title: Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.
abstract: OBJECTIVE
  The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both implemented procedures in order to shorten review time for marketing authorizations with potential therapeutic added value, called priority review and accelerated assessment procedure, respectively. The aim of this study is to compare the new molecular entities (NME) assessed in shorter review time by both agencies and to investigate whether granting a shorter review time status subsequently predicts its therapeutic value attributed by a health technology assessment agency, the French Haute Autorité de Santé (HAS).
  
  
  METHODS
  All NME approved by the EMA and the FDA with a therapeutic added value between 2007 and June 30, 2015 were extracted. We assessed the sensibility, the positive predictive value, and the EMA review time.
  
  
  RESULTS
  One hundred seventy-eight NME were approved by the FDA and the EMA and a therapeutic value was available for 160 NME. Eighty-eight (55.0 %) NME were on FDA priority review, 24 (15.0 %) on EMA accelerated procedure and 43 (26.9 %) were considered of high clinical added value. The sensibility was 86.0 % for the FDA and 30.2 % for the EMA. The positive predictive value was, respectively, 42.0 and 54.2 %. Twenty-five NME on FDA priority review and of high therapeutic added value were not on EMA accelerated assessment procedure, leading to a supplementary mean EMA review time of 146 days.
  
  
  CONCLUSIONS
  The EMA was restrictive to grant a shorten review time status for products with therapeutic interest during the study period.
authors.affiliation: French West Indies Toxicovigilance Coordination, Basse-Terre Hospital, Basse-Terre, France. denis.boucaud@gmail.com.
authors.forename: Denis
authors.initials: D
authors.lastname: Boucaud-Maitre
authors.affiliation: Department of Diabetology, Endocrinology-Nutrition, Georges Pompidou European Hospital, Paris, France.
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Altman
mesh_terms: D015331:Cohort Studies; D017277:Drug Approval; D005060:Europe; D006801:Humans; D007390:International Agencies; D004364:Pharmaceutical Preparations; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations
keywords: Accelerated assessment procedure; European medicine agency; Food and Drug Administration; Priority review