FDA paves way for domestic creation of No. 1 imaging radioisotope

The U.S. Food and Drug Administration (FDA) and the Nuclear Regulatory Commission (NRC) on Feb. 8 announced the approval of the RadioGenix System, which may help stabilize the United States’ supply of a radioisotope crucial for medical imaging.

NorthStar Medical Radioisotopes received approval for the system, which produces the Technetium-99m (Tc-99m) commonly used in imaging procedures to detect cancers and coronary artery disease. Currently, Molybdenum-99 (Mo-99)—the parent of Tc-99m—can only be made in six government-owned nuclear research reactors, none in North America.

American patients use nearly half of the world’s supply of moly-99 but the supply chain is precarious, especially considering the product only has a shelf life of a few days because of rapid decay, The New York Times reported in January.

More than 80 percent of nuclear imaging procedures in the U.S. require Tc-99m, according to the FDA, and now a path is cleared for its domestic creation.

Congress signed the American Medical Isotopes Production Act in 2012, and since then the U.S. Department of Energy has been working with the private sector on ways to produce Mo-99 without using highly enriched uranium. Previously, the U.S. has exported highly enriched uranium to other countries to finish production of the isotope.

“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, MD, 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.”

FDA Commissioner Scott Gottlieb pointed out in a separate statement the unreliable supply of Tc-99m caused some clinicians to shift to alternatives that were more expensive or exposed patients to higher doses of radiation.

“The system we’ve approved today will not only help save and improve the lives of patients, but will reduce the risk of drug shortages and strengthen our national security by creating a U.S.-based manufacturing capacity that is less vulnerable to supply disruptions,” Gottlieb said.