U.S. Bests Canada, Europe in Drug Approvals
Yale research shows FDA ahead of other regulators in the approval process
WEDNESDAY, May 16, 2012 (HealthDay News) -- New drugs are approved faster in the United States than in Europe and Canada, new research shows.
The findings counter a common belief that the drug-approval process by the U.S. Food and Drug Administration is especially slow, according to Yale University School of Medicine researchers.
The study authors reviewed drug-approval decisions made between 2001 and 2010 by the FDA, Health Canada (the Canadian drug regulator), and the European Medicines Agency (EMA). The latter agencies were chosen for comparison with the FDA because they face similar pressures to approve new drugs quickly while ensuring patient safety, the researchers said.
"Among the subsample of drugs approved for all three regulators, the FDA's reviews were over three months faster than those of the EMA or Health Canada," study leader Nicholas Downing, a second-year medical student, said in a university news release.
"The total review time at the FDA was faster than EMA, despite the FDA's far higher proportion of applications requiring multiple regulatory reviews," he added.
The study also revealed that most new drug therapies were first approved for use in the United States.
"Examining novel drugs approved in multiple markets, we found that 64 percent of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86 percent of medicines approved in both the U.S. and Canada were also approved first in the U.S.," Downing said.
The study was published online May 16 in the New England Journal of Medicine.
The FDA explains how it approves drugs.