The US Food and Drug Administration (FDA) consistently approves new drugs more quickly than the European Medicines Agency (EMA) or Health Canada, according to a new study.
A comparison of drug approval decisions taken between 2001 and 2010 shows that the FDA's median total review time for New Drug Applications (NDAs) was 322 days, compared with 366 days in Europe and 393 in Canada, say researchers at Yale University School of Medicine, whose findings are published online this week by the New England Journal of Medicine (NEJM).
For drugs which were approved in both the US and Europe, 64% reached US patients first, a median of 96 days earlier, while for those approved by both the FDA and Health Canada, novel pharmaceuticals were approved a median of 355 days earlier in the US, with nearly 86% of medicines cleared first by FDA regulators, according to the study's senior author, Joseph Ross, assistant professor of internal medicine at the school.
"Our findings contradict recent criticisms that the FDA's new-drug review times have slowed, leaving American companies and patients at a disadvantage," comments Dr Ross. "In fact, our analysis shows that, compared to the EU and Canada, the FDA reviews new drugs more quickly and that American patients most often have access to new drugs first,” he adds.
Co-author Nicholas Downing said he decided to conduct the study because there have been no recent comparisons of the FDA's review speed with those of regulators in other countries. Canada and Europe were chosen as comparisons because they face similar pressures to approve new drugs quickly while ensuring that they do not put patients at risk, the authors note.
Among the subsample of drugs approved by all three regulators, the FDA's reviews were over three months faster than those of EMA or Health Canada, the researchers found. The total review time at the FDA was faster than EMA, despite the FDA's far higher proportion of applications requiring multiple regulatory reviews.
However, the Pew Health Group, which funded the research, cautions that the FDA must strike a careful balance between safety and speed.
"As we debate where the FDA should improve its performance, this paper indicates that the agency - at least at one key point along the regulatory pathway - is moving faster than its peers," said Alan Coukell, director of medical programmes at Pew.
"This should install greater confidence among drugmakers, doctors and patients in our government's ability to efficiently oversee new drug development,” he said.
- The study examined the time between a company's submission of an NDA and the FDA's final approval - it did not look at the time to complete studies required by the agency or review times for drugs that were not approved. Its findings will inform Innovate FDA, a new Pew Health Group initiative that will measure the FDA's effectiveness in regulating new drugs and medical devices and develop specific recommendations on how to improve its performance.