Teva breached ABPI Code over ‘intuitive’ inhaler ad for DuoResp Spiromax (AUTH/2810/12/15)

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Key facts

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Case number	AUTH/2810/12/15
Complainant	Anonymous, non-contactable (self-described general practitioner)
Company	Teva UK Limited
Product	DuoResp Spiromax (budesonide/formoterol fumarate dehydrate)
Material / channel	Advertisement in Primary Care Respiratory Update
Main claims at issue	“The moment I picked it up I knew how to use it*”; “Intuitive design”; “Intuitive to use”
Qualification / footnote	“Instructions for use should be followed as per the patient information leaflet” (small, grey font at bottom, below prescribing information)
Key evidence cited	Rychlik et al (2014); Plusa et al (2015) (Panel noted both effectively referred to Plusa et al data)
Panel concerns	Ad implied patients would not need counselling/training; risk of loss of symptom control if training omitted; study conditions included demonstration video and trying an empty device
Applicable Code year	2015
Breach clauses	Clause 7.2 and Clause 9.1
Complaint received	17 December 2015
Case completed	3 February 2016
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous, non-contactable complainant (self-described GP) challenged a Teva UK advertisement for DuoResp Spiromax placed in Primary Care Respiratory Update.
The ad featured a patient image with the headline claim: “The moment I picked it up I knew how to use it*” and the strapline “Intuitive design”.
Claims were referenced to Rychlik et al (2014) and Plusa et al (2015); “Intuitive to use” was also referenced.
The asterisk led to a statement in small, grey font at the very bottom of the ad (below prescribing information): “Instructions for use should be followed as per the patient information leaflet”.
The complainant said the patient information leaflet suggested correct use was not necessarily intuitive (eg, it should not be shaken; an air vent could be blocked), so patients might use it incorrectly without training.
Teva argued the references supported the device’s intuitive nature and noted the SPC described three steps (open, breathe, close), while still recommending HCPs refer patients to the leaflet.

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The Panel ruled the claims “The moment I picked it up I knew how to use it” and “Intuitive design” were misleading as to ease of use and breached the Code.
The Panel was very concerned about the potential risk that some asthma/COPD patients could lose symptom control due to inadequate training if the ad’s implication were followed.
The Panel ruled that high standards had not been maintained.
No appeal.

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