Abbott provided $650,000 to FDA advisory panel members

How should regulatory bodies and consumers weigh payments made by life sciences companies to FDA advisory panel members? That’s the question posed by the recent news that 10 of 14 voting members on the United States FDA advisory board for the Abbott TriClip G4 System received payments from Abbott between 2016 and 2022.

Based on their research, KFF Health News broke the story on April 8, 2024, noting that the federal agency failed to disclose the information upon approving the product. While financial relationships between some healthcare providers and pharmaceutical companies or medical device manufacturers are publicly available in Open Payments, a government database managed by the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS), the agency did not make a formal statement.

According to recent reporting by KFF, one advisory member had received $200,000 worth of payments from Abbott. Other members also received significant financial incentives, including one member who received $100,000 in monetary contributions and $50,000 in research funding. Another member worked on research with $180,000 of financing for the company.

The Abbott TriClip G4 System was reviewed by the FDA advisory panel in February 2024, and the panel unanimously voted that the tool's benefits outweighed any potential risks. While the advisory panel's votes do not directly account for the device's approval, the FDA heavily considers input from these experts when making final regulatory decisions. In this case, the agency ended up approving the device.

Although it is not uncommon for providers and researchers to receive financial support from biopharmaceutical companies to support research and other actions, there is no system to ensure that they cannot contribute to the regulatory approval of these drugs.

“This is a problem,” noted Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, in a statement to KFF Health News. “They should or must disclose this due to bias.”

However, FDA spokesperson Audra Harrison said, “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.”

While some advisory members maintained that they could remain impartial despite payments, others are still skeptical. Regardless of opinion, this matter sparked discussion about financial contributions in the regulatory space.