Teva respiratory websites: missing PI/AE signposting online, audience separation issues, and off-label implication from guideline content (AUTH/3451/1/21)

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Key facts

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Case	AUTH/3451/1/21
Company	Teva
Subject	Teva respiratory websites (Teva corporate site and “Let’s Talk Respiratory”)
Complaint received	5 January 2021
Case completed	2 December 2021
Applicable Code year	2019
Appeal	No appeal
Main issues upheld	Missing prominent PI signposting online; missing PI for Qvar and Tymbrineb on HCP page; missing AE reporting statement/signposting on HCP page; inadequate audience separation/signposting on public pages; guideline content deemed promotional and inconsistent with SPC (off-label implication)
Medicines referenced	DuoResp Spiromax, Braltus Zonda, Qvar, Cinqaero, Tymbrineb; also acitretin (public page allegation)
Sanctions	Undertaking received; Advertisement

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

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What happened

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An anonymous health professional complained about two Teva-owned websites: the Teva UK corporate site (tevauk.com) and the “Let’s Talk Respiratory” site (letstalkrespiratory.com).
Teva corporate site (HCP respiratory page): five respiratory medicines were listed (DuoResp Spiromax, Braltus Zonda, Qvar, Cinqaero, Tymbrineb). The complainant alleged there was no clear, prominent route to prescribing information (PI) unless users expanded content, and that PI was missing for Qvar and Tymbrineb. The complainant also alleged no adverse event (AE) reporting statement was visible on the page.
The complainant also alleged that public/patient-facing product pages showed brand names/images and included a DuoResp Spiromax “how to use” video with branding, and that audience separation/signposting was inadequate.
Let’s Talk Respiratory: Teva described it as non-promotional education. The complainant alleged a guideline-based masterclass video and a “research roundup” article were disguised promotion (even without naming products), lacked PI, and included off-label promotion (ICS/formoterol “as required” reliever use). Social sharing buttons were also criticised as potentially enabling promotion to the public.

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Outcome

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Teva corporate site (HCP respiratory page)
- No breach of Clause 11.1 (Panel view: 11.1 applies to material proactively sent/distributed, not HCPs accessing a website).
- Breach of Clause 4.6 (no clear, prominent statement at the outset as to where PI could be found for each of the five products listed).
- Breach of Clause 4.1 in relation to Qvar and Tymbrineb (PI should have been provided but was not).
- No breach of Clause 4.2 (Panel stated it was not possible to breach 4.2 in this instance; failure to provide required info is a 4.1 issue).
- Breach of Clause 4.9 (no AE reporting statement/signposting visible at the outset or within expanded content; particularly important for Cinqaero which was subject to additional monitoring).
- No breach of Clause 14.1 (no evidence the page was not certified).
- Breach of Clause 9.1 (failed to maintain high standards).
- Breach of Clause 2 (cumulative effect, including lack of AE reporting statement and black triangle/safety concerns, warranted particular censure for this part).
Teva corporate site (public/patient pages)
- Breach of Clause 28.1 (audience separation/signposting: patient-specific video content appeared integral to broader public reference information; intended audience not identified clearly at the outset).
- Breach of Clause 9.1 (failed to maintain high standards) in relation to the Clause 28.1 issue.
- No breach of Clauses 26.2, 26.3, 28.3 (and no breach of Clause 2 for this part). The Panel also did not uphold the narrow allegation that brand names/images on the public pages triggered promotional requirements, on the balance of probabilities.
- The Panel additionally expressed concern (advisory) that inviting the public to contact medical information about DuoResp Spiromax (including “how it works”) might solicit enquiries about a specific POM and go beyond reference/reactive information under Clause 26.2; Teva was asked to review signposting.
Let’s Talk Respiratory (masterclass video)
- The Panel considered the website and the presentation promotional for Teva’s medicines (even without naming products), given Teva funding, direction of HCPs to the site, and Teva review/certification.
- Breach of Clauses 4.1 and 4.6 (should have included PI for Qvar and DuoResp Spiromax and a clear prominent statement of where it could be found; did not).
- No breach of Clause 4.2 (same reasoning as above).
- No breach of Clause 4.9 (AE reporting available via the website at the bottom of relevant pages).
- Breach of Clause 3.2 (recommendation/implication that ICS/formoterol could be used “increasingly in an as required manner” was inconsistent with DuoResp Spiromax SPC; a small “off-licence” footnote was insufficient).
- Breach of Clause 9.1 (failed to maintain high standards) in relation to the Clause 3.2 issue.
- No breach of Clause 2 (Panel considered Clause 9.1 was sufficient additional censure here).
- No breach of Clause 26.3 (not intended for patients taking a specific POM).
- No breach of Clauses 9.9, 12.1, 26.2, 9.1 and 2 regarding social sharing (complainant did not establish it had been shared; burden of proof not met).
Let’s Talk Respiratory (research roundup article)
- The Panel considered the article promotional and containing promotional claims for budesonide/formoterol; Teva marketed DuoResp Spiromax.
- Breach of Clauses 4.1 and 4.6 (should have included DuoResp Spiromax PI and a clear prominent statement of where it could be found; did not).
- No breach of Clause 4.2.
- No breach of Clause 4.9 (AE reporting available via the website).
- No breach of Clause 26.3 (not intended for patients taking a specific POM).
- No breach of Clauses 9.9, 12.1, 26.2, 9.1 and 2 regarding social sharing (not established it had been shared).

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