AUTH/2734/9/14: Head of Prescribing Support Unit v Boehringer Ingelheim (Striverdi Respimat) – cycling imagery not misleading (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2734/9/14
Complainant	Head of Prescribing Support Unit (prescribing support pharmacist)
Company	Boehringer Ingelheim Limited
Product	Striverdi (olodaterol) Respimat
Material	Leavepiece (ref UK/SVR – 141004(1))
Therapy area	Chronic obstructive pulmonary disease (COPD)
Main issue	Whether cover artwork (woman cycling) misleadingly implied benefit
Applicable Code year	2014
Clause(s) considered	Clause 7.8
Decision	No breach
Complaint received	26 September 2014
Case completed	14 November 2014
Appeal	No appeal
Notable data referenced	Exercise endurance studies: average cycling at 75% maximal work rate for 7 minutes and 6.6 minutes; placebo-adjusted mean endurance differences after 6 weeks: 52 seconds (p=0.002) and 42 seconds (p=0.0018); epidemiology cited: 36% mildest COPD category (GOLD A) (Haughney et al 2014)

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

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A prescribing support pharmacist complained about a Striverdi (olodaterol) Respimat leavepiece (ref UK/SVR – 141004(1)) issued by Boehringer Ingelheim.
The front cover showed an older woman, smiling and cycling slightly uphill past a village church, with a newspaper and flowers in a basket; motion swirls were added around the pedals/wheel.
The complainant alleged the image did not truly reflect Striverdi’s likely effect in COPD and was misleading (referencing supplementary information to Clause 7.8 on artwork not misleading as to the nature of a medicine/claims/comparisons).
Boehringer Ingelheim cited two paired six-week exercise endurance studies (constant work rate cycle ergometry at 75% maximal work capacity) and argued the imagery reflected gentle, short-duration cycling consistent with the data and the target COPD population (including mild COPD).

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