AUTH/1918/11/06: Amgen voluntary admission—Aranesp branded materials visible to the public at patient conference

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Key facts

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Case number	AUTH/1918/11/06
Company	Amgen Limited
Product	Aranesp (darbepoetin alfa)
Issue	Promotion of a prescription only medicine to the public via branded exhibition materials/banner at a patient-organisation conference
Setting	National Kidney Foundation (NKF) annual conference (UK charity run by kidney patients for kidney patients; also attended by health professionals)
Timing	Stand set up night before; branded materials visible until about 9.30am the next day (short period)
Complaint type	Voluntary admission treated as a formal complaint
Applicable Code year	2006
Breach clauses	15.2, 20.1
Clause 2	Considered; no breach
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	15 November 2006
Case completed	10 January 2007
Appeal	No appeal

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

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Amgen made a voluntary admission that Aranesp (darbepoetin alfa), a prescription only medicine, had been promoted to the public.
At the National Kidney Foundation (NKF) annual conference (October 2006), an Amgen representative set up an exhibition stand the night before, believing the room was separate from public areas and for health professionals only.
The representative used Aranesp-branded materials and a branded exhibition banner.
By about 9.30am the next day, the representative realised the exhibition area was accessible to all delegates, including patients/the public.
The branded banner and materials were removed immediately and head office was informed.
Amgen stated exposure was limited (the representative believed only a handful of delegates passed by; “single figures”).

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The voluntary admission was treated as a formal complaint because promotion of a POM to the public is a serious matter.
Breach ruled of Clause 20.1 (promotion of a prescription only medicine to the public).
Breach ruled of Clause 15.2 (failure to maintain a high standard of ethical conduct).
No breach of Clause 2 (Panel considered the circumstances did not warrant the particular censure reserved for Clause 2).

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