AUTH/3039/5/18 - Tillotts v Dr Falk

Promotion of Budenofalk

  • Received
    11 May 2018
  • Case number
    AUTH/3039/5/18
  • Applicable Code year
    2016
  • Completed
    13 July 2018
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2018 Review

Case Summary

Tillotts Pharma UK complained about a Budenofalk (budesonide) advertisement used by Dr Falk Pharma UK. Budenofalk was available as 3mg gastroresistant capsules, 9mg gastro-resistant granules and a 2mg/dose foam enema.

Budenofalk capsules was indicated for the induction of remission of mild to moderate active Crohn’s disease in patients with mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon, the induction of remission of active collagenous colitis and for the treatment of autoimmune hepatitis whilst Budenofalk granules was indicated for the induction of remission of mild to moderate active Crohn’s disease in patients with mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon and the induction of remission of active collagenous colitis. Budenofalk foam was only indicated for the treatment of active ulcerative colitis that was limited to the rectum and the sigmoid colon.

Tillotts was concerned that the pharmaceutical form was not clearly stated on the advertisement given that Budenofalk was the root name for three separate products. The advertisement was headed by three indications: autoimmune hepatitis, Crohn’s disease and collagenous colitis however only Budenofalk 3mg capsules was licensed for all three indications. Tillotts alleged that the advertisement was thus misleading. The ambiguity surrounding which product was being advertised might also represent a further breach, as the specifc marketing authorisation being advertised was not clear. The advertisement implied that all forms of Budenofalk were indicated for all three conditions.

Tillotts further noted the ambiguity in the first of three bullet points which stated ‘The only budesonide with three indications’. Given that the specific preparation was not clearly identified, the claim was inaccurate as neither the granule nor the foam formulation had three indications (they had two and one indication, respectively). In addition, the claim should specify that it referred to an orally administered budesonide, as certain inhaled budesonides offer three indications, such as Rhinocort Aqua nasal spray.

Tillotts noted that the prescribing information referred to Budenofalk granules and capsules and stated in the indication section that autoimmune hepatitis related to the capsules only. The prescribing information was the only place on the page where the product names were mentioned and Tillotts alleged that this needed to be stated more prominently in the body of the advertisement. The reader should not be relied upon to read the prescribing information to understand the subject of the advertisement.

The detailed response from Dr Falk appears below.

The Panel noted that the top half of the advertisement bore photographs of 3 separate woman and the claim ‘Getting on with their lives By getting on with their steroid’. Above each woman was a description of her condition: autoimmune hepatitis, Crohn’s disease and collagenous colitis respectively. A bold red strip beneath the photographs read, on the right, ‘Budenofalk’ above in smaller font ‘Budesonide, the Dr Falk way’. To the left appeared three bullet point claims, the first of which read ‘The only budesonide with three indications’. The prescribing information appeared beneath.

The Panel noted the prominent reference to ‘Budenofalk’ and that there were three relevant products which had Budenofalk as the root name. Only one product, Budenofalk 3mg capsules was indicated for all three conditions. In the Panel’s view the failure to clearly identify the product in the body of the advertisement either implied that all three Budenofalk products were each licensed for all three conditions and that was not so, or was otherwise unclear which Budenofalk product was so licensed. The advertisement was misleading in this regard. The Panel also considered that Dr Falk had failed to maintain high standards. Breaches of the Code were ruled.

In the Panel’s view the claim ‘the only budesonide with three indications’ in isolation was inaccurate, however, the context in which it appeared was relevant. The Panel noted that the claim in question appeared in relatively small font on the left-hand side of a red box, to the right of which appeared the prominent brand name Budenofalk followed by Budesonide, the Dr Falk way beneath. In the Panel’s view, the relevant qualification, namely that the budesonide product in question was a Budenofalk product, appeared prominently and within the immediate visual field of the claim in question. In addition, it was clear that the three indications referred to were autoimmune hepatitis, Crohn’s disease and collagenous colitis as stated at the top of the advertisement. On balance, the Panel considered that the claim in question ‘The only budesonide with three indications’ was sufficiently qualified such that, within the context of the advertisement, it was not misleading as alleged and thus ruled no breaches of the Code.