FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!”January 31, 2012
We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-C™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.
The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Medical Clinic for two reasons:
- Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
- The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”
We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.
This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.
The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits.
The Centeno-Schultz Medical Clinic takes your blood and bone marrow, puts it into a centrifuge machine that separates the stem cells, and cultures it to get more cells before a doctor puts them back in your body to repair damaged tissue. The FDA states that when the stem cells are cultured, they become FDA-regulated drugs. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s bone marrow from his or her own body.
The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.
However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx same-day procedure.
Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.
The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.
Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.
Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”
Editors’ Note: An earlier version of this article reported that when blood and bone marrow were put into a centrifuge to separate the stem cells, the FDA considered the stem cells to be a drug and claimed authority to regulate them. The article has been updated to reflect that FDA only claims authority to regulate as drugs those stem cells which are cultured before being re-injected into the body.