AUTH/2844/5/16 - Voluntary admission by Amdipharm Mercury

Email sent by a representative

  • Received
    11 May 2016
  • Case number
    AUTH/2844/5/16
  • Applicable Code year
    2016
  • Completed
    07 July 2016
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2016 Review

Case Summary

Amdipharm Mercury Company (AMCo) voluntarily admitted a breach of the Code in that a representative sent an unapproved email promoting Lutrate (leuprorelin) to a prescribing advisor. Lutrate was indicated in the treatment of advanced prostate cancer.

AMCo stated that the email was discovered as a result of ongoing inter-company dialogue during which it had been brought to the company's attention that a budget impact model relating to cost savings for a specific clinical commissiong group (CCG) contained an error which seemed to have been confined to one territory. AMCo withdrew the model until it could be demonstated to work in all territories.

The representative concerned had noticed the error and sent revised and correct figures to the customer concerned. On further examination AMCo realised that the revised data itself was marginally incorrect (there was actually an additional cost saving available to the CCG). The inconsistency had since been fully explained to the customer with apologies from the company.

AMCo was disappointed that the representative's email included an unauthorized and unapproved claim which did not appear to be scientifically valid or clear. It was also inconsistent with the training provided to the sales force and fell short of the standards set for AMCo representatives.

The Panel noted AMCo's submission that the voluntary admission related to an email from an AMCo representative which included the claim 'Lutrate is available as a one month and three month formulation providing effective suppression and maintenance of testosterone to castration levels with the tolerability you would expect from each leuprorelin dose'. The Panel noted AMCo's admission that the claim was not scientifically valid and was confusing and ruled a breach of the Code. The claim could not be substantiated as acknowledged by AMCo and a further breach was ruled. Further breaches of the Code were ruled as the email had not been certified and high standards had not been maintained.

The Panel ruled no breach of the Code with regard to the frequency, timing and duration of calls by a representative on health professionals and others.