In a letter to the editor published in the April 6, 2017 issue of the New England Journal of Medicine, researchers reported on results of a study comparing FDA and EMA review times for new therapeutic agents approved between 2011 and 2015. During this period, the FDA approved 170 new therapeutic agents and the EMA approved 144 with a median total review time of 306 days at the FDA and 383 days at the EMA. The therapeutic areas of the approvals were similar, although more orphan drugs were approved by the FDA than by the EMA.
As stated by the researchers, the FDA faces continual pressure to accelerate the regulatory review and approval of new medicines. The speed of the regulatory review process is directed by the Prescription Drug User Fee Act (PDUFA). With Congress poised to consider the reauthorization of the PDUFA before it expires in October 2017, the speed of the FDA regulatory review process will come under renewed scrutiny.
The study was done by Nicholas Downing at Brigham and Women’s Hospital, Audrey Zhang at New York University School of Medicine and Joseph Ross at Yale School of Medicine. (Source: New England Journal of Medicine, 04 April. 2017)
To read the full text, please visit http://www.nejm.org/doi/full/10.1056/NEJMc1700103