Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006–2015: a cohort study

Abstract

Purpose

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.

Conclusion

The EMA was restrictive to grant a shorten review time status for products with therapeutic interest during the study period.

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Correspondence to Denis Boucaud-Maitre.

Ethics declarations

Declaration of competing interests

DBM was a member of the French Drugs Agency from 2007 to 2014 and was involved in drug assessment for the European Medicine Agency during the same period (European expert). JJA was an external expert at the French Drugs Agency from 1980 to 2013. He was an external member of the Scientific Advice Group Endocrinology of the European Medicine Agency, from 2006 to 2014. JJA reports personal fees from Bayer, personal fees from Lilly, personal fees from Abbott, outside the submitted work.

Details of contributors

  • DBM researched data, analyzed data and wrote the manuscript. JJA contributed to the discussion and reviewed the manuscript.

  • All authors had full access to all the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

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No ethical approval was necessary as all the data are public.

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Boucaud-Maitre, D., Altman, JJ. Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006–2015: a cohort study. Eur J Clin Pharmacol 72, 1275–1281 (2016). https://doi.org/10.1007/s00228-016-2104-3

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Keywords

  • European medicine agency
  • Food and Drug Administration
  • Accelerated assessment procedure
  • Priority review