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Industry group AdvaMed weighs in on the reauthorization process for the next version of the Medical Device User Fee Act—MDUFA IV—ahead of the July 13 FDA public meeting on the issue.
Marie Thibault
July 9, 2015
3 Min Read
Marie Thibault
It's time for another round of the reauthorization process needed for the next version of the Medical Device User Fee Act (MDUFA).
To kick off the process, FDA is holding a July 13 public meeting on reauthorization of the user fee program to hear from various stakeholders. During a July 9 media call, AdvaMed, a medical device industry group, praised FDA's efforts over the past few years and called for continued improvements.
Janet Trunzo, senior executive vice president of Technology and Regulatory Affairs at AdvaMed, said she believes "that the increased interaction industry has been having with the agency . . . is really one of the success stories of the latest user fee agreement. As I said, FDA leadership has shown a true willingness to work with the industry and we highly appreciate it. However, that's not to say everything is perfect. It still has some challenges that we need to work on."
Background
User fees paid by medical device companies go toward funding FDA's review of regulatory applications and submissions for devices. The practice of user fees for the medical device industry started in 2002 with the passage of the "Medical Device User Fee and Modernization Act of 2002." This has been reauthorized every five years, in 2007 and 2012, as versions known colloquially as "MDUFA II" and "MDUFA III."
MDUFA III is set to expire on September 30, 2017, so a user fee agreement must be reauthorized by Congress by that deadline in order to ensure appropriate funding for the device review process. Before approaching Congress, an agreement must be reached between FDA and industry on what MDUFA IV should entail. The hope is that a new user fee agreement will be ready to be sent to Congress by January 2017.
The FDA public meeting next week will ask attendees to consider:
"What is your assessment of the overall performace of the medical device user fee program under MDUFA III?
"What aspects of the medical device user fee program should be retained, changed, or discountinued to further strengthen and improve the program?"
AdvaMed's View
AdvaMed voiced their input on a July 9 call with members of the media. Trunzo said, "Going into the next round of user fees, we want to build on the progress that we have already achieved." AdvaMed would like to see continued improvement on device regulatory review times, review consistency, and clarity on combination products.
"Review times are still too high, although we've seen improvements from the peaks of 2009 and 2010 . . ."
Consistency of reviews—"Companies' review experiences are often very reviewer-dependent. This is something we've heard anecdotally from our members, but it was also borne out on the independent assessment of the CDRH review process management performed by the independent contractor. Now FDA is taking steps to address this through better training and follow up, so we believe that that should help and could be addressed through this corrective action plan that FDA has in response to the independent assessment."
Combination products—"Unfortunately, FDA's process for determining which of the centers has primary responsibility for reviewing these products as well as the actual review itself, often lacks predictability and efficiency."
Trunzo noted that MDUFA III approximately doubled the amount of user fees collected from industry during MDUFA II, from $285 million to $595 million. Asked to speculate on how much MDUFA IV might collect, she said it was too early to say, but that the amount would depend in part on what performance goals and initiatives are agreed upon during the discussion between industry and FDA.
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Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.
[Image courtesy of VLADO/FREEDIGITALPHOTOS.NET]
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