Michael Causey, Editor & Publisher, eDataIntegrityReport.com
Folks we’ve heard from are not entirely sure what to make of the FDA’s recent announcement that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval. The changes are effective May 1, 2010.
As a standalone move, most medical device firms we heard from (off-the-record) aren’t that impressed — yet. But if this signals more changes afoot, then we might actually speed up and improve the medical device approval process.
FDA says the changes were prompted by an increasing number of medical device advisory panel meetings in recent years. In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to the FDA’s Center for Devices and Radiological Health (CDRH).
The increased activity has created challenges for CDRH and the way it operates panel meetings, the agency said in a press release. In accord with current agency policy and guidance for advisory committees, the changes address staffing issues, voting procedures and other items related to information presentation and flow of discussion.
“I don’t see how the changes below can speed up the process,” says medical device consultant Kenneth L. Ripley.
“These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts,” said CDRH Director Jeffrey Shuren, M.D.
At first glance, consultant Brad Ryba doesn’t believe these changes will have much impact on the overall device approval process. “If anything it may give the individual panel members more of a voice.” His verdict: “Time will tell if this is the first in a series of changes that may have a greater impact.”
In the past, panel discussions have not always reflected a panel’s final vote on approvability, the FDA says. Now, instead of voting on the approvability of premarket approval applications, including conditions of approval, the panel will vote on the safety and effectiveness of a device and the device’s risk versus its benefit.
Kenneth applauds this move, “The clinical experts can concentrate their collective opinions on clinical utility and FDA can make the final decision on approval.”
“By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes,” Shuren said. “The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them.”
Kenneth also raises another important issue, “One area for the manufacturer that has been a severe problem in the past is, not predicate creep but, protocol creep. You make a deal with the FDA/clinical advisors on a protocol at point A and, some years later, come back to panel with the results. Now, the panel does not like your protocol. It would be really nice to get a solution to this.”
In addition, panels will vote by ballot instead of by a show of hands. While the votes will be publicly tallied so that panel members can be identified by their vote, the ballot process allows each panel member to cast his or her vote without immediate influence by other votes.
There are many issues involved in the FDA’s review of a medical device. Historically, the FDA’s presentations to panels included comments on approvability. With the changes, the FDA’s presentations will continue to include reviews of the agency’s data analysis, but will no longer include comments on approvability.
Before the changes, the agency medical device reviewers presented a unified, consensus analysis of supporting data. Now, reviewers will present together with data and analysis, the range of scientific opinion in the group. This move will allow more in-depth discussion on safety and effectiveness and risk versus benefit of the device under consideration.
The FDA and CDRH will continue to evaluate panel procedures and make changes when necessary. A detailed description of changes to panel operations can be found at here.
Kenneth has a caution here, though, “One very important issue left untreated here is that of panel member ties to industry and impartiality.”
Maybe they’ll address that next time around?
For more information:
FDA Advisory Committees: Medical Devices
Medical Devices Advisory Committee
Michael Causey, Editor & Publisher, eDataIntegrityReport.com
This isn’t your father’s FDA. It isn’t even George W. Bush’s FDA.
No, FDA vintage 2010 is beginning to look more and more like a revitalized, proactive government agency that wants to flex its muscle when it comes to food, drug and device enforcement.
The latest example? Check out this March 22, 2010 piece in the Wall Street Journal (subscription required) where the Journal reports the FDA is, “struggling to determine whether it has authority to re-evaluate a knee device that it had earlier cleared, raising questions about the scope of the agency’s powers and injecting fresh uncertainty into the medical-devices sector.”
This sounds serious for medical device makers, and it reminded me of the Supreme Court reversing a long-held decision and changing the way the law is interpreted.
Am I overreacting? Probably not says my510k.com blogger Brad Ryba. “It’s a concerning precedent,” he told me the day the story hit the fan. “FDA typically does not rescind an approval once it is granted.”
