Public reprimand for Sunovion

• Date posted
  01 November 2017
• Sanction
  Public reprimand,
• Case number/s
  AUTH/2935/2/17 - Anonymous Ex-employee v Sunovion

Sunovion Pharmaceuticals Europe Ltd has been publicly reprimanded by the Code of Practice Appeal Board for providing inaccurate and misleading information to the Panel and Appeal Board (Case AUTH/2935/2/17).

In Case AUTH/2935/2/17, the Panel ruled breaches of the Code as a Sunovion regional business manager (RBM) had encouraged staff at its February 2017 sales meeting to suggest to health professionals that if they did not consider Latuda (lurasidone) as part of a patient review there might be legal consequences. Latuda was indicated for the treatment of schizophrenia in adults aged 18 years and over. Sunovion accepted the Panel’s rulings and provided the requisite undertaking.

During its consideration of this case, the Panel was concerned to note that in its initial response Sunovion did not provide an accurate summary of the interviews carried out regarding the February sales meeting which was only discovered when the Panel requested copies of the interviews conducted.

The Panel queried why anonymised copies of these interviews had not been provided in the first instance. The Panel was disappointed by the conduct of Sunovion. Self-regulation relied, inter alia, upon the provision of complete and accurate information to the Panel.

On receipt of the case report as set out in Paragraph 13.4 of the Constitution and Procedure, the Appeal Board considered that the company’s initial response was misleading and that the imposition of additional sanctions under Paragraph 11.1 should be contemplated. At its subsequent consideration of the matter the Appeal Board noted that in response to questioning the Sunovion representatives stated that the interviews were solely conducted by a senior UK director whose findings were that although the picture was mixed and unclear there was a strong probability that the RBM had done something wrong and that, on the balance of probabilities, this was in breach of the Code. According to the company representatives, this was included in the initial draft of the company’s response to the complaint. However, the draft was altered by the US parent company based on external legal advice and it denied breaches of the Code stating that the interviews provided a mixed and somewhat unclear impression of the verbal direction provided. The Appeal Board considered that the responses of the company representatives to its questions were entirely contrary to Sunovion’s written submissions to both the Panel and the Appeal Board and to the company’s presentation at the consideration of this matter.

The Appeal Board was extremely concerned about the company’s explanation. It considered that such a deliberately inaccurate, misleading and disingenuous response brought discredit upon and reduced confidence in the pharmaceutical industry. It was the respondent company’s responsibility to provide accurate information. Self-regulation relied, inter alia, upon the provision of complete and accurate information from pharmaceutical companies. The Appeal Board noted the submissions from the Sunovion representatives and it considered that the company’s conduct in altering its response, contrary to that of the investigator and the clear evidence from the interviews, raised very serious concerns about system failure and company culture.

The Appeal Board decided to require an audit of Sunovion’s procedures in relation to the Code and on receipt of the report the Appeal Board would consider whether further sanctions were necessary.