AUTH/2059/10/07 - PCT Medical Manager v Janssen-Cilag

Risperdal Consta

  • Received
    17 October 2007
  • Case number
    AUTH/2059/10/07
  • Applicable Code year
    2006
  • Completed
    14 November 2007
  • Breach Clause(s)
    3.2, 7.2 and 7.8
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    February 2008 Review

Case Summary

A primary care trust medicines management director alleged that an advertisement for Risperdal Consta (risperidone, long-acting injection) issued by Janssen- Cilag was misleading. The advertisement featured a lone female figure in a playground walking away from a trail of articles which included a doll, photograph album, wedding veil, handbag, toothbrush and hairbrush.

The complainant alleged that the advertisement depicted a child who was clearly under 18 years of age. The complainant's immediate opinion on seeing the advertisement was that Risperdal Consta could be prescribed for a young teenager. A doll lying on the ground reinforced this impression. Conversely the prescribing information stated that the product had not been studied in children and adolescents under 18.

The Panel considered that the photograph depicted a lone figure apparently walking away from her own possessions. The figure was casually dressed and had her back to the camera; it was impossible to know how old she was. The impression that the figure had possibly once owned the articles on the ground was compounded by the adjacent text 'Prescribe early, because what she loses, she could lose forever'. The Panel queried how many readers would interpret the articles, as submitted by Janssen-Cilag, as representing things that the girl might never have ie marriage, motherhood etc. Further, the statement 'Prescribe early' implied that the figure in the photograph was a young person. The Panel noted that the Risperdal Consta summary of product characteristics (SPC) stated that the product had not been studied in children or adolescents younger than 18 years. The Panel considered that it had not been made sufficiently clear that the girl in the advertisement was at least 18 years of age. In that regard the Panel considered that the advertisement was misleading as alleged and inconsistent with the SPC. Breaches of the Code were ruled.