GSK voluntary admission: Uncertified Benlysta case studies emailed to HCPs with broken PI link and misleading nephritis content (AUTH/2592/4/13)

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Key facts

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Case number	AUTH/2592/4/13
Company	GlaxoSmithKline UK Limited
Product	Benlysta (belimumab)
Material	Two promotional patient case studies emailed as electronic “Dear Doctor” letters
Audience	48 health professionals (3 undelivered; 45 followed up)
Main issues	Uncertified promotion; PI not included as integral part and PI link inactive; misleading/SPC-inconsistent implication of use in severe active lupus nephritis (case described lupus nephritis class IV)
Applicable Code year	2012
Breach clauses	Clause 3.2, Clause 4.1, Clause 7.2, Clause 14.1
Complaint received	09 April 2013 (also stated in report text as 11 April 2013)
Case completed	14 May 2013
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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GlaxoSmithKline (GSK) voluntarily admitted that two promotional patient case studies for Benlysta (belimumab) were emailed to health professionals as electronic “Dear Doctor” letters before certification.
The case studies were submitted for approval in GSK’s system (Zinc), but there was a lag in raising the items and a commercial manager mistakenly believed they had been approved.
The unapproved emails were forwarded to 48 health professionals who had agreed to receive promotional emails; internal commercial and medical colleagues were blind copied.
On return from leave, a medical advisor/ABPI signatory identified the materials had not been reviewed/approved, that some content was inconsistent with the Benlysta SPC, and that the prescribing information (PI) link did not work.
GSK initiated an immediate recall email, included corrective SPC wording (including that Benlysta had not been studied in and was not recommended in severe active lupus nephritis), and requested recipients acknowledge receipt.
The Panel noted with concern that recipients were not asked to delete the original emails.

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Breach found for sending promotional material without certification.
Breach found because the emailed “Dear Doctor” letters did not include prescribing information as an integral part of the material and the PI link was inactive.
Breach found because one case study (lupus nephritis class IV) promoted use inconsistent with the SPC and was misleading.
No appeal.
Sanction recorded as: Undertaking received.

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