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Free speech rights outweigh restrictions on promoting drugs off label, court rules

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8324 (Published 06 December 2012) Cite this as: BMJ 2012;345:e8324
  1. Bob Roehr
  1. 1Washington, DC

A federal appeals court in New York has ruled that regulations prohibiting the off-label promotion of prescription drugs are a violation of constitutionally protected free speech.1 The decision in the United States v Caronia case is likely to be appealed.

The drug at the center of the case is sodium oxybate (marketed in the US as Xyrem), which carries two label indications to treat conditions associated with narcolepsy. Data are insufficient to extend the label indication to children and elderly people, and it carries a “black box” warning of side effects.

A drug sales representative, Alfred Caronia, argued that regulations of the Food and Drug Administration limiting promotional activity only to the …

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