On March 13, 2012, the compliance office within the Center for Biologics Evaluation and Research (CBER) at FDA sent a Warning Letter to IntelliCell Biosciences, Inc., alleging that the firm’s IntelliCell™ process, based on acquiring adipose-derived stem cells and resulting in stromal vascular fraction, is a biological drug regulated under the Federal Food, Drug, and Cosmetic Act. The letter reflects FDA’s interest in expanding its regulatory authority over products under the Federal Food, Drug, and Cosmetic Act (FDCA) to encompass health care services, including clinical laboratory testing and regenerative medicine procedures involving autologous use of stem cells and other human cellular and tissue-based material.
FDA’s authority is currently being challenged in United States v. Regenerative Sciences, LLC, No. 10-CV-01327 (filed Aug. 6, 2010, D.D.C.). That case involves FDA’s efforts to regulate under the FDCA a group of Colorado physicians using autologous stem cells to treat musculoskeletal and spinal injuries. The physicians assert that their use of stem cells constitutes the practice of medicine and therefore is beyond the scope of FDA’s regulatory authority. FDA has also continued to assert authority to regulate clinical laboratories under the medical device provisions of the FDCA, despite Congress’s enactment of legislation specifically applicable to such laboratories. Regenerative medicine is thus not the only area of practice in which FDA has sought to expand the scope of its authority.
The Warning Letter resulted from an inspection of IntelliCell’s New York facility in November and December and asserts violations arising out of the company’s procedure for isolating stem cells from adipose tissue samples using a proprietary ultrasound process. The stem cells are returned to doctors for use in the same patients from whom the samples were obtained (so-called “autologous” use). According to the Warning Letter, the stem cells are Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Some HCT/Ps are regulated solely under the Public Health Service Act, while others are also regulated as drugs or medical devices under the FDCA.
The Warning Letter contends that IntelliCell’s procedure is a biological drug manufacturing process on the ground that (1) the ultrasound process constitutes more than “minimal manipulation” of the cells because it alters the characteristics of the cells that would be relevant in their transplantation for reconstruction, repair, or replacement in a recipient, and (2) a YouTube video promotes the procedure for uses—such as treatment of wrinkles, osteoarthritis, and gum recession—that go beyond reconstruction, repair, or replacement (“non-homologous use”).
The Warning Letter, which is available here, also alleges numerous good manufacturing practice deficiencies, as well as violations of the good tissue practice regulations.