Telling People They Can Use A Drug In A Way Different Than How The FDA Says They Can Use A Drug Is Not A Crime, Says the Second Circuit

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Alfred Caronia was a sales rep for a pharmaceutical company. And, despite what you might think by reading some of the literature, being a pharmaceutical sales rep is not a crime. It's even more emphatically not a crime after the Second Circuit's opinion in United States v. Caronia.

1213599_pills.jpgPart of Mr. Caronia's job was to encourage folks to buy Xyrem.

According to the Second Circuit,

Xyrem's active ingredient is gamma-hydroxybutryate ("GHB"). GHB has been federally classified as the "date rape drug" for its use in the commission of sexual assaults.

Despite Xyrem's dark side, it was approved by the FDA for two uses for folks with narcolepsy.

Mr. Caronia's company thought that perhaps doctors should be prescribing it for an even greater assortment of problems.

Mr. Caronia's job, in part, was to find doctors who would talk to other doctors about the benefits of Xyrem's FDA-approved uses. The doctors did not provide this service for free.

One of the doctors who worked with Mr. Caronia was Dr. Peter Gleason.

And, by way of background - it's ok for a doctor to prescribe a drug for a use that isn't on the label. The FDA doesn't want to get between a doctor's relationship with her patient, even on off-label uses of prescription drugs.

At the same time, it's a crime to "misbrand" a regulated drug. A drug is misbranded if:

its label is false or misleading; the label fails to display required information prominently; its container is misleading; or it is dangerous to health when used in the dosage, manner, frequency, or duration prescribed, recommended, or suggested on the label.

The Wire

The federal government started investigating Dr. Gleason for promoting an off-label use of Xyrem.

The feds wired up a cooperator. The cooperator was another doctor, who called Mr. Caronia and asked about an off-label use of Xyrem.

Mr. Caronia, as only a man paid on commission can, talked up the benefits of the drug for many kinds of maladies - insomnia, Fibromyalgia, restless leg, Parkinsons, chronic fatigue, chronic pain, and MS.

He also said it will make you lose weight without dieting or exercise. [that was a joke]

These statements - and other related ones - got Mr. Caronia indicted for conspiracy to commit misbranding.

Indicted For Aggressive Sales

Mr. Caronia said that he was being indicted for commercial speech. There's a line of cases from the Supreme Court that say that even commercial speech is protected by the First Amendment.

The district court agreed. As the Second Circuit said,

The court observed that "the criminal information . . . allege[d] Caronia's promotion of off-label uses of an FDA-approved drug," and concluded that Caronia stood charged with a crime the actus reus of which was First Amendment speech.

But, the district court concluded that the prohibition on commercial speech is reasonably tailored to the objectives of the Food Drug and Cosmetic Act. So it's ok to charge people criminally for this First Amendment activity.

Mr. Caronia went to trial and was convicted.

The Second Circuit

One big question running through the appeal is whether Mr. Caronia was charged with a crime based on his speech - as the district court determined - or whether he was charged with misbranding and his speech was used as evidence of his other acts that were criminal.

The Second Circuit went through the trial testimony and found that the government's theory here was that Mr. Caronia violated the law by his speech.

So, the government is prosecuting Mr. Caronia's speech. Is that ok?

That's really two questions - first, is Mr. Caronia's conduct covered by the statute and, second, if his conduct is covered by the statute, does it violate the First Amendment.

The Second Circuit let that second question answer the first:

under the principle of constitutional avoidance, . . . we construe the FDCA as not criminalizing the simple promotion of a drug's off-label use because such a construction would raise First Amendment concerns. Because we conclude from the record in this case that the government prosecuted Caronia for mere off-label promotion and the district court instructed the jury that it could convict on that theory, we vacate the judgment of conviction.

So, according to the Second Circuit, promoting the off-label use of a drug is not a crime under the statute. If it were, the courts would have to think about whether such a statute is constitutional.