A three-judge panel of the Court of Appeals for the Ninth Circuit has affirmed the conviction and sentence of W. Scott Harkonen, M.D., former CEO of InterMune.
Dr. Harkonen was accused of directing his staff to issue a press release for the drug Actimmune regarding the results of a Phase III study in an unapproved indication — despite the fact that the FDA had informed the company that the data were insufficient to support that indication. The Actimmune press release discussed only one positive post-hoc subgroup analysis of the clinical trial results while omitting the fact that the study failed to meet its primary endpoint. After issuing the release, InterMune widely disseminated it to prescribers as well as members of the press. A jury found Dr. Harkonen guilty of wire fraud for issuing a fraudulent press release, and the district court sentenced him to three years of probation and a $20,000 fine.
The 9th Circuit found that there was evidence to support the conclusion that Dr. Harkonen knew the press release was misleading. For instance, Dr. Harkonen:
- prevented InterMune’s clinical personnel from viewing the press release prior to its publication, even when they asked to see it; at one point he became upset and castigated the head of the communications firm that helped prepare the press release for permitting InterMune’s Vice President of Regulatory Affairs to view a draft; and
- stated that he would cut the data and slice it until he got the kind of results he was looking for.
Also, at trial, InterMune’s former Senior Director of Biostatistics “winced” when he saw the press release because “the conclusiveness of the results was overstated.”
The appellate court was not persuaded by Dr. Harkonen’s argument that his statements were fraudulent only if they were universally considered objectively false. The court also rejected his argument that he was engaging in genuine scientific debate, because “genuine debates of any sort are, by definition, not fraudulent.” Notably, the appellate court stated that the documents at issue may demonstrate that the press release did not mislead some doctors, but that there was other evidence that the press release was widely and successfully used as a marketing tool, indicating that it was “capable” of misleading some addressees.
The 9th Circuit’s decision makes it clear that press releases can provide fertile ground for enforcement actions under the right facts. Pharmaceutical companies should take care to review all releases carefully and to assure they are not used for promotional purposes unless FDA’s promotional regulations are met.