A Bitter Pill to Swallow – The Perils in Off Label Promotion

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On September 29, the US. Attorney's Office for the Northern District of California announced that a former CEO of InterMune was convicted of wire fraud for the "creation and dissemination of false and misleading information about the efficacy of InterMune's drug Actimmune (Interferon gamma-1b)." 

There are several interesting insights from this case.  Here is what happened.  The label of Actimmune states that the drug is approved as a treatment for "reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease" and for delaying the time of disease progression in patients with severe, malignant osteopetrosis.  

The company had begun a clinical trial called INSPIRE which was exploring the use of Actimmune in the treatment of idiopathic pulmonary fibrosis ("IPF"), which is a fatal disease.   In 2007, after an interim analysis, it was announced that the INSPIRE trial would be halted because there was not a significant difference between the treatment arm and the placebo arm in patients in the clinical trial.  This was the second time the company conducted a trial for IPF that failed.  

The conviction of the former CEO was based on evidence at the trial that he had earlier caused InterMune to issue a "press release publicly announcing results of a clinical trial of Actimmune for the treatment if IPF" even though the clinical trial in that regard had failed.  According to the New York Times reporting on the conviction, the sales of Actimmune peaked in 2003 and the bulk of the sales were for the off-label use of the drug to treat IPF.  In 2002, the company had issued a press release stating "InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF".  The subheading was "Reduces Mortality by 70% in Patients with Mild to Moderate Disease."

Again, according to the times, while the initial trial for the treatment of IPF failed, the company saw that if you looked at people with only mild or moderate disease, then there was a positive effect.  

In October 2006, the company entered into a deferred prosecution agreement and paid $37 million to resolve criminal charges and civil liability in connection with illegal promotion.  

A search for a warning letter from FDA to InterMune about off-label promotion could not be found.  

There are few takeaways from this story:

  • When dealing with a drug that is already on the market, but going for a new indication, don't make claims on data that is being re-cut or re-interpreted that the FDA where the FDA hasn't endorsed the point of view;
  • The absence of a Warning or Untitled letter from the FDA does not mean that the U.S. Attorney's office won't act; 
  • The settlement by a company on the matters does not shield its executives;
  • A single, simple press release based on self-interpreted data can cause a lot of damage.

Be careful out there.  

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