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PMCPA Case

Allergan publicly reprimanded after fourth breach of undertaking over botulinum toxin dosing/potency messaging (AUTH/2487/3/12 & AUTH/2489/3/12)

📅 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
CompanyAllergan UK Limited
ComplainantMerz Pharma UK Ltd; taken up with the Director acting as complainant (PMCPA responsible for ensuring compliance with undertakings)
ProductsAllergan: Vistabel/Botox (onabotulinumtoxinA); Merz: Bocouture/Xeomin (incobotulinumtoxinA)
MaterialTwo March 2012 articles (Cosmetic News; PRIME) largely reproducing an Allergan press release (UK/0762/2011)
Main issuePress-release discussion of Moers-Carpi et al in isolation implied Bocouture was less potent than Vistabel (unit for unit) and breached a prior undertaking
Clauses breachedClause 2 and Clause 25
AppealAppeal by Allergan unsuccessful; Appeal Board upheld Panel rulings
SanctionsUndertaking received; Public reprimand; Audit of company’s procedures; Advertisement; further sanctions (including pre-vetting) considered depending on audit outcomes
Complaint received6 March 2012 (AUTH/2487/3/12) and 12 March 2012 (AUTH/2489/3/12)
Case completed15 October 2013
Review publicationNovember 2013 Code of Practice Review

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 and unbalanced comparative claims about botulinum toxin dosing/potency/efficacy: Vistabel/Botox (onabotulinumtoxinA) vs Bocouture/Xeomin (incobotulinumtoxinA).
  • The material complained of was two substantially similar March 2012 trade/journal articles (Cosmetic News and PRIME) that reproduced large sections of an Allergan press release (UK/0762/2011; date of preparation Dec 2011; examined 25 January 2012).
  • The press release focused on Moers-Carpi et al (2011) data (initially a poster presentation), comparing 20 units Vistabel with 30 units Bocouture in glabellar lines, and concluded dosing was “not interchangeable”.
  • PMCPA assessed the complaint based on what Allergan (or its agent) provided to the publisher/journalist, not the final article text.
  • The Panel found the press release discussed Moers-Carpi et al in isolation and did not set the data in the context of SPC dosing recommendations and other relevant evidence (including the Bocouture SPC statement on equal potency and Sattler et al (2010) non-inferiority at equal units).
  • The Panel and Appeal Board considered the inevitable implication for clinicians was that Bocouture was less potent than Vistabel (unit for unit), despite the press release not explicitly stating “potency”.
  • The press release was deemed sufficiently similar to issues in earlier cases and therefore covered by an existing undertaking (Case AUTH/2346/8/10), meaning its use constituted a further breach of undertaking.
  • Timing mattered: Allergan was notified of the outcome of Case AUTH/2460/11/11 on 26 January 2012 and sent the press release to the journals on 30 January 2012; Allergan signed the undertaking in AUTH/2460/11/11 on 3 February 2012. The Panel ruled this meant no breach of the AUTH/2460/11/11 undertaking (a timing “technicality”), but the earlier undertaking still applied.
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Outcome

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  • Breach found in each case: Clause 25.
  • Breach found in each case: Clause 2.
  • Appeal by Allergan was unsuccessful; the Appeal Board upheld the Panel’s rulings.
  • 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, the Appeal Board ultimately decided no further action was required (subject to completion of planned work and continued improvement).
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