- The Food and Drug Administration is bringing manufacturing of an isotope used in the vast majority of medical diagnostic tests back to the U.S., aiming to lower the risk of supply shortages.
- Through a collaboration with industry leaders and other regulatory bodies, the FDA approved the RadioGenix System, a technology makes the isotope, known as Technetium-99m or Tc-99m. More than 80% of nuclear medicine imaging that takes place in the U.S. uses Tc-99m, according to the agency.
- Regulators expect the approval will restore domestic supply of Tc-99m for the first time in 30 years. The Nuclear Regulatory Commission is in charge of licensing the RadioGenix system, and will be issuing guidance on how to do so — though it's unclear exactly when.
Radioisotopes are vital for both medical testing and drug development. Exemplifying the value of those atoms, Novartis AG in October agreed to purchase Advanced Accelerator Applications for $3.9 billion, in part because of the target's prowess at developing and manufacturing radiopharmaceuticals.
In the U.S., healthcare providers use Tc-99m in nuclear imaging to help them better understand what's going on in a patient's organs or how diseases like cancer are affecting various body tissues. Despite the isotope's integral role in stateside diagnostic testing, most of it was produced in other countries, leading to an expensive and sometimes shaky supply chain.
"Prior to today, the production process for Tc-99m involved shipping enriched uranium out of the U.S. for irradiation," FDA Commissioner Scott Gottlieb said in a Thursday statement. "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."
With supply chain disruptions comes added risk to patients.
In mid-2009, two reactors that produced more than 60% of the world's molybdenum-99, an isotope that decays into Tc-99m over time, closed because of either maintenance or repair work. The shutdowns caused the global Tc-99m supply to reach a "crisis level," according to Nature. Gottlieb noted too that Tc-99m shortages, and frequently just the threat of shortages, have pushed doctors to use other isotopes that were costlier and potentially more dangerous.
"Every day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "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."
The FDA OK'd the RadioGenix System for use with other agency-approved imaging drugs. More specifically, regulators also said the technology can be used to produce intravenous sodium pertechnetate Tc-99m for administration into the bladder or eye. NorthStar Medical Radioisotopes LLC, a Wisconsin-based provider of radioisotope supply solutions, received approval for the RadioGenix system.