Tillotts v Ferring: Cortiment leavepiece not withdrawn and misleading “generic budesonides” claim (AUTH/3143/1/19)

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3143/1/19
PartiesTillotts Pharma UK v Ferring Pharmaceuticals Ltd
IssueFailure to withdraw material; misleading use of the term “generic” in a Cortiment leavepiece
ProductCortiment (budesonide prolonged release tablets)
MaterialLeavepiece: “Guidance on Prescribing Cortiment by brand” (ref COR/2078/2017/UK)
Problematic claim“Generic budesonides lack this unique [multimatrix] MMX structure”
Key eventLeavepiece distributed at Scottish Society of Gastroenterology meeting (14–16 November 2018)
Complaint received07 January 2019
Case completed19 March 2019
Applicable Code2019 (Panel referenced the 2016 Code in its reasoning)
Breach clausesClause 9.1
SanctionsUndertaking received; Additional sanctions: Not stated
AppealNo appeal

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

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What happened

  • Tillotts complained that Ferring failed to honour an inter-company agreement to withdraw a Cortiment (budesonide prolonged release tablets) leavepiece titled “Guidance on Prescribing Cortiment by brand” (ref COR/2078/2017/UK).
  • The leavepiece included the claim: “Generic budesonides lack this unique [multimatrix] MMX structure”.
  • Tillotts objected during inter-company dialogue (16 October 2018), stating there were no generic oral budesonides available in the UK, so the term “generic budesonides” was inaccurate and misleading, and asked for withdrawal.
  • Ferring’s response (25 October 2018) said it would revise use of the term “generic” in future promotional activity and stated it would withdraw the leavepiece and replace the term.
  • Despite this, the same leavepiece was distributed from the Ferring stand at the Scottish Society of Gastroenterology (SSG) meeting (14–16 November 2018).
  • After Tillotts queried this (17 December), Ferring confirmed the leavepiece was withdrawn as of 18 December 2018 and replaced with a new piece.
  • Ferring argued its 25 October letter contained a grammatical error and should have said it was “willingness to withdraw” rather than confirming it had been withdrawn; it also said it waited for further response from Tillotts before changing the material.
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Outcome

  • The Panel ruled that high standards had not been maintained.
  • The Panel found the claim about “generic budesonides” was misleading because oral budesonide was not available as a generic in the UK and “generic” has a particular meaning for medicines.
  • Breach of Clause 9.1 was ruled; the Panel stated this covered both the failure to withdraw the leavepiece and its continued use.
  • No appeal.
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