Jury Still Out on FDA Move to Alter Expert Panel Protocol

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

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

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