AUTH/3461/1/21 - Health professional v Santen

Promotion of Cosopt to the public

  • Received
    21 January 2021
  • Case number
  • Applicable Code year
  • Completed
    17 June 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A contactable complainant who described him/herself as a health professional, complained that a journal wrap-around advertisement (ref PP-CSPT-UK-0006) for Cosopt (dorzolamide and timolol) eye drops, placed in ‘The Ophthalmologist’, December 2020 by Santen UK Limited, was visible to the general public. The advertisement featured a picture of a soaring eagle. Cosopt was indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudoexfoliative glaucoma when topical beta-blocker monotherapy was not sufficient.

The complainant stated the wrap-around advertisement for Cosopt was clearly visible through the plastic magazine wrapper and in that regard noted that medicines should not be advertised to the public. There was no active substance name and although the
wrap-around stated that the prescribing information was overleaf, it was actually inside the wrap-around. This was misleading. The complainant alleged very poor practice from the company.

The complainant stated that he/she was also surprised with the imagery and that it was well known that eagles had superb vision, far superior to humans. The company should not be implying that Cosopt would improve the vision of the patient to that of an eagle.

The detailed response from Santen is given below.

The Panel noted that the material at issue was an advertisement wrapped around The Ophthalmologist journal. It would have to be removed before the journal could be read. The outside of the wrap-around included on the front the statement ‘Preserve the freedom of sight with trusted power’, followed by the image of an eagle. The bottom right of the advertisement included the Cosopt brand logo, followed by a claim and the indication for Cosopt. The statement ‘Prescribing information and adverse event reporting information can be found overleaf’ was included below the indication. The back of the outside of the wrap-around included an image of an eagle, alongside Santen’s corporate logo, references for the claims, the date of preparation and a job code. The prescribing information for Cosopt was included on the inside of the wrap-around ie on the reverse of the front of the outside of the wrap-around.

In the Panel’s view, the statement on the outside of the wrap-around that directed the audience to view the prescribing information ‘overleaf’ was not misleading as alleged. The reverse side of the wrap-around included the prescribing information. The Panel therefore ruled no breach of the Code.

The Panel considered that the context and audience of the advertisement were important. In the Panel’s view, the imagery used would not imply that Cosopt would improve a patient’s vision to that of an eagle. Further the advertisement referred to preserving the freedom of sight. In the Panel’s view, the audience would not be misled as alleged and the Panel therefore ruled no breach of the Code.

The Panel noted Santen’s submission that due to a technical issue, the advertisement did not include the non-proprietary name. The certified copy of the advertisement included the non-proprietary name and this was also included in the version sent to the journal. It appeared that there was a printing error. As there was no non-proprietary name immediately adjacent to the most prominent display of the brand name in the final printed version, the Panel ruled a breach of the Code as acknowledged by Santen.

The Panel considered that because the journal with the wrap-around advertisement was visible in a transparent wrapper, this resulted in a prescription-only medicine being promoted to the public. The Panel ruled a breach of the Code, as acknowledged by Santen.

The Panel considered that Santen had failed to maintain high standards and ruled a breach of the Code.