Teva respiratory websites: missing PI signposting, AE reporting visibility and off-label messaging risk (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”)
Complainant	Anonymous, contactable health professional (later uncontactable)
Complaint received	5 January 2021
Case completed	2 December 2021
Applicable Code year	2019
Appeal	No appeal
Key products mentioned	DuoResp Spiromax, Braltus Zonda, Qvar, Cinqaero, Tymbrineb; also public pages referenced budesonide/DuoResp and acitretin
Main issues upheld	Prominent PI signposting missing (internet promotion); PI missing for some products; AE reporting statement visibility; audience separation/signposting on public pages; LTR deemed promotional; messaging inconsistent with SPC (off-label risk)
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 (initially contactable) health professional complained about two Teva-owned sites: the Teva UK corporate site (HCP respiratory section) and the “Let’s Talk Respiratory” (LTR) website.
On the Teva HCP “Respiratory in focus” page, five products were listed (DuoResp Spiromax, Braltus Zonda, Qvar, Cinqaero, Tymbrineb). Prescribing information (PI) was not clearly and prominently signposted at the outset; PI for Qvar and Tymbrineb was not provided.
The HCP page did not display an adverse event (AE) reporting statement at the outset/within expanded content; this was considered particularly important for Cinqaero (additional monitoring/black triangle).
On Teva’s public-facing product pages (eg budesonide/DuoResp and acitretin), the complainant alleged inappropriate public access to branded imagery and patient training content. The Panel focused on whether audiences were clearly separated and signposted.
On LTR, Teva described the site as non-promotional education with an editorial board. The Panel considered the broad definition of promotion and how HCPs were directed to the site (including via Teva’s HCP corporate site and field force signposting).
LTR content included a masterclass slide and transcript discussing GINA’s preferred “ICS/formoterol” first step and stating it was unlicensed in the UK, plus commentary that ICS/formoterol would be used increasingly “in an as required manner”.
LTR also hosted an article summarising evidence for budesonide/formoterol “taken as needed” and included claims the Panel considered promotional.
The complainant also raised concerns about social sharing buttons (Facebook/Twitter/LinkedIn) potentially enabling promotion to the public; the Panel noted the risk but the complainant did not prove sharing occurred.

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Outcome

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No breach of Clause 11.1 for the Teva HCP respiratory page being accessible to all health professionals (Panel view: Clause 11.1 applies to proactively sent/distributed material, not HCPs seeking website content).
Breach of Clause 4.6 on the Teva HCP respiratory page (no clear, prominent statement at the outset as to where PI could be found) in relation to each of the five listed products.
Breach of Clause 4.1 on the Teva HCP respiratory page for Qvar and Tymbrineb (PI should have been provided but was not).
Breach of Clause 4.9 on the Teva HCP respiratory page (no AE reporting statement visible at the outset/within expanded content).
No breach of Clause 14.1 (certification) for the Teva HCP respiratory page.
Breach of Clause 9.1 (high standards) for the Teva HCP respiratory page issues.
Breach of Clause 2 (Teva HCP respiratory page) due to cumulative effect, including lack of AE reporting visibility and concerns around black triangle requirements.
Breach of Clause 28.1 for Teva’s public product page(s) (budesonide/DuoResp) due to inadequate separation/signposting where patient-directed video content appeared integral to general public reference information.
Breach of Clause 9.1 in relation to the Clause 28.1 issue on the public product page(s).
No breach (based on the narrow allegation) for Clauses 26.2/26.3 regarding branded imagery/video on the public budesonide/DuoResp page; and no breach for acitretin in relation to the complainant’s allegation (including no breach of Clause 26.3).
For LTR, the Panel found the site/content promotional for Teva’s medicines (despite being presented as education) and ruled:
- Breach of Clauses 4.1 and 4.6 (presentation should have included PI for Qvar and DuoResp Spiromax and prominent PI signposting, but did not).
- No breach of Clause 4.9 (AE reporting available via the website at the bottom of relevant pages).
- Breach of Clause 3.2 (recommendation/messaging inconsistent with DuoResp Spiromax licensed indication; footnote “off-licence” was insufficient to negate the issue).
- Breach of Clause 9.1 (high standards) in relation to the Clause 3.2 issue.
- No breach of Clause 2 for LTR (Panel did not consider it brought discredit; Clause 9.1 was sufficient censure).
- No breach for Clauses 9.9, 12.1, 26.2, 9.1 and 2 regarding social sharing (risk acknowledged, but sharing not established).
For the LTR “Research roundup” article:
- Breach of Clauses 4.1 and 4.6 (PI for DuoResp Spiromax and prominent PI signposting were required but absent).
- 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 for Clauses 9.9, 12.1, 26.2, 9.1 and 2 regarding social sharing (sharing not established).

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Teva respiratory websites: missing PI signposting, AE reporting visibility and off-label messaging risk (AUTH/3451/1/21)

Key facts

What happened

Outcome

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