An ongoing investigation conducted by data analysts at Science found pattern of compensation by the drug industry to individuals in charge of FDA drug approvals.
For the analysis, researchers examined direct payments to physicians from drug companies whose products were voted on by FDA advisory committees. They used data from physician disclosures listed in freely available publications and CMS records from 2013 to 2016 posted on Open Payments.
Here are six things to know:
1. The FDA uses a system to identify possible conflicts of interest before medications meet an advisory panel. However, these safety measures are not designed to prevent further future financial ties.
2. The analysis identifies an ongoing pattern of "pay-later conflicts of interests," which go largely unnoticed and unpoliced, according to Science. For example, the FDA found no financial conflicts among the panelists who voted for the heart drug Brilinta. However after Brilinta's sales took off, AstraZeneca and other firms either selling or developing similar heart therapies gave four physicians on the panel money for travel and advice.
3. After examining compensation records from drug companies to physicians who sat on FDA advisory panels for 28 psychopharmacologic, arthritis and cardiac or renal drugs between 2008 and 2014, Science discovered a large amount of "after-the-fact payments and research support to panel members," according to the report.
4. Forty of the 107 physicians serving on an advisory panel over the last four years received more than $10,000 in post hoc earnings or research from drugmakers whose products they voted to approve. Twenty-six of those 40 gained more than $100,000, and seven gained more than $1 million.
5. Seventeen top-earning advisor, received more than $300,000 each, and 94 percent of the money came from drugmakers whose drugs they'd previously reviewed or from competitors.
6.The FDA told Becker's Hospital Review the agency conducts conflict-of-interest screening of potential advisory committee participants in accordance with all applicable laws and regulations. In preparation for the panel, committee members are required to report any financial interests related to the subject matter of the advisory committee meeting, according to the agency.
"The FDA implements a rigorous process for soliciting and vetting candidates for advisory committee meetings to minimize any potential for financial conflicts of interest," a FDA spokesperson told Becker's. "There is no question that we must appropriately address potential conflicts for our [panel participants.] At the same time we must also ensure that experts working in their fields are not unnecessarily excluded from participation in the advisory committee process."
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