AUTH/3378/9/20 - Complainant v Ferring

Alleged off-licence promotion of Cortiment

  • Received
    10 September 2020
  • Case number
    AUTH/3378/9/20
  • Applicable Code year
    2019
  • Completed
    03 March 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant alleged that an advertisement for Cortiment (budesonide) placed by Ferring Pharmaceuticals Ltd in Guidelines in Practice, promoted the medicine beyond the terms of its licence.

Cortiment was indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment was not sufficient. The product logo included the strapline ‘For flaring mild to moderate UC patients’.

The complainant provided an image of the advertisement and links to the Guidelines in Practice website and the Cortiment prescribing information and noted that in both it was stated that the medicine was indicated ‘For flaring mild to moderate UC patients’. The licenced indication of Cortiment was for use in adults for ‘induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment was not sufficient’ (emphasis added). The complainant alleged that the licenced patient group was smaller than that which was stated on the advertisement, therefore Ferring had promoted off-licence.

The detailed response from Ferring is given below.

The Panel noted that the claim in question ‘For flaring mild to moderate UC patients’ appeared as a strapline in the bottom right-hand corner beneath the brand and non-proprietary name on all five screens of the rotating banner advertisement. The Panel noted that, similarly, it appeared on the prescribing information and references page which was available via a click through from each of the five screens. The Panel noted that whilst Cortiment’s full indication was included in the linked prescribing information, it was not included on any of the screens of the rotating banner advertisement including the second screen of the banner advertisement which read ‘Cortiment The only oral budesonide licensed for active mild to moderate UC…’.

The Panel noted Ferring’s submission that in a diagnosed patient, relapse was called active ulcerative colitis or alternatively a flare. The Panel noted that there did not appear to be a confirmed definition of an ulcerative colitis flare and in this regard it noted that the NICE UC Guidance referred to acute exacerbations of severely active UC and inflammatory exacerbations of extensive UC.

The Panel noted Ferring’s submission that in the context of an established molecule, for an established and well documented medical condition, promoting a product ‘for flaring mild to moderate UC patients’ was completely consistent with a patient group for whom 5-ASAs were insufficient. The Panel noted, however, that according to the Asacol (mesalazine) 400mg MR SPC (accessed via the eMC on 9 February 2021), which was an ASA, Asacol was indicated for the treatment of mild to moderate acute exacerbations. For the maintenance of remission. It therefore appeared that it was similarly indicated for treating relapse/active ulcerative colitis or ‘flares’. The Panel further noted Ferring’s submission that the BSG recommended that ulcerative colitis patients flaring on 5-ASA therapy should receive dose escalation to 4–4.8 g/day orally alongside 5-ASA enemas.

The Panel noted Cortiment’s indication and considered that the strapline implied that Cortiment was suitable for treating all patients with mild to moderate flaring ulcerative colitis which was not consistent with the particulars listed in its SPC; it was only indicated in certain patients for whom 5-ASA treatment was not sufficient. The Panel therefore ruled a breach of the Code.

Whilst the Panel noted Ferring’s submission that diagnosis of ulcerative colitis and initiation of treatment took place in specialist care, and as such, it would only be in rare circumstances such as where 5-ASAs were not tolerated or contraindicated that a specialist would prescribe anything else first line for mild to moderate ulcerative colitis. The Panel noted that the first screen of the advertisement stated ‘Cortiment – Now supported by real-word evidence’ and the second screen stated ‘Cortiment the only oral budesonide licensed for active mild to moderate UC…’. In the Panel’s view, the claims on the first and second screens in conjunction with its ruling above, meant that the strapline was misleading with regard to the licensed indication of Cortiment. A breach of the Code was ruled.

The Panel ruled a breach as high standards had not been maintained. No breach of Clause 2 was ruled.