10 FDA panel members who voted on heart device connected to Abbott: Report

The FDA convened a committee of advisers to assess a cardiac device made by Abbott, but the agency did not disclose that 10 of the 14 members had received payments from the company or conducted research it had funded, KFF Health News reported April 8. 

The advisory panel was put together to weigh clinical evidence for an Abbott heart device called TriClip G4 System. The panel voted almost unanimously that the benefits of the advice outweigh the risks. 

The government database Open Payments records financial relationships between physicians and other healthcare providers and drug and medical devicemakers. KFF Health News found records of Abbott payments associated with 10 of the members, some totaling up to $200,000. At a public meeting, an FDA official said the committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.

An FDA spokesperson told KFF Health News that "the FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place. This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest."

The situation illustrates the reach of the medical industry money and the limits of transparency at the FDA, KFF Health News said, however, "The payments do not reflect wrongdoing on the part of the agency, its outside experts or the device manufacturer. The database does not show that any of the payments were related directly to the TriClip device."

An Abbott spokesperson told KFF Health News that the company "has no influence over who is selected to participate in FDA advisory committees."

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