by
John R. Fischer, Senior Reporter | July 25, 2018
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.
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