Getting Medical Isotopes to Patients

The Breakthrough Institute is engaging extensively as the Nuclear Regulatory Commission (NRC) implements its ongoing wholesale revision of its regulatory framework following Executive Order 14300. The proposed rule on medical use licensing is part of that effort. It aims to remove paperwork and licensing hurdles that stand between patients and the radioactive drugs used to diagnose and treat diseases like cancer.

BTI supports the rule, and several changes should be finalized as drafted. One example is letting hospitals store a wider range of radioactive waste on site until it decays to harmless levels, rather than paying to ship it away for disposal.

The rule removes old requirements on the assumption that one clear national standard will replace them, but in several places that standard is not spelled out well enough to work. The rule opens eligibility to more qualified physicians, for instance, but still lets states keep the old, narrower definition, so a doctor could qualify in one state and not the next. It also loosens supervision requirements without saying who may give patients these treatments. Hospitals are likely to fill that gap with cautious readings, which limits access, especially in rural areas. The comment also asks the NRC to require hospitals to record why they skipped reporting an event, and to confirm hospitals can store batches that take longer than expected to decay, such as those containing longer-lived isotopes.

The rule could also go further. The NRC cited rural patient access to justify loosening supervision rules, but it didn't apply the same reasoning to the question of who can be an authorized user in the first place. BTI thinks states should decide who is qualified to practice, but the NRC shouldn't close off that option. Under the ADVANCE Act, the agency is supposed to avoid rules that unnecessarily limit the benefits nuclear technology brings to society, and expanding who can deliver these treatments is one of the most direct ways to reach more patients.

This rule and the NRC's separate radiation protection rule are both changing the medical regulations at the same time. It is essential they maintain alignment before either is finalized.

Nuclear medicine is where radiation policy touches the public most directly. Closing these gaps would let the rule's improvements work as intended and reach the patients who need them.