Devices

10 FDA Advisors Had Financial Ties with Abbott: KFF

Ten members of an FDA advisory committee evaluating an Abbott heart device had financial ties to the company, according to a KFF Health News report carried by NBC. The media outlet used the federal government’s Open Payments database to find that one committee member was linked to hundreds of payments from Abbott totaling nearly $200,000, another member was connected to 100 payments totaling $100,000 plus research support of about $50,000, and a third member received research support of more than $180,000.

“The payments do not reflect wrongdoing on the part of the agency, its outside experts, or the device manufacturer,” the report says. “The database does not show that any of the payments were related directly to the TriClip device” that was being considered. The panel voted almost unanimously that the device’s benefits outweighed its risks.

KFF interviewed outside experts, including some who previously served on advisory committees, who said the payments should have been disclosed at the committee meeting.

In an email to KFF, agency spokesperson Audra Harrison said, “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 report says KFF spoke with one of the committee members who was associated in the database with $181,000 in research funding to the University of Utah Hospitals and Clinics. University of Utah Division of Cardiothoracic Surgery chief Craig Selzman said the money went to the university and not to him personally. Asked if a reasonable person could question the impartiality of committee members based on the company payments, Selzman said, “People from the outside looking in would probably say yes. There’s probably a better way to provide transparency.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome