Non-label marketing uses advertises the use of drugs for purposes not approved by local government.
Video Marketing of off-label use
Non-label promotional settlement list
Many of the conflicts among the largest lists of pharmaceutical settlements are due to off-label promotions.
Franklin v. Parke-Davis
In 1993, the FDA approved gabapentin, marketed by Pfizer under the name "Neurontin", only for the treatment of seizures. Pfizer's subsidiary Warner-Lambert illegally uses scientific activities, including continuing education and medical research, to promote gabapentin commercially, so that within five years the drug is widely used for the treatment of sick and psychiatric conditions without labels - conditions that have not been approved by the FDA. In 2004, Warner-Lambert acknowledged that the allegations violated FDA regulations by promoting drugs for off-label use: pain, psychiatric conditions, migraines, and other unapproved uses. The company paid $ 430 million to the federal government to settle the case.
Maps Marketing of off-label use
Non-label usage marketing
Access to pharmaceutical industry documents has revealed the marketing strategy used to promote drugs for use outside of labels. The United States federal government is aggressively pursuing civil and criminal cases against pharmaceutical companies and their employees for promoting the use of non-label prescription drugs. Between 2003 and 2008, US federal prosecutors and state prosecutors brought more than a dozen cases against drugmakers for unlabeled marketing and won over $ 6 billion in civil and criminal settlements. In September 2009, Pfizer paid $ 1.3 billion, the largest criminal fine ever imposed in the United States, for Bextra's off-label marketing and three other drugs. Pfizer paid an additional $ 1 billion in civil penalties resulting from the same illegal activity.
First Amendment Issues
The FDA takes the position that drug manufacturers should not promote their drugs for unapproved uses, and that such promotions are false and misleading only because are not FDA approved. However, many off-label uses are actually effective and safe, as evidenced by subsequent FDA approval of such use for many drug products. The Supreme Court in recent years began discussing the boundaries between the government regulation on drugs and the guarantee of freedom of speech of the First Amendment. Some legal observers have suggested that trends in Court decisions may ultimately diminish the FDA's ability to prevent the widespread spread of off-label information about approved drug products.
The three-judge panel of the United States Court of Appeals for the Second Circuit in Manhattan decides on December 5, 2012 that drug sales representatives charged with criminals for making off-label promotional statements about Xyrem have violated the First Amendment right to free speech.
References
Source of the article : Wikipedia
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