Court Ruling Could Open Door to More Drug Marketing

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A decision by a federal appeals court this week could have a dramatic impact on the marketing of prescription drugs in America, potentially affecting patient care and everything from TV drug advertising to future government prosecutions -- prosecutions which have in the past yielded billions of dollars in settlements -- doctors and attorneys said Tuesday.

"This risks taking us back to an era when people could promote snake oil without restrictions -- a situation I would hate to see," said Richard Deyo, a professor of family medicine at Oregon Health & Science University.

However, others say the ruling is a victory for free speech, one that could become the drug industry equivalent of Citizens United, the 2010 US Supreme Court decision that gave corporations and unions the right to spend unlimited sums on political ads.

Like the Citizens United case, the ruling Tuesday by the prestigious U.S. Court of Appeals for the Second Circuit in New York, involved the right of commercial free speech, applying it to the complicated world of pharmaceutical industry promotion of prescription drugs.

How wide-ranging the decision becomes likely will depend on whether it gets to the U.S. Supreme Court, attorneys said.

For years, it has been illegal for drug companies to promote their products for uses not approved by the Food and Drug Administration, what is known as off-label marketing. But doctors are free to prescribe approved drugs for whatever purpose they want.

The case involves Alfred Caronia, a sales representative with Orphan Medical, who was criminally prosecuted for making off-label promotional statements about Xyrem, a drug approved in 2002 to treat narcolepsy patients with a condition known as cataplexy. Cataplexy involves weak or paralyzed muscles. The FDA had put a black box warning on the drug stating that its safety and effectiveness had not been established in people under the age of 16. The active ingredient in Xyrem is GHB, a powerful medication that acts on the central nervous system and also is known as the "date rape" drug. In 2005, the federal government began investigating Orphan Medical for its alleged off-label promotion of Xyrem. In a taped conversation Caronia had with a doctor who was cooperating with the government, he said the drug could be used for other muscle conditions such as fibromyalgia, restless leg syndrome and Parkinson's. He also said it could be used in patients under 16. Caronia had claimed that his off-label promotion was constitutionally protected free speech, saying the First Amendment does not permit the government to prohibit or criminalize a drug company's truthful, non-misleading off-label promotion to doctors.  
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Source: Yellowbrix

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