- Category: About ICUS
On behalf of the International Contrast Ultrasound Society (“ICUS”)1, we respectfully submit this Citizen Petition under 21 C.F.R. §§ 10.30 and 201.57(c)(1) to request that the Commissioner of Food and Drugs remove the boxed warnings on ultrasound contrast agents in order to bring the product labeling into line with the current body of scientific research, which now clearly demonstrates the safety and clinical benefits of these radiation-free imaging products.
ICUS members are concerned that current boxed warnings may unduly deter the use of an exceedingly safe, reliable, non-invasive and cost-effective diagnostic imaging tool that does not expose patients to ionizing radiation.
Moreover, given the potential life-saving benefits of ultrasound contrast agents and the potential risks associated their non-use, ICUS believes the boxed warnings are inconsistent with the standards of the Food and Drug Administration (“FDA”) for use of boxed warnings and stand in direct opposition to the FDA’s statutory responsibility to protect promote the health of the American public.
ICUS appreciates that at the time the FDA required the boxed warnings there may have been insufficient data to support clinicians’ positive experience with ultrasound contrast agents, and that the FDA’s decision to add boxed warnings was, at that time, consistent with its regulatory authority and guidance. As advocates for the best interests of patients, ICUS members support legitimate and appropriate safety warnings that reflect currently available data.
However, as new scientific evidence emerges, the key question remains whether the available body of safety data warrants the most serious level of caution -- the boxed warning, with the linchpin being how the risks associated with ultrasound contrast agents relate to their benefits. Framed in this way pursuant to the FDA’s own guidance, the answer is clear: Ultrasound contrast agents are exceedingly safe and do not warrant boxed warnings. Accordingly, ICUS supports the removal of the boxed warning and a significant modification of the warning in order to reflect current scientific data supporting the safety and clinical benefits of ultrasound contrast agents.