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off-label marketing

First Amendment Protects Off-Label Promotion, Judge Rules

A federal judge ruled earlier this month that the Food and Drug Administration can't bar a drug company from promoting an unapproved use for its pills derived from fish oil, The Washington Post's Carolyn Johnson reports. U.S. District Judge Paul Engelmayer ruled that the First Amendment protects Amarin Corp. "'truthful and non-misleading speech'" in promoting a use of its pills that has not been approved by federal regulators.
 

U.S. Supreme Court Rejects Appeal of $142 Mil. Award Over Pfizer's Illegal Marketing

The U.S. Supreme Court has decided against granting Pfizer's appeal of a $142 million award in favor of Kaiser Foundation's health plan and hospitals regarding the off-label marketing of the Neurontin epilepsy drug, Bloomberg Businessweek reports. The Supreme Court's action also means that a national class action can proceed in which insurance companies, union funds and employers are suing for paying for coverage of "ineffective dosages of Neurontin" on the basis of aggregate data showing a correlation between Pfizer's off-label marketing and the number of off-label prescriptions, Bloomberg Businessweek further reports.

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