Last week, the D.C. Court of Appeals upheld the FDA’s District Court victory in United States v. Regenerative Sciences, LLC, No. 12-5254. The District Court in Regenerative Sciences held that the FDA had jurisdiction over stems cells extracted from a patient, processed, and then injected in the same patient even if all of these steps took place in the same clinical state. Regenerative Sciences argued that this stem cell activity was not a drug or biologic but, rather, that it was the practice of medicine and that there was no interstate commerce, and therefore no basis for federal jurisdiction.
The District Court, and now the appellate court, rejected both of Regenerative Sciences’ arguments. The appellate court agreed that the stem cell mixture met the definition of a drug and biologic under the Food, Drug and Cosmetic Act and that there were sufficient ties to interest commerce to give FDA jurisdiction. The court relied on the long line of expansive Supreme Court opinions on interstate commerce to conclude that the procedure implicated interstate commerce because the company used as part of the process an antibiotic that crossed state lines. In other words, if a component of an article is in interstate commerce, the article is in interstate commerce.
This case reinforces the FDA’s authority over stem cells and similar materials and further reinforces the difficulty of arguing that an article is not in interstate commerce.