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Pharma can't be prosecuted for off-label marketing, court rules

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People are people, they say. People have rights. Now, a U.S. appeals court has determined that sales reps are people, and their free speech rights apply on the job, even when that means talking about off-label uses of a drug. And their employers can rely on free speech to protect off-label drug marketing. Because, after all, corporations are people, too.

The case: Alfred Caronia, an Orphan Medical sales rep, was convicted in 2008 of pushing the narcolepsy drug Xyrem for uses not approved by the FDA. The appeal: Caronia claimed his First Amendment rights were violated. The latest: The 2nd Circuit Court of Appeals tossed Caronia's conviction on free speech grounds.

The upshot: "The government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetics Act] for speech promoting the lawful, off-label use of an FDA-approved drug," U.S. Circuit Judge Denny Chin wrote (as quoted by Bloomberg).

Say what? Isn't off-label marketing the very thing that put Big Pharma (and its smaller siblings) on the wrong side of the U.S. Justice Department? Haven't drugmakers paid billions over the past several years to put off-label marketing allegations to rest?

Indeed. The court itself cited off-label prosecutions, Bloomberg notes, mentioning several cases, including the record-setting $3 billion settlement with GlaxoSmithKline ($GSK) this year. Drugmakers themselves have brought up the free speech defense, too. Allergan ($AGN) sued the FDA on free speech grounds in 2009, saying it should be allowed to promote Botox for unapproved uses. Par Pharmaceutical filed a similar suit last year.

Dissenting Judge Debra Ann Livingston pointed out that the decision would upend longstanding proscriptions that developed for a purpose--"to protect consumers from misleading and unsubstantiated claims about drugs' safety and efficacy."

With so much at stake, prosecutors are likely to seek a higher authority--namely, the U.S. Supreme Court. The justices have favored corporate free speech before. But will they agree when it comes to drug promotions? That's just one of the many questions this ruling raises.

- read the Bloomberg story

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Related Articles:
GSK pays $3B to wrap up host of Justice Department claims
Par Pharma sues FDA, claiming free speech rights
Free speech defense gains in off-label case
Allergan deal spurs off-label debate