Allergan market research survey ruled promotional: missing PI, disguised promotion, and pre-/off-licence issues (AUTH/2614/6/13)

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Key facts

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Case number	AUTH/2614/6/13
Parties	Health professional v Allergan
Topic	Market research (online survey) on botulinum toxins and hypothetical ready-to-use formulations
Applicable Code year	2012
Complaint received	04 July 2013
Case completed	25 January 2014
Audience / sample	120 UK health professionals (included aesthetic nurse injectors and physicians; some nurse recruitment via referral)
Incentive	£65 (shopping voucher or cheque)
Core issue	Survey ruled promotional/disguised promotion; included detailed hypothetical product profiles (including price and comparative statements), leading to missing PI, pre-licence and off-licence promotion findings
No breach findings	Clause 2 (on appeal)
Breach findings	Clause 3.1 (x2), Clause 3.2, Clause 4.1, Clause 9.1, Clause 12.2, Clause 18.1
Sanctions	Undertaking received; additional sanctions not stated (Appeal Board: no further action required)

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

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A health professional (and ex-Allergan employee) complained about an online “market research” survey his wife (a nurse) was invited to complete about injecting botulinum toxins.
The survey referenced multiple botulinum toxin brands by name (including Vistabel/Botox, Azzalure, Bocouture and others) and presented detailed “potential profiles” for hypothetical ready-to-use (R2U) formulations (vials/syringes), including list prices and comparative statements.
Participants (120 UK health professionals) were asked to assume the products would become available and indicate likelihood of use; the survey also covered cosmetic injection sites including areas outside licensed indications.
Participants were offered £65 (voucher or cheque) for completing the survey.
The commissioning company was not clear from the documentation; the agency confirmed it was Allergan (marketing Botox and Vistabel).
Allergan initially stated Allergan Inc was not researching/developing an R2U neurotoxin, then later disclosed a licensing agreement with Medytox to develop certain neurotoxin products (mid-stage development).
The Panel (and Appeal Board) considered the survey went beyond bona fide market research and would solicit interest in the products, making it promotional in effect.

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Breach found: Clause 4.1 (prescribing information required because the material was promotional for Botox/Vistabel, but PI was not included) – upheld on appeal.
Breach found: Clause 12.2 (market research was disguised promotion) – upheld on appeal.
Breach found: Clause 18.1 (payment of £65 unacceptable because the activity was ruled in breach of Clause 12.2) – upheld on appeal.
Breach found: Clause 3.2 (promotion of Botox/Vistabel for unlicensed cosmetic indications, including provision to aesthetic nurse injectors) – upheld on appeal.
Breach found: Clause 3.1 (pre-licence promotion of unlicensed R2U Botox/Vistabel vial/syringe; and promotional references to unlicensed products X and Z) – upheld on appeal (Clause 3.1 breach ruled twice).
Breach found: Clause 9.1 (high standards not maintained) – upheld on appeal.
No breach: Clause 2 (Panel ruled breach, but Appeal Board overturned; Clause 2 reserved for particular censure).
No breach: allegation that the material advocated switching (Panel did not consider it advocated a switch).
Panel report to the Appeal Board under Paragraph 8.2 was made, but the Appeal Board concluded no further action was required (noting no breach of Clause 2).

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