FDA and NRC pave way for first domestic supply of isotope used in diagnostic imaging

The U.S. Food and Drug Administration and the Nuclear Regulatory Commission (NRC) took steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases. The FDA approved the RadioGenix System, a unique system for producing Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. The NRC is issuing guidance and will license the RadioGenix System to enable the Tc-99m it produces to be used for its medical purpose.

Tc-99m is a diagnostic agent that is used by healthcare professionals with FDA-approved imaging devices to detect potential diseases like coronary artery disease and cancer, as well as evaluating lung, liver, kidney and brain function. When used with the appropriate diagnostic scanner device, such as a SPECT imaging system, the Tc-99m emits signals that are captured and produces an image of internal organs to detect various medical problems and contribute to diagnosis and treatment decisions.

Tc-99m has been in use as a medical imaging diagnostic agent for decades and is used in more than 80 percent of nuclear medicine imaging procedures in the U.S. Before today, Molybdenum-99, or Mo-99, the parent of Tc-99m, could only be produced from enriched uranium by several facilities outside of the U.S. This required a complicated supply chain that involved shipping enriched uranium from the U.S. This left the U.S. vulnerable to possible shortages and/or supply chain issues.

To address these challenges, Congress enacted the American Medical Isotopes Production Act of 2012, which contained provisions to eliminate the use of highly enriched uranium for medical isotope production and encouraged the development of U.S. domestic supplies of Mo-99 and associated isotopes. As such, multiple federal agencies – including the FDA, NRC, as well as the Department of Energy’s National Nuclear Security Administration and National Laboratories, among others – have been working together with industry for several years to develop a technology that helps to minimize the industry’s dependence on highly enriched uranium and brings the supply chain within the U.S. As a result of this collaboration, the U.S. medical community will now have a domestic source of Tc-99m through the use of the RadioGenix System, which marks the first non-uranium process for the production of Mo-99 to prepare the Tc-99m.

As the regulatory authority responsible for overseeing the production, distribution, possession and use of radioactive materials and products containing radioactive materials, NRC is issuing guidance that will advise medical and commercial nuclear pharmacy users on the license amendments they will need to possess and use the RadioGenix System. The approval of RadioGenix System was granted to NorthStar Medical Radioisotopes.

Healthcare providers should ensure safe handling to protect patients and health care workers from unintentional radiation exposure in accordance with instructions for use in the product labeling. hpn