Source: FDA | Release | February 8, 2018
The U.S. Food and Drug Administration and the Nuclear Regulatory Commission (NRC) today 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 health care 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.
“Every day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This radioisotope is vital to disease detection, yet health care professionals have faced challenges with adequate supply due to a complex supply chain that sometimes resulted in shortages. Today’s approval has been the result of years of coordination across the FDA and with U.S. government organizations and marks the first domestic supply of Mo-99 – the source of Tc-99m – in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine.”
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.
Today’s actions granted approval for the RadioGenix System to produce sodium pertechnetate Tc-99m injection to be injected intravenously, instilled into the bladder or eye, or used with other FDA approved imaging drugs to examine specific tissues and organs.
This approval did not require new clinical studies because it relied on safety and efficacy information and data from an already FDA-approved Tc-99m generator.
The most common side effects of Tc-99m include allergic reactions, including anaphylaxis, that have been reported infrequently following the administration of sodium pertechnetate Tc-99m injection. Health care providers should monitor all patients for hypersensitivity reactions.
Sodium pertechnetate Tc-99m injection contributes to a patient’s long-term cumulative radiation exposure. Health care 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.
The approval of RadioGenix System was granted to NorthStar Medical Radioisotopes.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The NRC is an independent agency created by Congress to license and regulate the civilian use of radioactive materials in the U.S. to protect public health and safety, promote the common defense and security, and protect the environment. The NRC regulates commercial nuclear power plants; research, test and training reactors; nuclear fuel facilities; and radioactive materials used in medicine, academia and industry.