FDA Decides Contrast Agents Are Drugs

The US Food and Drug Administration has decided that all ultrasoundcontrast agents should be regulated as drugs through the Center for Drug Evaluation and Research, rather than as devices through the Center for Devices and Radiologic Health.

The decision was given in response to a court-ordered review of Citizen Petitions filed by three companies, Bracco, SONUS and DuPont Merck. Michael Friedman, Deputy Commissioner for operations at the FDA, said that the petitions filed by all three companies were being granted "to the extent that requests that microbubble and microsphere ultrasound contrast agents should be regulated under the same statutory standards." In addition, Dr Friedman said that "the agency is also granting the Bracco and SONUS petitions to the extent that each requests that the agency regulate these products as 'drugs' and 'new drugs'."