December 06, 2018

NRC Hears ACR Objections to Limited Authorized User Idea

In a meeting with Nuclear Regulatory Commission (NRC) Chairman, Kristine L. Svnicki, American College of Radiology leaders argued last week against the concept of watered-down training and education (T&E) requirements for clinicians authorized to perform certain radiopharmaceutical therapies.

Paul E. Wallner, DO, FACR, chair of the multi-specialty ACR workgroup, joined members of the College’s government relations staff in the meeting to oppose the agency’s consideration of a new “limited Authorized User (AU)” status for nominally trained clinicians, who would then be eligible to be named on an NRC (or Agreement State) license for use of specific therapeutic and theranostic radiopharmaceuticals.

The ACR also met with NRC Commissioners Jeff Baran and David A. Wright to express the medical stakeholder community’s concerns about the limited AU concept.

For years, drug manufacturers have advocated for weakened T&E requirements under 10 CFR 35.300 covering physicians who serve as AUs for unsealed materials requiring a written directive. While most AUs of these radiopharmaceuticals receive AU-eligibility through the American Board of Radiology (ABR) or the American Board of Nuclear Medicine (ABNM) certification, the radiopharmaceutical industry’s specific focus is on weakening the “alternate pathway” requirements for referring physicians lacking NRC-recognized board certification for Part 35.300 uses, thereby enabling them to bypass the patient care standard of multidisciplinary teams featuring sub-specialized physicians and staff.

Manufacturers argue that a supposed AU shortage has caused a patient access problem with regard to therapeutic and theranostic radiopharmaceuticals. They say this perceived AU shortage can only be solved by a fast track for non-traditional providers, particularly referring clinicians, to obtain AU eligibility after about 80 hours of training. Industry’s arguments fail to take into consideration the multifactorial determinants of cancer care decisions made by patients together with their physicians.

The NRC and its Advisory Committee on the Medical Uses of Isotopes (ACMUI) have historically countered against these often-repeated claims with evidence-informed arguments. The primary concern from NRC’s regulatory perspective is that limited AUs would pose serious public health and safety risks due to their lack of expertise in radiation and unsealed nuclear materials.

Despite ongoing concerns and opposition from NRC’s medical licensees, the agency began taking a closer look at possible ways to address the manufacturers’ request about a year ago. It is now considering a new concept of “limited AU” status, with less comprehensive T&E prerequisites, that would essentially enable referring physicians to become AU-eligible for a specific therapeutic or theranostic radiopharmaceutical.

The NRC medical team staff is currently gathering information from public comments received in response to a Request for Information as well as from public workshops intended to generate verbal input. The medical team plans to submit its recommendation to the NRC commissioners later in 2019 about whether rulemaking to eventually implement the “limited AU” concept should be initiated. If the agency decides to move forward with regulatory modifications, the rulemaking process could take several years.

Ultimately, the final decision on whether to proceed with rulemaking lies with the five NRC commissioners, each of whom was already knowledgeable about the ACR’s concerns before meeting with ACR leaders. The ACR has provided extensive input on this issue over the past year, including verbal comments to the Advisory Committee on the Medical Uses of Isotopes (ACMUI) in July 2018 and a letter to the NRC commissioners in August 2018.

The commissioners are expected to weigh both sides of the issue again after receiving the results of the NRC medical team staff’s information-gathering efforts.

The College will continue to work with like-minded stakeholders to oppose the limited AU concept for therapeutic and theranostic radiopharmaceuticals. Members with an interest in providing input on this topic should contact Michael Peters, ACR director of regulatory and legislative affairs, at 202-223-1670 or mpeters@acr.org.