AUTH/2968/8/17: Media/Director v Bausch & Lomb (Emerade shelf-life claims) – No breach | PMCPA Case

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Key facts

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Case	AUTH/2968/8/17
Complainant	Media/Director (author of letter in The Pharmaceutical Journal)
Company	Bausch & Lomb UK Ltd
Product	Emerade (adrenaline auto-injector)
Issue	Alleged overstatement/misleading impression of “superior” 30-month shelf-life vs shorter remaining shelf-life supplied via pharmacy
Material at issue	Not specifically identified; complainant discarded original documentation. Company provided leavepiece EME-UK-601-002DA (certified 6 Jan 2016) and a later item EME-UK-1706-004DA (June 2017) with no shelf-life claim.
Key dates	Complaint received: 8 Aug 2017; Case completed: 14 Dec 2017; Letter published: July 2017; Variation approved: 18 Jan 2017; Patient notification dated: 20 Jan 2017
Applicable Code year	2016
Clauses considered	7.2, 7.4
Panel decision	No breach
Appeal	No appeal

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

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A letter in The Pharmaceutical Journal (July 2017) criticised Bausch & Lomb’s claims that Emerade (adrenaline auto-injector) had a 30-month shelf-life versus 18 months for EpiPen.
The complainant said their pharmacist could only supply an Emerade pen with 13 months remaining shelf-life (dispensed 4 Aug 2016; expiry 19 Sep 2017).
The complainant corresponded with Bausch & Lomb (from 12 Jan 2017) asking how to obtain a pen with the “full” 30 months shelf-life; they felt the company overplayed the shelf-life advantage.
The complainant later found a patient information notification dated 20 Jan 2017 stating Emerade’s shelf-life would be reduced from 30 months to 18 months from Feb 2017.
The complainant attempted to withdraw, but could not because the company response had already been received (Constitution & Procedure Paragraph 15.1).
The PMCPA wrote to Bausch & Lomb drawing attention to Clauses 7.2 and 7.4.

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No breach of the Code.
No breach of Clauses 7.2 and 7.4.
Panel noted it was unclear what specific material(s) the complainant, GP, or pharmacist had seen (original documentation had been discarded).
Panel accepted the complainant’s frustration but did not consider the complainant had shown (on the balance of probabilities) that Bausch & Lomb’s shelf-life claims “at production/time of manufacture” were inaccurate, unbalanced, or incapable of substantiation.
Panel queried (as observations) whether the company should have explained the production/release process better and why it did not write back after the variation approval; it also queried appropriateness of continuing 30-month claims if stability issues were known pre-approval, but this was not the subject of the complaint and the Panel had no information on stability issues.

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