Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.

Less than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations.

In a recent retrospective cohort study published in the BMJ, researchers analyzed new drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April 2020. During the period, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program. In all, 267 new drugs during the study period were rated on level of therapeutic value, as determined by by Canada’s Human Drug Advisory Panel, France’s Ministry of Health, Germany’s Federal Joint Commission, the Italian Medicines Agency and the non-profit organization Prescrire.

Fewer than one-third of the new drugs, 84 approved by FDA and 83 approved by EMA, were considered by at least one of those five independent agencies to provide at least moderate improvement in clinical patient outcomes.

“Most of the increase in the number of new drug approvals over the past decade was driven by drugs rated as having low therapeutic value, which calls into question the common practice of using simple counts of new drug approvals as a measure of innovation,” the authors wrote.