AUTH/2240/6/09: Roche press release linked to lay press coverage of MabThera (rituximab) in early RA – no breach | PMCPA Case

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Key facts

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Case number	AUTH/2240/6/09
Parties	Regulatory affairs consultant v Roche Products Limited
Medicine	MabThera (rituximab)
Therapy area	Rheumatoid arthritis (RA)
Channel	Lay press articles (The Daily Telegraph, The Times) and television mention
Trigger	Press coverage following IMAGE trial data presented at EULAR (11 June 2009); Roche UK press release issued 15 June 2009
Main allegations	Disguised promotion/advertising to the public; off-label (early RA) promotion; unbalanced efficacy vs safety; lack of serious side effect information; conflict of interest
Key data cited	Press release stated 30.5% remission with rituximab+MTX vs 12.5% with MTX alone; stated not licensed for early RA; included brief safety paragraph
Clauses considered	2, 3.2, 9.1, 12.1, 22.1, 22.2
Decision	No breach of the Code
Complaint received	16 June 2009
Case completed	22 July 2009
Applicable Code year	2008
Appeal	No appeal

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

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A regulatory affairs consultant/scientist-writer complained about UK lay press articles (The Daily Telegraph and The Times) and TV coverage (16 June 2009) discussing early use of MabThera (rituximab) in rheumatoid arthritis (RA).
The complainant alleged the coverage was effectively a reproduced Roche press release and amounted to advertising/disguised promotion to the public, including for off-label (early RA) use.
Concerns included: unbalanced presentation, lack of serious side effect information, no reference to prescribing information, and an alleged conflict of interest regarding an investigator mentioned in the press.
Roche explained that Roche UK issued a UK press release on 15 June 2009 about IMAGE trial data presented at EULAR (11 June 2009); the complainant had provided a global press release which Roche said was not issued in the UK.
The UK press release stated rituximab was not licensed for early RA and included a short safety paragraph (eg hypertension, nausea, upper respiratory tract infections) and noted that a small proportion of more serious side effects were seen.

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No breach of the Code (Applicable Code year: 2008).
The Panel considered the UK press release factual, balanced and non-promotional.
The Panel did not consider it raised unfounded hopes, misled on safety, encouraged the public to request prescribing, or promoted an unlicensed indication.

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