New Drug Approval By FDA Reaches ‘Slowest Rate’ in a Decade
New drugs are coming into the market "at the slowest rate in a decade," despite drug companies' increased spending on research and development and a "costly expansion" of the FDA, the Washington Post reports. The number of new drugs entering the market peaked in the mid-1990s, when the FDA approved more than 120 new medicines in both 1996 and 1997. In comparison, the FDA approved 66 new drugs in 2001 and 54 in 2002 as of September. The "steep drop" in the number of drugs coming to the market has been "most pronounced" in "priority" drugs, those considered a breakthrough and life-saving medicine, and in "new molecular entities," which contain chemicals never before used as medicines. There were 32 "priority" applications in 1997, six in 2001 and five so far this year. In 1996, 53 new molecular entities drugs were approved, compared to 24 approvals in 2001 and 11 so far this year. The slowdown could be related to the fact that the FDA has become "notably more cautious" in its review process, in large part because 10 drugs were withdrawn from the market between 1998 and 2001 for safety reasons, the Post reports. "As we identify safety concerns with one product or area, that can lead to a need to evaluate another new product more closely than we would have if we didn't have that knowledge. It would be irresponsible for us not to do that," John Jenkins, the director of the office of new drugs for the FDA's Center for Drug Evaluation and Research, said. He added that the "primary" reason for fewer approvals is that the industry is submitting fewer applications.
Pfizer CEO Henry McKinnell said the FDA's regulatory atmosphere has had a "chilling effect" on drug companies, the Post reports. The drug recalls have caused the FDA to require more testing of drug-to-drug interactions, prompting some companies to "look at that burden and decide not to file" applications, McKinnell added. But Kenneth Kaitin, director of the Tufts University Center for the Study of Drug Development, said, "It's ludicrous to say the FDA is making it too hard. The industry pipeline is dry." For example, medications submitted for FDA approval are increasingly "me-too" types of popular drugs already on the market instead of completely new drugs, the Post reports. Drug industry officials, however, say the decreasing number of new drugs is related to the shift from "traditional" chemistry to "cutting-edge" biotechnology in medicine development, the Post reports. McKinnell said the drug industry is "trying to hit home runs, and it struck out a lot. Added to that, the (FDA) is giving greater scrutiny to each drug application. The result is that we are spending more time on each drug, spending much more on research, but seeing a definite drop in the number of new drugs." New FDA Commissioner Mark McClellan, who was sworn in last week, has said that speeding up the drug approval process is one of his priorities (Kaufman, Washington Post, 11/18).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.