Prying into FDA decision-making

WASHINGTON - A federal judge's intervention in a dispute among sponsors of competing ultrasound contrast agents could prompt the FDA to adopt more transparent and consistent policies for classifying products as drugs, devices or biologicals.

U.S. District Court Judge Paul Friedman ruled last week in Washington that it is likely that FDA was "arbitrary and capricious" in deciding to review FS069, a contrast agent developed by Molecular Biosystems Inc. (MB, San Diego, Calif.) as a device rather than a drug...