AUTH/2817/12/15: ALK-Abelló/Director v Bausch & Lomb — breach of undertaking over “new” claim on Emerade website | PMCPA Case

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Key facts

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Case number	AUTH/2817/12/15
Parties	ALK-Abelló/Director v Bausch & Lomb
Product	Emerade (adrenaline auto-injector)
Issue	Breach of undertaking regarding use of the word “new” in promotional material
Material/channel	Emerade website (HCP section)
Example claims	“The new adrenaline auto-injector for emergency treatment of anaphylaxis”; “New Emerade”
Applicable Code year	2015
Complaint received	23 December 2015
Case completed	02 February 2016
Breach clauses	Clause 2, Clause 9.1, Clause 29
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal
Related prior case	AUTH/2802/11/15 (breach of Clause 7.11 regarding “new higher dose” claim; undertaking signed 10 December 2015)

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

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ALK-Abelló alleged Bausch & Lomb UK failed to comply with an undertaking given in an earlier case (AUTH/2802/11/15) about using the word “new” in promotion of Emerade (adrenaline auto-injector).
The claim appeared on an Emerade website page aimed at UK healthcare professionals, including: “The new adrenaline auto-injector for emergency treatment of anaphylaxis” and “New Emerade”.
Because it was an alleged breach of undertaking, the matter was taken up by the PMCPA Authority in the name of the Director.
Bausch & Lomb said it had removed “new” from printed materials and had instructed the website administrator (2 March 2015) to remove “new” from the website; it believed this had been actioned and its checks confirmed it.
The Panel noted the webpage at issue was in the HCP section and was the second page HCPs were likely to click on, and queried the robustness of the company’s checks.
The Panel also expressed concern that after giving the undertaking (December 2015), Bausch & Lomb appeared to have reviewed only printed materials, despite the undertaking covering all closely similar materials regardless of format.

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Breach ruled: the company failed to comply with its undertaking because the website continued to describe Emerade as “new” after the undertaking was given.
The Panel ruled that high standards had not been maintained.
The Panel ruled the failure to comply with the undertaking brought discredit upon and reduced confidence in the pharmaceutical industry.
No appeal.

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