Medical Device Daily Washington Editor

Negotiations between industry and FDA are about to commence for the next round of medical device user fees, but the process for this round is already different from that of the first two iterations in that the agency held a public meeting on the subject. Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, advised attendees that review times for 510(k) filings may be affected by the ongoing restructuring of the device clearance process, but he also said the agency is interested in feedback from all stakeholders, one of which argued that user fees are too low.

Shuren said the user fee program has allowed reviewers "to reduce the time it takes to review 510(k) submissions" substantially, noting that about 70% of clearances were handled within 90 days before the program, but that "now more than 90% are."

"This means nearly 500 more 510(k)s receive a timely review each year" than was the case prior to the Medical Device User Fee Modernization Act (MDUFMA), Shuren said.

On the other hand, Shuren said "we recognize the critical importance" of expediting those changes and that "to the extent they are successful if adopted, they could improve performance." Still, he advised that the review of the 510(k) program could hold "other implications for MDUFA [Medical Device User Fee Act] reauthorization," pointing out that the fees "currently account for less than 20% of funding for CDRH activities covered by user fee program."

Shuren hinted that other parties will have a lot of influence on the user fee schedule. He said the agency "commit[s] to an open and transparent process" regarding user fees and that "we look forward to strengthening our relationship with all stakeholders throughout the reauthorization process."

Malcolm Bertoni, assistant commissioner for planning at FDA, told the audience that Congress requested the public meeting, although he did not name the parties who made the request. "Transparency is a very important and robust part of this process," he said.

FDA's negotiations with industry will now be public as well, Bertoni indicated, noting that FDA will "be publishing for the first time the summaries of these meetings." He backed up Shuren's remark regarding stakeholder input, noting that CDRH managers are "also going to be holding monthly meetings with stakeholders."

Regarding the time line for the draft user fee recommendations Bertoni said, "at this point we're thinking this will start officially in the new calendar year," to be completed by the end of next summer so the public can comment before presentation to Congress in January 2012. By that time, FDA is "hoping . . . there will be a minimal need to make revisions at that point" due to the monthly meetings with stakeholders. FDA is accepting preliminary comments on the subject for 30 days following yesterday's meeting.

User fees assailed from both ends

Two public health advocates spoke at the meeting, but while they both evidenced distaste for the 510(k) process, they had different views on user fees. Diana Zuckerman, president of the National Research Center for Women and Families (Washington) said "on some level, we would not care at all how high or how low user fees were if appropriations were higher," but nonetheless opined, "we think the user fees are too low."

"We also think there's no good reason why some of the largest corporations in the world . . . that pay very large user fees" for drug applications "pay much-much, much-much, much-much less" for device applications, adding that the "fees for the 510(k)s are especially egregious," given the relatively low sums required. Zuckerman stated further that the largest firms should pay for "the entire cost of a 510(k) review."

"We think they should also pay additional substantial user fees for every new advertisement they direct to consumers" for the agency's review mechanism for direct-to-consumer ads," Zuckerman said. "Even the much larger PMA user fees are disproportionately low compared" to fees charged for new drug applications (NDAs), she said, arguing that the fees and the quality of the reviews "should be similar" between the two application types.

Zuckerman asserted that the "vast majority of the recalls that FDA itself called high-risk recalls were 510(k) devices," saying that a 510(k) device is categorically not life-sustaining. "It seems to us if a device can kill you if it fails or does not work accurately . . . that device should be a high-risk device" and should "go through the PMA process." She said her organization wants to see legislation drafted to "ensure that FDA does not continue to approve dangerous devices just because they're similar to other dangerous devices," citing the case of luer lock connectors she described as responsible for "deaths across the country."

"It seems to us that the big issue is not what was approved before," but "how the device actually functions in the real world," Zuckerman said, adding that in her view, "changes in the law and in user fees are needed to support post-market surveillance of all medical devices." She further made the case that the lack of a requirement for a pre-clearance inspection is "something that has to change."

Amy Allina, program and policy director for the National Women's Health Network (Washington) said a user fee "undermines the agency's independence and has interfered with FDA's ability to allocate resources." She said FDA should be fully funded by appropriated monies, stating that "even a doubling [of the FDA budget] would not be a great price to pay" to ensure food drug and device safety.

"We need to raise the standards for reviewing medical devices," Allina said, noting that the difference in standards between drugs and devices allow some devices to go through with no clinical data. Even the PMA standard is not the same as that for drugs, she remarked, arguing that "this lower standard means that dangerous and ineffective devices are being approved."

Regarding the notion of substantial equivalence, Allina argued that CDRH "should use a more limited interpretation of what it means to say that one device has the same intended use as another," stating that the standard of "functioning in the same manner is not synonymous with having the same intended use."

Allina said predicate creep is an issue as well, adding that "over time . . . this has led to pretty vast chasms between the medical and technological characteristics of the new device and the predicate." She also made note of the resources issue associated with FDA, but said that an effective public safety resource is already in place. She claimed that "many of the disasters that have unfolded with medical devices were all the more tragic because they were not a surprise to the FDA staff who reviewed the products."

"We urge the agency to respect, support and empower the scientific staff to make decisions . . . based on evidence," Allina said, adding that FDA should "encourage the staff to identify the products for which a clinical trial is needed" and "to speak up when clinical data submitted fails to meet a standard of scientific rigor needed to protect the public health."

Medical Device Daily will review the comments made by representatives of three industry associations in tomorrow's edition.

Mark McCarty, 703-268-5690

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