AUTH/2251/7/09: Health professional v Cephalon (Effentora) – alleged off-label promotion (sublingual use) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2251/7/09
Complainant	Health professional
Company	Cephalon (UK) Limited
Product	Effentora (buccal fentanyl citrate)
Allegation	Representative(s) promoted sublingual administration (off-licence) as a benefit
Applicable Code year	2008
Clauses considered	3.2, 15.2, 15.9
Decision	No breach
Complaint received	20 July 2009
Case completed	16 October 2009
Appeal	No appeal
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth2251709-health-professional-v-cephalon

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

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A health professional alleged a Cephalon representative promoted sublingual administration of Effentora (buccal fentanyl citrate) as a product benefit.
Effentora was indicated for breakthrough pain in adults with cancer on maintenance opioid therapy; administration per SPC was buccal placement (upper portion of the buccal cavity).
The complainant said sublingual use was not licensed per the SPC and was concerned inaccurate information could affect prescribing and patient treatment.
On follow-up, the complainant said two different representatives had made the claim and that other physicians in the local PCT had also heard it (no corroborating evidence provided).
Cephalon stated reps were briefed only on buccal use; if asked about a published study (Darwish et al 2009) on sublingual vs buccal use, reps were verbally instructed to refer enquiries to medical information/medical scientific liaison.
The Panel noted Cephalon’s medical department had emailed sales/marketing management (25 Feb 2009) stating Darwish et al was outside the licence and must not be discussed with customers; after the complaint, Cephalon issued a written reminder (July 2009) to staff.
The Panel expressed concern that only verbal briefing was given to representatives on an off-label issue likely to generate prescriber interest, and also noted potential role confusion where medical scientific liaison could appear both non-promotional and promotional.

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No breach of the Code was ruled.
The Panel did not consider the complainant had provided evidence to show, on the balance of probabilities, that a representative or medical scientific liaison team member had promoted sublingual use.
No breaches of Clauses 3.2 and 15.2 were ruled.
No breach of Clause 15.9 was ruled (briefing material did not advocate sublingual use).

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