AUTH/1925/12/06: Novartis v ApoPharma (Ferriprox) — breach of undertaking and “Life is Getting Longer” hanging comparison | PMCPA Case

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Key facts

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Case	AUTH/1925/12/06
Parties	Novartis Pharmaceuticals UK Ltd v ApoPharma Inc
Product	Ferriprox (deferiprone)
Comparator mentioned	Desferal (desferoxamine) supplied by Novartis
Medium	Animated banner advertisement on British Journal of Haematology website; linked landing page on Ferriprox.com; link-out to PubMed
Key claims at issue	“Life is Getting Longer … in thalassaemia major patients”; “New Cardioprotection and Survival Data Now Available”
Core issue	Breach of undertaking (re-use of previously ruled hanging comparison) and associated high standards/industry discredit findings; substantiation point on “data available” wording overturned on appeal
Applicable Code year	2006
Complaint received	30 November 2006 (HTML); 1 December 2006 (PDF)
Case completed	18 April 2007 (HTML); 19 April 2007 (PDF)
Breach clauses (final)	2, 7.2, 9.1 and 22
Clause 7.4	No breach on appeal
Sanctions	Undertaking received; Additional sanctions: Advertisement
Prior related case	AUTH/1822/4/06 (undertaking given; “Life is Getting Longer” previously ruled a hanging comparison)

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

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Novartis complained about an animated Ferriprox (deferiprone) banner ad on the British Journal of Haematology website.
The banner stated: “New Cardioprotection and Survival Data Now Available”.
A link (“For reference or prescribing information please click here”) took users to Ferriprox.com, where the landing page was headed: “Life is Getting Longer … in thalassaemia major patients”.
From that landing page, a further link took readers to PubMed for Borgna-Pignatti et al (2006).
Novartis alleged the “Life is Getting Longer …” headline was a hanging comparison (as previously ruled) and therefore a breach of an undertaking given in Case AUTH/1822/4/06.
Novartis also alleged the survival-related messaging was unsubstantiated/misrepresented by the cited paper.
Because this involved an alleged breach of undertaking, the Director took the matter up with ApoPharma (PMCPA responsibility to ensure compliance with undertakings).
ApoPharma said the “Life is Getting Longer” phrase had been removed from the UK banner in August 2006, but remained on the linked page due to oversight; it also argued the banner was a notification that data existed.

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Panel: The reappearance of “Life is Getting Longer …” on the linked page was covered by the Code, was a hanging comparison, and breached the undertaking. Breaches ruled of Clauses 7.2, 22, 9.1 and 2.
Panel: Initially ruled a breach of Clause 7.4 in relation to “New Cardioprotection and Survival Data Now Available” (considered too strong/unsubstantiated given study limitations).
Appeal Board: Overturned the Clause 7.4 ruling—held the banner wording, as presented, was a statement of fact that data were available, not a claim of positive data. No breach of Clause 7.4.
The Clause 7.2, 22, 9.1 and 2 rulings were not appealed.

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