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PMCPA Case

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

📅 2013 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2618/7/13
PartiesAstraZeneca v Chiesi
ProductFostair (formoterol/beclometasone pressurised inhalation solution)
Comparator mentionedSymbicort (budesonide/formoterol turbohaler)
MaterialLeavepiece (ref CHFOS20130051)
Key claim/headline“New licence for Maintenance And Reliever Therapy for an extra fine day”
Applicable Code year2012
Complaint received22 July 2013
Undertaking received4 September 2013
Panel ruling (clauses)Breach Clauses 7.2 and 7.4; No breach Clause 9.1
Key procedural issueDistributed version differed from the version supplied/certified; final form not certified; inaccurate information provided (including initial incorrect last date of use)
Last date of use (corrected)30 March 2013
Appeal Board considerations15 October 2013; 9 April 2014; 10 December 2014
SanctionsUndertaking; Public reprimand; Advertisement; Audit; Re-audit
Case completed10 December 2014
PublicationReview February 2015 (Interim Case Report first published 11 December 2013)

Download the full case report (PDF)

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) (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 and the strapline “Extra-fine formulation. Adult asthma control”.
  • AstraZeneca alleged the phrase “for an extra fine day” was an unqualified, unsubstantiated product claim implying improved patient outcomes and (by implication) superiority, and that the imagery compounded this.
  • Chiesi argued it was a play on words referring to Fostair’s “extrafine” formulation (citing SPC section 4.2) and daily use/posology, and denied it implied clinical superiority over other ICS/LABA products.
  • The Panel ruled the headline was unclear about what “extra fine” referred to and implied an “extra” clinical benefit versus a comparator, without supporting data.
  • After the ruling, it emerged the version supplied to the Panel (lower case “extra fine”) was not the distributed version; a product manager had changed the final printed piece post electronic approval to “EXTRA FINE”.
  • Further issues arose: signatories had not certified the final form; the company’s response and undertaking contained inaccuracies (including an incorrect last date of use initially stated as 17 March 2013; later corrected to 30 March 2013).
  • The Panel reported Chiesi to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure due to concerns about certification arrangements and provision of accurate information.
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Outcome

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  • Breach of Clause 7.2 (misleading/ambiguous claim).
  • Breach of Clause 7.4 (claim not capable of substantiation).
  • No breach of Clause 9.1 (high standards) in relation to the promotional claim as considered by the Panel.
  • Company conduct issues (inaccurate information to PMCPA; failure to certify final form) resulted in escalation to the Appeal Board and additional sanctions.
  • Appeal Board required audits (March 2014) and a re-audit (October 2014); after October 2014 re-audit, no further action was required on balance (subject to continued progress and compliance focus).
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