FDA buys time
WASHINGTON - FDA announced that it will answer "on or before July 28" the various citizens petitions that have been filed in conjunction with the dispute over the agency's classification of Molecular Biosystems Inc.'s FS069 ultrasound contrast agent as a device (see BioCentury April 28). The response will address petitions and comments submitted on behalf of MB (San Diego, Calif.) and its opposition, Sonus Pharmaceuticals Inc. (SNUS, Bothell, Wash.), DuPont Merck (Wilmington, Del.) and Bracco Diagnostics Inc. (Milan, Italy), who want FS069 reviewed as a drug.
FDA's rules call for it to respond to a citizens petition within 180 days, which would have required a response to Bracco's petition before the end of June. In announcing that FDA will respond later, Michael Friedman, deputy commissioner for operations, stated that the agency had decided to deal with all three petitions "in a single, consolidated document." ...