12:00 AM
Dec 10, 2012
 |  BioCentury  |  Politics, Policy & Law

Free speech, in theory

A federal court's rebuke to FDA in Caronia won't unleash off-label marketing

A federal appeals court's decision to overturn the criminal conviction of a pharmaceutical salesman for promoting off-label uses of an FDA-approved drug is, at least in the short term, far less consequential than media coverage suggests. But it may signal the agency and Congress will have to accept less FDA regulation of speech.

The U.S. Court of Appeals for the Second Circuit last week ruled inU.S. v. Caronia that the government's prosecution of Alfred Caronia for statements he made while selling Xyrem sodium oxybate to a physician violated his free speech rights under the First Amendment to the U.S. Constitution.

But companies and individuals who take the decision as a signal that the rules of the road have changed and they are now free to promote off-label indications put themselves in great legal and economic peril, attorneys who helped persuade the court to overturn Caronia's conviction told BioCentury.

At the same time, the decision by one of the country's most influential and respected courts to overturn a criminal conviction on First Amendment grounds is persuasive evidence that, in the long term, FDA will have to change some of the assumptions underpinning its regulation of medical products.

FDA, which now has lost a string of First Amendment cases, cannot forever hold on to the notion that it is empowered to prohibit drug companies and their employees from saying things that anyone else is free to say. Sooner or later, according to legal experts, the agency will have to reconcile itself with the idea that industry has the right to truthful, non-misleading speech.

While change is inevitable, the pace of change is uncertain. It is also not clear who will shape that change - FDA employees, judges, or members of Congress.

The case

The Caronia story started in 2005 when Stephen Charno, a physician seeking to lighten his sentence for healthcare fraud, agreed to cooperate with the Department of Justice by soliciting information about off-label uses of pharmaceuticals and helping the government prosecute the resulting cases.

Among other companies, Charno contacted Orphan Medical Inc. about its narcolepsy product, Xyrem. Orphan was acquired by Jazz Pharmaceuticals plc in April 2005.

Charno surreptitiously recorded conversations with Caronia and Peter Gleason, a psychiatrist Orphan had hired to promote Xyrem. Both Caronia and Gleason made statements about uses of Xyrem that had been studied in clinical trials but were not approved.

DoJ separately prosecuted Caronia, Gleason and Jazz for conspiring to introduce a misbranded drug into interstate commerce.

Jazz settled, pleading guilty in 2007 to one count of felony misbranding and agreeing to pay $20 million over five years. Drug companies virtually always settle misbranding cases because a conviction could lead to the company being excluded from participation in federal healthcare programs such as Medicare.

Gleason pled guilty and was sentenced to one year of probation and a $25 fine.

Caronia contested the case.

Federal prosecutors told a jury in the U.S. District Court for the Eastern District of New York that Caronia's statements to Charno were in themselves evidence of his guilt. The judge supported this interpretation of the law in instructions to the jury.

Caronia was convicted in November 2009 of conspiring to introduce a...

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