Free speech, PhRMA? Not in this off-label marketing case, feds say

The pharma industry's free speech stand in a whistleblower lawsuit against Millennium Pharmaceuticals? Not so fast, says the Department of Justice. The First Amendment doesn't protect speech that spawns illegal conduct, federal prosecutors say in their own brief in the case.

The feds are responding to a brief filed by the industry trade group PhRMA, which argued that drugmakers should be able to talk up off-label uses of their products, as long as that talk is truthful. It's a First Amendment right, the trade group said.

But the Justice Department sees PhRMA's argument this way: The First Amendment confers a constitutional right to spur other parties to submit false claims to government health programs, as long as it's done by speech.

"This radical position has never been endorsed by any court and is not supported by any precedent," the prosecutors wrote in their brief.

All this free-speech debate has come up in a lawsuit over Millennium's alleged off-label marketing of its drug Integrilin, the latest in a series of pharma-industry cases that appeal to the First Amendment. And it comes at a time when drugmakers are increasingly arguing for their right to promote drugs off-label.

In their view, off-label promotion isn't a violation of federal law, in and of itself. But off-label marketing can be evidence that a drugmaker induced physicians or patients to use a medication off-label. That would mean the company knowingly caused claims to be filed for unapproved uses that really aren't eligible for Medicare or Medicaid coverage, the brief states.

The brief tries to poke holes in PhRMA's citing of two recent court decisions--Sorrell v. IMS Health and United States v. Caronia. And it takes issue with the group's characterization of protected speech. "If a course of conduct were constitutionally protected as long as it was effectuated through the use of speech, vast areas of federal and state law would be invalidated," the prosecutors say, citing antimonopoly and criminal conspiracy laws as examples.

In essence, the brief asks the court to determine that "speech that serves as a conduit for violations of the law" isn't protected by the First Amendment. PhRMA, of course, is asking for the opposite. It wants the court to decide that the law only prohibits "at most, false speech," which would give reps the chance to talk about off-label use of meds, as long as they're telling the truth.

Recently, the FDA has made some noises about being "open" to the free-speech argument. Now, it looks as if we'll soon see what another court has to say.

- read the DOJ brief (PDF)

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