US ahead of Canada and Europe in drug approvals
Yale study finds US FDA process is more than three months faster than EMA or Health Canada
The US Food and Drug Administration (FDA) generally approves drugs faster and earlier than its counterparts in Canada and Europe, a new study by Yale School of Medicine researchers has found. They say the study counters perceptions that the drug approval process in the US is especially slow.
Regulatory review is the final step in the process of bringing new medicines from the lab to the patient and if the process is efficient, patients will 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 Nicholas Downing, a second-year medical student at Yale School of Medicine. He says he decided to conduct the research because there have been no recent comparisons of the FDA’s regulatory review speed with those of regulating agencies in other countries.
Downing, senior author Dr Joseph Ross, and colleagues reviewed drug approval decisions of the FDA, 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 the FDA, 366 days at EMA and 393 days at Health Canada.
‘Among the sub-sample 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 reviews.’
Downing added that most new drugs were first approved for use in the US.
‘Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the US and in Europe were approved for US patients first, and 86% of medicines approved in both the US and Canada were also approved first in the US,’ he said.
The study was online by the New England Journal of Medicine.