In July, 2012, Rosemary N, Collyer, a United States District Court Judge for the District of Columbia, ruled that autologous stem cells re-injected into a person’ body following a acculturation of the cells with the use of another drug product shipped in interstate commerce is a “drug” subject to regulation by the U.S, Food and Drug Administration. The purpose of the re-injection is to stimulate the regrowth of bone, cartilage and other human tissue to regenerate them in lieu of joint transplants and other orthopedic surgical procedures.
In United States of America v. Regenerative Sciences, et al. (C.V. N0 10-1327), the FDA sued the a Colorado Clinic, The Centeno-Schwartz Clinic, and related parties engaging in the stem cell regenerative therapy to enjoin them from providing the therapy without first obtaining lengthly and expensive FDA approval for the “drug” and the process. This seems roughly equivalent to pounding a square peg into a round hole. If everybody’s stem cell make up is genetically different, presumably everyone interested in the procedure would be required to obtain a separate approval. (Each with its own individualized warnings labels and instructions). With personal, genetic based, designer drugs on the horizon, one seriously wonders whether the FDA is equipped from a practical point of view to engage in the assessment of 21st century biomedical products, or whether it will just kill off future development of personalized drugs with antiquated 20th century bureaucratic responses.
The Defendant Company, Regenerative Sciences, responded to the FDA with several interrelated arguments, that the autologous cells are not a drug that the Colorado clinic was engaged in the intrastate practice of medicine in which the FDA had not right to interfere and that the stem cells were not in the flow of interstate commerce giving rise to federal jurisdiction. The Judge, while admitting it was a “close call”, found in favor of the FDA on all issues and enjoined the procedure in the United States.
The net result of the ruling is that the defendants were forced to move is stem cell acculturated procedure off shore to the Cayman Islands were it is available only to professional athletes, movie stars, medical tourists and the “one percent.” (More limited procedures without the culture process are still available in Colorado.)
At the heart of the lelgal issue is the degree to which stem cells are altered or morphed into a new medical substance. In 1997 the FDA announced a new set of guidelines for dealing with human cell or tissue produces (“HCT/Ps”), which were intended to avoid the imposition of unnecessary restrictions on research, development or availability of new products in this category. Those HCT/Ps that do not meet the criterial of the regulations must be regulated as a “drug, device, and/or biological product.” One important criteria at 21 C.F.R. Section 1271.10(a)(1) is that HCT/Ps be “minimally manipulated,” which is defined as “processing that does not alter the relevant biological characteristics of cells or tissues.” Here we would expect to see a fact finding as to what relevant biological characteristics of the cells were altered.
The courts finding in this respect is disappointing and inapposite. She states in her opinion that the Defendants admit that,
[t]he processing of the cultured cell product involves many steps, including selective culture and expansion of a multitude of different types of blood-forming and rare bone marrow stromal cells using plastic flasks, additives and nutrients, and environmental conditions such as temperature and humidity, to determine the growth and biological characteristics of the resulting cell population.”
In other words they do a lot of stuff to the cells to stimulate growth (don’t forget the plastic flasks). If the only result of the procedures is that the cells are that they are stimulated to grow, is that an “alteration of the relevant biological characteristics.” Is that the thin reed upon which the FDA proposes to crush this useful modality of using one’s own stem cells to avoid greater surgical intervention (not to mention that Medicare’s biggest single procedure expense is currently for knee replacements).
There is no question that but this procedure takes place in intrastate commerce, even though there is precedent for the proposition that if a component of a new product travels in interstate commerce, the Commerce Clause gives jurisdiction to the FDA. Here the question appears to be unanswered as to whether the defendant’s “secret” acculturating factor is a “component” of a drug or is merely a process agent triggering certain pre-existing qualities inherent in a person’s own stem cells. (If all that was done was to aerate or heat the stem cells would it still be a new drug?) Hopefully the Court of Appeals will acculturate a more reasoned and altered opinion.
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