10 doctors on FDA panel reviewing Abbott heart device had financial ties with company

A U. of Utah doctor was among those who received payments, though he said the money went to the university, not him.| April 13, 2024, 12:00 p.m.

The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.

FDA spokesperson Audra Harrison said by email that the agency doesn’t comment on matters related to individual advisory committee members. One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.

The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that “may be impacted” by their work on the committee, The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.

Conflict Of Interest University Of Utah Craig Selzman Duke University FDA Food And Drug Administration Abbott Open Payments Transparency University Of Pennsylvania

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FDA Advisory Committee Members with Financial Ties to Abbott Not DisclosedThe Food and Drug Administration (FDA) did not disclose that most of the committee members assessing a cardiac device made by Abbott had financial ties to the company. Payments from Abbott and research funded by the company were not disclosed by the FDA. The government database, called 'Open Payments,' records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices.
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