The Food and Drug Administration (FDA) recently assembled a committee to evaluate a cardiac device manufactured by Abbott.
However, the agency did not disclose that most committee members had received payments from Abbott or conducted research funded by the company, information that is publicly available in a federal database.
One committee member received nearly $200,000 in payments from Abbott, while another received about $100,000 and conducted research supported by approximately $50,000 from the company.
A third member worked on research supported by over $180,000 from Abbott.
The database, known as “Open Payments,” records financial relationships between doctors and certain health care providers and the makers of drugs and medical devices.
Records show that Abbott made payments associated with 10 of the 14 voting members of the FDA advisory panel that evaluated the TriClip G4 System, a heart device.
The payments, m
ade between 2016 and 2022, totaled about $650,000.
Despite these financial ties, the panel almost unanimously concluded that the benefits of the device outweighed its risks.
The FDA subsequently approved TriClip on April 2 for treating leakage from the heart’s tricuspid valve.
These payments highlight the influence of medical industry money and raise concerns about transparency at the FDA.
While the payments do not imply wrongdoing, some argue that they should have been disclosed to ensure the objectivity of committee members.
The FDA, however, maintains that it followed all appropriate procedures and regulations in vetting the panel members.
The FDA distinguishes between appearance issues and financial conflicts of interest.
Appearance issues involve financial interests that might cause a reasonable person to question a member’s impartiality, while conflicts of interest occur when financial interests could be impacted by their work on the committee.
The agency has discretion to decide whether someone with an appearance issue can serve on a panel.
TriClip was designated a “breakthrough” device by the FDA, meaning it has the potential to provide more effective treatment for life-threatening diseases.
However, data from a clinical trial raised concerns, including higher mortality and heart failure hospitalization rates among patients treated with TriClip compared to a control group.
Despite these findings, the panel voted overwhelmingly in favor of the device.
Some committee members expressed concerns about the device but ultimately voted in favor.
They defended their impartiality, stating that they disclosed their financial ties to Abbott and that they could evaluate the device objectively.
The FDA’s approach to disclosure contrasts with rules for medical conferences, where speakers are required to disclose financial interests going back 24 months.
Critics argue that the FDA’s standards for disclosing financial ties are too lenient and that they undermine public trust in the agency’s decision-making process.