Is the FDA’s Attempt to Oversee Private Stem-Cell Treatments Warranted?

Every year the FDA (and other federal agencies) complain to their Congressional oversight committees that they lack the resources to do the job they were mandated to do, i.e., regulate the products (food, drugs, biologics, and devices) that clearly fall within their authority.  However, despite this constant cry that it is underfunded, the FDA always seems to be willing to stretch its authority and interject itself into new areas where its authority is questionable at best.  One such area of FDA intrusion is private adult stem-cell research, where the agency has taken the position that it has oversight over any stem-cell procedure that reinjects stem cells into the same patient from who they were removed. 

Take the case of  the Regenexx™ Procedure, pioneered by Drs. Christopher J. Centeno and John R. Schultz, which uses stem cell therapies to aid healing for their orthopedic patients. For this endeavor, the two Colorado doctors formed Regenerative Sciences, LLC (Regenerative). Their non-surgical procedure begins with a licensed physician taking a small bone marrow sample from the back of a patient’s hip through a needle. Blood samples are also taken from a vein in the patient’s arm. The samples are then sent to the Regenerative lab (also in Colorado) where the mesenchymal stem cells (MSCs) are isolated from the bone marrow and grown into greater numbers.  MSCs are important in this orthopedic procedure as they give rise to bone cells, cartilage cells, fat cells, and other kinds of connective tissue cells such as those in tendons.  Once the cells pass quality assurance testing, they are reinjected into the patient’s injured area. The stem cells then begin to repair the degenerated or injured area.

Back in July 2008, the FDA sent warning letter notifying Regenerative that the reinjected stem cell product used in the procedure constituted a drug under the Federal Food Drug & Cosmetic Act (21 U.S.C. sec. 321(g))  and a biological product under the Public Health Services Act (42 U.S.C. sec. 262). And because Regenerative had not obtained the necessary FDA drug and biologic approvals for the stem cell product, its actions were possibly unlawful.  Regenerative filed suit in federal court challenging the FDA’s determination that Regenerative is a drug manufacturer.  The FDA contended that Regenerative is subject to FDA enforcement because an antibiotic, doxycycline, is combined with the stem cell product and the doxycycline is shipped from out of state to the Colorado facilities. Therefore, according to the FDA, because a small component of the cell product is shipped through interstate commerce, the agency has jurisdiction to regulate the product as an adulterated or misbranded drug due to Regenerative’s failure to apply for and gain prior FDA approval.  The U.S. District Court for the District of Columbia granted the FDA summary judgment and a permanent injunction against Regenerative’s use of its Regenexx™ Procedure in U.S. v Regenerative Sciences, LLC. The matter is presently before the U.S. Court of Appeals for the District of Columbia. For an excellent analysis of the legal and policy questions raised by U.S. v Regenerative Sciences, see The FDA’s Misguided Regulation of Stem-Cell Procedures: How Administration Overreach Blocks Medical Innovation, by Richard A. Epstein, a columist for Defining Ideas, from the Hoover Institution, contributor to The Wall Street Journal and The New York Times, and visiting scholar at the Manhattan Institute.    

If this decision is upheld on appeal, we must ask, will anything performed in a physician’s private clinical setting remain outside the agency’s authority to regulate? If the courts allow the FDA to hold a physician’s clinical practice to the same standards as a large deep-pocket drug manufacturer, physicians will simply be unable, due to regulatory and monetary constraints, to continue their development of cutting edge treatments to cure many chronic and degenerative diseases.  The FDA’s centralized oversight of these physician-driven clinical treatments could very likely grind them to a halt.  In matters of medical treatment (long held to be a matter between patient and doctor), and especially in situations where withholding treatment is a matter of life and death, that intrusion would be simply unacceptable.