Tuesday, November 8, 2011

Another former pharma CEO contends the First Amendment allows him promote his drug without restrictions

From Pharmalot:
Two months ago, the feds excluded W. Scott Harkonen from doing business with various federal healthcare programs such as Medicare and Medicaid. Why? The former InterMune ceo was sentenced earlier this year for wire fraud in connection with disseminating false and misleading statements about the results of a clinical trial for a drug called Actimmune.
Specifically, he was convicted in a September 2009 trial after being accused of making up details about how effective Actimmune was in combating a fatal lung disease, idiopathic pulmonary fibrosis, or IPF.  And those details were trumpeted in a 2002 press release that was at the heart of the case (read here and here).  The clinical trial failed, but the press release stated a sub-analysis showed the drug helped IPF patients live longer, prompting docs to write scrips even though Actimmune wasn’t approved for that disease.
Now, though, Harkonen is appealing and, at the very least, wants a new trial. But in their brief filed with a federal appeals court late last month, his lawyers are attempting to turn his case into yet another alleged instance in which the First Amendment and commercial speech - as practiced by a pharmaceutical company - have been trampled by federal prosecution.
Click here for the rest of the story.  I've noticed these arguments are gaining a sympathetic ear from the judiciary and various legislatures. 

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