It is taking longer for new drugs to get approved by U.S. drug regulators. But while aspersions have been cast at the Food and Drug Administration as the
main source of the delays, drugmakers should shoulder some of the blame. One of the newer theories floating around about why drug regulators seem to take their sweet time is that drug companies are filing inferior applications. If the data submitted in the application are spotty or don't address issues likely to be raised in the review process, the FDA has little choice but to return the application or reject it altogether. If this is true, drug companies should be spending a lot of time and money making sure their regulatory staffs are up to snuff. Unfortunately, says Merrill Lynch analyst Steven Tighe, the quality of new drug applications sent to the FDA seems to vary widely. Tighe covers the pharmaceutical industry, so he and his colleagues looked back six years to analyze approval times and rejection rates. The best performers were Merck ( MRK) and Eli Lilly ( LLY), which got their drugs approved in an average time of 10.9 months and 11 months, respectively. The average review time for Bristol-Myers Squibb ( BMY), Schering-Plough ( SGP) and Pharmacia ( PHA) ranged from 14.6 months to 15.6 months. Alas, American Home Products ( AHP)and Pfizer ( PFE) brought up the rear of the rankings, with slothlike average review times of 19.8 months and 25.5 months, respectively.