The Food and Drug Administration recently assembled a committee of advisers to evaluate a cardiac device manufactured by Abbott. However, the agency did not disclose that most of the committee members had received payments from Abbott or conducted research funded by the company. This information is readily available in a federal database called “Open Payments,” which records financial relationships between doctors and health care providers and the makers of drugs and medical devices.
The database revealed that 10 out of the 14 voting members of the FDA advisory panel had received payments from Abbott, totaling approximately $650,000 from 2016 to 2022. Despite these financial ties, the panel voted almost unanimously to approve the TriClip G4 System, a heart device designed to treat leakage from the heart’s tricuspid valve.
While the payments do not imply any wrongdoing, some experts believe that they should have been disclosed at the meeting to ensure transparency and avoid questioning the objectivity of committee members. The FDA maintains that it followed all appropriate procedures to vet the panel members and ensure they do not have conflicts of interest.
The FDA’s approach to disclosure differs from rules for medical conferences, where speakers are required to disclose any financial ties with companies. The agency has designated the TriClip device as a “breakthrough” device with the potential to provide more effective treatment for life-threatening diseases. However, the device faced scrutiny for findings from a clinical trial that raised concerns about its safety and effectiveness.
Despite some committee members expressing concerns about the device, the majority voted in favor of its safety and benefits outweighing its risks. The financial ties between committee members and Abbott raise questions about impartiality and transparency in the FDA’s advisory panel selection process.
