AUTH/3274/10/19 - Complainant v Diurnal

Promotion of pipeline products

  • Received
    24 October 2019
  • Case number
  • Applicable Code year
  • Completed
    18 February 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the review

Case Summary

A complainant who described him/herself as a ‘concerned UK health professional’, noted that one webpage on Diurnal Limited’s corporate website, in the section aimed at health professionals, referred to current products and those in the company’s pipeline. A downloaded copy of the page which showed a table of data headed ‘Diurnal’s drug-development pipeline – Europe’ was provided. The complainant alleged that the table constituted pre-licence promotion and that there was no prescribing information or generic names for licensed products.

The detailed response from Diurnal is given below.

In the Panel’s view, it was not necessarily unacceptable for a company to refer in general terms to its pipeline products on its corporate website, however language, context, location, layout, intended audience and overall impression were important factors. Such references should not otherwise constitute promotion of an unlicensed medicine.

The Panel noted that the webpage at issue was in the health professionals’ section of Diurnal’s website. If health professionals wanted to find out about Diurnal medicines they had to visit the section of the website which detailed ‘Products and Pipeline’ – the two were not separate. The table of data which detailed five products in Diurnal’s European drug development pipeline, was within the ‘Clinical Trials’ section of ‘Products and Pipeline’; one of the products listed, Alkindi (hydrocortisone granules in capsules for opening), had been licensed for paediatric adrenal insufficiency in 2018. Four other products were listed together with the indication for which they were being developed, their clinical trial status and the expected approval dates – variously 2021, 2023 and ‘TBC’ (to be confirmed).

The Panel noted from the downloaded page provided by Diurnal that the table of data was introduced by, inter alia, ‘Diurnal is dedicated to bringing effective, high quality products to the global market for the life-long treatment of chronic endocrine conditions’; this implied that the medicines listed were effective and high quality. In addition, the indications were stated. In the Panel’s view, the webpage, which was directed at health professionals and was within a section of the website that promoted the company’s licensed medicine, was promotional and designed to elicit interest in both Diurnal’s licensed medicine and in its pipeline products. The Panel considered that the information about the unlicensed medicines constituted promotion of those medicines and a breach of the Code was ruled.

The Panel further considered that the information provided about Alkindi (product name and indication (paediatric adrenal insufficiency)) on a promotional section of the website, was promotional. The Code required that in digital promotional material, the prescribing information must be included in the material itself or by way of a clear and prominent direct single click link. There was no link to the Alkindi prescribing information and the non-proprietary name had not been provided. Breaches of the Code were ruled.

The Panel noted its rulings above and considered that high standards had not been maintained. A breach of the Code was ruled.

The Panel considered that the response from Diurnal showed a poor understanding of the requirements of the Code. In the Panel’s view the restrictions around how, when and what information could be provided about pipeline products and the definition of what constituted promotion of licensed medicines were such that companies should not combine the two. The promotion of a medicine prior to the grant of its marketing authorization was listed in the Code as an activity likely to be ruled in breach of Clause 2 – a sign of particular censure. The company had failed to recognise that the information it had provided was promotional. The Panel considered that the company’s conduct in introducing, formatting and providing the information that it had, fell short of competent care; unlicensed medicines had been promoted to health professionals. A breach of Clause 2 was ruled.