A RAT by Another Name: 21st Century Cures Act and Stem Cell Therapies

Regenerative medicine (“RM”) is a 21st century technology whose regulation has badly needed a 21st century cure. It is not clear that the 21st Century Cures Act (“Cures Act”) is that cure, but it has not been a poison. For some months prior to the passage of the Cures Act it seemed that it might be a catalyst for really endangering the field by allowing a flood of untested therapies to continue to enter the market. That, fortunately, did not happen. Thus far, the Cures Act has been a useful tonic; its effect on RM has been largely symbolic. But it has allowed the Food and Drug Administration (“FDA”) to redirect resources, and it demanded the quick adoption of guidance. That has allowed the Agency to finalize a regulatory framework that has been sorely needed. The evidentiary flexibility within the Cures Act is extremely important for the development of technologies that do not fit easily into the traditional approval rubric.