Professor defends research criticizing FDA

The Wall Street Journal reports that Daniel Carpenter, "[a] Harvard University professor, defended research suggesting the Food and Drug Administration (FDA) was making overly hasty approval decisions on medicines -- an analysis the agency has criticized as mistaken." The revised analysis indicates that "between 1993 and 2005, the 88 drugs approved near the FDA's deadline had a 15 percent chance of being flagged for severe safety problems," while the "rate was just five percent" for "226 other drugs." The FDA "has maintained that its own internal database showed only a modest increase in the rate of safety problems for such drugs." Comment: One more case of legislating in haste to regret the outcome at leisure. Several years ago activists complained the FDA took too long to make decisions., Congress leaned on the FDA to be quicker, without looking at the downside. No additional money was provided so the FDA had to cut corners. The results are a number of high profile drugs be let loose and then having to be withdrawn. The US syndrome of “want an answer immediately” does not work in science, but Congress will not learn. All of us who have managed large agencies have had to listen to legislators tell us what to do without the freedom to respond or discuss.