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Off-Label Promotion - An Indictment

By James M. Beck and Mark Herrmann

As regular readers of this blog know, we?re interested in off-label promotion issues, and we unapologetically take the position that, as long as the information involved is truthful, the right of a company to tell the public about all medical conditions, on and off label, that its product helps prevent or treat is protected by the First Amendment.

The First Amendment issue, of course, remains unresolved. In Caputo one of us intervened against the government as amicus to make sure that that issue was not resolved badly due to bad facts

Well, we?re wondering whether there may be another possible show-down coming from the left coast. We?ve just received word that the CEO, not just the operational people, of InterMune, a company that made an interferon-related drug, has been indicted for off-label promotion. The government?s press release says that the defendant lied about the results of a study, and other things. That may well be true; we don't know ? but that?s what we'd expect any good prosecutor to say at this stage of the game.

Who knows what the evidence will actually show.

Our advice? As long as the prosecutors stick to statements that are demonstrably and provably false, the First Amendment isn?t going to be implicated. But Caputo should be a lesson to everyone. Don?t throw in the kitchen sink, as it gives the defendants weighty constitutional arguments that prosecutors would do well to avoid. Even on pretty bad facts, the First Amendment issues surrounding off-label promotion gave the Seventh Circuit a lot of pause in Caputo.

We'll be watching to see if it happens again.

Full post as published by Drug and Device Law on March 18, 2008 (boomark / email).