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PMCPA Case

AUTH/2487/3/12 & AUTH/2489/3/12: Merz/Director v Allergan — press release implied rival botulinum toxin was less potent; breach of undertaking

📅 2012 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numbersAUTH/2487/3/12 and AUTH/2489/3/12
PartiesMerz/Director v Allergan
IssueBreaches of undertaking; implied comparative potency/sub-potency via press release reproduced in two publications
ProductsAllergan: Vistabel/Botox (onabotulinumtoxinA); Merz: Bocouture/Xeomin (incobotulinumtoxinA)
MaterialPress release (UK/0762/2011; date of preparation Dec 2011; examined 25 Jan 2012) leading to March 2012 articles in Cosmetic News and PRIME
Key study referencedMoers-Carpi et al (2011) poster (non-peer reviewed poster; authors included Allergan employees)
Core PMCPA concernMoers-Carpi data presented in isolation; not balanced with SPC context and other evidence; implied Bocouture less potent unit-for-unit than Vistabel
Breach clausesClause 2 and Clause 25 (in each case)
AppealAllergan appeal unsuccessful; Appeal Board upheld Panel rulings
SanctionsUndertaking received; advertisement; public reprimand; Authority audit and re-audits
Complaint received6 March 2012 (AUTH/2487/3/12); 12 March 2012 (AUTH/2489/3/12)
Case completed15 October 2013

Download the full case report (PDF)

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

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What happened

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  • Merz alleged Allergan again made disparaging/misleading/unbalanced comparative claims about botulinum toxin potency/efficacy: Vistabel/Botox (onabotulinumtoxinA) vs Bocouture/Xeomin (incobotulinumtoxinA).
  • The material complained of appeared as two substantially similar articles (March 2012) in Cosmetic News and International Journal of Aesthetic and Anti-Ageing Medicine (PRIME), written in the style of an Allergan press release and reproducing large sections of Allergan’s press release.
  • The articles were based on Allergan’s press release (UK/0762/2011; date of preparation Dec 2011; examined 25 January 2012) about Moers-Carpi et al (2011) (a poster presented at a European meeting).
  • The press release was sent to the publications on 30 January 2012—four days after Allergan was notified of the outcome in Case AUTH/2460/11/11 (26 January 2012), a prior case about similar potency implications and emphasis on Moers-Carpi data.
  • The press release discussed Moers-Carpi et al in isolation and did not set results in the context of SPC dosing recommendations (starting dose 20 units for both products) or other comparative evidence (including Sattler et al 2010 non-inferiority at 24U vs 24U).
  • The press release ended with a quote from an Allergan employee (an author of Moers-Carpi et al): “We are pleased to see further evidence for the efficacy of Vistabel and consider that this study provides further clarity that Vistabel and the Merz unit doses are not interchangeable in clinical practice”.
  • Although the press release did not explicitly state “potency”, the Panel and Appeal Board considered it implied that to achieve the same outcome 20U Vistabel vs 30U Bocouture was needed—i.e., unit-for-unit Bocouture was less potent.
  • The Panel considered the press release sufficiently similar to matters covered by an earlier undertaking (Case AUTH/2346/8/10), meaning it breached that undertaking.
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Outcome

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  • Breach found in each case: Clause 2 and Clause 25.
  • The Panel also considered whether there was a breach of the undertaking in Case AUTH/2460/11/11, but concluded no breach of Clause 25 in that respect because the press release was used on 30 January and the AUTH/2460/11/11 undertaking was dated 3 February (a timing “technicality” noted in the case narrative).
  • Allergan appealed the Clause 2 and Clause 25 rulings; the Appeal Board upheld the Panel’s rulings and the appeals were unsuccessful.
  • The Appeal Board stated these two cases together represented the fourth breach of undertaking and described Allergan’s conduct as “completely unacceptable”.
  • Following multiple audits and re-audits (April 2012 onward), the Appeal Board ultimately decided (October 2013) that no further action was required on the basis that planned work was completed and progress maintained.
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