Study Finds FDA Outpaces European Regulators in Review Times, Approvals of New Drugs
A new study published online in the New England Journal of Medicine reveals that the FDA outpaced the European Medicines Agency (EMA) in review times and approval of new drugs during a recent 5 year-period.
Researchers compared review times for new therapeutic agents that were approved by the FDA or the EMA, the primary drug regulator in Europe, between 2011 and 2015. The drug agents were then classified according to therapeutic area and orphan status. Investigators abstracted key regulatory dates and compared median total review times.
The researchers found that the FDA approved 170 new therapeutic agents between 2011 and 2015, compared with 144 by the EMA. In addition, during the same time period, regulatory reviews by the FDA were 60 days shorter (303 days for FDA vs. 369 days for EMA) on average than those by its European counterpart. The FDA approved 43.5 percent of applications for orphan drugs, compared with just 25 percent for the EMA. Meanwhile, the median total review time was 306 days at the FDA and 383 days at the EMA.
The 21st Century Cures Act, which was signed into law in December 2016, includes several reforms that are intended to further streamline FDA evaluations. However, the speed of the regulatory review process is directed by the Prescription Drug User Fee Act. Congress is due to consider the reauthorization of the Prescription Drug User Fee Act before it expires this October.
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