Federal Judge Rejects Effort to Invoke First Amendment to Overcome Misbranding and Fraud Indictment; Holds that Press Release in Case is Labeling

June 15, 2009

By Jamie K. Wolszon

Earlier this month, a U.S. District Court for the Northern District of California judge refused to dismiss a criminal indictment of the former Chief Executive Officer (“CEO”) of InterMune for misbranding and wire fraud charges connected to the off-label promotion of Actimmune (Interferon gamma-lb).  The judge rejected an argument that the First Amendment of the U.S. Constitution prohibits the government from relying upon a company press release and related communications alleged to be part of the wire fraud and misbranding that the defendant reportedly committed. 

The judge also held that the press release and related communications discussing the off-label promotion are labeling.  Although FDA views press releases as labeling, and has issued warning letters based on this position, the judge’s order appears to be the first judicial ruling to explicitly endorse that agency position.

FDA approved Actimmune to treat chronic granulomaous disease.  It subsequently approved the use of the drug to treat severe, malignant osteopetrosis in 2000.  The facts that led to the criminal charges, as alleged in the indictment, are as follows:

  • InterMune conducted a Phase III clinical trial to determine the efficacy of treating idiopathic pulmonary fibrosis (IPF) patients (patients with fibrotic scar tissue in their lungs) with Actimmune.  In August 2002, data from the clinical trial failed to show efficacy for this indication.  The company performed after-the-fact subgroup analysis suggesting a survival trend for patients with mild-to-moderate IPF. 

  • Former InterMune CEO, W. Scott Harkonen and other InterMune officials met with FDA reviewers who informed them that the trial data, including the subgroup analysis, were insufficient for approval of the indication.  Harkonen designed and enrolled patients for another study, but ultimately discontinued the additional study. 

  • On August 28, 2008, the company released the press release with the headline: “InterMune Announces Phase III Data Demonstrating Survival of Actimmune in IPF,” with the subheading “Reduces Mortality by 701 percent in Patients with Mild to Moderate Disease.” Harkonen wrote both the headline and the byline and controlled the content of the press release. 

  • In addition to the press release, the company conducted a market research study that indicated that the press release would increase the willingness of pulmonologists to prescribe Actimmune for IPF.  Harkonen also collaborated with a specialty pharmacy that sent a fax blast of the press release to more than 2,000 pulmonologists.  The pharmacy distributed information from the press release in a letter to patients taking Actimmune.

The first count of the March 2008 two-count indictment charged Harkonen with violating the federal wire fraud statute.  The second count charged Harkonen with “making false and misleading statements and doing acts, with ‘intent to defraud or mislead,’ resulting in drugs being misbranded while held for sale following shipment in interstate commerce under” the Federal, Food, Drug and Cosmetic Act.”

Harkonen’s attorneys filed a motion in limine, or, in the alternative, a motion to dismiss the indictment.  Defendant argued that the court should exclude from jury consideration the press release and related communications because they are not labeling and because the First Amendment protects those communications.  In the alternative, Harkonen requested dismissal of the indictment in its entirety.

The order discussed the constraints that the First Amendment imposes on FDA.  “While the FDCA prohibits speech that promotes off-label uses for approved drug products (which thereby ‘misbrands’ the drug), the government cannot wholesale prescribe the open dissemination of scientific opinions and ideas.  Such a prohibition has been deemed to violate the First Amendment rights of the speakers to communicate scientific information and engage in scientific discourse about such products.”  In particular, the court referenced the Washington Legal Foundation’s challenge to FDA restrictions on the dissemination of reprints of truthful, non-misleading peer-reviewed articles and text book excerpts.

The judge found the free speech argument to be unavailing as to the InterMune press release. “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.”

The judge also held that the press release and related materials are labeling under the FDCA and the guidelines the U.S. Supreme Court established in the landmark case Kordel v. United States.

Along with its discussion of the specific communications, the court noted generally that “both the FDA regulations and the case law make clear that labeling under the FDCA is construed expansively, such that it may encompass nearly every form of promotional activity, including package inserts, pamphlets, mailing pieces, fax bulletins, reprints of press releases, and all other literature that supplements, explains, or is otherwise textually related to the product.”