Original Article
The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports

https://doi.org/10.1016/j.jclinepi.2014.06.019Get rights and content
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Abstract

Objectives

To compare the accessibility, comprehensiveness, and usefulness of data available from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) drug reports.

Study Design and Setting

This is a cross-sectional study. All new molecular drugs approved between January 1, 2011 and December 31, 2012 from the FDA and EMA Web sites were eligible.

Results

We included 27 drug reports. Most were searchable, but the FDA table of contents did not match the file's page numbers. Several FDA documents must be searched compared with a single EMA document, but the FDA reports contain more summary data on harms. Detailed information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All reports but one contained sufficient information to be used in a meta-analysis.

Conclusion

Detailed data on efficacy and harms are available at the two agencies. The FDA has more summary data on harms, but the documents are harder to navigate.

Keywords

Unpublished data
Systematic reviews
Drug regulation
Harms
FDA
EMA

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Conflict of interest: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author). J.B.S. and L.B. declare that they have no conflicts of interest. M.A.S. worked as a paid intern at Genentech (June 2011 to August 2011) and served as a paid liaison for Genentech at University of California, San Francisco (November 2011 to July 2013).

Funding: No specific funding for this project.