MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more

The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.
 
FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal it has struck with the medtech industry. As previously reported by Regulatory Focus, it includes a number of major concessions from both sides, such as the TPLC pilot and the ability of industry to renegotiate user fees annually. It also includes a provision for the agency to take action on its draft guidances or withdraw them within five years. (RELATED: MDUFA V: We have a deal, Regulatory Focus 8 March 2022)
 
The MDUFA V commitment letter was supposed to be sent to Congress by 15 January but significant disagreements between the FDA and industry groups including AdvaMed, the Medical Device Manufacturers Association (MDMA), Medical Imaging and Technologies Alliance (MITA) and the American Clinical Laboratories Association (ACLA) led to a long delay.
 
One of the major sticking points was FDA’s proposal to fund a TAP program that would include input from outside stakeholders such as health care providers and insurers. Industry argued that outside stakeholders are unlikely to be interested in participating while the agency said it would help companies better understand what is expected of their products in the real world.
 
Ultimately, the two sides have agreed that instead of funding a full-fledged program, they will first launch a multi-year pilot program that can inform them whether the idea is successful and sustainable. In FY2023, the FDA has agreed to a “soft launch” of a voluntary TPLC pilot that will only enroll 15 products. That number will increase substantially each year, and by FY2027 the number of products enrolled in the pilot could grow to 225. The agency is required to publish an assessment of the TAP pilot by 30 January 2026.
 
As previously reported, commitment letter also includes certain claw back provisions that are tied to FDA’s performance metrics, how much carryover funds it accumulates and how many staff positions tied to MDUFA it can fill.
 
“MDUFA V will provide for FDA to decrease registration fees if the agency has more than 13 weeks of operating reserves in the carryover balance,” the commitment letter states. “In addition, during MDUFA V FDA will use funds in the carryover balance to support the Third Party Review program and the Total Product Life Cycle Advisory Program Pilot.”
 
It also states that at least once a year, the FDA and industry will negotiate on how to best use carryover funds to improve device application reviews.
 
As in previous MDUFA agreements, the commitment letter also includes provisions to hire independent third-party auditors to evaluate how well FDA is sticking to the provisions of the user fee deal. In the past that responsibility was handled by Booz Allen Hamilton.
 
The commitment letter states the contract for an independent audit of the MDUFA program will be awarded by 31 March 2025.
 
“The contractor will publish comprehensive findings and recommendations within 1 year, after reviews with FDA and industry and opportunities to provide feedback for the contractor’s consideration prior to finalizing the final report,” the letter states. “For all recommendations the contractor will provide an estimate of additional resources needed or efficiencies gained, as applicable.”
 
The commitment letter includes several other key provisions including agreed timelines on decisions for product applications, training of FDA staff, especially in growing areas such as digital health, and funding the agency’s IT infrastructure upgrades, which was another major sticking point during the negotiations. However, an interesting addition is holding the agency accountable for finalizing or withdrawing draft documents.
 
Industry stakeholders have often complained that FDA’s guidance-making process is slow and confusing, especially when a guidance is not finalized for many years. Industry has argued that this leads to uneven review of their products and creates uncertainty when they submit premarket applications.
 
Under the new commitment letter FDA will be required to either finalize a draft guidance within five years or withdraw it.
 
“The agency will strive to finalize, withdraw, reopen the comment period, or issue a new draft guidance for 80% of draft guidance documents within 3 years of the close of the comment periods as resources permit,” the letter states. “The agency will strive to finalize, withdraw, reopen the comment period, or issue a new draft guidance for 100% of draft guidance documents within 5 years of the close of the comment periods as resources permit.”
 
“The agency will continue to develop guidance documents and improve the development process as resources permit, but not to the detriment of meeting quantitative review timelines and statutory obligations,” it added.
 
Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), issued a statement saying the agreement underscores the agency’s commitment to prioritize innovation and increase patient access to medical devices.
 
“MDUFA V represents a substantial investment in the future of the agency’s medical device program and would provide for important improvements, including new hiring targets, greater engagement with developers of innovative technologies based on lessons learned from the pandemic, broadened international harmonization efforts and expanded opportunities to ensure patient perspectives are an integral part of medical device development,” he added.
 
AdvaMed CEO Scott Whitaker echoed those sentiments and characterized the deal as a historic first where FDA’s annual user fee increases are tied to its performance.
 
“This historic agreement connects increased industry user fees to FDA performance for the first time,” he said. “It holds innovators to high standards for communicating device performance to the agency. The result will be more timely approval of medical technology earning the FDA’s global gold standard of safety and effectiveness.”
 
MITA executive director Patrick Hope also lauded the agreement and asked that Congress quickly vote on approving it.
 
“Through over a year and a half of negotiations, we have agreed to a good deal for the FDA, industry and most importantly for patients,” he said. “The agreement will help get the FDA back on track after several years of grappling with the COVID pandemic and introduces new accountability measures related to hiring targets, accrual and use of carryover balance.”

MDMA CEO Mark Leahey said the agreement shows a significant investment in the user fee program.

"MDMA appreciates FDA’s dedication and efforts during the COVID-19 pandemic, and we are confident the agency will effectively leverage the additional resources to accelerate patient access to safe and effective medical technologies," he added.
 
Stakeholders interested in commenting on the commitment letter can do so on www.regulations.gov under docket no. FDA-2020-N-0907 until 21 April. FDA is also holding a virtual public meeting to discuss the MDUFA V deal with details yet to be disclosed on 19 April.