Product News and Recalls

Court reverses ‘off label’ drug marketing conviction

A federal appeals court has ruled that pharmaceutical sales staff can’t be convicted for promoting drugs for “off label” uses, as long as those uses are otherwise legal.

The U.S. Court of Appeals in New York issued the decision in the case of Alfred Caronia, a pharmaceutical sales representative convicted in 2008 of illegally promoting the narcolepsy medication Xyrem for unapproved uses. In his appeal, Bloomberg reports, Caronia contended that the conviction violated his First Amendment right of freedom of speech.

Under federal law, doctors are allowed to prescribe medications for any legal purpose. But pharmaceutical companies have been prohibited from prescribing drugs for purposes not explicitly permitted by the Food and Drug Administration, which are called off-label uses.

An entry on the blog “FiercePharma” speculates that prosecutors will likely pursue the matter in the U.S. Supreme Court.

The entry says: “Say what? Isn’t off-label marketing the very thing that put Big Pharma (and its smaller siblings) on the wrong side of the U.S. Justice Department? Haven’t drugmakers paid billions over the past several years to put off-label marketing allegations to rest?”

In July, for example, GlaxoSmithKline said it would pay $3 billion to settle criminal and civil accusations of fraudulently marketing its medications.

Widespread lawsuits also allege that GlaxoSmithKline and other manufacturers of antidepressants classified as selective serotonin reuptake inhibitors failed to adequately warn pregnant patients of studies linking the drugs to potentially dangerous heart and lung defects in newborns. SSRI antidepressants include Prozac and Zoloft.

See the Bloomberg story here:

http://www.bloomberg.com/news/2012-12-04/u-s-barred-from-prosecuting-off-label-sales-of-drugs.html

See the FiercePharma blog entry here:

http://www.fiercepharma.com/story/pharma-cant-be-prosecuted-label-marketing-court-rules/2012-12-04