GAO: Energy Department’s Isotope Program Fails to Align Production With Market Needs

·

A Government Accountability Office report publicly released Thursday said the Energy Department’s isotope program is not systematically matching production to market demand or moving quickly enough to address supply risks, leaving medically and strategically important materials vulnerable to disruption.

The report warned that weaknesses in how the Department of Energy manages critical isotopes could ripple into cancer care, national security and domestic industry. Isotopes are used in about 20 million medical procedures each year in the United States, according to GAO, and some are essential for diagnosing and treating cancer. Many are also difficult or unprofitable for private companies to make, making the federal program a key domestic supplier.

The report, titled “Managing Critical Isotopes: DOE Could Better Assess Market Needs and Respond to Risks,” examined the DOE Office of Isotope Research and Development and Production, or IRP, within the Office of Science. GAO said IRP “has not systematically assessed needs or aligned production activities to address those needs.”

GAO found that IRP produced, sold and distributed 265 isotopes during fiscal years 2020 through 2025 and made more than 7,700 shipments over that period, most of them for medical uses. Beyond health care, the isotopes support national security, industrial processes and manufacturing, and quantum science.

The shipment data also show how concentrated the program’s medical role can be. Actinium-225, a radioactive isotope used in cancer-related applications, accounted for 3,820 shipments from fiscal 2020 through 2025, more than half of all IRP shipments in that span. GAO also identified lutetium-177, with 591 shipments, and helium-3, with 583, among the most-shipped isotopes.

GAO said IRP now assesses market needs case by case and manually tracks interactions with customers and industry, rather than using a systematic tool to measure demand and align production. The watchdog agency said that without a more proactive approach, DOE may be too slow to respond when shortages emerge, leaving customers to rely on foreign sources in sensitive countries or face supply problems.

On supply-chain risk, GAO said IRP collects information from industry and other sources but has not developed timely actions to mitigate those risks. According to IRP data cited in the report, the number of isotopes with market disruptions fell from 40 in 2023 to 25 in 2025. Even so, GAO said the United States still relies on sensitive countries for a majority of those remaining isotopes. Supply disruptions could have “real-world implications for cancer patients, national security, and domestic industries,” the report said.

The report also highlighted a missed statutory requirement. Under 42 U.S.C. §18649, DOE was directed to assess domestic isotope requirements and establish an advisory committee within 90 days of Aug. 9, 2022. GAO nevertheless recommended that the Office of Science establish that committee, indicating it had still not been created at the time of the review.

GAO made four recommendations to DOE: develop a mechanism to systematically assess demand, establish the advisory committee required by law, take action to mitigate supply risks, and communicate risks and mitigation efforts to customers.

The report said “DOE concurred with all four recommendations.” According to GAO, the department told auditors it plans to establish the advisory committee by December 2026. DOE also said it aims by October 2027 to put in place a prioritization framework, market-trend tools, a risk-management framework and a five-year strategic plan.

The isotope program’s scale helps explain why GAO’s findings carry weight. The report said DOE received about $170 million in fiscal 2025 appropriations for the program, and IRP officials told auditors it brings in roughly $50 million to $70 million a year in isotope sales revenue.

For many customers, there is no easy backup. As GAO put it, “IRP is the only domestic supplier for many of the isotopes it sells.” That means the agency’s findings were not just about internal management, but about the resilience of supplies used in patient care, federal missions and U.S. manufacturing.

Tags: #doe, #isotopes, #healthcare, #gao