Marketing of off-label use isadvertising the use of drugs forpurposes not approved by the regional government. The practice is often illegal and has led to most of thelargest pharmaceutical settlements afterFranklin v. Parke-Davis, in which a court ruled off-label marketing a violation of theFalse Claims Act.
Many of the conflicts among thelist of largest pharmaceutical settlements were because of off-label promotion.
In 1993, the FDA approvedgabapentin, marketed byPfizer under the name "Neurontin", only for treatment ofseizures. Pfizer subsidiaryWarner-Lambert illegally used scientific activities, includingcontinuing medical education andresearch, to commercially promote gabapentin, so that within five years the drug was being widely used for the off-label treatment of pain and psychiatric conditions—conditions that had not been approved by FDA. In 2004, Warner-Lambert admitted to charges that it violated FDA regulations by promoting the drug for these off-label uses: pain, psychiatric conditions, migraine, and other unapproved uses.[1] The company paid $430 million to the federal government to settle the case.[2]
Access to pharmaceutical industry documents has revealedmarketing strategies used to promote drugs for off-label use.[3] The United States federal government is aggressively pursuing criminal and civil cases against pharmaceutical companies and their employees for promoting off-label uses of prescription drugs.[4] Between 2003 and 2008, U.S. federal prosecutors and state attorneys general brought more than a dozen cases against drug manufacturers for off-label marketing and won more than $6 billion in criminal and civil settlements.[5] In September 2009,Pfizer paid $1.3 billion, the largest criminal fine ever imposed in the United States, for the off-label marketing ofBextra and three other drugs. Pfizer paid an additional $1 billion in civil penalties resulting from the same illegal activities.[6]
The FDA takes the position that a drug manufacturer may not promote its drug for an unapproved use, and that any such promotion is false and misleading simplybecause it is not FDA-approved. However, many off-label uses are in fact effective and safe, as is evidenced by subsequent FDA approval of such uses for numerous drug products. TheSupreme Court has in recent years begun to address the boundaries between government regulation of pharmaceuticals and theFirst Amendmentfree speech guarantee. Some legal observers have suggested that the trend in the Court's decisions may ultimately reduce the ability of FDA to prevent broader dissemination of off-label information about approved drug products.[7]
A three-judge panel of theUnited States Court of Appeals for the Second Circuit in Manhattan ruled on December 5, 2012, that a drug sales representative who was criminally prosecuted for making off-label promotional statements aboutXyrem had suffered a violation of hisFirst Amendment right to freedom of speech.[8]