AUTH/2935/2/17 - Anonymous Ex-employee v Sunovion

Promotion of Latuda

  • Received
    13 February 2017
  • Case number
    AUTH/2935/2/17
  • Applicable Code year
    2016
  • Completed
    11 July 2019
  • Additional sanctions
    Audit of company’s procedures
  • Appeal
    No appeal
  • Review
    Published in the May 2020 Review See also the November 2017 Review

Case Summary

An anonymous, ex-employee of Sunovion alleged that a regional business manager (RBM) encouraged staff to pressurise customers into prescribing Latuda (lurasidone) for schizophrenia by suggesting that if Latuda was not considered as part of a patient review, they might be sued by patients or patient groups.  It was alleged that the RBM also encouraged staff to quote national guidelines which stated that a medication review should be considered if a patient had side-effects.  The complainant was concerned that if such an approach was shared with customers, it could bring the industry into disrepute.  The complainant added that the RBM cited a medico-legal presentation by a barrister as the basis and implied authority to challenge customers’ prescribing.

The detailed response from Sunovion is given below.

The Panel noted that interview transcripts from those who had attended a recent regional meeting clearly showed that the majority recalled that the RBM had verbally directed the sales team to suggest that there might be legal consequences if patients were not reviewed and alternative treatment options offered.  This was contrary to Sunovion’s original submission that the interviews provided a mixed and unclear impression of what the RBM had stated.

The Panel noted that certain interviewees stated that the RBM referred to the barrister and instructed the team to engage him/her in customer meetings to make customers feel uncomfortable about their medico-legal position with regard to monitoring antipsychotics.  The interview transcripts also stated that the RBM said that ‘if they do not offer a change of treatment and make a note of it, it could come back and bite them’ and ‘the barrister’s presentation was mentioned by the RBM as a way of endorsing this point’. 

The Panel considered that on the balance of probabilities the RBM had not maintained a high standard of ethical conduct and his/her verbal direction advocated a course of action which would be likely to lead to a breach of the Code.  Breaches of the Code were ruled. 

As there was no information about what Sunovion staff had said to health professionals, the Panel considered that the complainant had not shown, on the balance of probabilities, that the representatives had not maintained a high standard of ethical conduct when promoting Latuda, despite the RBM’s briefing.  No breach of the Code was ruled in that regard. 

The Panel further noted the allegation that the RBM had encouraged his/her staff to quote national guidelines that stated that a review of medication should be considered if a patient had side-effects.  In the Panel’s view, it was not necessarily unacceptable for companies to refer to the guidelines provided the manner in which it was done complied with the Code.  The Panel noted that one interviewee stated that the RBM asked the team to use the guidelines as a tool to inform customers that they should consider switching treatment in patients with cardiovascular risk factors.  It was not necessarily unacceptable under the Code for a company to promote a simple switch from one product to another.  The Panel considered that the complainant had not shown, on the balance of probabilities, that in referring to the guidelines the RBM had advocated a course of action which would be likely to lead to a breach of the Code.  No breach of the Code was ruled in that regard including no breach of Clause 2. 

The Panel noted Sunovion’s submission that referencing medico-legal consequences was not an acceptable approach to promote Latuda either directly or indirectly.  The Panel noted its rulings above including that the complainant had not proved his/her complaint on the balance of probabilities in relation to the promotion to health professionals etc.  In addition the Panel considered that its ruling of a breach of the Code in relation to the RBM covered the position regarding high standards.  The Panel ruled no breach of the Code.  The company had not brought discredit upon or reduced confidence in the industry and therefore the Panel ruled no breach of Clause 2.

Sunovion provided the requisite undertaking and assurance and the Appeal Board received the case report as set out in Paragraph 13.4 of the Constitution and Procedure.

The Appeal Board was very concerned to note that in its initial response to the Panel Sunovion did not provide an accurate summary of the interviews about the February sales meeting.  This was only discovered when the Panel requested copies of the interviews conducted.  The Appeal Board noted that self-regulation relied, inter alia, upon the provision of complete and accurate information but considered that the company’s initial response was misleading.  In that regard the Appeal Board’s view was that additional sanctions under Paragraph 11.1 of the Constitution and Procedure should be contemplated. Sunovion should respond to these concerns in writing and it was invited to appear before the

Appeal Board when the matter was considered. 

Sunovion was provided with a copy of the papers.

The detailed comments from Sunovion about the possible imposition of further sanctions is given below.

The Appeal Board noted the Panel’s rulings of breaches of the Code.  The Appeal Board noted that the company had apologised and admitted that it had made errors.

The Appeal Board noted that contrary to the written comments made by Sunovion in response to the concerns raised by the Appeal Board, the issue was that the summary was not a fair reflection of the interview transcripts, not that the transcripts had not been provided with the company’s original response.

