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PMCPA Case

AUTH/3528/6/21: Anonymous doctor v Advanced Accelerator Applications (AAA) – third-party CPD alleged to promote unlicensed PSMA therapy

📅 2021 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/3528/6/21
ComplainantAnonymous contactable complainant (doctor)
CompanyAdvanced Accelerator Applications (AAA), a Novartis company
Third partyNot stated (described as a global online destination for physicians/health professionals; Master Funding Agreement with WebMD Global LLC)
Materials/activitiesThird-party website CPD modules and email invitations; Activity 1: “Understanding Novel Therapeutic Options For Metastatic Castration-Resistant Prostate Cancer”; Activity 2: “Exploring Systemic Therapies in mCRPC: Targeting PSMA to improve patient outcomes”
Therapy referencedPSMA-targeted therapies; focus on 177Lu-PSMA-617 (and mention of 68Ga-PSMA-11)
Key issuePanel found the first activity promoted an unlicensed medicine prior to marketing authorisation; arrangement not strictly arm’s length so AAA responsible under the Code
Applicable Code year2019
Complaint received28 June 2021
Case completed11 April 2022
AppealNo appeal
Breach clausesClause 2; Clause 3.1; Clause 9.1
No breach clausesClause 7.2; Clause 7.9; Clause 23.1
SanctionsUndertaking received; Advertisement

Download the full case report (PDF)

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

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What happened

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  • An anonymous complainant (a doctor) received three email invitations in April 2021 (15, 22 and 27) from a third party promoting an online CPD activity about PSMA-targeted therapy for metastatic castration-resistant prostate cancer (mCRPC).
  • The CPD activities stated they were “supported by an independent educational grant from Advanced Accelerator Applications (AAA), a Novartis company” and were accessible to UK health professionals; one activity had UK CPD accreditation (Faculty of Pharmaceutical Medicine (FPM)).
  • The complainant alleged the content made efficacy/safety-type claims and endorsed clinical use of a “novel/new” therapy (including comparisons/positioning vs chemotherapy/cabazitaxel) without clearly stating it was not licensed/available in the UK (or anywhere).
  • The complainant also raised concerns about case-study discussion (including a patient receiving 10 cycles and later dying) and about suggested combinations with other treatments.
  • The complainant alleged inadequate disclosure of speakers’ relationships with Novartis/AAA/Endocyte.
  • AAA argued it provided a hands-off, arm’s-length educational grant under a Master Funding Agreement (signed 5 Nov 2020 by AAA Global Medical Affairs in Switzerland and the US-based third party), had no control over content/speakers/audience, and did not review/approve materials.
  • The Panel reviewed the funding request/proposal language and concluded the arrangement was not strictly arm’s length (eg, AAA could elect to fund, the proposal implied alignment with AAA “expectations”, and project scope/budget elements could be discussed), so AAA was responsible under the Code for the content provided to UK health professionals.
  • The Panel considered the first activity focused on AAA’s pipeline product 177Lu-PSMA-617 (and referenced 68Ga-PSMA-11) and included statements the Panel viewed as promotional for an unlicensed medicine.
  • The Panel made no rulings on the second activity’s content because there were no specific allegations about it.
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Outcome

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  • Breach ruled: Clause 3.1 (promotion of a medicine prior to the grant of its marketing authorisation).
  • Breach ruled: Clause 9.1 (failure to maintain high standards).
  • Breach ruled: Clause 2 (bringing discredit upon, and reducing confidence in, the pharmaceutical industry) – sign of particular censure.
  • No breach ruled: Clause 7.2 (misleading/exaggerated claims) in relation to the specific allegations about 10 cycles/QoL and combination discussion (Panel did not consider the complainant established these were misleading, noting the clinical trial context).
  • No breach ruled: Clause 7.9 (use of “safe” without qualification) – the Panel considered the cited statement related to cabazitaxel (not an AAA/Novartis product) and ruled no breach.
  • No breach ruled: Clause 23.1 (consultant disclosure obligations in contracts) – Panel considered AAA’s contracts required speakers to disclose relationships so the third party could disclose to learners.
  • No appeal.
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