July 03, 2019

ACR Responds to NRC on Subpart E AU T&E

On June 27, 2019, the American College of Radiology (ACR) submitted comments to the U.S. Nuclear Regulatory Commission (NRC) regarding its latest request for feedback on various “draft approaches” to Authorized User (AU) training and experience (T&E) requirements for unsealed byproduct material requiring a written directive (i.e., radiopharmaceutical therapy).

The ACR’s comment letter provides an analysis of each of NRC’s draft approaches and recommends that the agency maintain the status quo.

Certain drug companies and a vocal minority of commercial nuclear pharmacies have advocated for significantly weakened AU T&E requirements under 10 CFR 35.390 to obviate any need for referrals to subspecialized radiation oncologists, nuclear medicine physicians and nuclear radiologists. They argue that expensive, higher risk therapeutic radiopharmaceuticals are simple enough to be provided by referring clinicians with nominal manufacturer-provided training. The goal is to increase utilization of these uncommonly used agents by creating a regulatory environment conducive to self-referral.

The agency’s latest request is part of a series of information-gathering efforts to guide a future NRC medical team staff paper of recommendations to the commissioners. The paper will explore each of the draft approaches and ultimately recommend a preferred path forward. Any of the concepts, other than the status quo, would initiate a long, contentious rulemaking process.

ACR members with questions about this topic should contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at mpeters@acr.org | (202) 223-1670.