A report by Lehman Brothers suggests that at least 30 novel drugs, including seven biological products, could be approved for the market in 2003. Last year, only 25 new products were approved.
Between 1995 and 2001, an average of 45 new drug marketing authorizations were filed annually, about 50% above 2003 expectations. So there's still a relative shortfall of new drugs being filed. This dearth has received plenty of worried press, including laments that biotech has let us down. However, since research and development spending hasn't slowed, improvement is likely to arrive again, given patience. No industry can run on high-gear nonstop.
Companies in the hot seat this year -- that stand to gain the most or disappoint -- include GlaxoSmithKline
Overall, the FDA weighs safety against progress and speed. Patients benefit when new drugs get to market quickly, but only if they're safe. Caution causes delay in approving many drugs.