AUTH/3592/12/21: Bayer v Janssen (Erleada on-demand promotional video) – No breach | PMCPA Case

📊

Key facts

⌄

Field	Details
Case number	AUTH/3592/12/21
Parties	Bayer v Janssen
Material	Promotional on-demand video recording for Erleada (apalutamide) tablets
Video title	Castration-resistant prostate cancer: The evidence supporting the benefits of earlier treatment
Material code / date	CP-277649, November 2021
Channel / location	Hosted on the Janssen UK Medical Cloud (thejanssenmedicalcloud.co.uk)
Format / length	On-demand video; 29-minute recording
Complaint received	17 December 2021
Case completed	3 March 2023
Applicable Code year	2021
Appeal	No appeal
Decision	No breach
Clauses considered	2, 5.1, 6.1, 6.2, 6.3, 6.4, 6.6, 11.2, 14.1
Sanctions	None

Download the full case report (PDF)

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

What happened

⌄

Inter-company complaint by Bayer plc about a Janssen promotional on-demand video for Erleada (apalutamide) tablets: “Castration-resistant prostate cancer: The evidence supporting the benefits of earlier treatment” (CP-277649, November 2021), hosted on the Janssen UK Medical Cloud.
The 29-minute recording appeared to have been presented as part of a live promotional webinar held on 26 April 2021 and was aimed at a UK audience.
Bayer alleged three unresolved issues after inter-company dialogue (five areas were discussed; two were resolved):
- Off-licence promotion (micro-metastatic nmCRPC framing): Bayer said describing nmCRPC trial populations as “micro-metastatic” implied apalutamide use where metastases were present on any imaging modality.
- Safety presentation/cross-trial comparisons: Bayer said the video presented incomplete and unbalanced AE information (eg not discussing Grade 3–5 AEs), made speculative/unsubstantiated statements about AE capture frequency, and used side-by-side trial comparisons that were misleading/disparaging despite a disclaimer.
- Off-licence promotion (advanced imaging/PSMA-PET): Bayer said the presenter suggested management should not change if metastases were seen on PSMA-PET but not conventional imaging, and cited APCCC 2019 voting implying treatment “as nmCRPC” with agents like apalutamide/enzalutamide.
Janssen denied breaches, arguing nmCRPC and “metastatic” status in this context were defined by conventional imaging consistent with pivotal trials and guidelines; the video repeatedly cautioned against head-to-head comparisons and used placebo-arm context/relative risk to illustrate trial-design pitfalls.

⚖️

Outcome

⌄

No breach of the Code was found in relation to the video.
The Panel did not consider Bayer had established, on the balance of probabilities, that:
- Janssen promoted apalutamide off licence (including in relation to “micro-metastatic” language or advanced imaging/PSMA-PET discussion).
- Janssen limited discussion to selected AEs such that the safety presentation was incomplete/unbalanced as alleged.
- The presenter’s comments about AE capture frequency were purely speculative/incapable of substantiation or factually inaccurate.
- The side-by-side presentation of AEs across trials was a misleading comparison or disparaged another company’s product in the circumstances of this case.
No breach was also ruled for the associated “high standards” and “discredit” allegations.

📖

Clauses

⌄

No Breach of Clause 11.2 Requirement not to promote a medicine for an unlicensed indication
No Breach of Clause 6.1 Requirement that claims must not be misleading
No Breach of Clause 6.2 Requirement that claims must be capable of substantiation
No Breach of Clause 6.3 Requirement that all artwork must conform to the letter and spirt of the Code
No Breach of Clause 6.4 Requirement that claims must reflect the available evidence regarding possible adverse reactions
No Breach of Clause 6.6 Requirement that another company’s medicines must not be disparaged
No Breach of Clause 14.1 Requirement that misleading comparisons must not be made
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access

AUTH/3592/12/21: Bayer v Janssen (Erleada on-demand promotional video) – No breach

Key facts

What happened

Outcome

Clauses

Unlock the full case analysis

AQP Flagship Path — the complete UK ABPI signatory programme

📰 Weekly PMCPA Case Breakdown