Many of the physicians and other experts who sit on FDA advisory panels to review medical devices have financial ties to manufacturers, but the regulator has failed to disclose the relationships, according to an analysis of corporate, state and federal data by The Wall Street Journal.
In panels evaluating devices involved in cardiology, orthopedics and gynecology from 2012 through 2014, a third of 122 members received compensation–such as money, research grants or travel and food–from companies, the Journal writes. Nearly 10% of the FDA advisers received something of value from the specific company whose product they were evaluating. The agency disclosed 1% of the connections.
So far this year, the FDA has convened more than 20 meetings in which advisory panel members issued recommendations on whether to approve novel products or put new regulations on older ones.
The issue is not new, but experts say a fix is needed. “Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations,” Joseph Rose, an associated profess at the Yale School of Medicine, tells the Journal.
For its part, the FDA says the financial interests of advisory panel members are disclosed, but only when agency officials have determined panel members need a waiver in order to serve. Discretion is also involved. A panel member who has done paid work for a medical device maker is not disqualified nor is public disclosure required if the work was not related to the specific topic or product to be reviewed.
“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,” FDA Associate Commissioner Jill Hartzler Warner tells the Journal. “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].”
Agency officials worry that broader disclosure could discourage people from sitting on advisory panels and already has a challenge getting highly qualified experts to agree.Panel vacancies ranged from 13% to 17% between October 2013 and June 2014, the most recent month for which data were available, although the reasons for the vacancies were not specified.
A key problem, the Journal notes, is a lack of a central repository to learn of ties between panel members and manufacturers, which pay hundreds of millions of dollars a year to physicians in consulting, speaking and other fees, according to data from the Centers for Medicare and Medicaid Services. And even though CMS launched the Open Payments database this year, which displays payments to physicians, no database reveals stocks held by physicians or researchers, so any search can give only a partial picture of financial ties.
The Journal tally of payments to members of panels on cardiology, orthopedic and gynecology devices in 2014 found that 64% received no value from device makers in the past five years. The rest did, varying from less than $15 for food and beverage to more than $500,000 in research funding. Of doctors who received something from companies, 32% got less than $500 in value and 26% received $10,000 of value or greater.
As for the process, prospective panel members are asked to report all financial ties, including consulting fees, research grants and stock, in companies seeking a recommendation before the panel and their competitors. In general, if the value of current interests exceeds $50,000, a person will be excluded, although if the FDA decides a payment is not truly a conflict, a so-called “502 authorization” allows that person to serve. However, these are not waivers and are not publicly disclosed, nor does the agency say how many are issued each year.
“The problem with the FDA’s policy is you don’t know how they use their discretion,” Celia Wexler, a lobbyist for the Union of Concerned Scientists, a group that opposes political interference in scientific and regulatory matters, tells the Journal. “It’s very difficult for us to know to what extent the FDA probes, and the extent to which panel members take the disclosure requirements seriously.”
The Journal goes on to offer a few examples, which you can read here.