AUTH/1860/7/06: Anonymous GP v Profile Pharma (Promixin) – I-neb nebuliser package deal and dose equivalence claims (No breach)

📅 2006 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/1860/7/06
PartiesAnonymous general practitioner v Profile Pharma Ltd
ProductPromixin (colistimethate sodium)
IssueAlleged inducement via I-neb nebuliser provision; alleged unproven/misleading dose equivalence claims
Device/arrangementI-neb nebuliser system operated by a microchip disc supplied in packs of Promixin vials; Panel viewed it as a package deal with Promixin
Clauses considered7.2, 7.3, 15.2 and 18.1
DecisionNo breach of the Code
Complaint received3 July 2006
Case completed8 August 2006
Applicable Code year2006
AppealNo appeal

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

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What happened

  • An anonymous general practitioner complained about the promotion of Promixin (colistimethate sodium) by Profile Pharma Ltd.
  • The complaint focused on provision of an I-neb nebuliser system to cystic fibrosis patients, operated via a microchip disc supplied in boxes of Promixin vials.
  • The complainant queried whether the I-neb arrangement (described as a “free loan”) and the need for a Promixin disc implied an inducement to prescribe, especially given Promixin’s higher price versus other colistimethate sodium products.
  • The complainant alleged representatives claimed that 1 MIU of Promixin via I-neb was as effective as 2 MIU of colistimethate sodium via other nebulisers, and that this could not be proven.
  • Profile stated it did not promote to GPs; explained Promixin could be used with any conventional nebuliser; and that the I-neb could be obtained either via the Promixin package arrangement or purchased separately with appropriate discs.
  • Profile provided data and explanations about nebuliser efficiency (lower residual volume, delivery during inhalation) to support the dose comparison.
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Outcome

  • No breach of the Code was ruled.
  • The Panel found the I-neb was supplied as part of a package deal with Promixin and considered it fair, reasonable and relevant to the medicine.
  • The Panel found no evidence (on the material available) that representatives made misleading claims about dose equivalence/lung dose.
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