AUTH/3039/5/18: Tillotts v Dr Falk — Budenofalk ad misleading due to unclear formulation (Clauses 7.2, 9.1) | PMCPA Case

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Key facts

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Case number	AUTH/3039/5/18
Parties	Tillotts Pharma UK Limited v Dr Falk Pharma UK Ltd
Medicine / subject	Budenofalk (budesonide) advertisement
Core issue	Ad did not clearly identify which Budenofalk formulation was promoted, implying all Budenofalk products had three indications
Complaint received	11 May 2018
Case completed	13 July 2018
Applicable Code year	2016
Appeal	No appeal
Breach clauses	Clause 7.2; Clause 9.1
No breach points	Claim “The only budesonide with three indications” (in context) not misleading as alleged
Sanctions	Undertaking received; additional sanctions not stated

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

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Tillotts complained about a Dr Falk Pharma UK Ltd advertisement for Budenofalk (budesonide) (ref DrF17/159).
Budenofalk existed as multiple products sharing the root name: 3mg gastro-resistant capsules, 9mg gastro-resistant granules, and a 2mg/dose rectal foam enema.
The ad prominently used the brand name “Budenofalk” and presented three conditions/indications at the top: autoimmune hepatitis, Crohn’s disease and collagenous colitis.
Only Budenofalk 3mg capsules were licensed for all three of those indications; other Budenofalk presentations had fewer/different indications.
Tillotts alleged the ad was misleading because it did not clearly state the pharmaceutical form in the main body and could imply all Budenofalk forms had all three indications; it also argued the reader should not have to rely on prescribing information to understand which product was being promoted.
Tillotts also challenged the bullet claim “The only budesonide with three indications”, arguing it was ambiguous/inaccurate without specifying the preparation (and noting other budesonide products in other therapy areas could have three indications).

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Breach of Clause 7.2: the ad failed to clearly identify which Budenofalk product was being advertised, implying (or leaving unclear) that all Budenofalk products were licensed for the three conditions.
Breach of Clause 9.1: failure to maintain high standards.
No breach for the specific claim “The only budesonide with three indications” (the Panel considered it sufficiently qualified in context by the prominent Budenofalk branding and the three indications shown).
The Panel also raised a concern (not ruled as a breach in this case) that listing “Crohn’s disease” broadly could imply indication for all presentations of Crohn’s disease, and queried alignment with Clause 3.2.
The Panel advised it would be advisable for Dr Falk to review its prescribing information to ensure accuracy and Code compliance.

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