FDA postpones EchoGen meeting

Another ultrasound contrast agent has been affected by the U.S. District Court ruling in April barring any regulatory review by the Food and Drug Administration until the agency has responded to three citizen petitions. The citizen petitions, filed by Bracco Diagnostics, DuPont Merck Pharmaceutical and its partner ImaRx, and Sonus Pharmaceuticals, had asked the FDA to eliminate the disparity in the regulation of contrast agents (SCAN 4/30/97). The companies had filed lawsuits when they believed clearance was imminent for FS069, an agent from Molecular Biosystems that was being regulated as a device in the FDA's Center for Devices and Radiological Health; all other ultrasound contrast agents are being regulated as drugs through the FDA's Center for Drug Evaluation and Research.

Ironically, the regulatory action on EchoGen from Sonus Pharmaceuticals has also been stalled as part of the court order. The June 30 meeting of the Medical Imaging Drugs Advisory Committee to review EchoGen has been postponed due to the injunction, according to Sonus. A new meeting date has not been set.

Sonus officials don't appear to regret participating in the legal action, however. In a press release, Dr. Steven Quay, president and CEO of Sonus, said that the long-term benefits of a level playing field for all ultrasound contrast agents outweigh the delay in the advisory committee meeting.

Under FDA regulations, the agency has 180 days to respond to a citizen petition. As Bracco filed its citizen petition on December 27, the agency would need to respond by June 27. The court was advised during oral arguments preceding the court order, however, that a response might consist of only a letter advising a petitioner that the agency needs more time to consider the matter, according to court documents.