FDA Slowing Approval Times for New Drugs

U.S. drug regulators are taking longer to approve new drugs, which is forcing drugmakers to reluctantly reset Wall Street expectations. And that could mean trouble for biotech stocks.

Data released recently by the Food and Drug Administration show a four-month increase in approval times for at least one class of drug in 2000 from 1999. Official data are not available for this year, but observers say the FDA's go-slower approach continues.

It takes years to move a new drug from the laboratory to pharmacy shelves, so four months may not sound like much time to wait. But the delay is enough to force drugmakers to lower near-term revenue and profit estimates, which doesn't play well with anxious investors. ...