BMJ study shows pharma companies routinely fail to publicly acknowledge reason for FDA rejection

The British Medical Journal has published a study showing that pharma companies routinely fail to divulge the reasons their drugs are rejected by the US Food and Drug Administration.

It analyzed medicines that were not approved by the FDA between August 2008 and June 2013, and investigators found that the press releases issued by companies only matched the statements with reasons for rejection by the agency 14% of the time. The findings also suggest that companies did not publish press releases for 18% of complete response letters issued by the agency during the study period.

All 61 complete response letters issued by the FDA during the study period were assessed as part of the BMJ’s research. All complete response letters and press releases were divided into discrete statements, and determined the degree to which the complete response letters and their corresponding press releases matched in content. Press release statements matched 16% of statements on efficacy and 15% of statements on safety in the complete response letters. Among the 32 complete response letters that cited a need for new clinical studies for safety or efficacy, corresponding statements were found in only 59% of press releases. Of the seven letters where the FDA identified that mortality rates were higher in treated patients, only one associated press release cited this finding.