March 07, 2019

NRC ACMUI Approves Report Rejecting Limited Scope AU Concept

On February 26, 2019, the U.S. Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) approved a report that questions the controversial concept of limited scope Authorized User (AU) pathways for therapeutic radiopharmaceuticals for physicians who have not met the minimum requirements of 10 CFR 35.390 (Training for use of unsealed byproduct material for which a written directive is required).

Representing the American College of Radiology (ACR), Paul E. Wallner, DO, FACR (member, ACR Federal Regulatory Committee) generally supported the ACMUI’s findings and urged NRC medical team staff to follow the committee’s recommendations. The staff is expected to draft a paper on this topic for NRC commissioners to consider later this year.

The controversial “limited scope AU” concept is intended for referring clinicians who are unable to meet current training and experience (T&E) prerequisites in 10 CFR 35.390 to become AU-eligible for the use of radiopharmaceuticals that require a written directive.

Supporters of the limited scope AU concept — primarily manufacturers and suppliers of therapeutic radiopharmaceuticals — argue that a purported AU shortage has reduced patient access to therapeutic radiopharmaceutical agents in rural areas. They suggest a policy to weaken AU eligibility requirements and implement product-specific T&E would improve rural access by bypassing the need for comprehensively trained subspecialists, such as nuclear medicine physicians, radiation oncologists, nuclear radiologists and others.

The ACMUI’s report strongly supported current AU T&E requirements in 10 CFR 35.390 and found no objective evidence of an AU shortage based on the number of AU trainees and other indicators examined during the committee’s assessment of the radiopharmaceutical therapy landscape. It explicitly recommended against NRC implementation of the limited scope AU concept.

During ACMUI discussion, individual committee members warned the NRC about the perils of weakening oversight and pointed to myriad drivers of radiopharmaceutical therapy utilization unrelated to AU T&E requirements, such as the high cost of agents and special considerations for licensed facilities.