The American Medical Isotopes Production Act of 2012
Many countries like Japan and Australia have made headway in securing Molybdenum-99 (“Mo-99”) for their citizens. With the eminent closure of foreign production facilities that supply the U.S., it faces a potential crises where its citizens may not be able to obtain this lifesaving diagnostic and treatment.
In response, the 2013 National Defense Authorization Act (H.R. 4310), approved the American Medical Isotopes Production Act of 2012 (“ACT”), incentivizing the development of a robust and reliable domestic supply of Mo-99 and closing certain loopholes regarding the export by the U.S. of highly enriched uranium (HEU) that challenged its nuclear weapons non-proliferation goals.
The ACT provides that the Secretary of the Department of Energy (“DOE”) shall carry out a technology neutral program to evaluate and support projects for the production of significant quantities of Mo-99 without the use of HEU for the United States. As part of the program pursuant to the ACT, the DOE shall provide assistance for the development of fuels, targets, and processes for domestic Molybdenum-99 production that do not use HEU. In addition to the above, the Secretary shall establish a uranium lease and take-back program to make low enriched uranium (LEU) available through lease contracts, for irradiation for the production of Mo-99 for medical use (“Lease and Take-Back”).
The Coquí Pharma would use the only low enriched uranium (LEU) technology that has been successfully proven and implemented in several countries around the world that can make use of the Lease and Take-Back program. It will couple existing proven technology with tested designs to build a facility that will have the capability of supplying a large portion of the U.S. market and could ramp up production to supply international needs of Mo-99. In its endeavors, Coquí Pharma will perform and facilitate the advancement of research in nuclear medicine.
Coquí Pharma’s solution to the Mo-99 crisis holds the only clear path to licensing of its facility using proven technology that the Nuclear Regulatory Commission (NRC) is familiar with and that takes advantage of the LEU Lease and Take-Back program instituted by the ACT. Coquí Pharma has put together the tools for success to confront the challenges of financing especially the high cost of licensing for an industry that the government desires to be private but has historically been assisted by government funding. With the approval of the ACT, Coquí Pharma is moving ahead as one of the most reliable solutions to securing a stable, continuous and significant supply of Mo-99 for the United States.