FDA debuts domestic system for radioisotope production

The U.S. Food and Drug Administration (FDA) today approved imaging technology that will enable the domestic production of radioisotope Technetium-99 (Tc-99m), FDA Commissioner Scott Gottlieb, MD, has announced. The new tech will be known as the RadioGenix System.

Tc-99m isn’t new itself—it’s used in more than 80 percent of routine imaging procedures and is relied on by an average 50,000 Americans each day—but the RadioGenix System is, Gottlieb wrote. The U.S.-based technology was born from a need for a stable, reliable, domestic option for manufacturing the radioisotope.

“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 in the statement. “Because the imaging agent has a limited shelf life, a stable supply chain is critical.”

Older methods of producing Tc-99m involved shipping enriched uranium out of the U.S. for irradiation. Because the international facilities could be prone to shutdowns, delays or closures, Gottlieb said, the process could be “complicated, at times uncertain and potentially risky”—not to mention expensive.

And while the price tag on Tc-99m was already high, clinicians wary of production disruptions have begun to rely on alternative, more expensive isotopes they know are in good supply stateside, he wrote. Shortages of Tc-99m in 2009 and 2010 fueled these shifts.

“While we needed to preserve the availability of Tc-99m for its important medical purpose, it was critical that we find a more stable, secure and sustainable technology for production,” Gottlieb said, and that’s where the RadioGenix System came in.

According to the FDA’s release, the U.S. Department of Energy has been working with the private sector to encourage domestic production of Molybdenum-99 (Mo-99) since Congress signed the American Medical Isotopes Production Act in 2012. The goal of the legislation was to support projects that could produce Mo-99 without the use of highly enriched uranium, thereby enabling domestic production.

“My FDA colleagues, especially those in our Center for Drug Evaluation and Research and Center for Devices and Radiological Health, worked closely with both industry and other U.S. government colleagues ... in support of a shared goal—to bring a secure, clean and stable supply of the Tc-99m radioisotope to the medical community,” Gottlieb said. “And today’s approval will have an enduring benefit across the patient communities and toward strengthening our national security.”