By: Stephanie Smith
In 2011 Par Pharmaceutical (“Par”) was charged with violations of FDA regulations governing the off-label promotion of prescription drugs. In its defense, Par contended that its ability to convey “truthful” information to physicians was protected by the First Amendment, and that the FDA’s efforts to curb promotion of off-label use was an unconstitutional impingement of commercial free speech.
The crux of Par’s argument was that such promotion was not unlawful and provides valuable and tailored information to physicians regarding its products. The FDA justified its position by responding “Whatever interests Par may assert are far outweighed by the government’s paramount interests of protecting the public health by ensuring the safety and effectiveness of drugs for their intended uses.”
This week it was reported that Pan has now settled the lawsuit on the basis that it pay a fine of $22.5m. It has also agreed to discontinue its First Amendment case against the FDA.
http://www.pharmalot.com/2013/03/par-settles-off-label-probe-drops-free-speech-suit/