Does freedom of speech translate into freedom to market drugs for off-label use? That's what Allergan (AGN) is claiming in a lawsuit against federal health officials. The drugmaker contends that the government has violated its constitutional right to free speech by banning promotion of its Botox drug for uses that aren't approved by FDA.
Companies can't market drugs off-label--as is plenty evident in the recent multibillion-dollar settlements with the likes of Pfizer and Eli Lilly. But doctors can prescribe drugs for any use they see fit. And arguably, off-label scrips are more profitable for drugmakers because they don't require the costly clinical trials and regulatory work that approved uses do.
So it makes sense that drugmakers would challenge the rule. But though some pharma employees have done so, and so has an industry-funded think tank, the Wall Street Journal says, companies have shied away from suing. Cue Allergan stepping up for the battle, asking a federal court to declare the off-label marketing ban unconstitutional. Don't look for answers anytime soon, however. This isn't a fight that's likely to be decided quickly; the word "unconstitutional" practically guarantees a long slog.