Diurnal: ‘Products and Pipeline’ webpage ruled promotional—pre-licence pipeline promotion and missing PI/INN for Alkindi (AUTH/3274/10/19)

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Key facts

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Case	AUTH/3274/10/19
Parties	Complainant v Diurnal Limited
Issue	Promotion of pipeline products on an HCP-facing corporate website page; missing prescribing information link and non-proprietary name for a licensed product entry
Complaint received	24 October 2019
Case completed	18 February 2020
Applicable Code year	2019
Product(s) mentioned	Alkindi (hydrocortisone granules in capsules for opening) and four unlicensed pipeline products (names not stated)
Key Panel finding	Page was promotional in context and promoted unlicensed medicines; Alkindi entry lacked PI single-click link and non-proprietary name
Breach clauses	Clause 3.1; Clause 4.1; Clause 4.3; Clause 9.1; Clause 2
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth32741019-complainant-v-diurnal

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

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A ‘concerned UK health professional’ complained about a webpage in the health professionals’ section of Diurnal’s corporate website.
The page sat within a combined “Products and Pipeline” area (not separated) and included a table titled “Diurnal’s drug-development pipeline – Europe”.
The table listed five products: one licensed product (Alkindi; licensed in 2018 for paediatric adrenal insufficiency) and four unlicensed pipeline products.
For the pipeline products, the table included indications, clinical trial status and expected approval dates (2021, 2023 and ‘TBC’).
Introductory wording stated, among other things, “Diurnal is dedicated to bringing effective, high quality products to the global market…”, which the Panel considered implied the listed medicines were effective and high quality.
The Alkindi entry on that webpage did not include a clear and prominent single-click link to prescribing information, and the non-proprietary name was not provided.

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The Panel ruled the webpage was promotional in context (health professional audience, location within a section promoting the company’s licensed medicine, and overall impression).
Information about the unlicensed medicines was ruled to be promotion of unlicensed medicines (pre-licence promotion).
For Alkindi, the Panel ruled that required prescribing information was not provided via the material itself or a clear and prominent single-click link, and the non-proprietary name was missing.
High standards were ruled not to have been maintained.
The Panel ruled Diurnal’s conduct showed poor understanding of the Code and fell short of competent care; the matter was ruled a breach of Clause 2 (particular censure).

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