Celgene ‘meetings in a box’ materials: certification didn’t cover HCP use and reps weren’t adequately briefed (AUTH/3017/2/18)

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Key facts

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Case	AUTH/3017/2/18
Parties	Anonymous contactable v Celgene
Product	Otezla (apremilast)
Indication (as stated)	Treatment of adults with psoriatic arthritis or moderate to severe chronic plaque psoriasis
Materials	“Meetings in a box” slide deck modules refs UK-I&I160318a–g (UK-I&I160318d withdrawn/not used); briefing document ref UK-I&I160318y considered by Panel
Meeting type	On-label, promotional, locally run Type B meetings (representative-led; HCP speakers also presented; sometimes HCP presented the deck)
Key timeline	First meeting 28 February 2017; briefing document UK-I&I160318y certified 6 March 2017; materials withdrawn 5 January 2018
Complaint received	31 January 2018
Case completed	2 August 2018
Applicable Code year	2016
Breach clauses	9.1, 14.1, 15.9
No breach clauses	2
Appeal	No appeal
Sanction	Undertaking received

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

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An anonymous, contactable complainant alleged Celgene UK used “meetings in a box” materials for Otezla (apremilast) without proper certification/approval and that senior leadership tried to repress this.
The materials were modular PowerPoint slide decks for locally run, on-label promotional Type B meetings; sometimes an HCP speaker presented the slide decks rather than the representative.
Seven modules were central to the complaint (refs UK-I&I160318a–g; one module UK-I&I160318d was withdrawn and not used).
Celgene said job bags were certified for representative use, and materials were withdrawn on 5 January 2018 after a final signatory noted the job bag summary wording did not clearly state the materials were intended for use by HCPs as well as representatives.
The Panel focused on whether signatories were given accurate dissemination/intended-use information, whether HCP use was certified, and whether representatives had been given detailed clinical briefing before first use (first meeting: 28 February 2017).
A process briefing document (ref UK-I&I160318y) was certified on 6 March 2017, after it had been used.

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Breach of Clause 14.1: HCP use of the slide decks (UK-I&I160318a–c and e–g) had not been certified because signatories were given inaccurate information about dissemination/intended use.
Breach of Clause 15.9: on balance, detailed briefing on the clinical content of the modules had not been provided to representatives prior to first use in February 2017.
Breach of Clause 9.1: failure to maintain high standards (linked to the certification/dissemination issue, lack of pre-use clinical briefing, and use of an uncertified briefing document).
No breach of Clause 2: the case did not warrant the particular censure of Clause 2.
No breach found for the allegation that representative use was uncertified: the Panel accepted representative use had been certified.
No breach regarding the allegation that the senior I&I team tried to repress the issue: the complainant provided no evidence.

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