The U.S. Food and Drug Administration (FDA) reviews and approves new medicines in a shorter timeframe than its peer agency in Europe, the European Medicines Agency (EMA), says a Yale researcher. This finding comes at a time when the FDA is under renewed pressure to streamline and speed up its approval process, and provides data to inform ongoing policy discussions.
The report, co-authored with researchers at Brigham and Women’s Hospital and New York University School of Medicine, was published April 5 by the New England Journal of Medicine.
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 (PDUFA) — due for reauthorization by October 2017.