EMA’s Frias Defends EU Centralized Switch Procedure Despite Only Delivering Four Reclassifications In 10 Years

摘要

Delivering only four prescription- to-OTC re-classifcations in the last decade, the European Union’s (EU’s) centralized switch procedure is viewed by some as a failure. Having only approved only four switches – GlaxoSmithKline PLC’s Alli (orlistat) weight-loss drug in 2008, No- vartis AG’s Pantoloc Control (pantopra- zole) and Pfizer Inc.’s Nexium Control (esomeprazole) proton-pump inhibi- tors in 2009 and 2013 respectively, and HRA Pharma SA’s EllaOne (ulipristal acetate) emergency contraceptive in 2015 – out of seven applications in to- tal, many in Europe’s consumer health- care industry feel frustrated at the lack of progress made since the centralized switch procedure’s introduction just over a decade ago.