Statement from FDA Commissioner Scott Gottlieb, M.D., on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.

I’m proud to acknowledge the role the FDA played in the groundbreaking effort to develop a new imaging technology – the RadioGenix System. This new technology was the result of a broad collaboration across the federal government and industry, and has the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for the first time in 30 years.

The RadioGenix System is a novel manufacturing system for producing radioisotope called Technetium-99m (Tc-99m). Tc-99m plays a vital role in nuclear imaging studies for a wide range of uses, including cancer and cardiology. It is used in more than 80 percent of routine medical imaging procedures relied on by some 50,000 Americans every day. Because the imaging agent has a limited shelf life, a stable supply chain is critical.

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. Prior to today, the production process for Tc-99m involved shipping enriched uranium out of the U.S. for irradiation. All of the reactors that produced this source material were located outside of the U.S. creating a complicated, at times uncertain, and potentially risky supply chain. These foreign facilities were vulnerable to unforeseen shutdowns or closures, imperiling the U.S. supply. Additionally, shipping enriched uranium out of the U.S., and shipping materials back (in the form of Molybdenum-99, or Mo-99) was expensive.

This challenging supply chain had real-world access and financial impacts on the ability to use this important diagnostic tool to best support patient care. Because of frequent supply disruptions – or even the threat of disruptions – clinicians have shifted to alternative isotopes that may be more expensive or may expose patients to higher doses of radiation. This was the case during two supply disruptions in 2009 and 2010. Simply put, this complicated, international supply chain has been precarious.

For all these reasons, 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. In 2012, Congress signed into law the American Medical Isotopes Production Act, which directed the Department of Energy to work with the private sector to evaluate and support projects that could produce domestic Mo-99 for medical uses without the use of highly enriched uranium (HEU). The goal was to eliminate the export of HEU from the U.S. for the purposes of medical isotope production and ensure a reliable domestic supply of the isotope. Since 2009, the Department of Energy’s National Nuclear Security Administration has signed cooperative agreements with several private-sector companies to develop domestic production of Mo-99 without the use of HEU. In addition, several Department of Energy National Laboratories have strategically collaborated with companies seeking to develop innovative Mo-99 production technologies.

The FDA has been a fundamental part of these efforts, convening some of our most senior scientists in physics, microbiology, engineering and pharmacology. 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, including the Nuclear Regulatory Commission, which will be issuing guidance to its licensees who want to possess and use the RadioGenix System, in support of a shared goal – to bring a secure, clean, and stable supply of the Tc-99m radioisotope to the medical community. And today’s approval will have an enduring benefit across the patient communities and toward strengthening our national security.

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.