FDA Court Loss Shows ‘Disconnect’ Between Old Regulatory Language And Cell Therapy Technology

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.’

Disconnect maze
The gap between old regulatory langage and new technology is problematic for FDA regulation of stem cell treatments • Source: Shutterstock

A district court judge’s ruling that the US Food and Drug Administration could not prevent two stem cell clinics from administering unapproved stromal vascular stem cell treatments shows how difficult it is for the agency to regulate novel products.

Eva Temkin, a partner at King & Spalding, noted that one of the problems for the FDA is that it...

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