AstraZeneca: “Non-promotional” EAP webinar ruled promotional and disguised promotion (Calquence) (AUTH/3521/6/21)

📅 2021 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3521/6/21
ComplainantEx-employee
CompanyAstraZeneca UK Limited
ProductAcalabrutinib (Calquence)
ActivityEarly Access Programme (EAP) Clinical Practice Learns (CPL) Webinar
Date of webinar11 May 2021
Complaint received07 June 2021
Case completed29 April 2022
Applicable Code year2019
Allegation summaryDisguised promotion of Calquence as “non-promotional” education; slides not certified (only examined)
Panel findingWebinar was promotional; promotion was disguised; slides were promotional material and not certified
Breach clausesClause 12.1; Clause 14.1
SanctionsUndertaking received; Additional sanctions: Not stated
AppealNo appeal

Download the full case report (PDF)


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

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What happened

  • An ex-employee complained about an AstraZeneca UK “Clinical Practice Learns” webinar (11 May 2021) linked to the acalabrutinib (Calquence) Early Access Programme (EAP).
  • The webinar and materials repeatedly described the event as “non-promotional” and “educational”, and it was invitation-only for consultant haematologists enrolled in the EAP.
  • Four haematologists presented five patient case studies, including treatment outcomes and “key takeaways”; slides flagged when approaches might be inconsistent with the acalabrutinib SPC.
  • The slides contained an adverse event reporting statement but no prescribing information.
  • The complainant alleged the event was promotional but disguised as non-promotional, and that slides were not certified (only examined).
  • AstraZeneca denied the allegations, stating the steering committee directed content and that materials were handled under SOPs as non-promotional.
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Outcome

  • The Panel ruled the webinar content could not be anything other than promotion of acalabrutinib, given the proactive presentation of positive experiences and outcomes.
  • The Panel ruled the slides were promotional material and had been examined, not certified.
  • The Panel ruled that describing the meeting as “non-promotional” in invitations and slides disguised promotion.
  • No appeal.
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