A concerning precedent indeed. As reported in the Wall Street Journal, industry lobbyist Jeffrey Gibbs says, “…if the FDA could withdraw clearances for approved devices, it could create uncertainty for the industry and chaos for doctors who have used the product for patients. That said, the FDA has only limited options on how to deal with devices after they are cleared, he argued. “Congress has laid out reasons the FDA can revoke an approval, and none of them includes, ‘We goofed,’” he said.
Also, “In a November letter to the FDA, the company said it has been severely damaged by the controversy. ReGen says Menaflex has been used in 220 surgeries in the U.S and about 3,000 in Europe, where it has been on the market for several years. “
Ryba’s interpretation? “The FDA may be trying to show it has changed in response to public scrutiny. This new regime has made it clear that there will continue to be more activity around enforcement,” in the form of additional inspections and warning letters in the months and years ahead.
Certainly the FDA has gotten more aggressive when it comes to food regulation.
Is it the medical device industry’s turn?
Brad Ryba, Publisher, www.my510k.com
Much has changed in the FDA over the past year, and it appears more change is to come. Issues surrounding device approvals under the 510(k) process were front-and-center in a public meeting this past Thursday. The meeting was titled by the FDA, “Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process” and the agenda included a full day of discussion. FDA invited 30 speakers including industry executives, physicians, and policy advocates. Preceding the speakers, FDA did make some presentations citing its challenges under the current system. This was followed by a round-table discussion, along with some open Q&A sessions. From this meeting, it seemed two clearly differing agendas will shape policy changes over the coming months.
The FDA was clearly laying out the case for why it wants to make changes, while trying to broaden its powers beyond the current 510(k) process. When Dr. Donna-Bea Tillman, Director for CDRH Office of Device Evaluation made her presentation, she seemed to be open minded, stating that, “Trying to find the right balance between a regulatory process that enables us to foster innovation and at the same time ensures reasonable assurance of safety and effectiveness is the challenge we are here to talk about today.” Christy Foreman, CDRH Deputy Director for Engineering and Science Review was a bit more wary of industry, particularly in areas where FDA does not have as much authority. She contended, “Submission for [510(k) ] modifications are based on firm’s determination regarding the effect on safety and effectiveness. ” Ms. Foreman seemed to be hinting that this was an area she and FDA wanted to see addressed. Their concern is that documentation for incremental device changes is currently only kept in a firm’s internal files rather than defaulting to an FDA evaluation. Many other suggestions by FDA speakers indicated that The Agency wants increased oversight into clinical trials and labeling regulation. Further, the Director of 510(k) staff, Heather Rosecrans suggested that FDA needs broader powers to more easily rescind a 510(k) clearance if necessary. Many more comments and side issues emerged during the presentations, and these comments did not go unanswered by the industry representatives in attendance.
Most of the participants from the medical device industry advocated for the continuation of the 510(k) process, with a focus on consistency and transparency. Medtronic’s Chief Regulatory Officer, Susan Alpert highlighted the result of a cumbersome 510(k) process citing, “Our products go more quickly into other markets under other schemes than under this scheme”. She and her counterparts at the round-table discussion offered several suggestions to help the program evolve, while stressing that the current process works well for the majority of devices. Putting it another way, Craig Coombs, Head of Coombs Medical Device Consulting argued, “It’s not the 510(k) process. It’s what our interpretations are… predictability is really what needs to be there in order for us to comply.” These messages were echoed by many of the other industry speakers, and it is clear that this topic will continue to receive much further discussion.
FDA will continue to hear comments on the 510(k) process, and a Working Group is scheduled to submit its report to CDRH Director, Jeff Shuren, by the end of May 2010. The docket for comments on 510(k) process will remain open until Mar. 19, 2010. Comments are also being compiled by the community at my510k.com and on Twitter. While suggestions are being taken by FDA, their position seems clear that “Strengthening the 510(k) Review Process” means getting tougher on industry.
