WASHINGTON The Food and Drug Administration is on pace to approve just 18 new drugs by the end of 2007, according to the Dow Jones Newswires.
Pharmaceutical companies are blaming the FDA for being too cautious in approving new drugs. The agency has been decreasing new drug approvals almost every year since 2004, when Merck withdrew its painkiller Vioxx because of safety concerns.
FDA argues that its criteria for review haven’t stiffened substantially. “There have been no systematic changes in how FDA is approaching the approval standards for new drug applications,” a spokeswoman said. “Each application is reviewed on its own merit and judgments are made by the signatory authority as to whether the application meets the statutory standards.”