Congress passes Medical Isotope Production Act

Congress has passed the American Medical Isotope Production Act of 2011 (S. 99) by passing it out of the Senate by unanimous consent and referring it to the House Subcommittee on Energy and Environment. It will be included in the Conference Agreement for the National Defense Authorization Act for fiscal year 2013.

S. 99 was sponsored by Sen. Jeff Bingaman (D-NM), chair of the Senate Committee on Energy and Natural Resources, and Sen. Lisa Murkowski (R-Alaska).

The legislation will establish a technology-neutral program to support the production of molybdenum-99 (Mo-99) for medical uses in the U.S. by non-federal entities. It also calls for the U.S. to phase out the export of highly enriched uranium for the production of medical isotopes over a period of seven years.

“Sens. Bingaman and Murkowski have shown unwavering commitment to ensuring a stable isotope supply for the United States,” said Frederic H. Fahey, DSc, president of the Society of Nuclear Medicine and Molecular Imaging, in a statement. “For our patients to receive the best medical care, it’s essential that a reliable supply of Mo-99 be available in the United States. We greatly appreciate their efforts in seeing this bill come to fruition.” Also instrumental in moving the legislation forward were Energy and Commerce Chair Rep. Fred Upton (R-Mich.) and Rep. Ed Markey (D-Mass.).

Mo-99 is an isotope that decays to Technetium-99m (Tc-99m), which is used in more than 16.7 million procedures in the U.S. annually. Tc-99m is utilized in the detection of heart disease, detection and staging of cancer, detection of thyroid disease, study of brain and kidney function and imaging of stress fractures. There are currently eight foreign producers of Mo-99 approved by the FDA to import the product into the U.S.—and no domestic facilities exist dedicated to the production of Mo-99 for medical uses.

The aging foreign reactors regularly experience significant ongoing maintenance issues, frequently causing these reactors to go off-line. In 2009-2010, the U.S. experienced a shortage of Mo-99 that led to the disruption or delay of nuclear medicine procedures for an estimated 50,000 patients each day.