Diurnal: “Products and Pipeline” webpage ruled promotional—pre-licence pipeline promotion and missing PI

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3274/10/19
PartiesComplainant v Diurnal
IssuePromotion of pipeline products on an HCP-directed corporate website page; missing prescribing information and non-proprietary name for a licensed product on a promotional page
ChannelCorporate website (health professionals section)
MaterialTable headed “Diurnal’s drug-development pipeline – Europe” within “Products and Pipeline” / “Clinical Trials”
Licensed product referencedAlkindi (hydrocortisone granules in capsules for opening), licensed 2018 for paediatric adrenal insufficiency
Panel viewOverall impression was promotional; implied claims (“effective, high quality”) and inclusion of indications/timelines promoted unlicensed medicines; PI and non-proprietary name missing for Alkindi on that page
Breach clausesClause 3.1; Clause 4.1; Clause 4.3; Clause 9.1; Clause 2
SanctionsUndertaking received; Additional sanctions: Advertisement
Complaint received24 October 2019
Case completed18 February 2020
Applicable Code year2019
AppealNo appeal

Download the full case report (PDF)


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

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What happened

  • A “concerned UK health professional” complained about a Diurnal corporate website page in the health professionals section.
  • The page combined “Products and Pipeline” content and included a table titled “Diurnal’s drug-development pipeline – Europe” within a “Clinical Trials” section.
  • The table listed five products: one licensed product (Alkindi, licensed in 2018 for paediatric adrenal insufficiency) and four pipeline products with indications, clinical trial status and expected approval dates (2021, 2023, and TBC).
  • Introductory wording included: “Diurnal is dedicated to bringing effective, high quality products…” which the Panel considered implied the listed medicines were effective and high quality.
  • For Alkindi on that page, there was no link to prescribing information and the non-proprietary name was not provided.
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Outcome

  • The Panel ruled the webpage was promotional and designed to elicit interest in both the licensed medicine and pipeline products.
  • Information about the unlicensed medicines constituted promotion of unlicensed medicines.
  • For Alkindi, the page was promotional but did not include required prescribing information (or a clear, prominent single-click link) and did not include the non-proprietary name.
  • The Panel ruled that high standards had not been maintained.
  • The Panel ruled a Clause 2 breach, citing poor understanding of the Code and that the conduct fell short of competent care; promotion prior to marketing authorisation is an activity likely to be ruled in breach of Clause 2.
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