Analysis of Discrepancies in Drug Indications Approved by the US FDA, Health Canada and the European Medicines Agency

Background

Each drug regulatory agency performs its own risk-benefit assessment, resulting in potentially different approved drug indications and regulatory actions. This study assessed differences in drug indications approved by the US Food and Drug Administration (FDA), Health Canada (HC) and the European Medicine Association (EMA).

Methods

Regulatory information on drug approvals and indications were derived from the FDA, the EMA and HC for the period 1999-2011. Drug indications were analyzed to evaluate similarities and differences and the total number of indications approved for each drug.

Results

The FDA approved 152 new priority review drugs in the period 1999-2011, including 30 new therapeutic biologics applications (BLAs) and 122 new molecular entities (NME). A total of 93 new drugs (61.2%) were approved by the three regulatory agencies (63.3% of BLA and 60.7% of NMEs). 

Similar indications were found in 68.4% of the BLAs and 73.0% of the NMEs approved by the three agencies. In addition, the indications were similar in FDA and EMA and different in HC in 5.4% of the drugs, similar in HC and EMA and different in the FDA in 9.7% of the drugs, and similar in HC and FDA and different in EMA in 9.7% of the drugs. The three agencies approved different indications in 3.2% of the drugs.

Conclusions

Discrepancies in the number of approved indications was noted in one-third of the priority review drugs and biologics approved by the FDA, the EMA and HC. The basis, clinical implications, and consequences of these discrepancies warrant further investigation.