The Food and Drug Administration (FDA) published a draft guidance document entitled "Guidance for Industry: Internal Radioactive Contamination-Development of Decorporation Agents" to help ensure that medical products called decorporation agents -- drugs that help eliminate radioactive materials from the body -- will be available to protect U.S. citizens from radiation contamination. The guidance provides advice on what studies sponsors need to perform to evaluate new decorporation agents in the hopes of getting these products approved by the FDA.
Decorporation agents reduce health risks by increasing the rate of elimination or excretion of radioactive contaminants that have been absorbed, inhaled or ingested.
"The guidance we are publishing today represents yet another step by the FDA to make medical countermeasures available to counteract potential acts of terrorism," said acting FDA Commissioner Dr. Lester M. Crawford. "Protecting Americans from attacks is a fundamental part of FDA's public health mission."
The draft document provides guidance to industry on the development of those decorporation agents for which evidence is needed to demonstrate effectiveness but for which human efficacy studies are unethical or not feasible.
FDA convened a multidisciplinary group of scientists to discuss how provisions under the Animal Efficacy Rule, which took effect in 2002, could be used to facilitate development of new decorporation agents. This rule applies when adequate and well-controlled clinical studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. It is a major part of FDA's effort to help make medical countermeasures available and thereby help improve the nation's ability to respond to emergencies, including terrorist events.
Other examples of approved decorporation agents are Prussian blue, potassium iodide (KI), Ca-DTPA and Zn-DTPA. These drugs, when manufactured under conditions specified in an approved NDA, have been found safe and effective for the treatment of internal contamination with radioactive cesium (Prussian Blue), iodine (KI), and plutonium, americium, or curium(Ca-DTPA and Zn-DTPA).
Written comments on the draft guidance may be submitted up to 60 days from the date it is published in the Federal Register.
Comments should be sent to FDA's Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md. 20852.