March 11, 2016

ACR Supports Pending NRC Rule for Alpha and Beta Emitter Use

The American College of Radiology (ACR) submitted a letter March 7 to the U.S. Nuclear Regulatory Commission (NRC) urging the agency to finalize its long-awaited rulemaking to update its medical use regulations without further delay.

The extensive and largely noncontroversial rulemaking would address many long-standing issues identified by the medical community, including a revised “medical event” definition for permanent implant brachytherapy, the grandfathering of certain board certified professionals to be named on a license for uses they performed prior to the last major NRC medical rule update in 2005 and a new designation of “associate radiation safety officer,” among many other revisions.

However, NRC was recently encouraged by certain radiopharmaceutical manufacturers and affiliated groups to delay the imminent final rule — nearly a decade in the making — to accommodate a last-minute request to decrease the training and experience (T&E) requirements for authorized users (AUs) of alpha and beta emitters, such as Zevalin® and Xofigo®. The manufacturers aimed at reducing the T&E requirements for use of these agents from 700 hours in various radiation and nuclear materials topics to 80 hours for physicians without NRC-recognized board certifications for 10 CFR 35.390 uses. The requested change is intended to more readily enable referring physicians, such as hematologists and clinical oncologists, to obtain AU status for alpha and beta emitters.

Industry’s claim is that an alleged shortage of AUs for use of certain nuclear materials requiring a written directive under 10 CFR 35.390 was created by the agency’s T&E requirements. Manufacturers argued that lowering the bar for referring physicians to obtain AU responsibility for oversight of the radiation safety aspects of these procedures will increase the total number of AUs and increase the use of these agents.

A subcommittee of the NRC’s Advisory Committee for the Medical Uses of Isotopes (ACMUI) questioned industry’s arguments in a fall 2015 report and again in a March 2016 report, by pointing to multiple factors for the perceived underutilization of Zevalin®. They include cost/reimbursement concerns, the rise of competitive alternatives and a general lack of product awareness within the referring physician community. Questions were also posed as to whether decreasing the T&E requirements would drastically increase appropriate utilization of Zevalin® as argued by the manufacturers. The subcommittee pointed out that Xofigo® has not been on the market long enough to discern or analyze its utilization trends.

ACR’s letter to the NRC reiterated the ACMUI’s questions and recommended the agency conduct a public safety assessment of industry’s request and to comprehensively explore industry’s arguments before proceeding with any changes to the alternate pathway’s T&E requirements under 10 CFR 35.390. ACR recommended the agency explore the product manufacturers’ request via a separate process and to allow the current medical use rulemaking, now in the final stages of a lengthy process, to proceed without further delay.