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PMCPA Case

Norgine Movicol mailing: misleading implication of NICE first-line recommendation for 12+ patients (AUTH/2348/8/10)

📅 2010 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2348/8/10
ComplainantGeneral Practitioner
CompanyNorgine Pharmaceuticals Limited
Product/materialMovicol / Movicol Paediatric Plain mailing (ref MO/10/1995)
Main issueMailing implied NICE specifically recommended Movicol Paediatric Plain/Movicol as first-line for “children and young people”, which was misleading for ages 12+.
Applicable Code year2008
Breach clausesClause 7.2
Complaint received16 August 2010
Case completed23 September 2010
AppealNo appeal
SanctionUndertaking received

Download the full case report (PDF)

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

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What happened

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  • A general practitioner complained about a gate-folded promotional mailing for Movicol / Movicol Paediatric Plain (ref MO/10/1995) sent by Norgine.
  • The mailing used prominent headlines such as “Breaking news from NICE” and claimed: “Movicol Paediatric Plain/Movicol is now recommended as first-line treatment of faecal impaction and chronic constipation in children and young people”.
  • The complainant alleged the mailing seriously misrepresented NICE guidance, which referred to the generic class “polyethylene glycol 3350 plus electrolytes”, not specific brands.
  • Norgine argued the item accurately reflected NICE’s endorsement of polyethylene glycol 3350 plus electrolytes as first-line treatment and included the NICE footnote about Movicol Paediatric Plain being the only licensed macrogol with electrolytes for under-12s at the time.
  • The Panel considered the audience would take the mailing to mean NICE had specifically recommended Movicol Paediatric Plain and Movicol as first-line for both under-12s and 12+ (“young people”).
  • The Panel found NICE effectively specifically referenced Movicol Paediatric Plain for under-12s (via the footnote), but did not specifically recommend any brand for ages 12+; the mailing therefore misled regarding NICE guidance for 12+.
  • The Panel also noted (as concerns, not ruled breaches) potential issues around: (a) NICE recommending use in age groups outside the product licence (with a footnote about lack of UK marketing authorisation and informed consent), and (b) differences between NICE dosing escalation for 12–18 disimpaction and the Movicol SPC dose statement.
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Outcome

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  • Breach found: the mailing was misleading as to NICE guidance for children aged 12 years and over.
  • No appeal.
  • The Panel requested that Norgine be advised of its additional concerns regarding potential promotion beyond the marketing authorisation and dosing differences.
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