Photo courtesy of FDA
Pill production
The US Food and Drug Administration (FDA) reviews and approves new medicines in a shorter timeframe than the European Medicines Agency (EMA), according to an analysis published in NEJM.
The FDA has faced pressure from the public, politicians, and industry to accelerate review and approval of new medicines.
The FDA’s review process is currently being considered and reexamined as part of negotiations to reauthorize the law that directs funds to the agency—the Prescription Drug User Fee Act—which is due for reauthorization by October 2017.
To inform this debate, a group of researchers compared review times for new drugs approved by the FDA and the EMA between 2011 and 2015.
The results showed that the FDA approved more new drugs than the EMA—170 versus 144—during this time period.
The median review time was 306 days for FDA-approved drugs and 383 days for EMA-approved drugs (P<0.001).
Over the study period, the FDA approved 53 drugs intended to treat cancer/hematologic diseases, and the EMA approved 50. The median review times were 206 days and 379 days, respectively (P<0.001).
The FDA approved 74 orphan drugs, and the EMA approved 36. The median review times were 294 days and 403 days, respectively (P<0.001).
The current analysis is an update to a prior analysis, published in 2012, which showed the FDA approved new medicines more quickly than the EMA and Health Canada.
“The gap we had identified, where the FDA was 2 to 3 months faster, now it’s about 3 to 4 months faster,” said Joseph Ross, MD, of the Yale School of Medicine in New Haven, Connecticut, an author of both studies.
“This is more information that should inform upcoming debates. The FDA is already making decisions quickly, and increasing its regulatory speed shouldn’t be our number-one priority.”
