Abbott heart device under FDA panel review included 10 doctors with financial connections to suburban Chicago health giant

FDA Advisory Committee Members with Financial Ties to Abbott Raise Transparency Concerns

When the federal Food and Drug Administration recently convened a committee of advisers to assess a cardiac device made by North Chicago-based Abbott, it was revealed that most of the members had received payments from the company or conducted research funded by Abbott. This information, readily available in a federal database called Open Payments, raised concerns about transparency and potential bias in the regulatory approval process.

According to the database, several members of the FDA advisory committee had financial ties to Abbott, with payments totaling almost $650,000. Despite these financial relationships, the panel voted almost unanimously in favor of the device, known as the TriClip G4 System, which was designed to treat leakage from the heart’s tricuspid valve.

While the FDA maintains that it followed all appropriate procedures and regulations in vetting the panel members, critics argue that the financial ties should have been disclosed at the meeting to ensure transparency and avoid any appearance of bias. Dr. Joel Perlmutter, a former FDA advisory committee member, emphasized the importance of disclosing such financial relationships to prevent potential conflicts of interest.

Diana Zuckerman, president of the National Center for Health Research, criticized the FDA for allowing recipients of funding from Abbott to participate in the review of the Abbott product, stating that the agency takes too narrow a view of what should be disqualifying.

Despite the financial ties, some committee members expressed concerns about the device during the meeting. Dr. Paul Hauptman, who received the most money from Abbott according to the database, cast one of the votes against the device on effectiveness and the sole vote against the device on the risks versus benefits question. Hauptman emphasized the need for caution and better definition of who will benefit from the device.

Overall, the FDA’s approach to disclosure of financial ties contrasts with rules for conferences where doctors must disclose financial relationships with companies. Critics argue that more transparency is needed in the regulatory approval process to ensure the impartiality of advisory committee members and maintain public trust in the FDA’s decision-making.