AUTH/2953/4/17: Dr Falk journal ad for Salofalk Granules – “step change” headline ruled misleading | PMCPA Case

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Key facts

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Case number	AUTH/2953/4/17
Parties	Tillotts v Dr Falk
Product	Salofalk (mesalazine, prolonged release) Granules
Material	Journal advertisement (ref DrF 17/041) in Frontline Gastroenterology
Main issue	Headline “step change… Now that’s progress” implied significant/progressive change vs other mesalazines and was misleading/exaggerated/unsubstantiated
Complaint received	18 April 2017
Case completed	17 August 2017
Applicable Code year	2016
Outcome	Breach of Clauses 7.2, 7.3, 7.4, 7.10; other allegations not upheld
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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Tillotts Pharma UK Limited complained about a journal advertisement (ref DrF 17/041) for Salofalk (mesalazine, prolonged release) Granules placed by Dr Falk Pharma UK Ltd and published in Frontline Gastroenterology.
The headline claim was: “An oral ulcerative colitis treatment that’s a step change, not a step up. Now that’s progress”.
Tillotts alleged the “step change” headline implied new features and superiority over other mesalazine products/UC treatments and was unsupported (no reference cited for the headline).
Tillotts also challenged supporting copy about once-daily dosing/sachet/“tasty vanilla flavour”, a distal colon statement (“pretty good at getting there”), and an “Optimisation…” outcomes claim (days off work, hospital/GP visits, steroid courses) referenced to Aldulaimi et al.
Dr Falk argued the ad did not claim superiority in efficacy/safety; it was appropriate to inform HCPs about switching mesalazine rather than escalating therapy; and references supported the distal colon and “optimisation” statements (noting the correct reference was Aldulaimi et al (2016b)).

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Breach found for the headline “step change… Now that’s progress” claim: misleading, exaggerated and not substantiated.
No breach found for the once-daily/sachet/vanilla flavour copy, the distal colon statement, the “optimisation” outcomes claim (on the narrow grounds alleged), disparagement, and high standards allegations.
No appeal.

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