FDA DEVICE ADVISORY PANELISTS DROP BALL ON SAFETY, REPORT SAYS
A new report uses comments from FDA advisory panel members to show a disconnect between members' safety concerns and device approval rates.
The National Research Center (NRC) for Women & Families issued the report, titled "FDA Advisory Committee: Does Approval Mean Safety?," Aug. 28. The NRC is a Washington, D.C.-based organization focused on health information and policy issues.
While NRC researchers said device advisory committees acted as "rubber stamps for approval" for 82 percent of new device applications, the researchers found that some panel members' comments point to conflicts between their views and their votes.
For example, at a January 2002 Ophthalmic Devices Advisory Panel meeting, Allen Ho voted to approve a capsular tension ring for use in cataract surgery after concluding, "Poor study, poor execution, flawed from the beginning, I think."