark Leahey, CEO of the Medical Device Manufacturers Association, fielded most of the questions related to medical devices. MDMA, which represents smaller device manufacturers, supported the new agreement, which will give the FDA a minimum of $1.78 billion in fees over the next five years, with the option to collect up to $1.9 billion if it meets certain performance milestones.
A big component for manufacturers was staffing, with the FDA being able to hire a minimum of 273 full-time employees, and hiring targets tied to funding.
"This represents a historic increase in both overall funds and people, and it is our expectation that this will be the last major investment needed for the MDUFA program, and that moving forward any necessary increases will be much more modest and targeted," Leahey said.
Senators also posed questions over the increases to the FDA's budget, how medical device companies plan to handle cybersecurity going forward, as well as clinical trial diversity.
Sen. Richard Burr, R-N.C., in particular raised concerns about increasing application costs and a near-doubling of the FDA's user fee revenue, if it meets all of its performance targets. On the other hand, Liz Richardson, director of healthcare projects for the Pew Charitable Trusts, recommended that Congress pass the agreement, noting that user fees are important to the FDA being able to carry out its functions.
Richardson also emphasized that the fees do not cover all of FDA's public health functions, and "cannot and should not be a substitute for adequate appropriations."
Similar to last week's House subcommittee hearing, the FDA's sliding performance under the previous MDUFA agreement came up as a sticking point during Tuesday's Senate panel, as the agency divides its resources between the COVID-19 pandemic and reviewing new devices unrelated to the public health emergency.
However, senators also raised specific provisions related to the agreement, including potential policies to improve diversity in clinical trials and medical device cybersecurity.
Burr focused on the increasing budget for MDUFA V and the FDA's failure to meet 510(k) review times, which will start at 128 days next year under the new agreement, and gradually decrease to 112 days. By comparison, under the current agreement, the FDA is expected to reach a decision within 108 days for each application.
Specifically, Burr asked, why did industry agree to longer review times for more money?
"There's no doubt this is a significant increase in funding, and as I said in my opening testimony, this doubling in fees is certainly not sustainable," Leahey said. "But we do recognize the challenges that FDA went through during COVID, and this investment is obviously put forward to get them back on track, and there are additional accountability measures to make sure that these metrics are met going forward."
Lawmakers also took the opportunity to bring up proposed medtech legislation.
Sens. Tammy Baldwin, D-Wis., and Bill Cassidy, R- La., brought up the Protecting and Transforming Cyber Health Care Act, a bill they introduced that would require pre-market cybersecurity measures for devices and post-market updates for any issues that are discovered.
The senators also took the opportunity to ask Leahey how device manufacturers are thinking about cybersecurity in the context of hospital networks, where discussions over whose responsibility it is to maintain device security often fall apart.
"Fortunately, we haven't seen any issues directly related to compromising the devices themselves, but as united with the ransomware and other issues, these have certainly become challenges," MDMA's Leahey said.
Leahey referred to a cybersecurity plan for device makers published in 2019 by the Healthcare and Public Health Sector Coordinating Council (HSCC), a public-private partnership between manufacturers, hospitals, insurers, HHS and FDA, which provides a guide for managing the security of medical devices.
"But clearly, more work needs to be done," Leahey added.
Finally, senators also focused on diversity in clinical trials, which was identified by the FDA's Center for Devices and Radiological Health as one of its strategic priorities for the next three years. The agency hasn't added any specific requirements around this goal, but Sen. Patty Murray, D-Wash., chair of the Senate committee, and Sen. Christopher Murphy, D-Conn., brought it up in their statements and questioning.
Specifically, Murphy asked MDMA's CEO whether device makers were grappling with the question of how to ensure broader representation in clinical trials. Leahey responded that MDMA agrees that trial enrollment should accurately reflect the intended patient population.
Baldwin and Pew's Richardson also discussed renewing the Women's Health Research Roadmap, which was created in 2015 to outline priority areas for research.
For instance, that roadmap included supporting studies to understand how differences in sex affect the safety and effectiveness of AI-enabled devices, 3D printed devices and other new technologies.
"I think that in addition to additional research funding, it would be helpful for the agency to focus on how that research gets translated into policy at the level of the centers, which is where the rubber meets the road policy-wise," Richardson said, referring to CDRH.
Richardson added that the re-negotiation process gives FDA an opportunity to "think clearly and concretely about where it wants to focus attention over the next five years, not just on reducing review timelines or meeting procedures, but where it really wants to focus its policies."
The FDA announced that it will hold an April 19 virtual public meeting to discuss the MDUFA V agreement's recommendations.