FDA Approves More Drugs, and Faster, Than Europe
New research shows that contrary to some political claims, the U.S. Food and Drug Administration approved more drugs, and two to three months faster on average, than European regulators did over the last five years.
Researchers studied the track record of the FDA and its overseas counterpart, the European Medicines Agency. Between 2011 and 2015, the FDA approved more drugs than the Europeans, 170 versus 144. Median review times were 306 days at the FDA versus 383 days in Europe.
Reviews were speedier at the FDA for drugs for cancer and blood diseases, but not other maladies, compared to the Europeans. The FDA also moved quicker on so-called orphan drugs, for relatively rare conditions.
The work was published Wednesday in the New England Journal of Medicine.
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