Roche and Chugai voluntary admission: tocilizumab media release claims of superiority over methotrexate

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Key facts

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Case number	AUTH/2154/8/08 and AUTH/2155/8/08
Case reference	PRX3158 (media release reference)
Complainant	Voluntary admission by Roche and Chugai (treated as a complaint by the Authority)
Respondent/company	Roche Products Ltd and Chugai Pharma UK Ltd
Product(s)	Tocilizumab
Material/channel	Media release sent to UK national and medical media
Key issue	Unqualified superiority/“first and only” claims and statement that no previous biologic showed superiority vs MTX; Panel found the release not factual, unbalanced, and likely to raise unfounded hopes for an unlicensed product
Dates (received/completed if stated)	Proceedings commenced: 7 August 2008. Cases completed: AUTH/2154/8/08 on 7 October 2008; AUTH/2155/8/08 on 9 October 2008.
Appeal	Not stated
Code year	2006 Code (Clauses 2, 9.1, 20.2 considered; Clause 20.2 numbered Clause 22.2 in 2008 Code). Case considered under the 2008 Constitution and Procedure.
Breaches/clauses	Breach of Clause 20.2 (2006 Code) and Clause 9.1; no breach of Clause 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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Roche Products Ltd and Chugai Pharma UK Ltd made a joint voluntary admission about a media release (ref PRX3158) issued on 13 June 2008.
The release related to new clinical data on tocilizumab for rheumatoid arthritis, presented at the European League Against Rheumatism (EULAR) meeting in Paris.
Following discussions with Wyeth, Roche and Chugai considered that headline claims (including that tocilizumab was the “first and only” biologic to show superiority over standard of care/MTX) might be factually incorrect when read alone and could breach the Code.
Wyeth requested a corrective statement in scientific journals; Roche and Chugai considered this unachievable without potentially breaching the Code because tocilizumab was unlicensed.
The voluntary admission was treated as a complaint because issuing a potentially misleading press release was considered a serious matter.
The media release was sent to UK national and medical media; the product was not authorized in the UK.

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The Panel ruled the media release was not factual and the AMBITION study results had not been presented in a balanced way.
The Panel considered the release would raise unfounded hopes of successful treatment.
Breach ruled of Clause 20.2 (2006 Code).
Breach ruled of Clause 9.1.
No breach of Clause 2 (the Panel did not consider the matter warranted Clause 2 censure).

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