Endo Ventures breached ABPI Code over fluoxetine ad claim “for treatment of depressive illness” (AUTH/3149/1/19)

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Key facts

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Case number	AUTH/3149/1/19
Company	Endo Ventures Ltd
Complainant	Anonymous (concerned UK health professional)
Product	Fluoxetine
Material	Advertisement in Pulse (ref FLUO 0010/2018)
Main issue	Headline claim “for treatment of depressive illness” considered broader than licensed indications / inconsistent with SPC
Applicable Code	2016
Breach clauses	Clause 3.2; Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	09 January 2019
Case completed	30 April 2019
Appeal	No appeal
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth3149119-anonymous-complainant-v-endo-ventures

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

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An anonymous complainant (a concerned UK health professional) challenged a fluoxetine advertisement (ref FLUO 0010/2018) placed in Pulse by Endo Ventures Ltd.
The ad included the claim “for treatment of depressive illness” beneath the product name.
The complainant alleged the phrase “depressive illness” was broader than the licensed indications and appeared to promote off-licence (including by age and severity).
Endo Ventures said it used a third-party consultancy for medical approval and provided an approval certificate.
After the complaint, the third-party signatory accepted the claim could be too broad “in isolation”; Endo Ventures withdrew future ads using the claim and said it would use a more specific statement (eg “for the treatment of major depressive episodes in adults”).
The Panel noted the ad’s prescribing information included the licensed indications and age range, but the first indication statement in the ad was the broad “depressive illness” claim.

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Breach of Clause 3.2 (claim not an accurate reflection of the licensed indications / inconsistent with the SPC).
Breach of Clause 9.1 (high standards not maintained).
No appeal.
Undertaking received.

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