Takeda breached ABPI Code over unclear differentiation between Prostap SR DCS and Prostap 3 DCS indications (AUTH/3320/3/20)

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Key facts

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Case	AUTH/3320/3/20
Company	Takeda UK Limited
Product	Prostap (leuprorelin acetate) – Prostap SR DCS and Prostap 3 DCS
Channel	Online promotion hosted on the Guidelines in Practice website
Materials referenced	UK/PRS/1905/0010b (website landing page); UK/PRS/1905/0010 (Formulary Decision Guide)
Main issue	Insufficiently clear differentiation between formulations for ovarian function preservation; omission of MHRA-required “should not be used” precaution for Prostap 3 DCS in context
Applicable Code year	2019
Complaint received	10 March 2020 (HTML) / 11 March 2020 (PDF)
Case completed	30 July 2020
Appeal	Appeal by respondent (Takeda)
Breach clauses	Clause 4.1; Clause 9.1
No breach clauses	Clause 2; Clause 3.2; Clause 9.1 (in relation to prescribing information, on appeal)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A UK health professional complained about Takeda promotional material for Prostap (leuprorelin acetate) hosted on the Guidelines in Practice website.
The materials included a “Formulary Decision Guide” and a landing page, plus a link to combined prescribing information for Prostap SR DCS and Prostap 3 DCS.
Both formulations were indicated for certain breast cancer patients; only Prostap SR DCS was indicated for preservation of ovarian function.
The complainant alleged the materials did not include MHRA-required wording (added Aug 2019 to the Prostap 3 DCS SPC) that “Prostap 3 should not be used for preservation of ovarian function”, and therefore promoted an off-licence indication and raised patient safety concerns.
The Panel and Appeal Board focused on the risk of confusion created by the way the “Preservation of ovarian function” bullet was presented when two formulations had different indications.
Takeda appealed aspects of the Panel’s decision; the Appeal Board upheld breaches of Clauses 4.1 and 9.1, but overturned one Panel finding of Clause 9.1 (high standards) relating to the prescribing information.

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Breach of Clause 9.1 (high standards) in relation to the Formulary Decision Guide being unclear about Prostap 3 DCS not being indicated for ovarian function preservation (upheld on appeal).
Breach of Clause 4.1 (prescribing information) because the combined prescribing information did not include important precautionary information relevant to the indications quoted (upheld on appeal).
No breach of Clause 3.2 (the Panel did not consider the product had been promoted for ovarian function preservation on the evidence before it).
No breach of Clause 2 (the Panel did not consider the circumstances warranted the particular censure of Clause 2).
No breach of Clause 9.1 in relation to the prescribing information (Appeal Board considered concerns were adequately covered by the Clause 4.1 breach).

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