The FDA reports were more difficult to use than the EMA reports?

By William Chin, PhD, Project Manager, EUCRAF

A recent research paper entitiled "The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports" was published in the January 2015 issue of Journal of Clinical Epidemiology.

Schroll JB et al. looked into 27 approval reports of new molecular drugs published between January 1, 2011 and December 31, 2012 from the FDA and EMA websites. The aim was to compare the accessibility, comprehensiveness and usefulness of data published in these reports by both agencies. 

The authors reported the FDA documents were more difficult to navigate compared to EMA documents. Examples cited were that several FDA documents must be searched compared with a single EMA document. On the other hand, the FDA reports contain detailed information on harms (25 of 27 reports) compared to the EMA reports (7 of 27 reports). 

Source

1. J Clin Epidemiol. 2015 Jan;68(1):102-7. The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports. Schroll JB, Abdel-Sattar M, Bero L.