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U.S. FDA fails to fine drug companies for not reporting clinical trial information


The U.S. government could impose more than $11.2 million in fines on pharma companies for failing to report study results on ClinicalTrials.gov, but has so far failed to do so.


Fining pharma companies for hiding the results of their studies might sound like a creditable initiative, but in practice – at least as currently designed – it hasn’t a chance of succeeding. Even after the so-called AllTrials initiative was set up in 2015 (a project advocating that all clinical trials conducted should be registered and their results shared as open data), it remains the case that only around half of drug company policies thus far examined refer to trials carried out in the past. As such, we essentially have no idea how many pharmaceutical trials have historically been suppressed because they failed to show a positive result.

While the United States Food and Drug Administration (FDA) has the power to levy fines of 10 thousand dollars a day when pharma companies fail to report the results of trials, even if it did so this amount is not even close to being enough to solve the problem. With the pharma industry’s total global sales now exceeding one TRILLION dollars a year, fines of 10 thousand dollars a day – equating to a mere 3.65 million dollars a year – are simply peanuts to drug companies. Given this reality, one could be forgiven for thinking that, far from being intended to constrain the pharma industry’s ruthless pursuit of profit, such initiatives have instead been deliberately designed to fail.

Read article at statnews.com