Jazz Pharmaceuticals: Sunosi website—mobile prescribing information not sufficiently prominent (Clause 4.6) and high standards breach (Clause 9.1)

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Key facts

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Case	AUTH/3446/12/20
Company	Jazz Pharmaceuticals UK
Material	Sunosi (solriamfetol) website (HCP pages)
Complaint received	21 December 2020
Case completed	15 June 2021
Applicable Code year	2019
Appeal	No appeal
Key issue(s)	Prominence of prescribing information on mobile; external link clarity; dosing/titration claim presentation
Breach clauses	Clause 4.6; Clause 9.1
No breach clauses	Clause 2; Clause 4.1; Clause 7.2; Clause 7.4; Clause 28.6
Sanctions	Undertaking received; Additional sanctions: Not stated
Company action noted	Website taken down pending investigation; withdrawn from public access on 24 December 2020

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

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An anonymous, non-contactable complainant (self-described health professional) challenged content on the Sunosi (solriamfetol) HCP website (sunosi.co.uk).
They alleged external hyperlinks (MHRA Yellow Card and a Narcolepsy UK reference link) lacked a disclaimer/pop-up indicating the user was leaving the company site.
They alleged prescribing information (PI) was not provided on the mobile version of HCP pages (desktop had a PI tab).
They alleged the dosing/titration statement under “Sunosi is a convenient, once-daily dose in a single tablet” was misleading and not capable of standing alone, omitting key cardiovascular monitoring qualifiers from the SPC.
Jazz took the website down during investigation (withdrawn from public access on 24 December 2020) and stated the issue was a technical/design behaviour on mobile where the PI tab was no longer “sticky” and became contracted into the hamburger menu; PI was also linked near the bottom of the page.

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No breach for external-link clarity: MHRA Yellow Card link and Narcolepsy UK reference link were considered sufficiently clear as external destinations (no breach of Clause 28.6).
No breach that PI was unavailable on mobile (no breach of Clause 4.1) because the Panel had no evidence PI could not be accessed (via hamburger menu and a link near the bottom).
Breach because the mobile presentation did not provide a clear, prominent statement as to where PI could be found (Clause 4.6).
Breach of high standards because Jazz should have checked the final mobile rendering and spotted the PI tab behaviour change (Clause 9.1).
No breach for the titration/max dose claim (no breach of Clauses 7.2 and 7.4) and, in that context, no breach of Clause 2 or Clause 9.1 in relation to the claim.

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