August 30, 2018

ACR to NRC: Scientific Basis Needed to Justify Radiopharmaceutical Therapy T&E Changes

On August 27, 2018, the American College of Radiology (ACR) urged each of the five commissioners of the U.S. Nuclear Regulatory Commission (NRC) in writing to establish a scientific basis for revising training and experience requirements under 10 CFR 35.390 (“Training for use of unsealed byproduct material for which a written directive is required”) prior to pursuing any regulatory modifications that may put public health and safety at risk.

The letter was developed with the guidance and input of a workgroup under the ACR Federal Regulatory Committee comprised of radiation oncologists, nuclear medicine physicians, radiologists and medical physicists.

In the NRC’s current regulatory paradigm, prospective Authorized Users (AUs) for 10 CFR 35.390 uses, without certification from an NRC-recognized board, would need 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training in applicable radionuclide handling techniques and designated subtopics. They would also have to meet various AU-supervised work experience requirements and obtain preceptor attestation of competency. The requirements ensure that physicians other than usual providers of radiopharmaceutical therapy (who would typically be AU-eligible through what is colloquially known as the “board certification pathway”) can adequately perform their responsibilities as AUs of unsealed sources requiring a written directive.

Certain radiopharmaceutical manufacturers have pushed the NRC’s politically-appointed leaders to significantly reduce the 700-hour training prerequisite to enable referring clinicians without subspecialized expertise to more easily become AUs for specific therapeutic and theranostic radiopharmaceuticals. In response to industry lobbying, the commissioners directed NRC’s medical team staff to report to them by August 31 with an evaluation of possible radionuclide-specific, “limited scope” AU pathways. Any future limited AU status could potentially require less extensive training and experience under 10 CFR Part 35.390 for physicians without NRC-recognized board certification, though establishing these pathways would require future rulemaking. The staff evaluation paper is expected to make various recommendations regarding a limited AU concept, most notably highlighting the need for more input from public stakeholders.

Meanwhile, the Advisory Committee on the Medical Uses of Isotopes (ACMUI), which is the NRC’s federal advisory committee of external experts, has been tasked with recommending a potential curriculum and alternative methods for demonstrating competency for those seeking AU status via these conceptual, reduced-scope pathways for physicians without NRC-recognized board certification. The ACMUI’s recommendations may be released and voted on as early as its fall business meeting in September or possibly at a later teleconference or meeting. However, the ACMUI’s proposals would serve as merely advice for the agency staff, and its recommendations could be used, modified or ignored at the NRC’s discretion in any future rulemaking to establish a limited AU concept.

All aforementioned NRC efforts have progressed rapidly with an alarming lack of trustworthy evidence to demonstrate such activities are a justifiable use of limited agency resources (which are funded predominantly through annual fee revenue collected from current medical licensees) or that future regulatory revisions to create a limited AU pathway would be necessary or even helpful in terms of AU accessibility and radiopharmaceutical therapy utilization. Thus, the ACR letter urged the NRC to first address these fundamental questions before making any attempt to revise the regulations.

ACR members with questions or concerns about NRC policy issues should contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at mpeters@acr.org or (202) 223-1670.