Glenmark and iQ Pharma: Renocontin cost table and bioequivalence claim implied an unavailable 80mg tablet; prescribing information out of date

📊

Key facts

⌄

Case numbers	AUTH/3359/6/20 and AUTH/3360/6/20
Complainant	Anonymous, non-contactable NHS employee
Companies	Glenmark Pharmaceuticals Limited (MAH) and iQ Pharma Limited (distributed under licence; CactusRx trading style)
Product	Renocontin (prolonged release oxycodone hydrochloride)
Material	Promotional material ref PP-UK-REN-0002
Main issues	Misleading implication of an available 80mg tablet via cost table and bioequivalence claim; prescribing information not updated after SPC change
Panel findings	Breach of Clause 7.2 (two breaches), Clause 4.1, Clause 9.1
Sanctions	Undertaking received; additional sanctions: Not stated
Complaint received	3 June 2020
Case completed	30 November 2020
Appeal	No appeal
Notable detail	23 copies used/emailed in early July 2019 after SPC update without updating prescribing information

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

An anonymous, non-contactable NHS employee complained about promotional material for Renocontin (prolonged release oxycodone hydrochloride) (ref PP-UK-REN-0002).
The material was issued by CactusRx (a trading style of iQ Pharma Limited). iQ Pharma distributed Renocontin under licence from Glenmark Pharmaceuticals Limited (the marketing authorisation holder).
The material stated that prescribing Renocontin by brand could halve prescribing costs for prolonged release oxycodone hydrochloride tablets.
A cost comparison table listed “presentations” including 80mg* with a footnote “as 2 x 40mg”, alongside competitor brands that did have an 80mg tablet.
Renocontin tablets were commercially available in strengths 5mg to 60mg; an 80mg marketing authorisation existed but the 80mg tablet was not commercially available.
The material also claimed: “Bioequivalence to OxyContin tablets in strengths 5mg, 20mg, 40mg and 80mg in steady state has been proven”.
The complainant also raised that the SPC had been updated (variation approved 5 June 2019) but the prescribing information in the piece was dated January 2019.
23 copies of the material were used/emailed in early July 2019 after the SPC update, without updating the prescribing information.

⚖️

⌄

The Panel ruled the cost comparison table was misleading because it implied an 80mg Renocontin tablet was available; the footnote was not sufficient to negate the misleading impression (breach of Clause 7.2).
The Panel ruled the bioequivalence claim was misleading because it implied an 80mg Renocontin tablet was available (second breach of Clause 7.2).
The Panel ruled the prescribing information was not up to date following the June 2019 SPC update (breach of Clause 4.1).
The Panel was extremely concerned that patient compliance and patient safety might have been compromised (breach of Clause 9.1).
Case AUTH/3360/6/20 had the same rulings as AUTH/3359/6/20.
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access