Syner-Med
📋 Case Summary
What happened A freelance medical writer complained about promotional material for Ferinject (ferric carboxymaltose) distributed by Syner-Med (Pharmaceutical Products) Limited at the British Renal Society meeting in Glasgow on 13/14 May 2008. Materials at issue: a 12-page detail aid (“The next generation intravenous iron”, ref F07/01-05-08-039), a two-page brochure (“Anaemia Service… Redesigning Provision”, ref F09/07-05-08-045) and a leavepiece (“The next generation intravenous iron”, ref F08/06-05-08-044). Dosing concern: the detail aid prominently stated “Up to 1000mg… Dose in 15 mins” and “allows for 1000mg to be given in 15 mins”, while the qualifying limit “should not exceed 15mg/kg” appeared separately as a footnote on another page. Comparative claim concern: the materials claimed “Reduces infusion time… 6 hrs to 15 mins” (and the brochure presented “Time to Deliver i.v. Iron Dose” data) referenced to CosmoFer SPC; the complainant argued CosmoFer infusion time in the SPC was 4–6
📌 Clauses Breached
NONE