Marketing of off-label use is advertising the use of drugs for purposes not approved by the regional government. The practice is often illegal and has led to most of the largest pharmaceutical settlements after '' Franklin v. Parke-Davis'', in which a court ruled off-label marketing a violation of the False Claims Act.

List of off-label promotion pharmaceutical settlements

Many of the conflicts among the list of largest pharmaceutical settlements were because of off-label promotion.

Franklin v. Parke-Davis

In 1993, the FDA approved gabapentin, marketed by

Pfizer Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 184 ...

under the name "Neurontin", only for treatment of

seizures A seizure is a sudden, brief disruption of brain activity caused by abnormal, excessive, or synchronous neuronal firing. Depending on the regions of the brain involved, seizures can lead to changes in movement, sensation, behavior, awareness, o ...

. Pfizer subsidiary Warner-Lambert illegally used scientific activities, including

continuing medical education Continuing medical education (CME) is continuing education (CE) that helps those in the medical field maintain competence and learn about new and developing areas of their field. These activities may take place as live events, written publications ...

and

research Research is creative and systematic work undertaken to increase the stock of knowledge. It involves the collection, organization, and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to ...

, 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. The company paid $430 million to the federal government to settle the case.

Marketing of off-label use

Access to pharmaceutical industry documents has revealed

marketing Marketing is the act of acquiring, satisfying and retaining customers. It is one of the primary components of Business administration, business management and commerce. Marketing is usually conducted by the seller, typically a retailer or ma ...

strategies used to promote drugs for off-label use. 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. 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. In September 2009,

paid $1.3 billion, the largest criminal fine ever imposed in the United States, for the off-label marketing of Bextra and three other drugs. Pfizer paid an additional $1 billion in civil penalties resulting from the same illegal activities.

First Amendment issues

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 simply ''because'' 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. The

Supreme Court In most legal jurisdictions, a supreme court, also known as a court of last resort, apex court, high (or final) court of appeal, and court of final appeal, is the highest court within the hierarchy of courts. Broadly speaking, the decisions of ...

has in recent years begun to address the boundaries between government regulation of pharmaceuticals and the First Amendment

free speech Freedom of speech is a principle that supports the freedom of an individual or a community to articulate their opinions and ideas without fear of retaliation, censorship, or legal sanction. The right to freedom of expression has been recognise ...

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. A three-judge panel of the

United States Court of Appeals for the Second Circuit The United States Court of Appeals for the Second Circuit (in case citations, 2d Cir.) is one of the thirteen United States Courts of Appeals. Its territory covers the states of Connecticut, New York (state), New York, and Vermont, and it has ap ...

in Manhattan ruled on December 5, 2012, that a drug sales representative who was criminally prosecuted for making off-label promotional statements about Xyrem had suffered a violation of his First Amendment right to freedom of speech.

References

{{reflist Drug advertising Off-label drug use