FDA’s Lax Oversight, Bad Decision-Making Leave Consumers at Risk

The Food and Drug Administration’s (FDA) questionable oversight of a blockbuster blood thinner raises serious concerns about whether the agency is failing in its role to keep consumers safe, according to a report published today by the Project On Government Oversight.

POGO’s report describes a long 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. That was par for the course; the agency has taken a toothless approach to doctors who violate standards of clinical trials, disqualifying only 26 out of thousands in the realm of 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 vetting of new drugs, have extensive financial ties to the industry they help oversee. According to public databases, 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, Boehringer Ingelheim.

“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. “The FDA needs to grow a spine.”

POGO’s report notes that the FDA has not required that the Pradaxa label 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 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.

Follow the link to read the full report.