Dr Falk Pharma: website product pages and external links lacked compliant prescribing information (AUTH/3154/2/19)

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Key facts

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Case number	AUTH/3154/2/19
Complainant	Anonymous contactable health professional (“concerned UK health professional”)
Company	Dr Falk Pharma
Issue	Provision of obligatory information on a website (prescribing information on product pages and linked materials)
Products referenced	Budenofalk (budesonide), Salofalk (mesalazine), Ursofalk (ursodeoxycholic acid), Jorveza (budesonide)
Applicable Code	2016
Complaint received	04 February 2019
Case completed	24 May 2019
Appeal	No appeal
Breach clauses	Clause 4.1; Clause 9.1
No breach clauses	Clause(s) 2, 4.1, 4.3, 12.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth3154219-anonymous-contactable-health-professional-v-dr-falk-pharma

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

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A “concerned UK health professional” complained about Dr Falk Pharma’s health professional website and links from it, referencing Budenofalk, Salofalk, Ursofalk and Jorveza.
On Budenofalk, Salofalk and Ursofalk product pages, there were links to the SPCs but no prescribing information presented on the pages.
A media link first mentioning Jorveza allegedly lacked the generic name and prescribing information (the Panel did not have the material).
A Jorveza article (published in Pharmacy Magazine and hosted/linked via the site’s media page) was considered promotional in effect, but did not include prescribing information and the link wording did not clearly indicate it led to prescribing information.
A link from the site led to a historical Budenofalk advertisement (Gastroenterology Today, Summer 2017) with prescribing information that was not up to date at the time the link was used.
Another published article (review of ursodeoxycholic acid in primary biliary cholangitis) was linked/hosted; the complainant alleged it was promotional/disguised promotion and lacked prescribing information.
Dr Falk Pharma said the omission of prescribing information from its website was accidental and it was working to remedy and revise content; it could not provide a copy of the relevant media webpage because it had been updated and no copy was kept.

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Breach of Clause 4.1 for Budenofalk, Salofalk and Ursofalk product pages (SPC link alone was insufficient; legal classification and cost also required).
No breach of Clauses 4.1 and 4.3 regarding the media link’s first mention of Jorveza (Panel lacked the material and was not satisfied it was promotional on the balance of probabilities).
Breach of Clause 4.1 for the Jorveza article: treated as an advertisement in effect, with no clear link to prescribing information.
Breach of Clause 4.1 for linking to a historical Budenofalk advertisement with out-of-date prescribing information (treated as equivalent to hosting it if directly linked).
No breach of Clause 4.1 and no breach of Clause 12.1 for the published review article (not shown to be promotional/disguised promotion on the balance of probabilities).
Breach of Clause 9.1 (overall high standards not maintained with the website).
No breach of Clause 2 (Panel did not consider the circumstances warranted particular censure).

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