Tillotts detail aid on Octasa vs Asacol dissolution profiles ruled misleading (but no breach of prior undertaking): AUTH/2706/3/14

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Key facts

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Case	AUTH/2706/3/14
Parties	Warner Chilcott/Director v Tillotts
Complaint received	25 March 2014
Case completed	9 June 2014
Applicable Code year	2012
Material	Octasa (mesalazine MR) detail aid, ref UK/OC/0002/0114; page 5 dissolution profile comparison
Products referenced	Octasa 400mg MR; Asacol 400mg MR
Main issue	In vitro dissolution graph and statements implied clinical relevance/equivalence without clinical data
Breach findings	Breach Clause 7.2; No breach Clauses 26 and 2
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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Warner Chilcott UK (marketer of Asacol) complained about a Tillotts Pharma UK detail aid for Octasa (mesalazine MR), ref UK/OC/0002/0114.
The complaint alleged the detail aid breached an undertaking given by Tillotts in an earlier case (AUTH/2610/6/13) concerning misleading use of in vitro dissolution data.
Page 5 of the detail aid presented a graph comparing dissolution profiles of Asacol 400mg MR, Octasa 400mg MR, and reformulated Octasa 400mg MR (triethyl citrate excipient vs dibutyl phthalate).
The page included statements such as: “Octasa 400mg MR with triethyl citrate had a comparable mesalazine release profile to Asacol 400mg MR…”, and “There are no direct clinical comparisons…”
The Panel assessed whether, even if readers understood the data were in vitro, the overall presentation implied clinical relevance without supporting clinical data.

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Breach found: Clause 7.2 (misleading presentation of in vitro dissolution data implying clinical relevance).
No breach found: Clause 26 (undertakings) and consequently no breach of Clause 2.
No appeal.

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