While we're still digesting the news that one U.S. appeals court figures off-label discussions are protected by the First Amendment, another panel is considering a similar argument. The Ninth Circuit U.S. Court of Appeals will hear an appeal from former InterMune ($ITMN) CEO Scott Harkonen, convicted on wire fraud for a news release that touted the lung drug Actimmune.
As The Wall Street Journal reports, Actimmune had failed a clinical trial in idiopathic pulmonary fibrosis; the drug didn't hit its primary endpoint or any of the 9 secondary endpoints. But two weeks after the study data was released, InterMune issued a press release--based on a re-analysis of that data--saying Actimmune delivered a "survival benefit" and "reduces mortality by 70%" in certain patients. Neither of those were set up as trial endpoints, the WSJ notes. But the release didn't point out those distinctions.
Actimmune is FDA-approved to treat chronic granulamatous disease and severe, malignant osteopetrosis--but not for idiopathic pulmonary fibrosis. Harkonen's lawyers say that regardless of FDA approval or the fine points of clinical trial reporting, the press release "expressed a scientific view" protected by the First Amendment.
Prosecutors maintain that free speech doesn't apply. "[F]alse statements with an intent to defraud" aren't immune from prosecution just because they address scientific matters, the government said in its brief (as quoted by the WSJ).
This isn't an exact replica of the Caronia case addressed by the Second Circuit earlier this week. But the Ninth Circuit's decision could affect FDA's authority to go after drugmakers for promoting their products for off-label use. And it brings up a point raised by some industry experts after the Caronia ruling: Would free speech rights protect sales reps who share substandard--and potentially misleading--data supporting off-label use?
The industry has previously argued its right to broadly dispense information about drugs--for uses approved and unapproved. The government, of course, is convinced of its right to police those discussions. Right now, the Second Circuit's decision only applies in that region. But if the free speech argument ends up before the Supreme Court, as it seems destined to, it would set up a watershed moment for pharma marketing across the U.S.
- read the WSJ piece (sub. req.)