US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case
Federal judge denies government’s request to permanently enjoin California stem cell clinic from administering unapproved stromal vascular stem cell treatments, concluding they are not ‘drugs’ under the FD&CA. Ruling runs counter to decision in similar case involving a Florida stem cell clinic.
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That statutory regulatory language never quite keeps up with change in science is an ‘existential crisis,’ former FDA official says. California district court ruling preventing FDA enforcement action against stem cell clinics was ‘a little bit disrespectful to the agency.’
Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.
Pew Charitable Trusts calls for FDA to take more aggressive enforcement against regenerative medicine products, but the outcome of a bench trial involving two stem cell clinics may limit what the agency can do.