AUTH/3154/2/19 - Anonymous contactable health professional v Dr Falk Pharma

Provision of obligatory information on a website

  • Received
    04 February 2019
  • Case number
  • Applicable Code year
  • Completed
    24 May 2019
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2020 Review

Case Summary

An individual who described him/herself as a ‘concerned UK health professional’, complained about the Dr Falk Pharma website for health professionals and links from that website.  The complainant referred to information provided for Budenofalk (budesonide, used to treat, inter alia, Crohn’s disease), Salofalk (mesalazine, used to treat ulcerative colitis), Ursofalk (ursodeoxycholic acid, used to treat, inter alia, primary biliary cirrhosis) and Jorveza (budesonide, used to treat eosinophilic esophagitis).

The complainant noted that on the webpages for Budenofalk, Salofalk and Ursofalk, there was only a link to the relevant summary of product characteristics (SPC) and no prescribing information.  In a media link there was a first mention of Jorveza but there was no generic name stated nor any link to prescribing information.  An article on Jorveza, accessed by a link on the website, similarly had no prescribing information.  A  link to a different website took the reader to an advertisement for Budenofalk which included out-of-date prescribing information as two updates, which included details of special warnings, had not been included.  Finally, a link to another published article had no prescribing information and it was not evident that the article was promotional although it was from a promotional website. 

The detailed response from Dr Falk Pharma is given below.

The Panel noted that the complainant had only provided a screen shot of one part of the website and not shots of the other pages.  Dr Falk Pharma had not been able to supply full details.  In the Panel’s view, it was important that complainants provided screen shots at the time of their complaint to ensure that the PMCPA had access to the same material as they did.  A website could be updated by a pharmaceutical company immediately after the complainant viewed it and before the PMCPA had been notified.

The Panel noted from Dr Falk Pharma that the health professional section of the website was intended for registered health professionals only and was password protected.  The media page and other pages were not password protected.  The media page was intended for the press and media agencies.  Dr Falk Pharma submitted that the article on Jorveza was available to readers once they clicked on the title of the article and that the link to the SPC including the prescribing information was also available. 

The Panel noted that it appeared that the media pages on the website referred to the latest articles, press releases etc, content produced and published by Dr Falk Pharma for the media.  In addition the media pages also appeared to include content where Dr Falk Pharma and/or its products were mentioned. 

This was described as ‘Dr Falk Pharma in the media’.  The Panel noted that on the pages for health professionals although there were links to the SPCs for (Budenofalk, Salofalk, and Ursofalk), prescribing information had not been provided.  The links to the SPCs were not sufficient to meet the requirements of the Code.  The legal classification and the cost were also required.  The Panel therefore ruled breaches of the Code in relation to Budenofalk, Salofalk and Ursofalk.

In relation to the media link and the first mention of Jorveza, the Panel did not have access to the relevant material.  Such a link should not be advertising and therefore although it might be helpful to give the non-proprietary name, there was no requirement to do so.  Nor was there a requirement to include prescribing information.  The Panel did not consider that the complainant had shown on the balance of probabilities that this material was promotional.  Given the circumstances, the Panel ruled no breach of the Code.

In relation to the Jorveza article and the alleged lack of prescribing information, again the Panel noted that it did not have access as to how this appeared on the website.  It appeared that the material was an article published in Pharmacy Magazine.  The material provided by Dr Falk Pharma was headed ‘New drug for eosinophilic oesophagitis’ followed by a photograph of a woman who was clutching her stomach.  The text below the photograph referred to Jorveza and its indication.  The Panel considered that the material was in effect an advertisement for Jorveza.  The prescribing information was not provided as part of the material but according to Dr Falk Pharma, a link to the SPC including the prescribing information was provided on the media page.  The Panel noted that the media page link stated ‘for more information about Jorveza please click here’.  There was no mention that this was the link to the prescribing information and as there was no clear link a breach was ruled. 

The Panel noted that the complainant had accessed a link from the Dr Falk Pharma website to an advertisement for Budenofalk which appeared in an online journal.  The complainant provided the address for the link.  The Panel had no information about the link from Dr Falk Pharma or from its website.  Historical advertisements would be available in third party publications.  If Dr Falk Pharma had provided a direct link to the historical advertisement then this was in effect the same as the company having that advertisement on its own website.  The prescribing information in the advertisement for Budenofalk in Gastroenterology Today, Summer 2017 was not up-to-date at the time such a link was used.  Given that the complainant had provided the direct link and that the Dr Falk Pharma media page included links to Dr Falk Pharma in the media, the Panel decided, on the evidence before it, on the balance of probabilities, that the link was to the actual advertisement.  Thus the Panel ruled a breach of the Code.

The Panel noted that the published article referred to by the complainant was a review of ursodeoxycholic acid in primary biliary cholangitis.  If Dr Falk Pharma had a role in the production/publication of the article then this was not clear.  The final page stated the author’s conflict of interest as having served on advisory boards and lectured on behalf of Dr Falk Pharma and another company.  The Panel did not consider it had sufficient information to understand the arrangements for the publication of the article.  Having a published paper on a pharmaceutical company website was not necessarily promotional.  The Panel did not consider that the complainant had shown, on the balance of probabilities, that this material was promotional and thus required prescribing information or that placing the article on the website amounted to disguised promotion as alleged.  No breach of the Code was ruled.  The Panel noted its rulings set out above and ruled a breach as overall high standards had not been maintained.  It did not consider the circumstances warranted a ruling of a breach of Clause 2 of the Code which was used a sign of particular censure.