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Pharma 'sensitive' about off-label marketing

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Don't be skeptical of the U.S. government's recent spate of off-label marketing claims against drugmakers. That's what AstraZeneca chief (and current chair of the trade group PhRMA) David Brennan (photo) told the Wall Street Journal in an interview. Those fines are actually working, Brennan says.

Big Pharma is "more sensitive than we've ever been" about policing off-label promotion of their meds, Brennan told the Journal, because of the government's crackdown, carried out by some very active U.S. attorneys and the Justice Department. "If you go back ten years in this industry, this was not an issue," Brennan says. "I mean, we trained our people not to promote off-label... so it's always been sensitive. But now, it's even more sensitive because we're paying fines."

Besides his ability to take Big Pharma's current temperature through his work with PhRMA, Brennan also knows just how sensitive the issue is via his own experience. AstraZeneca recently reached a tentative, $520 million deal to settle a government probe into the marketing of its atypical antipsychotic Seroquel. The terms are still being finalized, so there's no word yet on whether AstraZeneca will admit wrongdoing as part of the deal. Brennan says the company is in the clear: "We don't promote products off-label."

As you know, the $520 million AstraZeneca is set to pay on the Seroquel claims is just a fraction of the $1.3 billion Eli Lilly settlement and the $2.3 billion Pfizer settlement, both of which were announced in recent months. And it's only about a fifth of Seroquel's 2008 global sales. Still, it's not piggybank money. And all these settlements generate plenty of publicity. As for their long-term effects--only time will tell.

- read the WSJ piece

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Are fines enough to deter off-label marketing?
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Did AZ plan to tout Seroquel off-label?

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