OBJECTIVES: Since 1992, the Food and Drugs Administration (FDA) accelerated approval pathway has enabled market entry of drugs for serious conditions based on a surrogate endpoint that is likely to predict clinical benefit with confirmatory trials to be completed post-approval. However, five drugs have since been withdrawn or severely restricted following accelerated approval due to lack of efficacy (bevacizumab, [indication: breast cancer; withdrawn 2011; approved 2009], amifostine [indication: renal toxicity; withdrawn: 2006; approved: 1996], gefitinib [withdrawn: 2005; approved: 2003), safety concerns (gemtuzumab, withdrawn 2010; approved 2000), or lack of confirmatory trial data (celecoxib, indication: Familial Adenop Polymatosis [FAP], withdrawn: 2011, approved 1999), leading to criticisms that this pathway allows drugs to enter the market prior to their efficacy and safety being adequately demonstrated. This research aims to evaluate these criticisms by comparing how the drugs were assessed by the European Medicines Agency (EMA). METHODS: EMA and FDA evaluations of these drugs were sourced; the approval decision, date, and rationale were compared, alongside any post-approval restrictions/withdrawals. RESULTS: EMA appraisal information was publically available for bevacizumab, gefitinib, gemtuzumab, and celecoxib. Gemtuzumab (EMA refused, 2008) and gefitinib (EMA submission withdrawn 2005 after failing Phase III trial) were not granted EMA licences in the FDA-approved indications. In contrast, bevacizumab (2007) and celecoxib (2003) were EMA-approved with the same data package used to gain approval by the FDA. In 2011, celecoxib was withdrawn for FAP in both Europe and US due to lack of confirmatory trial data. However, bevacizumab was EMA approved a year earlier than the FDA and has not been withdrawn by the EMA in this indication. CONCLUSIONS: FDA accelerated approval pathway criticism due to post-approval drug withdrawals may be overstated, as the EMA approved two of the five drugs subsequently withdrawn by the FDA, one of which the EMA has not withdrawn.