Significant Court Ruling Affects Off-Label Drug Marketing Print E-mail
By Staff and Wire Reports   
Tuesday, 04 December 2012 08:45

icon_newslinkThe New York Times is reporting on a case that could have broad ramifications for the pharmaceutical industry.


A federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech.

According to the report, the 2-to-1 decision by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.

Because pharmaceutical companies market their drugs nationally and the ruling applies only within the Second Circuit, the ruling is not likely to lead drug makers to change their marketing policies. Rather, some said, the F.D.A. will be unlikely to pursue convictions in similar cases until the legal issues are resolved.

Read the entire article here:

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