AUTH/3398/10/20 - Voluntary admission by Merck Sharp & Dohme

Promotion of Steglatro to the public via exposed promotional material sent with a journal

  • Received
    08 October 2020
  • Case number
    AUTH/3398/10/20
  • Applicable Code year
    2019
  • Completed
    15 March 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

Merck Sharp & Dohme Limited voluntary admitted that as a number of copies of the September 2020 edition of Guidelines in Practice had been sent out in transparent wrappers instead of the standard opaque wrappers, a formulary decision guide for Steglatro (ertugliflozin) sent out with the journal would have been visible to the general public, in breach of the Code.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Merck Sharp & Dohme.

Further details from Merck Sharpe & Dohme are given below.

The Panel noted that because some copies of the September 2020 edition of Guidelines in Practice had been sent through the post in a transparent wrapper, a promotional formulary decision guide for Steglatro, a prescription only medicine, had been visible to the public. A breach of the Code was ruled as acknowledged by Merck Sharp & Dohme.

The Panel noted that the journal was printed for the publisher by a third party and whilst the publisher had provided clear instructions to the printer, stressing the need for the wrapper to be opaque, it was decided by one of the printer’s employees to complete the task using a transparent wrapper when supplies of the opaque wrap ran out.

The Panel considered that Merck Sharp & Dohme had been badly let down by the printer which had not followed the agreed procedures and clear instructions from the publisher regarding use of an opaque wrap when distributing the journal at issue. The Panel considered that the printer’s error meant that a prescription only medicine had been promoted to the public and therefore high standards had not been maintained; a breach of the Code was ruled.

Whilst an error of judgement by the printer had resulted in a prescription only medicine being promoted to the public, the Panel did not consider that Merck Sharp & Dohme had, through an act of commission or omission, promoted Steglatro to the public. The Panel did not consider that the particular circumstances of this case thus warranted a ruling of a breach of Clause 2 a sign of particular censure and reserved for such use. No breach of the Code was ruled.