Merck Withdraws Fosamax UK Ad Claiming Superiority To Generic
This article was originally published in The Pink Sheet Daily
Executive Summary
UK Merck subsidiary issues corrective statement acknowledging no superiority over Teva’s generic alendronic acid, as required by the British Medicines & Healthcare products Regulatory Agency.
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Merck Sharp & Dohme has been ordered to withdraw promotional material suggesting that Teva UK Limited's generic alendronic acid is inferior to Merck's osteoporosis therapy Fosamax Once Weekly ,the UK's Medicines & Healthcare products Regulatory Agency announced July 28. According to a corrective statement issued by the Merck UK subsidiary, Teva's generic of Fosamax 70 mg tablets does not differ in bioavailability, and therefore does not offer additional risk of esophageal injury. The ad contained a superiority claim regarding Fosamax' bioavailability compared with Teva's generic, which was launched in March. Fosamax Once Weekly has been available in the UK since 2000. Fosamax costs £22.80 ($40.05), compared with £15.00 ($26.35) for Teva's generic. "MHRA have drawn to our attention their view that the overall impression given by the relevant promotion is that the bioavailability of Fosamax Once Weekly is an important factor in the incidence of esophageal injury and that, accordingly, this issue will also affect a generic medicinal product," the corrective statement says. "In fact, bioavailability and esophageal injury are not linked in any way." The offending promotion was used from March 21 to June 10, MSD said. Teva lodged a complaint against Merck in April. "The complainant was concerned that MSD representatives were suggesting that the generic brand is not bioequivalent, or the data on dissolution for the generic is poor," MHRA said. A subsequent MHRA investigation into the claims "found them to be incorrect, and therefore upheld the complaint." In June, MHRA cited Pfizer for omitting warnings about contraindications from a professional advertisement for its COX-2 inhibitor Dynastat (parecoxib) (1 (Also see "Pfizer's Parecoxib Ad Cited By U.K. For Using Out-Of-Date Labeling" - Pink Sheet, 13 Jun, 2005.)). - Kathleen Michael |