Ferring breached ABPI Code over Cortiment banner strapline implying broader ulcerative colitis use than licensed

📊

Key facts

⌄

Case number	AUTH/3378/9/20
Company	Ferring Pharmaceuticals Ltd
Product	Cortiment (budesonide)
Channel/material	Online rotating banner advertisement in Guidelines in Practice (ref UK-COR-2000004) with click-through prescribing information/references page
Main issue	Strapline “For flaring mild to moderate UC patients” implied broader use than licensed (omitted “where 5-ASA treatment was not sufficient”)
Complaint received	10 September 2020
Case completed	3 March 2021
Applicable Code year	2019
Breach clauses	3.2, 7.2, 9.1
No breach clauses	2
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A UK health professional complained about an online rotating banner advertisement for Cortiment (budesonide) placed in Guidelines in Practice.
Cortiment’s licensed indication: adults for induction of remission in mild to moderate active ulcerative colitis (UC) where 5-ASA treatment was not sufficient.
The banner (five rotating screens) and the linked prescribing information/references page used the strapline: “For flaring mild to moderate UC patients”.
The banner screens did not include the full licensed indication; one screen stated: “Cortiment the only oral budesonide licensed for active mild to moderate UC…”.
Ferring argued that “flare” equated to active/relapse UC and that clinicians would understand budesonide sits after 5-ASA failure in the pathway.
The Panel noted there was no confirmed definition of a UC “flare” and that 5-ASAs (eg mesalazine) are also indicated for mild to moderate acute exacerbations, so “flaring” does not inherently mean 5-ASA insufficient.
Ferring also disclosed that the final colour art-worked version of the references/prescribing information piece had not been formally certified prior to release (the Panel could not rule on this as it was not alleged, but expressed concern).

⚖️

⌄

Breach found for implying Cortiment was suitable for all mild to moderate flaring UC patients, which was broader than the SPC (limited to patients where 5-ASA was not sufficient).
Breach found for misleading presentation of the licensed indication when the strapline was read alongside other claims on the banner.
Breach found for failure to maintain high standards.
No breach of Clause 2 (Panel did not consider the matter brought the industry into disrepute).
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access