Health and Human Services Secretary Robert F. Kennedy Jr. seems ready to flip the script on Food and Drug Administration oversight of biologics like stem cells.
Normally, the FDA is in the driver’s seat, determining proper oversight and regulations based on its scientific, medical, and legal expertise. However, under Kennedy, the FDA instead looks ready to follow the lead of a hodge-podge of state laws, politicians, and stem cell clinic doctors.
For decades, the agency has rightly set the tone for oversight of stem cells and other regenerative medicine therapies. Sponsors like physicians, biotechs, academics running clinical trials, and state regulators generally followed the FDA’s guidance and federal law.
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