An investigative report has unearthed potential conflicts of interest among physicians who serve on advisory panels for the US Food and Drug Administration (FDA).
The investigation revealed that some FDA advisers are receiving significant post-hoc payments from the makers of drugs they reviewed.
The investigation also uncovered relationships between advisers and drug companies that predate drug reviews.
Journalist Charles Piller and his colleagues conducted this investigation and detailed the results in Science.
The report includes data—from the federal Open Payments website—on 107 physicians who voted on FDA advisory committees between 2013 and 2016.
Forty of these advisers received more than $10,000 in post-hoc earnings or research support from the makers of drugs they reviewed or from competing drug companies.
Twenty-six advisers received more than $100,000, and 7 advisers received more than $1 million.
The 17 top earners received more than $300,000 each. For these advisers, 94% of their earnings came from the makers of drugs they previously reviewed or from those companies’ competitors.
The data also show that some advisers received funds from drug companies concurrent with or in the year before their advisory service.
Of the 17 top-earning advisers, 11 received financial support from competing companies on one or more of the drugs they reviewed. Five advisers also received support from the makers of one or more of the drugs reviewed.
The FDA did not disclose this information to the public or issue waivers for these potential conflicts. The FDA can issue a waiver to allow the participation of an adviser with an active conflict or one that ended in the year before a vote, as long as the adviser in question can provide expertise that cannot be provided by someone else.
It is possible that the FDA dismissed the aforementioned financial ties that predated drug reviews, deciding these relationships were not conflicts and did not require a waiver. However, it is also possible that the FDA did not know about these potential conflicts.
Piller and his colleagues were unable to determine what the FDA knew, as the agency refused to release disclosure documents, discuss individual advisers, or explain what steps, if any, the FDA takes to validate advisers’ disclosures.