Remember that study that seemed to show that drugs FDA approved on deadline were more likely to end up with safety problems? Since its March publication in the New England Journal of Medicine, FDA hit back, saying that the Harvard professor who did the research made mistakes. Well, now Daniel Carpenter admits that FDA did find mistakes--but when he corrected those mistakes and added more recent data, he said, his original finding still holds.
Now, Carpenter says, the 88 drugs approved on deadline between 1993 and 2005 had a 15 percent chance of getting tagged with severe safety problems: Either a black-box warning or complete withdrawal. For the 226 other drugs approved the rate was just 5 percent. That compares with 14 percent and 3 percent, respectively, in the original published study. And when Carpenter extended that data through 2007, both groups got red flags: 20 percent of on-deadline drugs were withdrawn or got a black-box warning compared with 9.7 percent of other drugs. And, Carpenter says, he may have missed some warnings in his earlier study, but the FDA data omitted "a whole bunch" of them.
FDA didn't comment for the Wall Street Journal, but when the first study was released, said that its own records showed no statistically significant difference in safety performance among those drugs approved right before deadline and those that weren't.
- see the WSJ article