OEMs, advocacy groups and nuclear medicine providers worldwide are calling on Congress to provide $20 million toward a domestic supply of Molybdenum-99 (Mo-99) in the U.S.

Addressing their request in a letter, the group called for the Subcommittee on Energy and Water Development to approve a provision in both the House of Representatives and Senate Fiscal Year 2019 Energy and Water Appropriation bills that would help fund production of Mo-99 as part of the National Nuclear Safety Administration’s medical isotope program, stressing the need as necessary to ensuring a “secure supply of Mo-99” is available for the creation and distribution of technetium-99m for use in the diagnosis of cancers and other serious health conditions.

“We are experiencing problems with international sources due to various technical reasons. Mo-99m and Tc-99m are used every day in the clinic, from cancer staging to the detection of cardiac disease to neurological evaluation,” Satoshi Minoshima, the president of the Society of Nuclear Medicine and Molecular Imaging and one of the signatories of the letter, told HCB News. “It is critical for the U.S. to develop sustainable sources of Mo-99m so that we will not be reliant on foreign sources for a product that is essential to healthcare in the U.S.”

More than 50 million scans using Mo-99 are performed annually worldwide, with approximately half taking place in the U.S. The lack of a domestic source, though, has forced the U.S. to rely completely on supplies shipped in from other countries, a complex process that comes with the risk of possible shortages and issues within overseas supply chains.

Under the provision, funding would be provided through the Laboratory and Partnership Support account within the NNSA, aiding in the fulfillment of the objective outlined in the American Medical Isotope Production Act of 2012, which calls for establishment of a sufficient domestic supply of Mo-99.

The parties behind the letter point this out in their argument, along with global supply challenges that place patient access to necessary nuclear medicine procedures at risk and their first-hand accounts of seeing the benefits that Mo-99 brings to patients in more than 30 distinct diagnostic procedures, two of which are myocardial perfusion tests for heart disease and bone scans for determining if a cancer has metastasized.

In addition, the groups ask that the Department of Energy (DOE) be directed to use maximum flexibility to allow pre-award funding for expenses directly related to projects from the beginning of 2018 fiscal year.

Endeavors to create such a supply are currently being carried out by numerous players in healthcare, such as NorthStar Medical Radioisotopes LLC, which just received FDA clearance for its RadioGenix System, and SHINE Medical Technologies Inc., which recently completed construction of the first building for its medical isotope production facility.

Minoshima says that the set up for such a source is more complex, involving multiple stakeholders, from technical groups to regulatory groups. “While the government (such as DOE) can provide seed funding for the development and evaluation of new technologies for the production of Mo-99, even if these technologies are successful, there is no guarantee they will receive regulatory approval for the construction of the necessary facilities, running the new facilities (NRC), or human use of the new product (FDA). However, there are some success stories, too.”

He adds that other challenges also must be addressed to ensure full access to necessary nuclear imaging exams is met. “Industries will be reluctant to sustain and develop radiopharmaceutical-based imaging studies if their use is not reimbursed appropriately, and if reimbursement is insufficient to cover development costs. Radiopharmaceutical-based technology brings a critical value to modern patient care in many medical conditions. We are looking forward to working with the government and all stakeholders to bring our highest value of clinical practice to the patients.”

The letter was addressed to Chairman and Senator Lamar Alexander; Chairman and U.S. Representative Mike Simpson; Ranking Member and Senator Dianne Feinstein; and Ranking Member and U.S. Representative Marcy Kaptur.

Signatories included SNMMI, SHINE, NorthStar, GE HealthCare, Siemens Healthineers, Cardinal Health, the American College of Radiology, the American College of Cardiology, American Society of Nuclear Cardiology, American Cancer Society Cancer Action Network, and Lantheus Medical Imaging Inc.

The Subcommittee on Energy and Water Development did not return requests for comment.