AstraZeneca v Chiesi: “for an extra fine day” headline ruled misleading; certification failures led to public reprimand and audits (AUTH/2618/7/13)

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Key facts

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Case number	AUTH/2618/7/13
Parties	AstraZeneca v Chiesi
Product	Fostair (formoterol/beclometasone pressurised inhalation solution)
Comparator mentioned	Symbicort (budesonide/formoterol turbohaler) (marketed by AstraZeneca)
Material	Leavepiece (ref CHFOS20130051)
Key claim/headline	“New licence for Maintenance And Reliever Therapy for an extra fine day”
Complaint received	22 July 2013
Applicable Code year	2012
Breach clauses	7.2 and 7.4
No breach clauses	9.1
Undertaking received	4 September 2013
Sanctions	Undertaking received; Public reprimand; Advertisement; Audit of company’s procedures; Re-audit
Appeal Board consideration dates	15 October 2013; 9 April 2014; 10 December 2014
Case completed	10 December 2014
Key process failures identified	Final distributed version not certified; post-certification alteration by product manager; inaccurate information provided to PMCPA (including date of last use); discrepancy between versions not identified

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

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What happened

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AstraZeneca complained about a Chiesi promotional leavepiece for Fostair (formoterol/beclometasone pressurised inhalation solution), ref CHFOS20130051.
The front-page headline stated: “New licence for Maintenance And Reliever Therapy for an extra fine day”, alongside imagery of a woman in a field.
AstraZeneca alleged the phrase “for an extra fine day” was an unqualified, unsubstantiated product claim implying improved patient outcomes (and potentially a return to a pre-symptom state), and was ambiguous as to what benefit was being claimed and versus what comparator.
Chiesi argued the phrase was a play on words referring to Fostair’s extrafine formulation (citing SPC section 4.2) and that the page also included “Extra-fine formulation. Adult asthma control” to reinforce the formulation link.
The Panel found the headline was not sufficiently clear about what “extra fine” referred to and implied an additional clinical benefit (comparative by implication) without supporting data.
After the Panel ruling, it emerged that the version supplied to the PMCPA (lower case “extra fine”) was not the version distributed. A product manager had altered the leavepiece after electronic certification so the distributed version used “EXTRA FINE” in upper case.
Signatories had not certified the final form of the distributed material; a printed PDF was certified and it was wrongly assumed no changes had been made post-approval.
Chiesi also provided an incorrect final date of use in its original undertaking (initially stated 17 March 2013; later corrected to 30 March 2013).
Due to concerns about inaccurate information and certification arrangements, the Panel reported Chiesi to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure.

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Outcome

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Breach of Clause 7.2 (misleading) in relation to the headline claim.
Breach of Clause 7.4 (substantiation) in relation to the implied comparative/clinical benefit.
No breach of Clause 9.1 (high standards) on the original promotional claim assessment.
Company conduct issues (inaccurate information to PMCPA; failure to certify final form) resulted in escalation to the Appeal Board and additional sanctions.

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