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Bit Quicker, Actually

The US Food and Drug Administration typically reviews drugs two months faster than its European counterpart, according to an analysis appearing in the New England Journal of Medicine.

A trio of researchers led by Yale School of Medicine's Joseph Ross note that their analysis — an update to a 2012 NEJM paper that compared review times at FDA, the European Medicines Agency, and Health Canada — comes at a time when FDA is under pressure to speed its approvals process. The Prescription Drug User Fee Act, the law that funds drug approvals at the agency, is due for reauthorization by October, they add.

The researchers compared review times for new therapeutics approved by FDA or the EMA between 2011 and 2015. In that timeframe, they note that FDA approved 170 new therapeutic agents to the EMA's 144. At FDA, the median review time was 306 days, while it was 383 days at the EMA. Additionally, for the 142 therapeutics approved by both agencies, the median review time at FDA was 303 and at the EMA was 369.

"The report provides data that demonstrates the FDA is moving faster than the European peer agency," Ross says in a statement.

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