Does free speech apply to pharma marketing? Last year, a U.S. appeals court ruled that it does--and that sales reps and drugmakers that tout drugs for off-label use can't be prosecuted. And that point of view could soon get additional support from a higher authority.
The case, U.S. v. Caronia, might have gone to the U.S. Supreme Court, had the FDA elected to appeal the Second Circuit's decision. But the agency didn't. Now, however, former InterMune CEO Scott Harkonen has asked the U.S. high court to review his fraud conviction. Once again, off-label speech is at issue, this time in a press release.
Here's the background: InterMune ($ITMN) had been trying to develop Actimmune for a new use in idiopathic pulmonary fibrosis, but when the trial data arrived, the drug failed on all the trial endpoints. But the company crunched some numbers on subsets of patients, and found some attractive results in people with mild to moderate IPF. So, in a press release he wrote himself, Harkonen touted those numbers, without explaining that they came from a post hoc analysis of the trial data.
Harkonen did note in the release that Actimmune had officially failed the trial. But he highlighted the positive numbers--and projected that the drug could bring in up to $500 million a year if approved for use in that subset of patients. Prosecutors tagged InterMune with off-label marketing, but Harkonen's eventual conviction came under the category of wire fraud.
Harkonen is now serving a sentence of 6 months of home confinement. He's not happy about that. Nor is he happy that he'll be effectively barred from the pharma business once he's free, because he won't be able to work for a company that bills Medicare. He appealed on free speech grounds, but an appeals court didn't buy the argument--and he since has asked the Supreme Court to take on his case.
As the Washington Post reports, there's some consternation in the scientific community about Harkonen's case, because it involves interpretation of research data, which scientists do every day (as one Post source points out). But In the Pipeline notes that Harkonen's post hoc data analysis is sketchy business. Eventually, in one subset of patients or another, something promising will pop up, if only due to chance. (Incidentally, Intermune did eventually test Actimmune in that very patient group--and the drug failed again.)
For the marketing side of things, a Supreme Court ruling in Harkonen's favor wouldn't be a direct hit to off-label marketing rules. But it could bolster the free speech argument enough to make pursuing it--as Allergan ($AGN) and Par Pharmaceutical both have with their own free-speech lawsuits against the FDA--worth pharma's money. First, though, the Supreme Court has to agree to hear the case. Stay tuned.
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