A Menarini: BMJ website Migard ad linked to out-of-date SPC and lacked required prescribing information (AUTH/3047/6/18)

📅 2018 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3047/6/18
ComplainantAnonymous contactable health professional
CompanyA Menarini
ProductMigard (frovatriptan)
ChannelBMJ website (digital advertisement)
Main issuePrescribing information not provided; SPC link used and was out of date; missing legal classification and cost when using SPC approach
Applicable Code year2016
Complaint received08 June 2018
Case completed03 September 2018
AppealNo appeal
Breach clauses4.1, 4.4, 9.1
No breach clauses2
SanctionsUndertaking received; Additional sanctions: Not stated

Download the full case report (PDF)


Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

  • An anonymous contactable UK health professional complained about a Migard (frovatriptan) advertisement on the BMJ website.
  • The ad did not include prescribing information; instead it provided a single-click link to an SPC.
  • The linked SPC appeared to be out of date (dated November 2014) versus the current Migard SPC (dated April 2017).
  • A Menarini said the material was generated, approved and placed on the BMJ website by global colleagues (around January 2016) without UK knowledge, review or approval.
  • The Panel applied the principle that UK companies are responsible for acts/omissions of overseas affiliates when within the scope of the Code, and found the BMJ content was clearly an advertisement for Migard.
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Outcome

  • Breach found of Clause 4.1.
  • Breach found of Clause 4.4.
  • Breach found of Clause 9.1.
  • No breach of Clause 2.
  • No appeal.
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