Teva DuoResp Spiromax BMJ-hosted digital ad ruled misleading and out of date

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Key facts

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Case number	AUTH/3226/7/19
Case reference	DuoResp Spiromax advertisement on BMJ hosted website
Complainant	Concerned UK health professional
Respondent/company	Teva UK Limited
Product(s)	DuoResp Spiromax (budesonide/formoterol fumarate); comparator referenced: Symbicort Turbohaler (budesonide/formoterol)
Material/channel	Digital advertisement on BMJ hosted website (https://hosted.bmj.com); ad ref UK/DUO/15/0053a(1)
Key issue	Misleading “standalone” claims relying on footnotes; implied broader licensed populations (age, MART strength, COPD criteria) and misleading comparison; out-of-date prescribing information remained live beyond intended period
Dates (received/completed if stated)	Complaint received 16 July 2019; Case completed 7 April 2020
Appeal	Yes; Teva appealed; Appeal Board upheld Panel rulings; appeal unsuccessful
Code year	Not stated
Breaches/clauses	Clauses 7.2, 3.2, 9.1, 2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A concerned UK health professional complained about a DuoResp Spiromax (budesonide/formoterol fumarate) digital advertisement placed on a BMJ-hosted website by Teva UK Limited.
The ad promoted two strengths (160/4.5mcg and 320/9mcg) and used prominent bullet-point claims with small-font footnotes.
The complainant’s initial impression was that the product was licensed for all asthma and COPD patients; footnotes indicated use was limited to adults aged 18+ and that only one strength had a MART licence in asthma.
The complainant alleged promotion beyond the licence and said the prescribing information appeared over two years out of date.
The Panel and Appeal Board considered that key claims could not “stand alone” and were misleading when read without the footnotes/prescribing information.
Teva submitted the ad was intended for a limited period but remained published on the BMJ website for longer than intended due to human error by a third-party agency/publisher; Teva accepted responsibility for third parties under the Code.

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Breaches were ruled in relation to misleading claims about licensed use in asthma/COPD, MART licensing, and comparison to Symbicort Turbohaler, as well as failure to maintain high standards and bringing discredit on the industry.
On appeal, the Appeal Board upheld the Panel’s rulings: breaches of Clauses 7.2, 3.2, 9.1 and 2 were upheld; Teva’s appeal was unsuccessful.
The Appeal Board considered the out-of-date prescribing information could create a patient safety issue, including because a later update added “post bronchodilator” to the COPD criterion, potentially narrowing the indicated population.

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Clause 7.2 (misleading claims/claims must be capable of standing alone): upheld in relation to “Licensed for asthma and COPD*” and “MART licence for asthma**” being misleading in isolation and relying on footnotes.
Clause 3.2 (misleading information/inconsistency with SPC particulars): upheld in relation to (1) comparison to Symbicort Turbohaler potentially implying paediatric use, and (2) implying licensing for all COPD patients despite SPC criteria.
Clause 9.1 (high standards): upheld, including due to the continued publication of the ad with out-of-date prescribing information and lack of robust follow-up to ensure removal after the contracted period.
Clause 2 (bringing discredit/reducing confidence): upheld, with emphasis on the importance of up-to-date prescribing information for patient safety.

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