Marketing Risperdal Part I: Off-label Sales of Risperdal to Children

von freakoutcrazy

This is the first in a series of posts that will delve into Johnson & Johnson’s marketing strategy for its antipsychotic drug, Risperdal. In this post, I present data showing the extensive off-label use of Risperdal in children. In future posts, I’ll describe J&J’s strategy for promoting Risperdal for unapproved uses.

My knowledge about J&J’s marketing of Risperdal comes from Johnson & Johnson’s data and my experience as a former J&J insider. As a sales rep, I sold Risperdal for 3 1/2 years for J&J subsidiary, Janssen Pharmaceutica. I then worked at Janssen-Ortho McNeil Pharmaceuticals (JOMP) corporate headquarters for four years, where I was involved in a variety of Risperdal marketing projects.

Risperdal was approved in 1993 for the treatment of acute psychosis in adults with schizophrenia. Risperdal was not approved for use in children until October 2006 when it received FDA approval for the treatment of irritability associated with autistic disorder in children and adolescents. In August 2007, the FDA approved Risperdal for short term treatment of schizophrenia in adolescents aged from 13 to 17 and for short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17.

However, J&J had already been promoting Risperdal for the treatment of aggression and behavior disorders in children since at least 1999, which is when I began working for the company. J&J carried out an aggressive marketing campaign to increase revenue by promoting Risperdal off-label for use in children and for other unapproved uses. Janssen sales reps even promoted Risperdal for unapproved uses directly to child psychiatrists.

Following are several charts from the September 2006 “Business Analytics Franchise Report.” When this report was generated, Risperdal was approved only for the treatment of schizophrenia in adults and for short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults.

This first chart shows the market share for various antipsychotics by age group.

(RIS O = Risperdal Oral; RIS CON = Risperdal Consta (injectable); ZYP = Zyprexa; SER = Seroquel; ABI = Abilify; GEO = Geodon; CONV = conventional antipsychotics (i.e. older generics such as haloperidol); CLZ – Clozaril; MKT = market)

The above chart shows that 21.8% of Risperdal use for the 12-month period ending August 2006 was by children.

The next chart shows that 62.3% of Risperdal sales were for “Non-Promoted” uses, meaning unapproved uses. In reality, Risperdal was heavily promoted for off-label uses such as anxiety, and sleeplessness in adults, and aggression in children. J&J monitored very closely the revenue and market share of Risperdal for unapproved uses. The schizophrenia market is a relatively small, finite market. The only way Johnson & Johnson could grow Risperdal revenue was to increase off-label sales of the drug.

How much money did Johnson & Johnson make by selling Risperdal off-label? A lot. The following chart shows that for the 12 month period ending August 2006, Risperdal oral sales in the U.S. were $2.8 billion. Sixty-two percent of that, or $1.7 billion, came from off-label Risperdal sales.

In future posts I’ll go into greater detail about Johnson & Johnson’s off-label marketing strategy for Risperdal.