Faster Than You Think

FDA critics often say that the agency is too slow in approving new cancer drugs, says Pharmalot's Ed Silverman. But a new study by researchers at nonprofit think tank Friends of Cancer Research recently published in Health Affairs shows that the median approval time for oncology drugs in the US is about half that of Europe. The researchers looked at 35 cancer drugs reviewed by FDA and the European Medicines Agency between 2003 and 2010. The median time for approval in the US was six months. FDA approved 32 drugs, of which 20 were approved within 184 days, Silverman says. The EMA approved 26 of the drugs and took a median of 350 days to do it. The researchers say that continued financial support will be important in keeping FDA efficient.