Drug reps can now promote their products for off-label indications. Or can they?

December 8, 2012, 6:52 pm

In 2005, Alred Caronia, a drug rep for Orphan Medical Inc., was charged with promoting the company’s new drug Xyrem — which had recently been approved for the treatment of narcolepsy — for use in treating chronic pain and fatigue. In 2008, he was convicted of introducing a misbranded drug into interstate commerce. In a split decision published this week, a 3-judge panel of the U.S. Second Circuit Court of Appeals reversed that conviction, ruling that it violated Caronia’s first amendment right of free speech.

The best coverage of this important had evolving case has been in the Pharmalot blog. In a must-read post, Ed Silverman points out that the majority stated in their opinion that this does not protect fraud, and that “off-label that is false or misleading is not entitled to First Amendment protection”. In a separate Pharmalot post, Arnie Fried — formerly FDA associate chief counsel and then senior corporate counsel at Pfizer — argues that the immediate effect of the ruling may be limited, since the decision is binding only in the Second Circuit, which covers New York, Connecticut and Vermont.

However, it seems to me that in many cases it would be difficult for the government to prove that a statement promoting off-label use of a drug is “false or misleading”, even if there is not good or extensive evidence to back it up. In addition, as a commenter on Pharmalot notes, the majority based its “First Amendment” argument in part on a U.S. Supreme Court decision (Sorrell v. IMS Health, Inc.), which is binding on all courts and that could be used as precedent.

The next step looks to be review by the entire Second Circuit Court of Appeals, or by the U.S. Supreme Court. The outcome will enormously effect the ability of the FDA to regulate prescription drug marketing. Look to the  Pharmalot blog for continued superb coverage of new developments.

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