Analysis Finds One-Third of FDA Reviewers Have Industry Ties

The U.S. Food and Drug Administration (FDA) did not disclose financial ties between medical device manufacturers and physicians and other experts the agency used to review such devices, according to a Wall Street Journal review of state and federal data.

According to the Journal‘s analysis, one-third of the 122 members of FDA panels evaluating medical devices for use in cardiology, orthopedics, and gynecology from 2012 to 2014 received compensation form medical device companies. Such compensation included:

• Money;
• Food;
• Travel expenses; and
• Research grants.

Specifically, the analysis found that 64 percent of experts on FDA panels for cardiology, orthopedics, and gynecology devices did not receive anything of value from the companies who manufactured the devices being reviewed. The remaining physicians received some sort of compensation, ranging from $15 in food and beverage costs to more than $500,000 in research grants. About 32 percent of those who were compensated received incentives totaling less than $500, while 26 percent received incentives totaling $10,000 or more.

Overall, almost 10 percent of the advisers FDA used received something of value from the company that produced the product being evaluated, the analysis found.

The findings sparked concern among critics of the practice. Yale School of Medicine associate professor Joseph Ross said, “Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations.”

FDA said current law and policy require the agency to disclose such connections only when it has determined that the experts require a waiver in order to participate in the evaluations. FDA officials added that the agency has discretion over making such determinations. For example, experts usually do not require waivers if they completed paid work for the companies, as long as the work was not related to the panel’s specific focus.

Meanwhile, FDA Associate Commissioner Jill Hartzler Warner said current consulting work and having ownership in a large portion of a company’s stock usually disqualifies experts from participating in the panel, but FDA can issue waivers if they feel an individual’s expertise cannot be found elsewhere. Such waivers are posted to FDA’s website.

Further, physicians have said their consulting work does not have bearing over their evaluations. David Kandzari, a cardiologist who has served on FDA panels that have reviewed products from companies with which he has worked, said, “I’ve never sat there on a panel and thought, ‘I wonder what my friends at companies X, Y and Z would say.’ I just don’t view it that way.”