The Appeal Board asked the Sunovion representatives to explain how the interview transcripts from the six representatives could be summarised as giving a mixed and somewhat unclear impression of the verbal direction provided by the RBM when 5 of the 6 supported the complainant.  This point had not been addressed by Sunovion.

The Appeal Board noted that in response to questioning the Sunovion representatives stated that the interviews were conducted by a senior UK director solely responsible for investigating this complaint.  That director’s 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 which was sent to the US parent company.  The US parent company decided, based on external legal advice that, in spite of self-regulation, it was not Sunovion’s responsibility to prove the complaint.  Although the US parent company did not see the interview transcripts it, nonetheless, altered the UK company’s draft and denied breaches of the Code stating that the interviews provided a mixed and somewhat unclear impression of the verbal direction provided.  Before signing the amended draft of the company’s response, a senior European executive requested sight of the interview transcripts.  Sunovion’s representatives stated that when the senior UK investigating director had been shown the revised draft and advised of the legal opinion from the US he/she still stood by his/her original draft.  The Appeal Board noted that the senior European executive stated that he/she was not an expert on the Code.

The Appeal Board considered that the responses of the company representatives to its questions were contrary to Sunovion’s written submissions to the Panel and the Appeal Board and to the company’s submission at the consideration of this matter that the summary of the interviews provided with the company’s response to the complaint was a good faith attempt to set out the relevant facts.  The company’s presentation also stated that Sunovion supported the Code, was committed to compliance, self-regulation and transparency.

The Appeal Board noted that the senior UK investigating director’s findings had been undermined by the US parent company which had not even seen the interview transcripts.  At the Appeal Board hearing the US parent company representative acknowledged that it had compromised the professional integrity of the senior European executive.  It did not stand behind the letter today.  The US parent company representative also stated that many lessons had been learned and apologised.  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.  Whilst it might not be the respondent company’s responsibility to prove a breach of the Code, 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 that in accordance with

Paragraph 11.3 of the Constitution and Procedure, Sunovion should be publicly reprimanded for providing inaccurate and misleading information to the Panel and Appeal Board.  The Appeal Board also decided to require an audit of Sunovion’s procedures in relation to the Code.  The audit should include interviews with staff at the US and Japanese parent companies.  The audit would take place in November 2017 and on receipt of the report the Appeal Board would consider whether further sanctions were necessary.

Sunovion was audited in November 2017 and on receipt of the audit report in January 2018 the Appeal Board questioned how seriously the whole Sunovion organisation was taking its commitment to self-regulation.  The culture with regard to the Code and leadership on compliance matters needed to urgently improve across the organisation.  The company in the US, Sunovion Pharmaceuticals Inc, and in particular the parent company in Japan, Sumitomo Dainippon Pharma Co, needed to demonstrate that the seriousness of the situation was understood and appropriate action taken.

 

The Appeal Board noted that the audit report highlighted many issues and concerns to be addressed including arrangements for advisory boards, certification, updating and compliance with standard operating procedures, role of medical science liaison staff, control and updating of material and attention to detail and management of all thirdparty service providers.  Significant commitment was required to address these issues. 

On receipt of further information in February and March 2018, and on noting the dates for completion of some of the actions etc, the Appeal Board decided that the company should be re-audited in June 2018. 

On receipt of the report for the re-audit the Appeal Board would decide whether further sanctions were necessary.

Sunovion was re-audited in June 2018 and on receipt of the report of the re-audit in September 2018 the Appeal Board noted that Sunovion had made some meaningful progress and that there appeared to be a genuine wish to create a more sophisticated compliance infrastructure and to build on the improvements made.  The Appeal Board noted that Sunovion had committed greater staff resource to help address its compliance needs. The Appeal Board welcomed the reported improved relationship between Sunovion and its US parent company.

The Appeal Board was again concerned about the inaccurate responses from the company with regard to its disclosure of payments to patient organisations at the re-audit and it noted the related issues that arose in Case AUTH/3027/3/18.  It was paramount that Sunovion ensured its responses to the PMCPA were accurate.

The Appeal Board noted that the report of the reaudit still highlighted further important issues and concerns to be addressed including a review of its material, updating standard operating procedures, urgently address the company’s apparent lack of understanding of the definition of promotion, review of the active materials list and further training.  Significant ongoing commitment was required to address these issues. 

The Appeal Board decided that Sunovion

Pharmaceuticals Europe should be re-audited in April 2019.  On receipt of the report of the re-audit the Appeal Board would decide whether further sanctions were necessary.

Sunovion was re-audited in April 2019 and on receipt of the report of the re-audit in July 2019 the Appeal Board noted that there had been significant progress at Sunovion since the re-audit in June 2018.  The Appeal Board noted that Sunovion had a compliance action plan to address recommendations from the re-audit.  The Appeal Board noted some actions were already completed and that others were due to be completed very shortly.  On the basis that this work was completed, the progress shown to date was continued and a company-wide commitment to compliance was maintained, the Appeal Board decided that no further action was required.