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PMCPA Case

Janssen voluntary admission: Crohn’s “disease awareness” campaign ruled pre-licence promotion for ustekinumab (AUTH/2871/8/16)

📅 2016 | 🖉 Dr Anzal Qurbain
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Key facts

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CaseAUTH/2871/8/16
CompanyJanssen-Cilag Ltd
IssuePre-licence promotion via Crohn’s disease awareness campaign (email + Medscape headlines) linking to ustekinumab Crohn’s studies
MedicineStelara (ustekinumab)
Unlicensed indication promotedCrohn’s disease (at the time not in Stelara SPC)
Audience/channelUK gastroenterologists via third-party email and Medscape “information from industry” headlines
Key datesEmail sent 2 June 2016; Medscape placements 29 June–29 July 2016
Reach/engagement (UK)2,303 emails sent / 414 opened / 4 Stelara-link click-throughs; 1,042 saw headlines / 345 accessed email content / 10 Stelara-link click-throughs
Complaint received22 August 2016 (voluntary admission treated as a complaint)
Case completed6 October 2016
Applicable Code year2016
Breach clauses2, 3.2, 9.1, 14.1
SanctionsUndertaking received; Advertisement
AppealNo appeal

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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  • Janssen-Cilag voluntarily admitted that a Crohn’s disease “awareness” campaign initiated/approved by the Janssen European team was used in the UK and amounted to pre-licence promotion.
  • The campaign included an email sent on 2 June 2016 and Medscape “news headline” images/links shown to gastroenterology members from 29 June–29 July 2016.
  • The email included messaging such as “Crohn’s. Let’s re-write their story” and “Remission”, discussed treatment challenges and the need for more effective options, and stated Janssen was “committed to discovering pioneering treatments for Crohn’s disease”.
  • The email contained a call-to-action (“Learn more about Janssen’s commitment…”) linking to three online publications about ustekinumab in Crohn’s disease (UNITI-2 summary; ECCO abstract; IM-UNITI abstract).
  • At the time, Stelara (ustekinumab) was indicated for plaque psoriasis and psoriatic arthritis, and did not yet have a licensed indication for Crohn’s disease (EMA application sought November 2015).
  • Janssen Europe deployed the materials to UK HCPs without Janssen UK involvement, so the materials were not UK-certified as required.
  • Distribution metrics provided by Janssen:
    • 2,303 emails sent to UK health professionals; 414 opened; 4 click-throughs to Stelara-specific links.
    • Medscape headlines shown to 1,042 UK gastroenterologists; 345 accessed the email content; 10 click-throughs to Stelara-specific links.
  • Janssen stated the failure to route materials for local approval was due to human error and that the campaign had ceased; the third-party provider confirmed cessation in writing.
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Outcome

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  • The Panel ruled the email and linked Medscape headlines were promotional and constituted promotion outside the marketing authorisation for Stelara in Crohn’s disease.
  • Breaches were ruled for promotion inconsistent with the SPC, lack of certification, failure to maintain high standards, and bringing discredit to the industry.
  • The Panel was extremely concerned that Janssen Europe created and sent UK-facing promotional material without local approval, contrary to the company’s SOP.
  • The Panel also raised concerns (not ruled as breaches in this case) about whether the material might be disguised (Clause 12.1) and whether certain claims could be all-embracing (Clause 7.10), and asked that these concerns be drawn to Janssen’s attention.
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