FDA Panel Members Who Voted on Abbott’s Heart Device Had Financial Ties to Company

The U.S. Food and Drug Administration (FDA) recently convened a committee of independent advisors to review a cardiac device made by Abbott but failed to disclose that most of them had financial ties to the company. According to the Open Payments database, 10 of the 14 voting members on the FDA’s advisory panel tasked with reviewing the clinical data for Abbott’s heart device and voting on information related to its premarket approval application received a total of roughly $650,000 between 2016 and 2022. The panel, during its Feb. 13 meeting, voted almost unanimously, 13 to 1 that the benefits of Abbott’s TriClip G4 System used to treat tricuspid regurgitation outweigh the risks, The panel also voted 14 to zero that TriClip is safe for its intended use, and 12 to 2 that the device is effective, despite concerning clinical trial results provided to the panel in an FDA briefing document....