AUTH/2516/6/12: Allergan/PMCPA Director v Merz — Bocouture ad implied 1:1 interchangeability with Botox (breach of undertaking) | PMCPA Case

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Key facts

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Case number	AUTH/2516/6/12
Parties	Allergan / PMCPA Director v Merz Pharma UK Ltd
Product(s)	Bocouture (botulinum toxin type A); comparator referenced: Botox (botulinum toxin type A)
Material	Advertisement (ref 1075/BOC/DEC/2011/JH) in Cosmetic News, June 2012
Main claim at issue	“In glabellar frown lines, clinical studies suggest Bocouture vs Botox: Equal Potency 1:1 Clinical Conversion Ratio”
Key concern	Implied clinical equivalence and unit-for-unit interchangeability; non-inferiority evidence used to imply equivalence; potential patient safety concerns
Complaint received	15 June 2012
Case completed	24 August 2012
Applicable Code year	2012
Breach clauses	Clause 2, Clause 9.1, Clause 25
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions (details not stated)

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

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Allergan complained that a Merz Pharma UK Ltd advertisement for Bocouture (botulinum toxin type A), published in Cosmetic News (June 2012), breached an undertaking given in Case AUTH/2270/10/09.
The PMCPA Director took the matter up because the PMCPA is responsible for ensuring compliance with undertakings.
The ad showed Bocouture and Botox vials side-by-side with the headline claim: “In glabellar frown lines, clinical studies suggest Bocouture vs Botox: Equal Potency 1:1 Clinical Conversion Ratio”.
A less prominent statement appeared below: “Unit doses recommended for Bocouture are not interchangeable with those for other preparations of botulinum toxin”.
The “equal potency”/non-interchangeability statement was referenced to the Bocouture SPC (June 2010); the “1:1 clinical conversion ratio” was referenced to Sattler et al (2010) (a non-inferiority study).
Allergan argued the overall impression was that Bocouture and Botox were clinically equivalent and interchangeable unit-for-unit, creating potential patient safety risk by encouraging transfer of dosing assumptions between products.
Merz said the ad had been withdrawn due to an SPC update and that Cosmetic News published the old ad in error; Merz stated it had reviewed its processes to ensure publishers used only current approved ads.

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Breach found: the Panel ruled the ad breached the prior undertaking and therefore the Code.
The Panel applied the Appeal Board’s reasoning from a related case (AUTH/2496/4/12) and concluded the ad implied clinical equivalence and interchangeability without supporting data.
The Panel also ruled that failure to comply with an undertaking meant high standards had not been maintained.
The Panel ruled the circumstances brought discredit upon and reduced confidence in the industry, including because the withdrawn ad reappeared due to publisher error and robust withdrawal controls were expected.

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