October 13, 2016
The Nuclear Regulatory Commission (NRC) held the fall meeting of its Advisory Committee on Medical Uses of Isotopes (ACMUI) on October 6 and 7, 2016. The ACMUI typically meets for public meetings during the spring and fall of each year and holds public teleconferences as needed. The ACMUI discussed several topics of importance to SNMMI, including an update on CFR 10 Part 35, training and experience (T&E) requirements, worldwide supply of Molybdenum-99, Germanium/Gallium-68 medical use generator Decommissioning Funding Plan (DFP) update, and enhancing communications with the medical community.
Part 35 Update
NRC staff provided an update on CFR 10 Part 35, Final Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments. The proposed rule was published July 21, 2014, and the NRC received 69 comment letters, including the society's. The ACMUI provided NRC staff with its recommendations on the Final Rule in January 2016 and discussed its recommendations. NRC reported that the final process for publication includes Commission review as well as review and approval from the Office of Management and Budget. The Final Rule will become effective 180 days from the date of publication. The agreement states will have 3 years from the effective date to adopt the final rule.
Training and Experience Requirements
As previously reported in March, an ACMUI subcommittee was formed to address training and experience requirements. The subcommittee proposed two recommendations, one of which was to form a standing subcommittee to review the T&E requirements for all modalities and recommend making changes as warranted. On Friday, October 7, the subcommittee provided a status report to the full Committee. The subcommittee recognized that any recommendations for or against changes in T&E should be made to ensure that the requirements in Part 35 (which ensure radiation safety requirements for the public, workers, patients, and human research subjects) are met, while also ensuring that patient access to procedures is not unnecessarily compromised. Though the subcommittee provided no new recommendations, it did outline a charge, provide considerations, and create a plan to move forward. Going forward, the subcommittee plans
Newly appointed ACMUI member and nuclear pharmacist, Richard Green, RPh, BCNP, provided a presentation on Worldwide Supply of Molydenum-99. Mr. Green reported that several factors undermine the future availability of Mo-99 in the U.S., which consume approximately half of the world's supply of the medical isotope Mo-99. Currently, only seven reactors provide Mo-99 worldwide and most are over 40 years old. Mr. Green also reported that there are possible new U.S. producers, however, challenges are present with irradiator disruptions (permanent shutdown at NRU and OSIRIS) and rising prices.
Concerning the Decommissioning Funding Plan (DFP) for Ge-68/Ga-68, NRC staff have been working on language for a temporary exemption of a DFP while the rulemaking process begins to appropriately regulate Ge-68/Ga-68. Currently, a DFP must be developed by the licensee before it can possess the Ge-68/Ga-68 generator. In July NRC issued License Specific Exemption, exempting the DFP requirement. The NRC has concluded that the planned action will be sufficient to ensure public health and safety, while at the same time allowing access to the radiopharmaceuticals developed from these generators until a permanent regulatory solution is reached through rulemaking. A direct final rule process has been initiated.
ACMUI Chairman, Philip Alderson, MD, reported that the ACMUI has begun outreach efforts to enhance communication with the medical community, including SNMMI. Various ACMUI members were charged with speaking to their respective organizations and encouraged to speak at relevant annual societal meetings. SNMMI has and will continue to engage with ACMUI and looks forward to a possible presentation from an ACMUI member at Annual Meeting.
The notice of the next public ACMUI meeting will be published in a Federal Register Notice, but will likely take place in March or April 2017.
Also of Note: Mallinckrodt Pharmaceuticals and Lantheus Medical Imaging have both sent letters to nuclear medicine professionals stating that they don’t anticipate an increased risk of isotope supply shortage and explaining the steps taken to secure the supply of Mo-99. Read the Mallinckrodt letter and the Lantheus letter.
In addition, the Council on Radionuclides and Radiopharmaceuticals (CORAR) issued a press release affirming that "the risk of a substantial shortage of Mo-99 in the next five years is overstated."