Novartis v ApoPharma & Swedish Orphan: Ferriprox ‘Life is getting longer’ claim, missing PI link, and public-facing patient newsletter issues (AUTH/1822/4/06, AUTH/1823/4/06)

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Key facts

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Case numbers	AUTH/1822/4/06; AUTH/1823/4/06
Complainant	Novartis Pharmaceuticals UK Ltd
Companies complained about	ApoPharma (Apotex group); Swedish Orphan International (UK) Ltd
Product	Ferriprox (deferiprone)
Comparator product mentioned	Desferal (desferoxamine) (supplied by Novartis)
Materials	Electronic journal banner ad (British Journal of Haematology homepage); UK Thalassaemia Society Patient Newsletter (March 2006) article and adjacent advertisement
Main issues	Missing direct PI link in HCP banner ad; hanging comparison and lack of substantiation for “Life is getting longer”; unbalanced public-facing language encouraging patients; POM advertising to the public in a patient newsletter
Applicable Code year	2003
Complaint received	4 April 2006 (both cases)
Case completed	AUTH/1822/4/06: 23 August 2006; AUTH/1823/4/06: 18 August 2006
Appeal	No appeal
Breaches	AUTH/1822/4/06: 4.1, 7.2, 7.4; AUTH/1823/4/06: 7.2, 7.4, 20.1, 20.2
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Novartis complained about Ferriprox (deferiprone) promotion: (1) a banner ad on the electronic British Journal of Haematology homepage and (2) Ferriprox content in the March 2006 UK Thalassaemia Society Patient Newsletter.
Ferriprox was distributed in the UK by Swedish Orphan International (UK) Ltd; the marketing authorisation was held by Apotex Europe Ltd (ApoPharma described as the Innovative Drug Division of Apotex Inc.).
Case AUTH/1822/4/06 (ApoPharma): banner strapline “Life is getting longer” was alleged to be exaggerated, misleading, a hanging comparison, and lacked prescribing information/link.
Case AUTH/1823/4/06 (Swedish Orphan): a patient newsletter article titled “New Data Show Ferriprox Tablets are More Efficacious than Desferoxamine…” was alleged to be promotional to the public; it used emotive terms (“stunning”, “exciting”) and the newsletter also carried an advertisement stating “With licensed oral iron chelation life is getting longer”.
The Panel treated the newsletter content as, in effect, Swedish Orphan’s press release (the actual press release was not supplied).

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AUTH/1822/4/06 (ApoPharma): Breach for failure to include a direct link to prescribing information in the banner ad; breach for hanging comparison; breach for lack of substantiation. No breach for alleged inconsistency with the SPC due to not stating the disease area.
AUTH/1823/4/06 (Swedish Orphan): The article itself was not ruled to be an advertisement to the public (no breach of Clause 20.1 for the article), but it was ruled unbalanced and likely to encourage readers to ask their health professional to prescribe Ferriprox (breach of Clause 20.2).
AUTH/1823/4/06 (Swedish Orphan): The advertisement in the patient newsletter was ruled to be advertising a prescription only medicine to the general public (breach of Clause 20.1) and the “life is getting longer” claim was ruled a hanging comparison and unsubstantiated (breaches of Clauses 7.2 and 7.4). No breach of Clause 3.2 and no breach of Clause 4.1 for that public ad (PI not required because it was not HCP-directed promotion).

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