Reinjection of Patient’s Stem Cells Is Drug Regulated by FDA; Agency’s Authority Upheld

The Food and Drug Administration has the authority to regulate as a drug a physician-developed treatment for bone pain that extracts, manipulates and reinserts a patient’s stem cells, the U.S. Court of Appeals for the District of Columbia Circuit affirmed Feb. 4 (United States v. Regenerative Scis., LLC, 2014 BL 29197, D.C. Cir., 12-5254, 2/4/14).

Judge Thomas B. Griffith, who wrote the appeals court opinion, agreed with the district court that Regenerative Sciences LLC’s Regenexx is a drug used in interstate commerce and so subject to the FDA’s regulations. The court rejected the company’s argument that Regenexx constituted ...