Consumer advocates are suggesting FDA request considerably more funding from device companies in the next round of user fee negotiations, but companies are reluctant to foot more of the bill for device reviews without seeing promised improvements in FDA's pre-market program.

FDA held a public workshop Sept. 14 to hear input from stakeholders on how well the user fee program is working and what, if any, aspects of the medical device user fee program should be maintained, changed or terminated altogether.

The agency says it hopes to release draft recommendations regarding user fee reauthorization in about a year's time and then hold another public meeting. Final recommendations are due to Congress by January 2012.

User fees and associated review performance goals were first instituted in the Medical Device User Fee and Modernization Act of 2002 to make device reviews more timely and predictable.

The Medical Device User Fee Amendments, enacted as Title II of the 2007 FDA Amendments Act, reauthorized the fee program through fiscal year 2012.

Consumer Groups Push For Higher User Fees

As FDA prepares for the next round of reauthorization negotiations, the agency is required by law to seek input from a broader group of stakeholders.

The public user fee meeting is a first for FDA. It was mandated by Congress in the prior user fee reauthorization legislation to help shed more light on the process (¹ Also see "Medical Device User Fee Negotiations: Here We Go Again" - Medtech Insight, 16 August, 2010.).

Consumer advocates and device makers at the meeting had different ideas about the appropriate amount of industry contributions and how they should be used.

Diana Zuckerman, president of the National Research Center for Women and Families, argued that device user fees are too low, particularly compared to the amount of user fees the drug industry doles out.

The "inadequacy" of user fees for 510(k) submissions "is especially egregious," she added.

CDRH Director Jeffrey Shuren noted at the meeting that current device user fees fund less than 20% of activities covered by the medical device user fee program, and are "roughly one-twelfth of the user fee funding provided for the agency's human drug program."

Zuckerman's group estimates that user fees cover about one-quarter of the resources that go into the review of a 510(k) or PMA. She suggested that most companies should instead pay the full cost of such reviews.

"The vast majority of device companies should be able to afford a 510(k) user fee of $5,000 to $10,000 or more," she said.

Amy Allina, program director at the National Women's Health Network, on the other hand, expressed concerns that the device program is relying too heavily on industry-provided funds. "We believe this arrangement undermines FDA's independence," she said.

"We'll be advocating for reforms to restore the agency's independence by cutting the industry strings that come with the user fees today," Allina said.

Other presenters at the meeting urged FDA to allow user fee dollars to be applied more flexibly, or establish more performance goals that are not related to the speed of reviews.

Device Firms Want To See Program Improvements

Industry reps, on the other hand, pushed back.

Mark Leahey, president and CEO of the Medical Device Manufacturers Association, noted that the amount of user fees contributed by industry nearly doubled in the last round of negotiations, from $150 million over five years to $287 million over five years.

According to David Fisher, executive director of the Medical Imaging and Technology Alliance, member companies are concerned that the link between the fees and FDA's performance has broken down.

Janet Trunzo, executive VP for technology and regulatory affairs at AdvaMed, agreed that "troubling trends have emerged in FDA's device review performance."

According to FDA's most recent data, the agency met its user-fee performance goals for 510(k) submissions, but not for original PMAs.

"We're taking a very close look at exactly what is causing us to not meet these goals," said FDA Assistant Commissioner for Planning Malcolm Bertoni, who is heading up the agency's reauthorization group.

He suggested that some of the more complex submissions, such as those for first-of-a-kind devices or that require expert panel review, could be a contributing factor.

MDMA's Leahey agreed that device companies are unlikely to support user fee program reauthorization without needed changes.

Key shortfalls are the guidance development process and so-called interactive review, industry reps said. FDA is not getting guidance out the door fast enough, nor is it fulfilling its promise for more informal back-and-forth during pre-market reviews, speakers said.

"As it currently stands right now, I think our members would be hard-pressed to support the continuation of this program," Leahey said. "But I am confident ... we'll be able to work together to develop a program with reasonable fees, enhanced performance and greater predictability."

User Fees For 510(k) Reform?

CDRH Director Shuren acknowledged that FDA's ongoing review of its 510(k) program - with an eye toward reforms - will have implications for user fees.

"We recognize the critical importance of strengthening the 510(k) program expeditiously, and we will do so," Shuren told meeting attendees.

"We also acknowledge that some of these efforts could impact our review process."

Many of the recommendations in CDRH's preliminary internal assessment of the 510(k) program, released in August, include steps that "would improve the predictability, consistency and transparency of the 510(k) program," Shuren said (² Also see "FDA Maps Out Potential 510(k) Reforms In Long-Awaited Report" - Medtech Insight, 9 August, 2010.).

This could also improve FDA's pre-market performance. But if success depends on additional resources, "there may be other implications for MDUFA reauthorization," he concluded.

AdvaMed's Trunzo, however, urged FDA to think carefully about which reforms it seeks to implement, given that resources are already stretched.

Some of the recommendations "will require enormous FDA resource commitments with little or no public health benefit," Trunzo asserted in a Sept. 14 statement.

Comments Due By Mid-October

In addition to Bertoni, FDA's user fee reauthorization working group includes staffers Don St. Pierre, deputy director of new product evaluation in CDRH's diagnostics office; Barbara Zimmerman, deputy director for pre-market program management in the center's Office of Device Evaluation; and Kate Cook, regulatory counsel at the Center for Biologics Evaluation and Research.

Comments on FDA's reauthorization questions are due Oct. 14.

Closed-door negotiations will begin around January 2011. Once negotiations start, FDA is also required to release a public summary of those proceedings, listing any substantial proposals or significant controversies, and to hold monthly discussions with patient and consumer advocacy groups to gain additional input.

Information on how to participate in the monthly stakeholder meetings will be made available in a Federal Register notice sometime this fall, CDRH's Shuren said.

- Jessica Bylander ( ³ j.bylander@elsevier.com )

FDA User Fee Renewal Should Include Pre-Market Improvements - Industry

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