Allergan is suing U.S. to allow it to promote Botox for off-label uses


In a reversal of the traditional roles, Allergan Inc. (AGN) is suing the U.S. government, claiming current rules on so-called off-label drug promotion violate its First Amendment right to free speech. It wants to be allowed to "share relevant information with the medical community on the safe use" of its wrinkle-smoother Botox for off-label uses.

Drugs are approved by the United States Food and Drug Administration for specific uses, but doctors are allowed to use their judgment to prescribe them for off-label uses, meaning, to treat illnesses other than the ones the FDA has approved the drug for. Pharmaceutical companies, however, are not allowed to promote such off-label uses.