Healthy Skepticism Library item: 19224

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Publication type: news

Comer B
Court hears arguments in drug rep's free speech case
Medical Marketing & Media 2010 Dec 21
http://www.mmm-online.com/court-hears-arguments-in-drug-reps-free-speech-case/article/193177/

Full text:

The 2nd US Circuit Court of Appeals heard oral arguments in Caronia vs. US on December 2, a case that challenges a sales rep’s inability to speak about off-label uses of a drug, in this case, Jazz Pharmaceuticals’ Xyrem.

In the oral arguments, Eric Murphy, a Washington Legal Foundation attorney speaking on behalf of Caronia, said that “one of the off-label uses that Caronia spoke about – excessive daytime sleepiness – was already going through the FDA [approval] process, so the government didn’t need to incentivize the manufacturer” to conduct new trials for new drug uses, a key aspect of FDA’s rule against off-label drug promotion, according to Murphy.

In response to Murphy’s statements, Judge Reena Raggie wondered if salesmen were the problem, not legitimate scientific discussions. “As I understand it, these people are working on commissions based on their sales, and that’s what the government is concerned about. Because now there’s an incentive to sell that’s divorced from the procurement of further [drug] approval,” said Raggie.

In an attempt to move the discussion away from speech and First Amendment concerns, Douglas Letter, a Justice Department attorney arguing on behalf of the federal government, repeatedly suggested that off-label speech and even promotion are not the actual crimes, but that they both indicate “objective intent” to introduce a misbranded drug into interstate commerce, or in other words, to sell a drug for off-label uses.

Caronia was convicted on conspiracy charges, not because of the off-label speech he participated in, but because that speech proved his involvement in a conspiracy, said Letter. Raggie asked Letter if he had “ever proved this crime without speech, without proving promotion…is there any case that the government has secured a conviction on without speech?”

Letter responded that the speech itself was not a crime, and that “the crime is introducing the drug into commerce.”

The Appeals Court said it would take the case under advisement.

Xyrem (sodium oxybate), which is currently approved for narcolepsy – to reduce too much daytime sleepiness – and to reduce cataplexy attacks, was voted down by an FDA panel for a new fibromyalgia indication last August, partly over concerns about the drug’s potential for misuse, according to a Wall Street Journal report.