November 08, 2018

NRC Seeks Input on Weakening Radionuclide Therapy T and E Requirements

The U.S. Nuclear Regulatory Commission (NRC) is requesting feedback and plans to convene a series of public webinars and meetings on the highly controversial, “limited Authorized User (AU)” pathway for the administration of certain therapeutic and theranostic radiopharmaceuticals.

Currently, any physicians who lack NRC-recognized board certification (e.g., medical oncologists, etc.) would need to satisfy prescriptive training and experience (T&E) prerequisites and other specified requirements in 10 CFR 35.390 intended to ensure minimum competency to supervise the medical use of unsealed materials requiring a written directive. By contrast, the limited AU concept under preliminary consideration would involve as-of-yet-unspecified, but assuredly less comprehensive, set of T&E prerequisites that are currently required in 10 CFR 35.390.

The primary purpose of any regulatory changes to 10 CFR 35.390 would be to enable physicians who are not specialized in the use of radiopharmaceuticals and radiation to relatively easily and rapidly become AU-eligible on a radionuclide-specific basis.

Radiopharmaceutical manufacturers have lobbied the NRC for years to weaken its T&E requirements to ostensibly address what they argue is a regulation-caused underutilization of therapeutic radiopharmaceuticals. Historically, these arguments have not held under scrutiny, and medical licensees have not reported problems with Part 35.300 AU shortages; however, the Commissioners have made exploration of this topic a recent priority for further exploration with exceedingly negative implications for patient care quality as well as public health and safety.

The American College of Radiology (ACR) challenged industry’s arguments in a July 2018 verbal statement and an August 2018 letter to the political leadership of the NRC. The ACR’s comments stressed the multifactorial drivers of cancer care decision making, the safety risks and regulatory oversight issues with establishing a limited AU pathway, the need to collect more public input from the medical licensee community and the need to address the lack of trustworthy evidence to justify any future rulemaking on this controversial issue.

To that end, the NRC published a Request for Comments (RFC) in the October 29, 2018, Federal Register, with direct and indirect questions designed to collect information from public stakeholders on the limited AU concept under consideration. The ACR’s positions were also addressed in two separate articles in the August 30, 2018 and September 27, 2018, issues of Advocacy in Action.

The NRC also plans to convene town hall-style meetings and webinars on November 14 and December 11, 2018, and January 10 and January 22, 2019, to collect necessary input. Following these and other information-gathering efforts, the agency will decide whether to pursue regulatory changes in the next year or so.

A multi-specialty workgroup of the ACR Federal Regulatory Committee has been working on this issue for most of the past year. As always, the ACR Government Relations team welcomes feedback from interested members. Detailed input on the explicit RFC questions would be particularly beneficial. To provide feedback, contact Michael Peters, ACR director of regulatory and legislative affairs, at or 202-223-1670, ext.4546.

Additionally, ACR members involved in radiopharmaceutical therapy are encouraged to participate in one or more of the following public webinars to provide NRC with their personal perspectives on the RFC questions: