AAPS Supports Request for the U.S. Supreme Court to Review FDA Authority to Regulate Certain Stem Cell Procedures
This Bulletin is brought to you by AHLA’s Life Sciences Practice Group.
- July 22, 2025
- Danielle Sloane , Bass Berry & Sims PLC
- Jansen Carver , Bass Berry & Sims PLC
The utilization of stem cells has grown exponentially in recent years, and unsurprisingly that growth attracted regulatory attention from the U.S. Food and Drug Administration (FDA). In United States v. Cal. Stem Cell Treatment Ctr., Inc., the Ninth Circuit overturned a lower court decision by finding that the FDA does have the authority to regulate a stem cell product involving cells collected from a patient, isolated from other cells and implanted back into the patient because it qualified as a “drug” under the Food, Drug and Cosmetic Act (FDCA) and does not qualify for an FDA exemption pertaining to human cells, tissues and cellular and tissue-based products (HCT/P) that are collected and reinserted into the same patient during the same surgical procedure.
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