Washington, D.C.-Pressure to uncover potential adverse events before a new drug reaches patients seems to be taking a toll on drug development and marketing. The Food and Drug Administration (FDA) approved only 19 innovative new drugs in 2007, according to preliminary analyses. That's way down from the peak of 53 new drugs in 1996, but in line with a steady decline in new drug approvals since 2002.
Pharmaceutical companies believe this trend reflects a "new environment" at FDA that has raised the bar for new drug approvals. FDA reviewers routinely request additional studies, according to R&D executives, and delays in launching new products are common. One industry response is to seek more new indications for existing medicines, particularly expensive biologics. FDA officials claim that they have not changed standards, but have become better at detecting safety problems, especially for drugs to treat chronic conditions.