But 11 others took more than 18 months. The head of FDA's Center for Drug Evaluation and Research countered by noting that the agency in 2000 met all of the goals imposed by the 1992 law-including reviewing half of all original new drug applications within ten months. She also noted that the average approval time in 2000 compared with the average in 1999 reflected far fewer priority reviews. A financial analyst speculated that the FDA was taking longer to review new compounds because an alarming number of drugs have been withdrawn from the market in recent years after patients died or developed serious side effects while taking them. The FDA has received a great deal of criticism because of the recalled drugs.
Critics charge the agency with carrying out inadequate reviews.
Confusion Reigns Over Safety Claims for COX-2 Inhibitors. The label change, however, may turn out to be narrow and of limited use for marketing purposes. Even so, Merck seemed to fare better than Pharmacia. The sole reason for the development of COX-2 inhibitors was improved GI safety. Despite the rejection of improved safety claims, both drugs have done very well in the marketplace and some experts say that the precise labeling does not particularly matter, as prescribingof these products will continue to increase.