United States Drug Review Process Faster Than Europe or Canada

In a study from the New England Journal of Medicine, researchers from Yale and the Mayo Clinic have found that the US is faster than both Europe and Canada in approving more medicines in less time.  This is significant news since the FDA has long been criticized for falling behind other peers in approving new important drugs.  The study states, ”between 2001 and 2010, the FDA’s typical review of a new drug was about 15 percent faster than those by the European Medicines Agency and Health Canada.”

The approval process time decrease seems to have improved since the passing of the 1992 Prescription Drug User Fee Act.   The FDA website explains the act as authorizing “FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.”

Harlan Krumholz, MD writes in a Forbes article (5/17),  ”we found that the FDA was almost two months faster than the European Medicines Agency and Health Canada. Moreover, the majority of the agents that we evaluated were approved first in the United States.”   Krumholz goes on to argue that there should now be more regulations for market studies.