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Appeals Court Upholds Ruling that FDA Can Regulate Therapeutic Stem Cells

Friday, February 07, 2014
Sandler, Travis & Rosenberg Trade Report

In a Feb. 4 decision, the U.S. Court of Appeals for the District of Columbia Circuit upheld a lower court decision in ruling that the Food and Drug Administration can regulate stem cells cultured outside the human body and used for therapeutic purposes.

The court rejected the plaintiff’s argument that the procedure at issue was nothing more than the routine practice of medicine, which is regulated by individual states and beyond the FDA’s regulatory authority. This procedure, which was promoted as an alternative to surgery for various orthopedic conditions, involves the extraction of bone marrow or synovial fluid from the patient, isolation of the mesenchymal stem cells, culturing the cells in vitro, adding (among other things) an antibiotic to prevent bacterial contamination, and then reintroducing the mixture into the patient. The three-judge panel unanimously ruled that while the procedure may amount to the practice of medicine, the mixture itself is a drug and thus regulated by the FDA. The court also rejected arguments that FDA regulation of the mixture violates the Commerce Clause of the Constitution.

“The court’s conclusion that the FDA can regulate aspects of the practice of medicine that have historically been understood to be subject only to state regulatory jurisdiction will come as a disturbing surprise to many physicians, particularly those engaged in using innovative stem cell techniques in their practice,” said Arnold I. Friede, senior food and drug law attorney for Sandler, Travis & Rosenberg, P.A. “But the court construed the Federal Food, Drug and Cosmetic Act broadly as quite clearly encompassing the practice of medicine, with certain statutorily enumerated exceptions. In essence the court said that while the FDA has elected in most instances to defer regulation of the practice of medicine to the states, this does not erode the agency’s underlying authority to regulate on its own.”

ST&R will continue to follow developments in this important area of the law. For more information, please contact Arnold Friede at (305) 894-1033 or Shelly Garg at (305) 894-1043.

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