SPOTLIGHT: Revised study still finds that FDA approval rush may cause harm

Harvard University professor Daniel Carpenter has come out with a revised version of a study concluding that drugs moving too quickly through the FDA approval process are more likely to be linked to safety problems later. Though admitting to data mistakes in his original study, he stands behind his original conclusion, Carpenter says. According to his new numbers, between 1993 and 2005, 88 drugs approved near agency deadlines had a 15 percent chance of being identified as having severe safety problems, as compared with 5 percent of 226 other drugs. Article [1]