Ever Pharma found in breach over Dacepton stability and cost-saving claims (AUTH/3275/10/19)

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Key facts

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Case number	AUTH/3275/10/19
Complainant	Britannia Pharmaceuticals Limited
Respondent	Ever Pharma
Medicine	Dacepton (apomorphine for injection)
Indication (as stated)	Treatment of motor fluctuations (‘on-off’ phenomena) in patients with Parkinson’s disease not sufficiently controlled by oral anti-Parkinson medication
Materials at issue	Email from nurse advisor; Pump leavepiece (ref EVP-091, Sept 2019); Cartridge/Pen leavepiece (ref EVP-090)
Main breach theme	Misleading stability and cost-saving claims due to omission of microbiological contamination caveats from SPC; incomplete information leading to misleading impressions and lack of substantiation
Complaint received	24 October 2019
Case completed	31 August 2021
Applicable Code year	2019
Appeal	Appeal hearing: No appeal (an appeal from Ever was subsequently withdrawn)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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What happened

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Britannia Pharmaceuticals complained about Ever Pharma’s promotion of Dacepton (apomorphine for injection) in two presentations: 10mg/ml cartridge (pen) and 5mg/ml solution for infusion (pump).
The complaint covered: (A) an email from an Ever Pharma nurse advisor to a health professional; (B) a leavepiece for the Dacepton pump (ref EVP-091, Sept 2019); and (C) a leavepiece for the Dacepton cartridge/pen (ref EVP-090).
Email allegations included that it was unsolicited/disguised promotion, offered an improper benefit via nurse support linked to arranging a sales call about cost, lacked prescribing information, lacked non-proprietary name/active ingredient list, was not certified, was sent without consent, and was sent by someone acting as a representative without the required exam.
Pump leavepiece allegations included: a potentially misleading image of pump size; a stability claim (“7 days in-use stability data supports entire content use”) said to cherry-pick the SPC and omit microbiological contamination risk; a comparator heading (“20ml Syringe Driver used with APO-go”) alleged to mislead/disparage; and cost-saving claims alleged to be unclear, misleading and based on incomplete SPC wording.
Pen leavepiece allegations included: comparative table statements about “safety stop” and dose correction alleged to be unfair/misleading; an “In-use stability: 15 days” claim alleged to omit microbiological contamination caveat; and a cost comparison model alleged to be misleading (including because apomorphine injections are used “as needed” rather than a fixed daily dose).
Britannia attempted to withdraw the complaint later, but it could not be withdrawn at that stage under the Constitution and Procedure.

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Outcome

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No breach was ruled for the nurse email allegations because the complainant did not establish, on the balance of probabilities, that the email was unsolicited and therefore promotional; related allegations (including exam requirement) were not made out on the evidence available.
No breach was ruled for the pump imagery allegation (pump size depiction) and for the “20ml Syringe Driver used with APO-go” heading/disparagement allegations.
Breaches were ruled for multiple claims in the pump and pen leavepieces where stability and cost-saving messages omitted the SPC’s microbiological contamination caveat, making the presentations misleading and/or not sufficiently complete, and in some instances incapable of substantiation.

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Clauses

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Breach Clause(s): 3.2
Breach Clause(s): 7.2
Breach Clause(s): 7.3
Breach Clause(s): 7.4
Breach Clause(s): 7.10
No breach Clause(s): 2
No breach Clause(s): 4.3
No breach Clause(s): 7.2 (in relation to certain allegations)
No breach Clause(s): 7.4 (in relation to certain allegations)
No breach Clause(s): 7.8
No breach Clause(s): 8.1
No breach Clause(s): 9.1
No breach Clause(s): 9.9
No breach Clause(s): 12.1
No breach Clause(s): 14.1
No breach Clause(s): 16.3
No breach Clause(s): 18.1

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Key facts

What happened

Outcome

Clauses

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