FDA advisory panel members will no longer take an up or down vote on the approvability of medical devices, or on recommended conditions of approval, CDRH announced April 26.
Article preview from "The Gray Sheet"- May 3,2010
FDA advisory panel members will no longer take an up or down vote on the approvability of medical devices, or on recommended conditions of approval, CDRH announced April 26.
Instead, device panel members will vote only on scientific questions of safety and effectiveness, and on risk versus benefit.
The change to long-term practice is one of several reforms of the device advisory panel process that CDRH put in place May 1 in an attempt to improve the quality of information FDA reviewers receive from the panels.
"We hope to have more penetrating advice from panels about a device's risk and benefits, safety and effectiveness," said Dick Thompson, a spokesman for the center.
CDRH will also make changes to its presentations at advisory panel meetings. FDA reviewers will present data and analysis to the panel representing the range of scientific opinions within the agency on a pre-market submission, rather than simply presenting a "consensus" analysis.
Further, the reviewers will not make comments to the panel specifically addressing approvability of a device. And the panel will be afforded more uninterrupted time to deliberate and ask questions of FDA and sponsors toward the end of the meeting.
Finally, panel members will now vote via electronic ballot, rather than a show of hands, to minimize peer influence.
"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," CDRH Director Jeffrey Shuren said in a statement.
Center Cites Increasing Panel Activity
The center cites the increasing number of device panel meetings in recent years as a primary trigger for the changes. There were 10 device panel meetings on 14 major topics in 2008 compared to 17 meetings on 20 topics in 2009. So far, 2010 is on track to surpass those numbers, according to CDRH.
"The increased activity has created challenges for CDRH and the way it operates panel meetings," an April 26 statement notes. Part of the device center's response to date has been to centralize and hire more staff dedicated to organizing panel meetings.
The issues addressed by the new reforms are not necessarily new ones, but they have increasingly come up with more frequent meetings.
Critics have long complained, for instance, that panel members, who are typically clinical experts, often have limited knowledge of FDA regulations. This sometimes causes confusion and disconnects between in-depth medical discussions early on in a panel meeting and subsequent votes addressing more limited regulatory questions.
- David Filmore
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