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Articles Posted in Off-label promotion

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First Amendment Protection and Off-Label Promotion: What Drug Companies Can and Can’t Say

The First Amendment of the United States Constitution protects the freedom of speech.  Not all forms of speech, however, receive total protection, such as yelling “fire” in a crowded theater if doing so is likely to cause injury.  So-called “commercial speech” is a category of speech afforded partial, but not…

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Pharmaceutical Sales Rep Plays Whistleblower for Second Time, Resulting in $520 Million Off-Label Promotion Settlement

AstraZeneca recently settled federal investigations regarding its marketing practices of Seroquel for $520 million.  Although Seroquel had only been approved by the FDA to treat schizophrenia and acute bipolar I disorder, whistleblower James Wetta accused the company of embarking on a national sales program to promote Seroquel for off-label use…

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Drug Maker Novartis in Trouble Again for Illegal Marketing: This Time on Facebook

The U.S. Food and Drug Administration (FDA) has issued a letter to drug maker Novartis warning it to cease its incomplete and misleading promotion of the leukemia fighting drug Tasigna on Facebook.  Novartis had been using Facebook’s “share button” to market the drug on the social website giant.  However, in…

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Alpharma Settles False Claims Act Suit for $42.5 million

A multi-state agreement was reached between 49 states, the District of Columbia, and Alpharma Inc. on June 8 to settle allegations of kickbacks and off-label promotion of its drug, Kadian. A whistleblower receiving $5.33 million of the total $42.5 million settlement initially filed the lawsuit in 2006 under the False…

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Elan Pharmaeuticals Settles Off-Label Charges

Pharmaceutical company Elan Corporation recently announced an agreement with the DOJ to pay $203.5 million to settle Medicaid fraud claims involving its previously divested antiepileptic drug, Zonegran. As a result of the agreement, Elan pled guilty to a misdemeanor violation of the Food Drug and Cosmetics Act (FDCA) and plans…

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