AUTH/2346/8/10: Merz/Director v Allergan — presentation found to breach an undertaking (botulinum toxin potency implication) | PMCPA Case

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Key facts

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Case number	AUTH/2346/8/10
Parties	Merz/Director v Allergan
Issue type	Breach of undertaking
Meeting context	Botulinum Toxin Information Day (July 2010) for health professionals deciding which botulinum toxin to purchase
Key material	Slide 19 comparing/juxtaposing Hunt and Clarke LD₅₀ assay data with Dressler et al data; wording included “Reference Standard (regulatory release)” and “real world”
Panel outcome	No breach of Clause 25; no breach of Clauses 9.1 or 2
Appeal outcome	Breaches upheld on appeal: Clauses 25, 9.1 and 2
Applicable Code year	2008
Complaint received	12 August 2010
Case completed	06 December 2010
Sanctions	Undertaking received; Advertisement; Additional sanctions: Not stated

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

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What happened

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Merz alleged that Allergan gave a July 2010 presentation to NHS decision-makers (consultants/registrars/pharmacists/managers) choosing which botulinum toxin to purchase.
The complaint was taken up by the Director because it concerned an alleged breach of an undertaking given by Allergan in an earlier case (AUTH/2183/11/08).
Allergan’s slide 19 presented Hunt and Clarke animal LD₅₀ assay data suggesting different potencies, showing Xeomin vial potencies (eg 69–78U/vial; later 61–67U/vial) without comparable Botox vial data, and described the assay as a “Reference Standard (regulatory release)” and “real world”.
The same slide also included Dressler et al data showing equipotency (Botox mean 101.7U/vial; Xeomin 103U/vial) and a statement referencing Mander et al about equipotency when stabilizing agents were used.
The Appeal Board considered the layout and wording gave Hunt and Clarke greater prominence and implied it was more robust than Dressler et al, and that describing Dressler’s assay as “non saline-based” implied it was inferior.
The Appeal Board noted the presentation did not include the Bocouture SPC statement: “Comparative clinical study results suggest that Bocouture and the comparator product containing conventional Botulinum toxin type A complex (900 kD) [ie Botox] are of equal potency”, despite it being available to Allergan at the time.
Allergan initially treated the presentation as non-promotional; this was rejected, and at appeal Allergan accepted it was promotional.

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Outcome

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Panel (first instance): No breach of Clause 25 (undertaking) and therefore no breach of Clauses 9.1 or 2.
Appeal Board (on Merz’s appeal): Appeal upheld; Allergan was found in breach of the undertaking and therefore in breach of the Code.
The Appeal Board concluded the use of Hunt and Clarke data implied Botox was more potent than Xeomin, inconsistent with SPCs and available clinical data, and sufficiently similar to the issue in AUTH/2183/11/08 to be caught by the undertaking.

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AUTH/2346/8/10: Merz/Director v Allergan — presentation found to breach an undertaking (botulinum toxin potency implication)

Key facts

What happened

Outcome

Clauses

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