MDUFA VI: FDA eyes growth while industry seeks refinement

SILVER SPRING, MD – Medtech industry stakeholders kicked off the latest round of medical user fee negotiations by stressing they want to ensure user fees supplement Congressionally appropriated funding for the US Food and Drug Administration (FDA), while agency leaders pushed for expansion amid global competition.

FDA’s stance

FDA Commissioner Marty Makary started off the MDUFA meeting and noted that since the program was first launched, there has been a five-fold increase in the number of innovative device authorizations and there's been a significant increase in the number of companies who have said they want to bring their products to the US first, which he noted is in line with the Trump administration's America First agenda. Furthermore, he added that it was in line with its work promote domestic manufacturing and ensure national security while growing American jobs.

Makary also said that the US represents 40% of the medtech market and two-thirds of those products are made domestically. He noted that the US has fierce competition from China and Europe, which means that FDA must modernize to meet the challenges.

"We can't just be satisfied with what we have," said Makary.

"We want to be the best," he added. "That means we want to be the most efficient, the fastest, and yet not compromise a single iota on our goal to safeguard the public."

CDRH Director Michele Tarver also stated that while FDA has met or exceeded most of its MDUFA V goals, the agency needs to continue to build on its success and find ways to do better in the next user fee cycle.

“Holding steady doesn't lead to excellence, it leads to mediocrity,” she said.

Industry seeks program refinements, restraint on fee growth

MDMA CEO Mark Leahy said industry wants to make sure that FDA has the resources it needs to do their job, especially for frontline staff such as reviewers.

FDA’s user fees programs have faced criticism from Health and Human Services Secretary Robert Kennedy Jr. as a pay-to-play scheme that gives industry undue influence over regulators.

“It's all nonsense,” said Leahey. “From MDMA's perspective, user fees have always meant to be supplemental to congressional appropriations, we think that Congress should be the primary funder of FDA, part of that being [the Center for Devices and Radiological Health (CDRH)].

“User fees were always meant to provide that supplemental support to increase the capacity of the premarket review side to drive greater transparency, predictability and reasonableness,” he added. “If you look at the data here, the review times, pre-user fees and post don't indicate a pay-to-play dynamic.”

Leahy said that considering that one year of the current MDUFA program brought in more revenue than the combined 10 years of the first two versions of the program, he wants more transparency for industry. He also said the continued ramping up of user fees is unsustainable.

Leahy hinted that they may want to revisit some of the issues that industry and FDA negotiated under MDUFA V, such as the total product lifecycle advisory program (TAP) and consider its feasibility. “Bigger isn’t always better,” he said, adding that stakeholders need to consider ways to streamline the MDUFA program to serve its purpose without looking to increase fees.

Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, echoed some of the same themes regarding how much of CDRH’s funding should come from user fees and how they affect the agency’s relationship with the industries it regulates.

“While user fees support timeliness and predictability by providing FDA with additional resources, user fees are not a guarantee of approval. They never have been, and they never should be,” said Trunzo.

She noted that industry and FDA have updated every consecutive MDUFA program since it was first established in 2002 to improve the review process.

“Each MDUFA cycle included significant resources and investments, including increasing the number of FTEs to support the program,” said Trunzo. “Now that we have approached nearly 25 years of user fee programs for medical devices, we are now in a position of fine tuning the current program.”

Zach Rothstein, executive director for AdvaMedDx, highlighted that industry also wants to continue the work it has done to promote global harmonization under the current user fee program in MDUFA VI. His colleague, Patrick Hope, executive director of AdvaMed’s Medical Imaging Division, also called for the current performance goals to be maintained and improved.

"We strongly support continuing the MDUFA program as an efficient and transparent funding mechanism for premarket medical device review,” said Hope. “Supplementing FDA funding with user fees and maintaining the MDUFA structure and goals, ensures that the FDA has the appropriate resources and expertise to bring stability to the device premarket review process and decision timelines."

"Given the satisfactory performance to commitments the agency has achieved under MDUFA V, we do not currently anticipate any need for major new programmatic initiatives or major new commitments," he added. "We hope to carry forward and build on the continued success of what works."

Several patient advocates also spoke during the meeting, including Annie Kennedy

Annie Kennedy, chief of policy, advocacy and patient engagement at EveryLife Foundation for Rare Diseases, asked that FDA and industry include patient advocacy groups as more formal partners in MDUFA VI. More specifically, she asked for pilot programs that include patient advocacy organizations.

Diana Zukerman, president of the National Center for Health Research, raised concerns that less than 5% of medtech companies have conducted postmarket reviews of their products and asked that user fees be used to fund postmarket studies, and communicate the status of products with the public.

MDUFA VI: FDA eyes growth while industry seeks refinement

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