Tariffs will have a significant impact on the nuclear imaging supply chain in the US
Leaders of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) told the U.S. Department of Commerce this week that tariffs will likely have a significant impact on nuclear imaging since more than 80% of diagnostic nuclear medicine procedures rely on imported radioisotopes. Society President Cathy Cutler, PhD, FSNNMI, also said moving production of isotopes to the U.S. would be a massive technical undertaking that could take years.
“Despite rising demand, the United States remains heavily reliant on foreign sources for key medical isotopes. Over 80% of diagnostic nuclear medicine procedures depend on technetium-99m (Tc-99m), which is produced from molybdenum-99 (Mo-99). The U.S. consumes more than half of the global Tc-99m supply, sourced exclusively from abroad, and trade stability has been imperative for patients to receive lifesaving nuclear medicine imaging and therapies,” Cutler explained in the letter sent to Stephen Astle, director of the Defense Industrial Base Division Office of Strategic Industries and Economic Security at the Bureau of Industry and Security, U.S. Department of Commerce.
Cutler said the United States imports more than 30 medical isotopes from other nations. That supply chain is especially fragile due to the short shelf life of isotopes and the limited number of suppliers.
“Geopolitical instability, unplanned reactor outages, and adverse weather can further disrupt supply. Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” Cutler said. “In addition, domestic capacity to produce additional medical isotopes depends on specialized equipment produced overseas, such as linear accelerators, cyclotrons, and hot cells. Quickly onshoring the manufacturing of this equipment would be difficult given the complexity of the technology, the infrastructure needed, and the highly trained workforce employed by the current international manufacturers.”
SNMMI's letter was responding to a request for public comments on the impacts of tariffs and the vulnerabilities of the U.S. pharmaceutical industry due to imports. On April 16, public comments were requested through the Federal Register to help in the Secretary of Commerce’s investigation to determine the effects on the national security of imports of pharmaceuticals and ingredients. The Department of Commerce is seeking comments about the impact of current trade policies on domestic production of pharmaceuticals and whether additional tariffs are necessary to protect national security. The department wants to better understand the current and projected U.S. demand for pharmaceuticals, the extent to which domestic production can meet domestic demand, and the role of foreign supply chains.
The Department of Commerce also is trying to assess the risks of the concentration of U.S. pharmaceutical imports from a small number of suppliers. There are concerns that import reliance for drugs or raw materials could enable foreign nations to weaponize their control over these supplies.
This concern was likely raised after China weaponized foreign access to seven rare earth minerals where it dominates the market. China did this immediately following Trump’s announcement of the first round of new tariffs against them in February. Their new exportation restrictions include yttrium, lutetium, samarium, terbium, each of which are used to treat cancers. Gadolinium was also included, which is used for MRI contrast agents.
U.S. radioisotope supply is extremely limited
Isotope supply is not the only area impacted by the implementation of tariffs. Cutler indicated that American radiopharmaceutical producers will also be deeply affected by disruptions in the supply chain for medical equipment, including cyclotrons and particle accelerators needed to domestically produce isotopes. Some larger hospitals and academic centers have this equipment to produce certain types of isotopes, but expansion to enable additional wider domestic production is already limited by the sudden and substantial price increases for these systems due to current tariffs.
“Depending on the specifications, a cyclotron, a machine used to produce radiopharmaceuticals for PET/CT, SPECT/CT, and other imaging procedures, can cost between $2 million and $4 million. These machines are produced by several international manufacturers, using proprietary technology, employing a highly trained and experienced workforce. Even the current 10% tariffs being levied on all nations are impacting American producers and hospitals. A $2 million imaging machine will now cost $2.2 million. This increase will disproportionately impact underserved hospitals in urban and rural areas, which already operate on razor thin budgets,” Cutler explained.
She noted recent breakthroughs in nuclear brain imaging have allowed for better treatment of Alzheimer’s disease, and novel therapeutic agents have created new personalized treatment options for patients with prostate cancer. Advances in theranostics will also soon enable new radiotracers to both image and treat numerous forms of cancer and rare diseases. But Cutler said that progress could be jeopardized by tariffs making these medical breakthroughs too expensive to be widely used.
“Given the delicate nature of the current radiopharmaceutical supply chain, SNMMI believes that tariffs would increase patient costs, reduce access to nuclear medicine procedures, and impact reimbursement for populations on Medicare. We ask the administration to consider deferring future tariffs on the radiopharmaceutical industry while we continue our goal of building a resilient and strong domestic supply chain,” Cutler told the Department of Commerce.
SNMMI offers to help with domestic isotope production policy
The letter ended with an offer by SNMMI to help the administration on policies that would reduce regulatory burdens, streamline licensing and create financial incentives to foster a durable radioisotope business to thrive in the United States. Cutler, chair of the Isotope Research and Production Department at Brookhaven National Laboratory, has been involved in this discussion of creating a new domestic isotope industry, which has been ongoing for years.
For a much lower price, foreign research reactors that make medical isotopes can do so much more than U.S. reactors, so nearly all production has moved outside the U.S. These cheaper foreign production sites are sometimes government subsidized, which has made it very difficult to restart U.S. production, even with federal incentives. The one company that did gain the extensive licensing required to start production, Wisconsin-based NorthStar, quickly ended it because it could not compete with the less expensive foreign price points.
"The Missouri University Research Reactor (MURR) is the only U.S. facility producing Mo-99, and for research purposes only. As a result, the U.S. depends entirely on six foreign research reactors in Europe, South Africa, and Australia for commercial supply," Cutler explained in her letter.
In 2012, the American Medical Isotope Production Act (AMIPA), which aimed to promote domestic production of medical isotopes without the use of highly enriched uranium (HEU), was passed. Despite this, low foreign prices have continued to prevent the U.S. from competing in the industry. The only company left in an AMIPA program created to promote domestic production of Mo-99, Wisconsin-based Shine, just purchased the SPECT division of Lathneus May 7, which could signal movement on that front.
"Despite more than a decade of public-private collaboration and $1 billion in public-private investment between industry and federal agencies, efforts to establish a domestic commercial supply have faced persistent challenges, including high costs, strict regulatory requirements, and long development timelines. These challenges continue to impact current efforts to build a sustainable domestic Mo-99 supply chain," she said.
Cutler explains in more detail in this video interview she did with Health Imaging at RSNA 2024.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]