Federal Court: Stem Cell Prep Is Subject to FDA Drug Regulation

In a case with ramifications for the emerging field of stem cell medicine, a federal district court has ruled that a stem cell preparation offered by a Colorado stem cell clinic met the classification of both a “drug” or “biological product” - and therefore subject to federal regulation by the FDA. The case posed the general issue of when a biotechnology-related procedure was no more than the practice of medicine – state and professionally-regulated – or whether the use of a novel biotech product (the stem cell preparation) triggers federal drug regulation as enforced by the FDA. In U.S. v. Regenerative Sciences (D.D.C. 2012), the FDA asked a court to order the company to stop performing the Regenexx stem cell treatment it offered to patients suffering from a number of musculoskeletal conditions, because it involved the use of an unapproved drug (stem cells). The procedure involved withdrawing bone marrow from a patient, extracting mesenchymal stem cells from the patient, and processing the cells to create a therapeutic preparation for injection to a site of interest, with a goal of restoring function to impaired joints. This is an “autologous” stem cell treatment – the patient’s own cells are used; immune rejection should be avoided. The FDA argued that the stem cell preparation used by Regenerative became a ‘drug”– subject to existing federal regulation by the FDA under the Federal Food Drug and Cosmetic Act (FDCA). The judge found that the interstate commerce requirements to invoke federal jurisdiction were met, as the stem cell preparation included an antibiotic that had been procured out of state. The judge rejected the argument of Regenerative that the procedures used to product the stem cell preparation constituted “minimal manipulation.” In contrast, the judge recited the techniques used to take the harvested cells from the patient and distill it down to the stem cell population, and regarded them as extensive enough to support the FDA’s argument that the stem cells met the “drug” classification. In addition, the judge also reviewed several FDA inspections of the facility which revealed a failure to comply with good manufacturing practices (GMP); such deficiencies supported the FDA’s further assertion that the Regenexx product was “adulterated.” Two definitional questions were posed in the case – were the stem cells a drug, regulated under the FDCA, and/or were the stem cells a biological product regulated under the Public Health Services Act (PHSA)? In both cases, the answer was yes. The stem cells performed as an “article” intended to impact patient health, and are also a biologically-derived product, subject to the separate requirements that such products must meet. Because the company had not sought FDA approval to use this product, the FDA sought a permanent injunction to stop Regenerative from offering the stem cell procedures, and it was granted. The company intends to appeal. This case provides a foundation for the FDA to assert its jurisdiction over many such clinics in the U.S. which are providing such services, using the FDCA. The FDA has been stepping up its oversight and investigations of stem cell clinics in the U.S.,  including the issuing of a 2012 critical report on Celltex, a Texas based stem cell clinic (where Gov. Rick Perry received treatment); the FDA found numerous manufacturing deficiencies that undermined the legitimacy of the claims made for its stem cell products. With this new ruling in hand, the FDA can now use the FDCA to target stem cell clinics where the treatment involves more than a “minimal manipulation” of biological materials – and it remains to be seen whether any of the treatments that use a patient’s own cells will meet that standard and escape the FDCA.