ALK-Abelló: Jext formulary materials—misleading “33% longer shelf-life” claim (AUTH/2387/2/11)

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Key facts

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Case number	AUTH/2387/2/11
Parties	Pharmacist (consultant to Lincoln Medical) v ALK-Abelló Ltd
Product	Jext (adrenaline auto-injector; adrenaline tartrate)
Materials	Formulary pack (ref 569AD) and formulary template (ref 584AD)
Key issue	Summary claim “33% longer shelf-life …” implied patients would receive a full 24 months’ shelf life; not guaranteed due to supply chain
Complaint received	15 February 2011
Case completed	04 April 2011
Applicable Code year	2008
Breach clauses	7.2 and 7.4
Sanction	Undertaking received
Appeal	No appeal

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

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A pharmacist (consultant to Lincoln Medical, which marketed Anapen) complained about ALK-Abelló’s formulary pack (ref 569AD) and formulary template (ref 584AD) for Jext (adrenaline auto-injector).
The materials were circulated shortly after Jext received marketing authorizations (12 November 2010); documents were distributed for use on 18 and 30 November 2010.
The complaint alleged misleading “better/longer” shelf-life claims (said to mirror a prior Anapen case) and an unsubstantiated claim that with Jext “there is less likelihood of needle stick injury”.
The formulary pack summary stated Jext had a “33% longer shelf-life than EpiPen/EpiPen Jr and 14% longer than Anapen Junior, potentially reducing the number of auto-injectors that a patient has to replace in a lifetime”.
The Panel noted it was not always clear—particularly in the summary—that the shelf life being discussed was the maximum shelf life from date of manufacture (supply chain effects meant patients might not receive the full 24 months).

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No breach of Clause 3.1: promotion occurred after marketing authorization.
Breach of Clauses 7.2 and 7.4: the “33% longer shelf-life …” claim in the summary was misleading and not capable of substantiation because it implied patients would receive a full 24 months’ shelf life, which could not be guaranteed.
No breach of Clause 7.4 for the needle-stick claim: given the device design (locking needle shield) the Panel did not consider the claim “there is less likelihood of needle stick injury” to be unsubstantiable as alleged.
No breach of Clause 2: the Panel did not consider the circumstances warranted particular censure.
No appeal.

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