In Law360, Attorneys Analyze FDA Regulation of Stem Cell Clinics

In The News
January 4, 2023

In a Law360 article, life sciences regulatory & compliance partner Joshua Oyster, counsel Beth Weinman and associate Austin Laroche discuss potential implications for future U.S. Food and Drug Administration regulation of stem cell clinics arising from two conflicting federal court decisions in recent enforcement actions brought by the government against two stem cell clinics.

The article summarizes the different outcomes in the cases and discusses the implications for future oversight of such clinics by the FDA and other government regulators, depending on the outcome of a pending 9th Circuit appeal of one of the cases.

The authors note that stem cell clinics that market therapies without sufficient scientific support are likely to continue to face scrutiny, and any instances of patient injury, like those alleged in the relevant enforcement actions, will serve to ratchet up the pressure from regulators.