The U.S. Food and Drug Administration (FDA)
generally approves drug therapies faster and earlier than its counterparts in Canada and Europe,
according to a new study by Yale University School of Medicine researchers. The
study counters perceptions that the drug approval process in the U.S. is
Led by second-year medical student Nicholas
Downing and senior author Dr. Joseph S. Ross, assistant professor of internal
medicine at Yale School of Medicine, the study will be published by the New England Journal of Medicine.
Regulatory review represents the final step
in the process of bringing new medical technologies from the laboratory to the
bedside. Efficient regulatory review processes may enable patients to get
access to promising new therapies sooner, while ensuring drug safety.
“The perception that the FDA is too slow
implies that sick patients are waiting unnecessarily for regulators to complete
their review of new drug applications,” said Downing, who decided to conduct
the study because there have been no recent comparisons of the FDA’s regulatory
review speed with those of regulating agencies in other countries.
Downing, Ross, and colleagues reviewed drug
approval decisions of the FDA; the Canadian drug regulator, Health Canada; and the
European Medicines Agency (EMA) between 2001 and 2010. They studied each
regulator’s database of drug approvals to identify novel therapeutics as well
as the timing of key regulatory events, allowing regulatory review speed to be
calculated. Canada and Europe were chosen as a comparison because they face
similar pressures to approve new drugs quickly while ensuring they do not put
patients at risk.
The team found that the median total time
to review was 322 days at FDA, 366 days at EMA, and 393 days at Health Canada.
“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,”
said Downing. “The total review time at the FDA was faster than EMA, despite
the FDA’s far higher proportion of applications requiring multiple regulatory
added that most new drug therapies were first approved for use in the U.S. “Examining novel drugs approved in multiple markets, we found that 64% of
medicines approved in both the U.S. and in Europe were approved for U.S.
patients first, and 86% of medicines approved in both the U.S. and Canada were
also approved first in the U.S.,” he said.
Filed Under: Drug Discovery