The U.S. Nuclear Regulatory Commission (NRC) is requesting additional public comments regarding possible ways to address authorized user (AU) training and experience (T&E) requirements for radiopharmaceuticals requiring a written directive. The NRC will also host two additional public meetings on May 14 and May 23.
The request, formally issued on May 2, 2019, came less than six months after a November 2018 NRC request for feedback and series of public webinars and meetings on the same controversial issue.
The current request for public comments focuses on specific ideas gleaned from the earlier round of comments, including maintaining the status quo, revising the regulations to create “tailored” pathways for authorized use of specific products and allowing licensed facilities themselves to determine if physicians are qualified to serve as AUs of therapeutic radiopharmaceuticals on NRC and Agreement State licenses. Public feedback on these ideas will help inform NRC staff’s future paper of recommendations to the commissioners.
The American College of Radiology (ACR) has repeatedly expressed opposition to the controversial concept of weakened T&E requirements for AUs of therapeutic and theranostic radiopharmaceuticals.
On January 29, 2019, The ACR submitted a detailed comment letter to NRC arguing against rulemaking to created limited-scope AU pathways. Among the many quality- and radiation safety-based concerns expressed in the College’s letter was the belief that “the limited-scope AU concept could foster an environment of financially-motivated utilization, conflicting with the broadly accepted standard of cancer care of a multidisciplinary team of subspecialized experts working collaboratively to provide the right treatment, at the right dose, at the right time.”
Also in January 2019, Paul E. Wallner, DO, FACR, a member of the ACR’s Federal Regulatory Committee (FRC) issued an ACR Voice of Radiology blog that challenged the unsubstantiated claim of an AU shortage by pointing to approximately a thousand trainees who are now moving through the traditional T&E pipelines to soon meet the prerequisites to serve as radiopharmaceutical therapy AUs.
The ACR’s FRC established a multidisciplinary ad hoc working group in early 2018 to develop the College’s position on this issue. ACR members interested in providing input to the FRC workgroup should contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at 1-202-223-1670 or firstname.lastname@example.org.