In July 2014, an adviser on a U.S. Food and Drug Administration (FDA) gynecology panel stepped down after he was questioned about conflicts of interest. It was later discovered that this panel member had received payments from the maker of the device he was evaluating. The FDA had not made this clear to the public. Such incidents influenced The Wall Street Journal to look into the relationship between the FDA, its expert advisers, and their ties to devices being evaluated.
The Wall Street Journal analysis of corporate, state, and federal data showed that some FDA panel experts have ties that could undermine objective panel rulings. Only 1% of these connections were publically acknowledged by the FDA.
Of the 122 members on panels evaluating gynecology, cardiology, and orthopedics devices, one-third had received compensation from a medical-device company. In this analysis, compensation includes anything from sponsored travel to money and research grants. Additionally, nearly 10 percent of the panel members had received compensation from the company whose device they were evaluating. These findings show a conflict of interest from the FDA advisers and the devices they evaluate.
Committees that sit on FDA panels are usually influential in the FDA’s decisions. The agency often follows the advice of their committee members when approving devices and placing regulations. The FDA does take financial ties and career history into consideration. But, their method of evaluation is unclear and has raised questions concerning the fairness of panel evaluations.
The FDA and their expert advisers have expressed that financial connections should not always disqualify members. According to the FDA, financial ties are only considered disqualifying if they are directly connected to the device in question. But, it appears this guideline is not always followed.
The agency holds that disclosing doctors’ personal information, such as financial ties and career history, will discourage qualified experts from serving on panels. In response to public disapproval of FDA advisers’ financial ties, the Open Payments database was recently launched by the federal government. It aims to create more transparency but ultimately it gives the public a limited view of panel members’ stockholdings and payment history.
