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by Mitchell Fuerst on Categories: fda regulation



Mitchell Fuerst and Andrew Ittleman - Fuerst Ittleman, PL

Stem cells have been the focus of a tremendous amount of recent media coverage. While most of this coverage has been dedicated to the politically charged issue of embryonic stem cells, adult stem cells have moved into a position of prominence in the medical community, while garnering relatively little media attention.

The National Institutes of Health (NIH) defines adult stem cells as those that are “found among differentiated cells in a tissue or organ that can renew themselves and can differentiate to yield some or all of the major specialized cell types of the tissue or organ.” These cells serve to “maintain and repair the tissue in which they are found.” While not as potent as embryonic stem cells, adult stem cells have received widespread praise both for their effectiveness in treating a variety of indications and for their separation from the embryonic stem cell debate.

Autologous stem cell therapies allow a patient to use his or her own adult stem cells to treat a given condition. Generally, these therapies are performed by physicians and involve the removal of stem cells from the patient’s bone marrow or fat, the expansion of the stem cells outside the patient’s body, and the implantation of the cells back into the patient. Autologous stem cell therapies have been used in cosmetic procedures, as well as for the treatment of musculoskeletal injuries, multiple sclerosis, diabetes, Crohn’s Disease and colitis, heart disease, and a host of other conditions.

Pursuant to regulations found at Chapter 1271 of Title 21 of the Code of Federal Regulations, the FDA regulates autologous stem cell therapies in the exact same way that it regulates the mass manufacturing of biological drugs. The FDA purports to derive this power from the Public Health Service Act, which empowers the FDA to draft regulations “necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.” 42 U.S.C. § 264. Thus, when a physician removes a patient’s stem cells and then uses those stem cells to treat that same patient’s medical conditions, the FDA views this as the manufacturing of a biological drug which must be vetted through the FDA’s standard drug approval process before the patient can be treated.

However, some very basic questions confront the FDA’s position. First, given that Congress has never authorized the FDA to regulate the practice of medicine, how can the FDA inject itself into a one-on-one doctor patient relationship? Second, if FDA’s authority is derived from a statute that authorizes FDA to prevent the spread of communicable diseases, how does FDA purport to regulate the autologous use of stem cells? In other words, if a doctor removes stem cells from me and then re-implants those same cells back into me, how does that possibly create a risk of spreading communicable disease? Finally, given that FDA’s drug approval processes are designed to ensure the safety, efficacy and uniformity of millions of doses of drugs to be consumed by millions of people, how would such a process be appropriate for an autologous stem cell therapy? In other words, given that the cells used in such therapies are only used in the patient from whom they were removed, how would a standardized approval process be appropriate? As the American Red Cross has argued, the stem cells used in an autologous stem cell procedure are only as good as the patient from whom they are removed.

All of these questions are at issue in the case of United States v. Regenerative Sciences LLC, which is currently being litigated in the United States District Court for the District of Columbia. In that case, the FDA has alleged that Regenerative Sciences, a medical clinic in Colorado, manufactured unapproved biological drugs when it treated its patients’ musculoskeletal injuries using its patients own stem cells. Regenerative Sciences – which had sued the FDA on two separate occasions seeking to challenge FDA’s regulation of autologous stem cell therapies – has answered the FDA’s complaint and filed eight counterclaims of its own, alleging that its stem cell therapy is highly safe and effective, and arguing that the FDA’s entire regulatory regime governing autologous stem cell therapies is unlawful.

Regenerative Sciences is represented by Mitchell Fuerst and Andrew Ittleman of Fuerst Ittleman, PL, in Miami, Florida. They also represent a variety of other participants in the stem cell industry, both public and private, including medical device manufacturers, cryogenic banking facilities, and physicians engaged in the development of autologous stem cell therapies.

By Mitchell Fuerst and
Andrew Ittleman
Fuerst Ittleman, PL
1001 Brickell Bay Dr., 32nd Floor
Miami, FL 33131

South Florida Legal Guide 2011 Edition

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