An appeals court decision earlier this week against Regenerative Sciences (see story) has “far-reaching implications, particularly for physicians performing a variety of autologous stem cell procedures,” according to an analysis (see below) by attorneys Arnold I. Friede and Shelly Garg (Sandler, Travis & Rosenberg). The appellate judges sided with FDA and a lower court ruling that the clinic’s Regenexx stem cell procedure is a drug within the meaning of the Federal Food, Drug, and Cosmetic Act and thus is subject to FDA regulation. The company claimed that the procedure was solely covered by the practice of medicine under Colorado law, where the Regenerative Sciences clinic is located.
“The conclusion that 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,” the attorneys write. “But the Court construed the Federal Food, Drug, and Cosmetic Act (the Act) broadly as quite clearly encompassing the practice of medicine, with certain statutorily enumerated exceptions; that FDA has elected in most instances to defer regulation of the practice of medicine to the states does not erode the agency’s underlying authority to do so.”
Breaking News: U.S. Court of Appeals Upholds Injunction in Regenerative Sciences Case Involving
Autologous Stem Cell Procedure
by: Arnold I. Friede and Shelly Garg*
In a decision with far-reaching implications, particularly for physicians performing a variety of autologous stem cell procedures, the United States Court of Appeals for the District of Columbia Circuit on Tuesday, February 4, 2014 upheld a broad injunction against Regenerative Sciences and its principals that effectively prohibits the use of the so-called Cultured Regenexx Procedure.[i] The Procedure is promoted as an alternative to surgery for various orthopedic conditions. In summary, it 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 (doxycline) to prevent bacterial contamination, and then reintroducing the Mixture into the donor-patient. Regenerative Sciences primarily argued that this was nothing more than the routine “practice of medicine” regulated by the States and beyond FDA’s regulatory authority.
In surprisingly dismissive terms, a unanimous three judge panel of the Court had little difficulty in rejecting the “practice of medicine” argument, as well as the several other arguments advanced by Regenerative Sciences. It held that, even if the practice of medicine is beyond FDA’s jurisdictional reach, the Mixture itself was regulable by FDA as a “drug”. In this context, the Court accepted as valid the differentiation proffered by FDA between the Procedure used in the extraction and reintroduction of the Mixture from and into the patient, and regulation of the Mixture itself. The former—the procedure—may amount to the practice of medicine, whereas the latter—the Mixture—is no different than any other manufactured drug. Accordingly, according to the Court, FDA has ample jurisdictional reach over the Mixture as an unapproved new drug.
The Court likewise rejected the argument that, even if the Procedure using the Mixture amounts to the practice of medicine, it was for that reason beyond FDA’s reach. The conclusion that 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. But the Court construed the Federal Food, Drug, and Cosmetic Act (the Act) broadly as quite clearly encompassing the practice of medicine, with certain statutorily enumerated exceptions; that FDA has elected in most instances to defer regulation of the practice of medicine to the states does not erode the agency’s underlying authority to do so.
The Court of Appeals likewise gave short shrift to the numerous other arguments advanced by Regenerative Sciences. It deridingly rejected as contrary to the last 70 years of Supreme Court jurisprudence the proposition that FDA regulation of the Mixture was constitutionally infirm under the Commerce Clause. It held that the detailed definitional provisions of the Act in fact covered what it construed essentially as a manufacturing process used to create the Mixture. The fact that doxycycline, which had traveled in interstate commerce, was used in the Mixture reinforced the Court’s conclusion that it was within FDA’s regulatory ambit. The Court likewise rejected numerous technical legal arguments advanced by Regenerative Sciences concluding that none of them individually nor all of them collectively in any way undermine the conclusion that FDA may regulate the Mixture as a drug.
We continue to follow developments in this important area of the law.
* Mr. Friede is Of Counsel, Senior Food and Drug Law Attorney, in the Miami, Florida office of Sandler, Travis & Rosenberg. He is a former FDA Associate Chief Counsel, with more than 37 years experience in food and drug law. He can be reached at AFriede@strtrade.com. Ms. Garg is an Associate in the Firm’s FDA Practice Group with significant experience in representing clients on complex FDA-related matters. She can be reached at SGarg@strtrade.com
