AUTH/1870/7/06: Amgen v Roche – NeoRecormon congress materials and misleading comparative/guideline claims | PMCPA Case

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Key facts

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Case number	AUTH/1870/7/06
Parties	Amgen Limited v Roche Products Limited
Medicine	NeoRecormon (epoetin beta)
Comparator mentioned	Aranesp (darbepoetin alfa)
Setting	European Dialysis and Transplant Association Congress, Glasgow (15–17 July 2006)
Materials	Exhibition panel, brochure, slides
Main references	Goldsmith et al (2005) poster; Revised European Best Practice Guidelines 2004 (EBPG); Tolman et al (2005) discussed
Key issues	Misleading comparative dose reduction claim; incomplete Hb target context; inconsistent Hb target messaging; misleading/unsubstantiated guideline statement about SC administration
Breach clauses	Clause 7.2 (four breaches) plus 7.3 and 7.4
Complaint received	26 July 2006
Case completed	03 December 2006 (also stated as 4 December 2006 in report text)
Appeal	No appeal
Applicable Code year	2006
Sanction	Undertaking received

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

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Amgen complained about Roche promotional materials for NeoRecormon (epoetin beta) used at the European Dialysis and Transplant Association Congress (Glasgow, 15–17 July 2006): an exhibition panel, a brochure and slides.
Materials relied on a poster presentation (Goldsmith et al (2005), retrospective analysis) and included comparative messages versus darbepoetin alfa (Aranesp).
Key claims included:
- “In a retrospective study, a 24% dose reduction has been demonstrated with NeoRecormon SC compared with darbepoetin alfa SC”.
- Hb control claims using a 10–12 g/dl target range (including “75%” within range and “significantly more” vs darbepoetin alfa).
- “Guidelines favour SC administration for both clinical and economic reasons” (referenced to EBPG).
Roche argued the balance of evidence supported its position and that Goldsmith et al was appropriately referenced; it disputed the relevance/weight of Tolman et al (2005) raised by Amgen.

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Breach found for the “24% dose reduction” claim: considered an oversimplification and not reflective of the balance of evidence; misleading.
No breach on a narrow point regarding a slide bar chart about SC vs IV dose saving for epoetin beta (referenced to data on file) because it did not, on the evidence, constitute a misleading comparison with darbepoetin alfa.
Breach found for an exhibition panel on Hb stability: not sufficiently complete to enable readers to form their own opinion; EBPG recommended target not mentioned.
Breach found for the brochure Hb messaging: text referred to “recommended Hb levels ≥11 g/dl” but the accompanying chart used 10–12 g/dl, creating inconsistency and misleading impression.
Breach found for “Guidelines favour SC administration for both clinical and economic reasons”: misleading in context about guideline recommendations for darbepoetin alfa and not capable of substantiation.

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