AUTH/2958/5/17 - Voluntary admission by Astellas Europe

Use of withdrawn advertisement

  • Received
    23 May 2017
  • Case number
    AUTH/2958/5/17
  • Applicable Code year
    2016
  • Completed
    17 July 2017
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Advertisement
  • Appeal
    No Appeal
  • Review
    November 2017 Review

Case Summary

​Astellas Pharma Europe (Astellas Europe) voluntarily admitted that an electronic advertisement for Xtandi (enzalutamide) referred to the medicine as 'new' more than 12 months after it was introduced. Xtandi was for use in certain men with metastatic castration-resistant prostate cancer.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Astellas Europe.

Astellas Europe explained that Xtandi was approved on 21 June 2013, and the 'new' indication and data referred to in the advertisement at issue related to an extension of indication approved in November 2014.

The detailed response from Astellas Europe is given below.

The Panel noted Astellas Europe's submission that the extended indication referred to in the claim 'new indication' had been available for over 12 months. Thus the Panel ruled a breach of the Code as acknowledged by Astellas Europe.

Similarly, the TERRAIN study (Shore et al 2016), described as a new publication, was published in January 2016, more than 12 months before the advertisement which was the subject of the voluntary admission. The Panel considered that the description of the publication as new was misleading and high standards had therefore not been maintained. A breach of the Code was ruled.

As the advertisement, subject to the voluntary admission, had not been certified a further breach of the Code was ruled.

 The Panel noted the sequence of events that led to the publication of the advertisement at issue and that fundamental errors had occurred. In certain respects Astellas had been let down by third parties for which it was, nonetheless, responsible under the Code. Nonetheless, Astellas Europe's governance of its agency and control of materials had been poor. High standards had not been maintained. A breach of the Code was ruled. The Panel found it difficult to understand how such errors could occur at a time when compliance at Astellas was under the spotlight with particular reference to Cases AUTH/2780/7/15, AUTH/2883/10/16, AUTH/2939/2/17 and AUTH 2940/2/17. In this environment the Panel considered that the company's failure in 2017 to send any instruction to its agency in relation to the withdrawal of the advertisement certified in June 2016 (ref XTD/15/0027/EU) and to follow the withdrawal/ recall process was incomprehensible. In addition, the advertisement subject to the voluntary admission had not been certified. The Panel considered that the circumstances had brought the industry into disrepute. A breach of Clause 2 was ruled.