Allergan “Neurology Pharmaceutical Survey” ruled disguised promotion for unlicensed headache/migraine use (AUTH/2274/10/09)

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Key facts

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Case number	AUTH/2274/10/09
Parties	Consultant neurologist (complainant) v Allergan
Material	“Neurology Pharmaceutical Survey” (2 pages, 22 questions) and covering letter; £35 cheque enclosed
Therapy/medicine	Botulinum toxin injections; Allergan product: Botox
Key issue	Survey deemed promotional/disguised promotion that would stimulate interest in unlicensed use for primary headache/migraine and promoted Botox inconsistently with its SPC
Audience/scale	Sent to 805 senior neurologists in the UK (over 800 clinicians)
Payment	£35 cheque included with survey
Applicable Code year	2008
Complaint received	07 October 2009
Case completed	25 January 2010
Breaches (final)	Clause 3.2, Clause 9.1, Clause 12.1
No breach (final)	Clause 2, Clause 3.1, Clause 12.2, Clause 18.1
Sanctions	Undertaking received; additional sanctions not stated

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

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A consultant neurologist complained about a two-page “Neurology Pharmaceutical Survey” (22 questions) sent by a market research agency.
The covering letter described it as a “marketing study” on management of primary headache and migraine; respondents would be identifiable to the commissioning company.
A £35 cheque was enclosed with the survey.
The commissioning company was not clear from the documents; the agency confirmed it was Allergan.
Most questions on page 2 related to botulinum toxin injections; six questions specifically referred to use in primary headache/migraine.
The survey included questions about preferred botulinum toxin brands and listed all UK brands.
None of the botulinum toxin injections marketed at the time were licensed for primary headache or migraine; Botox (Allergan) was not licensed for that use.
Allergan argued the survey was non-promotional market intelligence/database building to support future planning and targeted communications (anticipating a potential licence extension for chronic migraine), and that “marketing study” wording was driven by data protection/confidentiality distinctions.

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The Panel considered the survey a marketing tool subject to the Code because its nature and broad distribution would stimulate interest in botulinum toxin injections for an unlicensed indication.
On appeal, the Appeal Board upheld that the survey would stimulate interest in unlicensed use and that reasonable steps had not been taken to prevent identification of the medicine at issue.
Final breaches (Applicable Code year 2008): Clauses 3.2, 9.1 and 12.1.
No breach (final) of Clause 2, Clause 3.1, Clause 12.2, or Clause 18.1.
The Panel reported Allergan to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure; the Appeal Board decided to take no further action.

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