Takeda: ‘ASH 2020 Highlights’ webinar ruled promotional for an unlicensed indication (ixazomib frontline myeloma)

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3469/2/21
CompanyTakeda UK Limited
Activity‘ASH 2020 Highlights’ online meeting (webinar)
Date of meeting21 January 2021
ComplainantAnonymous, contactable; described self as a UK oncologist
Products referenced in case backgroundNinlaro (ixazomib); Adcetris (brentuximab vedotin)
Core issueMeeting ruled not to be legitimate scientific exchange; discussion of ixazomib first-line myeloma ruled promotional for an unlicensed indication
Attendance192 health professional delegates
Complaint received02 February 2021
Case completed23 July 2021
Applicable Code year2019
Breach clausesClause 3.2; Clause 9.1
No breach clausesClause 2; Clause 3.1; Clause 12.1
SanctionsUndertaking received
AppealNo appeal

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

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What happened

  • An anonymous UK oncologist complained about a Takeda UK-organised, CPD-accredited online meeting: “ASH 2020 Highlights” (21 January 2021).
  • The complainant said the content was good but there was limited time for Q&A/discussion and it “felt like” Takeda wanted HCPs to prescribe after the meeting.
  • The complainant was concerned that unlicensed use/indications were discussed (example given: ixazomib for first-line multiple myeloma) and queried whether this was allowed.
  • The complainant also queried: (a) the use of the black triangle symbol and whether it implied reporting side effects for unlicensed medicines, and (b) advertising/registration via Twitter.
  • Takeda said the meeting was organised by its medical department as a non-promotional “scientific exchange” forum, with speakers selecting abstracts independently and with licence status clearly stated on relevant slides.
  • Meeting logistics included 4 presentations (43–92 slides each), planned 20 minutes speaking + 5 minutes Q&A per talk, plus a 15-minute panel discussion; 192 HCP delegates attended.
  • The Panel focused on whether the format delivered a genuine two-way scientific exchange (rather than a one-way flow of information) and whether discussion of unlicensed indications crossed into promotion.
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Outcome

  • Breach of Clause 3.2 (promotion of an unlicensed indication): the meeting discussed ixazomib for first-line myeloma and, as it was not legitimate scientific exchange, this was ruled promotional for an unlicensed indication.
  • Breach of Clause 9.1 (high standards): high standards were not maintained in relation to the meeting.
  • No breach of Clause 2 (not considered warranted in the circumstances).
  • No breach of Clause 3.1 (the issue related to an unlicensed indication for a licensed medicine, considered under Clause 3.2).
  • No breach of Clause 12.1 (promotional nature not disguised; it was clear it was a Takeda-organised meeting and that investigational and licensed agents would be discussed).
  • No breach found regarding Twitter advertising/registration (Panel was unclear what the allegation was; tweets were certified, did not mention products, and linked to HCP-gated registration).
  • No breach found regarding use of the black triangle on relevant slides (Panel did not consider this failed to maintain high standards in the circumstances).
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