Tillotts: “Corporate announcement” in BMJ ruled promotional for Dificlir—missing prescribing info and AE reporting

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3509/5/21
CompanyTillotts Pharma UK Limited
ComplainantAnonymous
MaterialBMJ advertisement (ref EO-00328, April 2021) framed as acquisition/corporate announcement
MedicineDificlir (fidaxomicin)
Indication referencedTreatment of Clostridioides difficile infections (noted as adults and children with body weight ≥12.5 kg)
Main issuePromotional content presented as corporate announcement; missing prescribing information and AE reporting statement
Applicable Code year2019
Breach clauses4.1, 4.9
SanctionsUndertaking received; additional sanctions: Not stated
Complaint received11 May 2021
Case completed14 January 2022
AppealNo appeal

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

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What happened

  • An anonymous complainant challenged a BMJ advertisement (ref EO-00328, April 2021) about Tillotts Pharma UK acquiring Dificlir (fidaxomicin) for Clostridioides difficile infections.
  • The complainant alleged it was promotion disguised as a corporate announcement and that required prescribing information and adverse event (AE) reporting information were missing.
  • Tillotts argued it was a factual, informative ownership-change announcement (not promotion) and therefore did not include prescribing information or an AE reporting statement; it said signatories reviewed it but it was not certified.
  • The Panel considered the content promotional: it named the medicine and indication, described the “significant addition” to the portfolio, and invited readers to contact medical information and visit a website/QR code to “learn more” and see support offered.
  • No prescribing information or AE reporting statement appeared in the advertisement.
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Outcome

  • Breach of Clause 4.1 (prescribing information not provided for promotional material).
  • Breach of Clause 4.9 (no statement on how to report adverse events).
  • No appeal.
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