Teva breached ABPI Code over DuoResp Spiromax website: mobile version not separately certified and PI link hidden in hamburger menu (AUTH/3641/4/22)

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Key facts

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Case	AUTH/3641/4/22
Company	Teva
Product / material	DuoResp Spiromax (budesonide/formoterol) website (mobile vs desktop rendering)
Issue focus	Mobile display differences, certification of final form, and prominence of prescribing information access
Complaint received	28 April 2022
Completed	23 March 2023 (case report notes case completed 22 March 2023)
Applicable Code year	2021
Breach clauses	5.1, 8.1, 12.6
No breach clauses	2, 26.2 (and no breach found on the narrow job-code allegation under 8.1/5.1/2)
Appeal	No appeal
Sanctions	Undertaking received
Webpages cited (mobile PI prominence issue)	https://duoresp.co.uk/hcp/indication; https://duoresp.co.uk/hcp/placebo; https://duoresp.co.uk/hcp/Rep

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

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An anonymous, contactable complainant (a health professional) raised concerns about the DuoResp Spiromax (budesonide/formoterol) website, particularly when viewed on a mobile device.
The complaint alleged (among other points) that: (1) the homepage lacked a separate area for the public; (2) the mobile version had not been certified separately despite differences vs desktop; (3) the mobile pages lacked a clear prominent statement about where prescribing information (PI) could be found; and (4) it was odd that the same approval code appeared across pages/sections.
Teva said it had certified the website (desktop/tablet/mobile previews) under one approval code, and that PI was accessible via the hamburger menu on mobile; it also said the site was not indexed by search engines (“Do not index”).
The Panel considered whether the mobile and desktop versions were identical “final forms” for certification purposes, and whether PI access via a hamburger menu met the requirement for a clear prominent statement.

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Breach of Clause 8.1 (Failure to certify promotional material).
Breach of Clause 12.6 (Failing to include a clear, prominent statement as to where prescribing information could be found) – ruled in relation to each of three webpages cited.
Breach of Clause 5.1 (Failing to maintain high standards).
No breach of Clause 26.2 (public access allegation not established on the facts presented).
No breach of Clause 2 (Panel did not consider the circumstances warranted particular censure).
No breach of Clause 8.1 / 5.1 / 2 in relation to the narrow allegation that the same job code across pages/sections meant it had not been certified as required.
No appeal.

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Breach of Clause 8.1 – Failure to certify promotional material
Breach of Clause 12.6 – Failing to include a clear, prominent statement as to where prescribing information could be found
Breach of Clause 5.1 – Failing to maintain high standards
No Breach of Clause 26.2 – Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the public to ask their health professional to prescribe a specific prescription only medicine
No Breach of Clause 2 – Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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