AUTH/2819/2/16: General Practitioner v Otsuka — Jinarc patient materials (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2819/2/16
Complainant	General practitioner
Company	Otsuka Pharmaceuticals (UK) Ltd
Product	Jinarc (tolvaptan)
Issue	Alleged advertising of a POM to the public via patient materials and raising patients’ hopes/expectations (including implied cure)
Materials reviewed	Patient alert card (OPUK/0315/JIN/1091d); patient brochure (OPUK/0315/JIN/1091c); patient support line user guide (OPUK/0116/JIN/1032); disease awareness website (OPUK/0115/GEN/1010)
Applicable Code	2016
Clauses considered	2, 9.1, 26.1, 26.2
Panel decision	No breach of the Code
Complaint received	3 February 2016
Case completed	23 March 2016
Appeal	No appeal

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

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A general practitioner complained that Jinarc (tolvaptan) patient support materials portrayed the medicine as a treatment for ADPKD, amounting to advertising to the public and risking raised patient hopes/expectations.
The complainant did not provide the materials complained about and did not respond to a request for more information.
Otsuka provided the materials it believed relevant: a patient alert card and patient/carer brochure (risk management plan materials), a user guide for a patient support line, and a disease awareness website (with separate HCP and patient sections).
The Panel reviewed whether the materials promoted a prescription-only medicine to the public and/or raised unfounded hopes (including any implication of a cure).

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No breach of Clause 26.1 (advertising prescription only medicines to the public) was ruled.
No breach of Clause 26.2 (public information must be factual/balanced and not raise unfounded hopes, etc) was ruled.
No breach of Clause 9.1 (high standards) was ruled.
Consequently, no breach of Clause 2 was ruled.
No appeal.

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