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PMCPA Case

Allergan publicly reprimanded after repeated breach of undertaking on botulinum toxin potency messaging (AUTH/2460/11/11)

📅 2011 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2460/11/11
PartiesMerz/Director v Allergan
IssueBreach of undertaking; implied potency superiority and unbalanced presentation of evidence regarding Vistabel/Botox vs Bocouture/Xeomin
ProductsVistabel/Botox (onabotulinumtoxinA) vs Bocouture/Xeomin (incobotulinumtoxinA)
ContextMeeting presentation by scientific services manager; conduct of a sales representative providing Moers-Carpi et al poster
Applicable Code year2011
Breach clausesClause 2 (x2), Clause 9.1 (x2), Clause 25 (x2)
SanctionsUndertaking received; Public reprimand; Advertisement; Audit of company’s procedures; Re-audit(s)
Complaint received30 November 2011
Undertaking received26 January 2012
Appeal hearingNo appeal (Panel report to Appeal Board)
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 continued to misrepresent comparative potency between Vistabel/Botox (onabotulinumtoxinA) and Bocouture/Xeomin (incobotulinumtoxinA), despite prior undertakings in AUTH/2183/11/08 and AUTH/2346/8/10.
  • The case was taken up by the Director because it concerned alleged breach of undertakings.
  • An Allergan scientific services manager delivered a presentation (“Botulinum Toxin Review and Update”) at an aesthetic practitioners meeting.
  • The presentation emphasised non-interchangeability of units and presented Moers-Carpi et al (2011) comparing Vistabel 20 units vs Bocouture 30 units, without explaining the dose choice in the context of SPC dosing (Bocouture starting dose 20 units, may increase to 30 units).
  • The presentation highlighted the Bocouture SPC statement on non-interchangeability but did not highlight/include the SPC statement that comparative clinical study results suggest equal potency (and did not otherwise present that balance).
  • Allergan acknowledged the slide deck used at the meeting had not been reviewed/approved for use.
  • Separately, Merz alleged an Allergan sales representative used/provided an A4 copy of the Moers-Carpi et al poster to support an assertion that Bocouture potency was inferior to Vistabel, leaving the customer with that impression.
  • The Panel considered Allergan’s Vistabel sales aid (“Not all toxins are Vistabel”, ref UK/0775/2011) relevant context: it heavily featured Moers-Carpi et al, included a back-page claim that unit doses were not interchangeable in clinical practice (referenced to Moers-Carpi et al), and omitted the Bocouture SPC equal-potency statement and did not reference Sattler et al on the back page.
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Outcome

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  • The Panel ruled the meeting presentation implied Botox/Vistabel was more potent than Bocouture/Xeomin, did not reflect the balance of evidence, and breached prior undertakings.
  • The Panel ruled the representative’s arranged provision of the Moers-Carpi et al poster would, on the balance of probabilities, leave the health professional with the impression that Bocouture did not have the same clinical potency as Vistabel, breaching prior undertakings.
  • The Panel reported Allergan to the Appeal Board due to the repeated and serious nature of the breaches and concerns about company procedures.
  • The Appeal Board found successive breaches of undertaking completely unacceptable, issued a public reprimand, and required an Authority audit followed by multiple re-audits until improvement was demonstrated.
  • After four audits (April 2012, August 2012, January 2013, September 2013), the Appeal Board decided no further action was required on the basis that planned work was completed and progress maintained.
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