January 15, 2020
On January 2, the U.S. Department of Energy (DOE) issued a letter certifying that the current global supply of Mo-99 produced without the use of highly enriched uranium (HEU) is not sufficient to meet the need in the United States and, therefore, extending the deadline for implementation of a ban on HEU export. This will help to ensure adequate domestic supply of Tc-99m in the United States for the next few years, minimizing the shortages that negatively impact patients.
The American Medical Isotopes Production Act of 2012 (AMIPA) had highly encouraged a move to low-enriched uranium for medical isotope production as of January 2020, but it also allowed for the extension of that deadline for up to 6 years should there be insufficient global supply of Mo-99 to satisfy the U.S. market.
On November 27, 2019, the Department of Energy submitted a request for public comment on “Exports of U.S-Origin Highly Enriched Uranium for Medical Isotope Production: Sufficient or Insufficient Supplies of Non-HEU-based Molybdenum-99 for United States Domestic Demand.” On December 23, SNMMI submitted its comments, explaining that “on multiple occasions over the past several years, members throughout the United States reported limited supplies of Tc-99m for clinical imaging because of disruptions in the production of Mo-99” and that “the supply of non-HEU Mo-99 needs to be significantly more robust before we feel confident that the supply is reliable enough to meet day-to-day patient-care needs.”
The 2-year delay is a very positive development for patients whose care is facilitated by this important nuclear medicine isotope.