The Food and Drug Administration’s questionable oversight of a widely-used blood thinner raises serious concerns about whether the agency is failing in its role to keep consumers safe, according to a report published by the Project On Government Oversight.
POGO’s report describes a series of questionable calls the FDA has made in its oversight of Pradaxa, a new-generation blood thinner that has been named in thousands of “adverse event” reports, including cases involving patient deaths.
Some of the most alarming issues include the FDA’s handling of the clinical trial used to win Pradaxa’s approval.
POGO found that dozens of doctors the FDA had cited for violating standards in prior clinical trials, including repeat and even three-time offenders, were allowed to enroll and monitor patients in the Pradaxa trial.
The agency has taken a toothless approach to doctors who violate standards of clinical trials, disqualifying only 26 out of thousands in drug evaluation over a 10-year period, POGO found.
POGO’s investigation also found that members of FDA advisory committees, which play an important role in the agency’s approval of new drugs, have extensive financial ties to the industry they help oversee.
Two of the advisory committee members who voted for approval of Pradaxa went on to receive tens of thousands of dollars from the maker of the drug, the German company Boehringer Ingelheim, according to public databases.
“The deeply disturbing part is that the public has to trust the FDA to keep it safe, and the way the agency handled Pradaxa doesn’t inspire confidence,” POGO Executive Director Danielle Brian said.
POGO’s report said that the FDA hasn’t required the Pradaxa label to include a “black box” warning about the risk of serious or fatal bleeding. In contrast, the label for warfarin, the decades-old drug Pradaxa was meant to replace, comes with such a warning, despite the fact that there is an antidote for warfarin to stop bleeding but not one for Pradaxa.
The FDA’s questionable calls in the case of Pradaxa included:
Allowing the drug maker to finalize the scoring system for the clinical trial after the experiment was over and the data had been gathered, according to FDA documents.
Approving the drug on the basis of an unblinded trial that could have been biased by the fact that doctors knew which test subjects were taking the experimental drug, and, according to one of the main FDA reviewers, handled them differently.
In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle lawsuits alleging Pradaxa had harmed patients.
