AUTH/3612/2/22 - Complainant v Daiichi Sankyo

Promotion of Nilemdo and Nustendi at a symposium

  • Received
    19 February 2022
  • Case number
  • Applicable Code year
  • Completed
    23 February 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to a live and on-demand promotional symposium for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) which allegedly did not mention that both medicines were contraindicated with simvastatin >40mg on the indications slide and this was allegedly inconsistent with each medicine’s marketing authorisation. The complainant further alleged that the prescribing information was displayed for an insufficient amount of time and that the recording of the presentation was accessible on an open access platform.

The Panel ruled a breach of the following Clause(s) of the 2021 Code for failing to make the contraindication with simvastatin >40mg immediately apparent when presenting Nilemdo and Nustendi’s indications which referred to their therapeutic use in combination with a statin; and for failing to display prescribing information for adequate time for each medicine during the live symposium:

Breach of Clause 5.1

Failure to maintain high standards

Breach of Clause 2

Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Breach of Clause 12.5

Failing to display prescribing information for sufficient duration so that it is easily readable

The Panel ruled no breach of the following Clause(s) of the 2021 Code based on the complainant not having established that:

A lack of reference to Section 4.3 of the SPC meant that Nilemdo and Nustendi had been promoted inconsistently with their SPCs as alleged; nor that the prescribing information for each medicine, which could be paused by the viewer in the on-demand recording, was displayed for insufficient time; nor that the on-demand recording, which was hosted privately, and accessible from the on-demand section of the society’s website where members had to self-certify that they were health professionals, constituted promotion of a prescription only medicine to the public; nor that information had been made available to the public:

No Breach of Clause 11.2

The requirement for promotion to not be inconsistent with the SPC

No Breach of Clause 12.5

Requirement to display prescribing information for sufficient duration so that it is easily readable

No Breach of Clause 26.1

Requirement not to advertise prescription only medicines to the public

No Breach of Clause 5.1 


Requirement to maintain high standards 


No Breach of Clause 2   

Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 

This summary is not intended to be read in isolation.
For full details, please see the full case report