Bill Would Establish U.S. Medical Isotope Production

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More than 16 million nuclear medical procedures are done in America every year using a medical isotope produced outside the United States. The supply of this isotope has been dramatically reduced by an unexpected shutdown of a Canadian reactor in May to repair a heavy water leak.

The Subcommittee on Energy and Environment of the House Energy and Commerce Committee is now considering legislation to provide federal assistance for the development of this isotope, molybdenum-99. Authored by subcommittee chairman Edward Markey (D-MA), and cosponsored by the subcommittee’s Ranking Republican, Fred Upton (R-MI), H.R. 3276, the American Medical Isotopes Production Act, was the subject of a hearing earlier this month.

There has been long-standing concern about the supply of Mo-99 and its production using highly enriched uranium. The Energy Policy Act of 2005 included a provision requiring the Secretary of Energy to contract with the National Academies to study the feasibility of eliminating HEU in the production of medical isotopes. The National Research Council’s Committee on Medical Isotope Production Without Highly Enriched Uranium issued its final report in January of this year. This 220-page report concluded that both technically and economically this isotope could be produced without HEU, which is now being done in Argentina and Australia. The Vice Chairman of this committee, Steven Larson, testified at the hearing, and reviewed the report’s major findings and recommendations. Among them were steps that the Departments of Energy and State, the Food and Drug Administration, and the U.S. Congress should take to encourage isotope production with Low Enriched Uranium that could likely be accomplished in a seven to ten-year phase-out period. Larson explained that several of these recommendations are included in H.R. 3726.

Also testifying at this hearing was Parrish Staples, Director of the Office of European and African Threat Reduction, Global Threat Reduction Initiative, National Nuclear Security Administration. He told the subcommittee that HEU could be used by terrorists or rogue states to produce nuclear weapons or explosive devices. Staples described NNSA’s efforts to convert 57 research reactors from using HEU to LEU fuel. He told Chairman Markey and the subcommittee that “The American Medical Isotopes Production Act of 2009 is crucial to ensuring the success of these efforts to accelerate development of a domestic supply of Mo-99 without the use of HEU. This legislation will accelerate greatly the development of a reliable supply of this isotope for use in the U.S. medical community, and further support U.S. objectives to reduce the use of proliferation-sensitive HEU in civilian applications.”

The third witness at this hearing was Michael Duffy who testified on the behalf of Lantheus Medical Imaging and the Council on Radionuclides and Radiopharmeceuticals (CORAR). He described how Mo-99 decays into Tc-99m in a generator that Lantheus produces. The imaging agents produced by the generator are employed in heart, brain, bone, and other imaging procedures. Duffy described the problems that medical providers are having, and submitted written testimony stating “CORAR is supportive of H.R. 3276 and increasing the capacity for medical radionuclides in the U.S.”

H.R. 3276 is thirteen pages long, and begins with several pages of well-reasoned findings outlining the rationale for the bill. It then outlines how the Secretary of Energy “shall establish a program to evaluate and support projects for the production in the United States, without the use of highly enriched uranium, of significant quantities of molybdenum-99 for medical uses.” It authorizes $163.0 million in funding for FY 2010 through 2014. The bill also has sections on exports, domestic medical isotope production, and reports by the Department of Energy and the National Academies of Sciences.

At the hearing on the legislation, Markey began by describing a “crisis in nuclear medicine” that threatens the health care of Americans. He spoke of the fragility of the foreign reactors supplying the United States with medical isotopes, estimating that the current shortage is impacting 80 percent of doctors and their patients. Markey called for a robust domestic production of medical isotopes, sentiments which were endorsed by Ranking Republican Upton who said “we are really at a crisis,” adding that he hoped the bill would move quickly. After a round of questions about the provisions of the legislation, including discussion about how rapidly the conversion from HEU to LEU could be made, Chairman Markey adjourned the hearing.

During the hearing, Markey cited a number of letters in support of the legislation. One of these letters was from the American Association of Physicists in Medicine, which is a Member Society of the American Institute of Physics. The July 15 letter signed by AAPM President Maryellen L. Giger describes the difficulties nuclear medicine professionals have encountered, resulting in the delay or cancellation of imaging procedures. The letter then states: “Your bill, the American Medical Isotope Production Act of 2009, will help patients who rely on medical imaging for the treatment and diagnosis of many common cancers by authorizing funding and providing a clear road map to create a domestic supply of Mo-99 while also allowing a responsible timeline and safeguards for the transfer of HEU to low enriched uranium (LEU); therefore, AAPM endorses the American Medical Isotope Production Act of 2009.”