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FDA Reviewers Found Accepting Industry Payments After Drug Approvals

Pills and dollars

(Images Money, Flickr)

6 July 2018. A new report finds a large percentage of panel members that review drug applications for the Food and Drug Administration accept payments and other rewards from companies after their drugs are approved. The report led by investigative correspondent Charles Piller appears in today’s issue of the journal Science.

Piller and colleagues looked into the practice of drug developers providing financial benefits to members of FDA advisory committees after the panels review drug applications and vote to recommend approval. Advisory committees, often comprised of physicians and academic scientists, are recruited by FDA to independently evaluate drug applications in addition to the agency’s professional staff. While FDA does not always follow the assessments of these committees, an endorsement from these panels is often a predictor of FDA approval.

The Science team looked into advisory panels that recommended approval of 28 cardiovascular/renal or psychopharmacologic drugs as well as treatments for arthritis from 2008 to 2014, and were later approved by FDA. The reporters matched up participants on these panels to payments listed in the Open Payments database, collected by Centers for Medicare and Medicaid Services in the U.S. Department of Health and Human Services, from 2013 to 2016. The team also scanned conflict-of-interest disclosures in scientific and medical journals, at least those not behind paywalls. (Editor’s note: Much of Science magazine’s content is behind a paywall.) In their inquiries, the reporters looked for payments from the companies whose products were reviewed, as well as competitors of those companies making similar drugs.

The team found 107 advisers taking part in the committees and recommending the 28 drugs for FDA approval. Of the 107 participants, 40 — or 37 percent — received payments of $10,000 or more in compensation or research support after they voted to approve the drugs, either from the developers of the drugs or from competitors. In addition, 26 of the committee participants earned at least $100,000 from these companies, and 7 gained $1 million or more. The reporters also found the 17 top earning advisers, those making $300,000 or more, took in a total of $26 million over this period, of which nearly all, 94 percent, came from the companies making the products they reviewed or competitors.

An FDA spokesperson told Science in a statement that advisory committee members must disclose prospective employers, but not anticipated payments. The spokesperson added, “FDA also screens potential participants for relationships and situations that do not create a financial conflict of interest but that may create the appearance that a committee member lacks impartiality.” Nonetheless, the investigative team found as well that the top earners and others among the 107 advisory committee participants received payments from drug companies with products being reviewed and competitors in the same year or before the time the panels met. The reporters say they found these details in the academic journal disclosures, not from FDA.

While Science’s investigation focused mainly on the advisory committees, the team also found some FDA professional staff with at least the appearance of conflicts. Through web searches, including on LinkedIn, the reporters found 11 of 16 medical staff that worked on the 28 drugs reviewed by the agency between 2008 to 2014 left the agency to work for the companies submitting the drugs for review, either as direct hires or consultants.

Bioethicist Carl Elliott at University of Minnesota who studies industry conflicts of interest told Science that compensation and other benefits after the fact are just as ethically troubling as direct quid pro quo rewards. “You do something positive for a company that you feel confident is going to pay you back for it later on,” notes Elliott. “And they do.”

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