FDA's review of BI's Pradaxa was 'lax' and 'permissive,' watchdog claims

Boehringer Ingelheim's next-gen anticoagulant, Pradaxa, has been plagued by safety worries that have cropped up since its 2010 FDA approval. And according to one watchdog group, that's because the agency was "lax" and "permissive" in reviewing the drug in the first place.

U.S. regulators took steps to "accommodate" BI by easing Pradaxa's path to market and then shrugging off postapproval safety questions, the Project on Government Oversight alleges in a new report. Among its FDA criticisms: The agency "tolerated sloppiness and arguably loose controls in the management" of Boehringer's clinical trial, "redacted a key document related to its evaluation of Pradaxa in a way that protected the product's image at the expense of the public," and "acceded to the company's wishes" in permitting it to claim superiority over old-guard therapy warfarin, POGO claims.

For its part, Boehringer found the article to be "biased and misleading," a spokeswoman told FiercePharma in an emailed statement.

"The points raised have been previously addressed publicly and found to be baseless. In fact, the overwhelming clinical data and real world experience continue to support the safety and efficacy of Pradaxa, which has been studied, evaluated and approved in over 100 countries," she wrote, noting that the company takes "offense to anyone or any organization who would question our integrity."

Still, concerns over Pradaxa's safety have taken a toll on the drug's market share. The German drugmaker has been hit with thousands of lawsuits claiming it failed to properly warn patients that the drug caused life-threatening and sometimes fatal bleeding--4,000 of which it wrapped up last year with a $650 million settlement. And in the meantime, Johnson & Johnson's ($JNJ) rival med Xarelto has taken over the top spot among new-age clot-busters.

Boehringer is hoping that it can reverse that trend once it comes out with a bleeding antidote, though. The company's reversal agent is currently in late-stage studies, and winning approval for the product could help it gain ground against both Xarelto and warfarin, which still boasts a large population of users despite its more difficult dosing and requirement for ongoing monitoring.

- read POGO's report (PDF)

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