If any company thinks a press release is protected speech under the First Amendment of the U.S. Constitution and, therefore, can’t be used by the government when bringing criminal charges, well, they can forget about it.
That’s what W. Scott Harkonen, a former chief executive at InterMune, is learning this month, thanks to a federal court ruling that decided a press release can be used by the U.S. Department of Justice to press a criminal indictment; in this case, the charges are wire fraud and misbranding of a medication under the Food, Drug and Cosmetic Act.
The backdrop: InterMune marketed a drug called Actimmune to treat chronic granulomatous disease and severe, malignant osteoporosis. In 2000, the company began studying the drug for combating idiopathic pulmonary fibrosis (IPF), a fatal lung disease, but the study didn’t show effectiveness. In a 2002 meeting with FDA staffers, InterMune was told a subgroup analysis suggesting a survival trend for some patients was insufficient for approval.
Nonetheless, InterMune began promoting the drug to treat IPF and, in 2002, issued a press release announcing the results of its clinical trial and the headline boasted the drug demonstrated a survival benefit and reduced mortality in people with mild to moderate effects of the disease. Harkonen wrote the headline and byline, and controlled the content of the entire press release, according to the ruling. InterMune also hired a marketing firm to determine whether the press release would affect prescribing behavior of pulmonologists; a survey indicated it would.
But it looks like Harkonen’s words will come back to haunt him. U.S. District Court Judge Marilyn Hall Patel refused to dismiss the indictment, writing: “It is undisputed that the government has the right to regulate false and misleading statements made to doctors and patients about drug products in interstate commerce. Accepting the indictment’s allegations as true for the purposes of this motion, it is clear to the court that the speech at issue is not outside the bounds of the FDCA’s regulatory reach as being wholly protected by the First Amendment as a matter of law.”
Hat tip to FDA Law.
