Celgene voluntary admission: third-party invitations for Otezla meetings, uncertified materials, missing AE statement and gifts (AUTH/2831/4/16)

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Key facts

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Case number	AUTH/2831/4/16
Company	Celgene Limited
Product	Otezla (apremilast)
Issue type	Meetings organised by representatives; third-party invitations; certification failures; missing AE statement; gifts; promotion to public risk
Meetings	November 2015 (held) and March 2016 (planned, cancelled)
Third party	Aesthetics company emailing invitations to ~3,000-person database (estimated up to ~50% non-HCPs)
Notable facts	Uncertified invitation used (Nov); AE reporting statement removed (Nov & Mar); PI missing (Nov third-party email); gifts provided by third party at Otezla promotional meeting; one non-HCP (Celgene staff member) received March invite
Breach clauses	2, 4.1, 4.10, 9.1, 14.1, 15.2, 18.1, 26.1
Sanctions	Undertaking received; Advertisement; Audit of company’s procedures; Re-audit(s)
Complaint received	01 April 2016
Undertaking received	04 July 2016
Completed	18 April 2018
Applicable Code year	2016
Appeal	No appeal (reported to Appeal Board)

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

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What happened

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Celgene made a voluntary admission after an internal alert that a promotional meeting invitation for Otezla (apremilast) had been sent to a Celgene employee’s personal email address (the employee was not a health professional).
Two Otezla promotional meetings were organised by field staff (KAMs) with support from a third-party aesthetics company that emailed invitations to its customer database (~3,000 contacts; the third party estimated up to ~50% might not be health professionals as defined in the Code).
Meeting 1 took place in November 2015; Meeting 2 (planned for March 2016) was cancelled as soon as the issue came to Celgene’s attention.
There was no written agreement defining the third party’s services/responsibilities; the arrangement appeared to be an informal oral agreement.
Invitations/materials were altered and/or used outside the certified process: the third party used an uncertified agenda/Word document for the November email invitation and removed prescribing information; for March, the third party cut-and-pasted the invitation into an email and removed the adverse event reporting information.
For both meetings, printed invitations (identical to certified electronic versions) were not checked and signed in final form until after posting.
At the November 2015 meeting, the third party provided branded bags, pens and skincare product samples to attendees; the Panel calculated the perceived value to recipients at just under £19 plus bag/pen costs.
Attendees at the November meeting included a mix of roles (including dentists, an MSc student and a theatre manager), raising questions about appropriateness/relevance for a POM promotional meeting.

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Outcome

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Breach rulings were made for multiple clauses (see below).
No breach was ruled for Clause 26.1 in relation to the November 2015 invitation (on balance, the content was not considered promotion of Otezla to the public).
No breach was ruled for Clause 4.1 in relation to the March 2016 invitation (prescribing information had been included).
The Panel reported Celgene to the Appeal Board due to serious concerns about widespread compliance failings.
The Appeal Board required an audit of Celgene’s procedures in relation to the Code, followed by multiple re-audits (Oct 2016; May 2017; Feb 2018) before concluding no further action was required provided progress continued.

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Key facts

What happened

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