ALK-Abelló v Bausch & Lomb: Pulse Quick Guide breached Code by using “new” for an established dose

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Key facts

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Case number	AUTH/2802/11/15
Complainant	ALK-Abelló UK
Respondent	Bausch & Lomb UK Ltd
Material	Pulse Quick Guide article “New approaches in management and treatment of anaphylaxis” (ref EME-UK-1507-04, prepared July 2015)
Product	Emerade (adrenaline auto-injector)
Main issue	Use of “new” in “Emerade offers a new higher dose…” when the higher dose had been available for over 12 months
Applicable Code year	2015
Breach clause(s)	Clause 7.11
Panel decision	Breach of Clause 7.11 (acknowledged by the company)
Sanctions	Undertaking received; additional sanctions: Not stated
Complaint received	5 November 2015
Case completed	11 December 2015
Appeal	No appeal

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

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ALK-Abelló UK complained about a promotional article published in Pulse as a “Pulse Quick Guide” titled “New approaches in management and treatment of anaphylaxis”.
The guide discussed adrenaline auto-injectors including Emerade (Bausch & Lomb). Page 1 stated the material had been initiated, developed and funded by Bausch & Lomb; an Emerade advertisement appeared on the reverse.
The conclusion included the claim: “Emerade offers a new higher dose…”.
ALK-Abelló alleged this implied the higher dose had been launched within the last 12 months, which it said was not the case (SPC first marketing authorisation date: 3 January 2013).
Bausch & Lomb accepted the wording was not compliant because the higher dose had been available for over 12 months, apologised, and said it wrote to Pulse to prevent reprint/circulation.

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