Some physicians on FDA panel have undisclosed ties to device manufacturers

The FDA has not disclosed financial ties between medical device makers and physicians and other experts who review devices on their advisory panels. Nearly 10 percent of FDA advisers have received something of value from a medical device making company whose product they were evaluating, but the FDA only disclosed about 1 percent of these corporate connections, according to the Wall Street Journal.

According to the article, between 2012 and 2014, a third of 122 panel advisers evaluating devices involved in cardiology, orthopedics and gynecology received some sort of compensation, including money, research grants or travel and food, from medical device companies.

The WSJ's analysis of corporate, state and federal data is concerning for the possible conflicts of interest it exposes. "Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations," Joseph Ross, MD, MHS, an associate professor at Yale School of Medicine, told WSJ.

The FDA said under the current law it is only obligated to disclose panel advisers' financial ties to device making companies when it has determined — based on its own discretion — the experts need a waiver in order to serve, the article said. Doing paid work for a company whose product is under evaluation does not disqualify a physician from the panel, nor requires public disclosure, so long as the work wasn't specifically related to the topic or product the panel focuses on, the FDA said.

"If you have a financial interest with a sponsor or a related firm, but it’s not related to the product at the meeting, it’s not disqualifying," Jill Hartzler Warner, FDA Associate Commissioner told WSJ. "The firms are often large and diverse, and whatever position the FDA takes, it won’t affect the relationship between the firm and the [expert adviser.]"

Furthermore, the FDA is concerned that broader disclosure could discourage physicians and other experts from joining advisory panels, as the agency already faces difficulty getting highly qualified experts to participate.

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