Meda Pharmaceuticals: concerns about call/contact rate expectations and alleged off-licence promotion of Aldara

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Key facts

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Case number	AUTH/2102/3/08
Case reference	Anonymous representative v Meda
Complainant	Anonymous company representative
Respondent/company	Meda Pharmaceuticals Limited
Product(s)	Aldara (imiquimod cream)
Material/channel	Salesforce meeting slides/emails on customer targets and call/contact expectations; letter to doctors used by representatives; teleconference minutes (original and amended)
Key issue	Instructions likely to lead to excessive unsolicited calling (call vs contact rate confusion) and promotion inconsistent with the marketing authorisation (off-licence promotion concern to plastic surgeons); letter to doctors also reviewed
Dates (received/completed if stated)	Complaint received 7 March 2008; Case completed 22 April 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breach of Clause 15.9; Breach of Clause 3.2; No breach of Clauses 15.4, 14.1, 9.1, 2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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An anonymous company representative complained about Meda Pharmaceuticals Limited’s promotion of Aldara (imiquimod cream) and the activities of its representatives.
Concerns included: (1) call-rate expectations introduced in January 2008; (2) use of a letter to doctors (a “GPwSI letter”) to gain appointments; and (3) alleged encouragement to promote Aldara off licence to maxillofacial units and plastic surgeons.
The Panel reviewed salesforce briefing materials and emails about customer targets, including a slide stating call frequency was to be within ABPI guidelines and setting quarterly coverage/frequency expectations for 100 target GPs.
The Panel considered the Code’s supplementary information that unsolicited calls on a doctor/prescriber should normally not exceed three per year on average (with specified exclusions), and noted briefing material should distinguish between expected call rates and contact rates.
For the letter, Meda stated it had been certified and prescribing information was provided on the reverse; the complainant’s version did not show prescribing information.
For off-licence promotion, the Panel considered original (undated) minutes of a 10 March teleconference referring to “successfully promoting to plastics” for “shrinking of lesions, prior to surgical excision,” and an amended version stating they should never promote off-licence and should not contact that specialty directly, only follow up requests.

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Call rates/contact frequency: The Panel ruled that the slide presentation and other instructions advocated a course of action likely to lead to a breach of the Code (breach ruled).
Overcalling: The Panel found no evidence that overcalling had occurred and ruled no breach in that regard.
Letter to doctors: The Panel ruled no breach; it was not necessarily unacceptable to use a letter to gain an appointment, and the complaint about the letter was not entirely clear.
Off-licence promotion: The Panel ruled a breach because it was concerned Meda was promoting Aldara to plastic surgeons to shrink lesions prior to surgery, which was inconsistent with the SPC indication for topical treatment of sBCCs.
The Panel did not consider the circumstances warranted rulings under Clause 9.1 or Clause 2.

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Clause 15.9: Breach ruled (instructions/briefing material likely to lead to breach regarding call/contact expectations).
Clause 15.4: No breach ruled (no evidence that overcalling had occurred).
Clause 14.1: No breach ruled (letter to doctors).
Clause 3.2: Breach ruled (promotion inconsistent with marketing authorisation/SPC; off-licence promotion concern regarding plastic surgeons).
Clause 9.1: No breach ruled.
Clause 2: No breach ruled.

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