Federal judge Rosemary Collyer has ruled that stem cell therapy for orthopedic patients constitutes a drug—a ruling that exposes manufacturers to liability for adulteration and misbranding. According to Ryan Abbott, writing July 16 for Courthouse News Service, the Food and Drug Administration has, since 2008, argued its position that the stem cell procedure should be classified as a drug, making it subject to Federal Food, Drug and Cosmetic Act regulations.
This case is the latest round in Regenexx’s battle to be able to provide autologous stem cell therapies to their clients. In January 2011, the U.S. government filed a motion for summary judgment and made the claim that there was no issue of material fact in the case since, in their view, Regenexx was manufacturing a “drug” (the cultured stem cells) and selling it “after one or more of its components have been shipped in interstate commerce.” The government also argued that Regenexx did not comply with current Good Manufacturing Practices.
The government also argued that the autologous stem cells were misbranded since they did not bear the symbol “Rx only” and do not have adequate directions for use.
Regenexx countered by saying that the practice of medicine is outside of the FDA’s jurisdiction and that the FDA may not “interfere with a physician prescribing lawfully marketed products for uses other than those for which they are approved, licensed, or cleared by FDA, the agency’s role in determining the availability of therapeutic products inevitably affects the options available to practitioners seeking to use or prescribe those products.”
The Government’s lawyers then answered by saying that while it is true that the FDA may not directly interfere with a physician’s prescribing habits, it CAN limit what drugs are available to physicians to prescribe in the U.S. market. Therefore the Government argued, the FDA was not impinging on the clinic’s ability to practice medicine as it is only requiring a drug product to be approved for sale in the U.S.
In deciding the case, Judge Collyer wrote, “It is a close question but ultimately the court concludes that the Regenexx Procedure is subject to FDA enforcement because it constitutes a ‘drug’ and because a drug that has been shipped in interstate commerce is used in the solution through which the cultured stem cells are administered to patients.” Collyer permanently enjoined Regenexx from using the procedure, which she described as “a non-surgical procedure for patients suffering from moderate to severe joint, muscle, tendon or bone pain due to injury or other conditions.”
In August 2010, Regenexx accounted for about one-third of the procedures performed by a Colorado-based clinic. The practice argued that Regenexx “constitutes the practice of medicine as defined by Colorado law, ” and that the FDA lacked jurisdiction to regulate it. However Judge Collyer disagreed.
Regenexx and the U.S. Government have now been arguing this case for more than ten years. Parsing out where the government can enter the practice of medicine and where it can’t is still an extremely close call when it comes to the patient’s own cells and tissues. We expect that this fight is still in its middle rounds.
I think there may be some logic in Judge Collyer’s decision to label our autologous stem cells as drugs. For instance, my adrenal glands are capable of manufacturing cortisol which can be extracted, cultured and then injected into me for medicinal purposes. (Reducing inflammation, for example.) However, upon receiving a cortisol injection, a Doctor does not necessarily have to initially extract and then culture from my own adrenal glands. He or she simply needs to draw the drug from out of a vile and into a hypodermic syringe and then inject me with it. Now, that particular manufactured cortisol does fall under FDA regulation/jurisdiction. On the other hand, it seems as though my stem cells are particular only to me and cannot successfully be used in another person without causing extreme side effects for which I would be free of. With manufactured steroids this does not seem to be the case generally speaking. In other words, steroids, like cortisol, work pretty much the same in me as they would any other person whether manufactured by Merck or another pharmaceutical company. In other words, steroids and stem cells appear to be two different animals as far as the label drug goes. If stem cells are drugs then they are certainly different types of drugs than are steroids or anti depressants or blood thinners, for instance. However, I can purchase anti depressants and blood thinners on the open market. I’m not aware of any stem cell based drugs that can be purchased either over the counter or by prescription for, say, conditions like arthritis. In other words, what open market stem cell “drugs” might or could Judge Collyer compare my stem cells to if stem cells are in fact truly drugs in a way that, say, steroids, blood thinners and antidepressants are drugs? After all, part of Judge Collyer’s decision in favor of the FDA was made on the basis of commerce.
And, as far as I know, a proposal for new drugs has to go through the rigors (and expense) of a New Drug Application (NDA) which can cost hundreds of millions of dollars. So, by labeling my stem cells as drugs, I now have the unfair burden of trying to come up with the necessary capital in order to help bring my stem cell based “drug” to market. And that stem cell based “drug” unlike other drugs like steroids, blood thinners and anti depressants would potentially treat only a single person for which those stem cells are particular to. (Namely me)
Perhaps the FDA is going to help the Pharmaceutical industry begin to manufacture a new line of drugs based upon stem cells. But, whose stem cells? And for the moment, it seems as though we have available right now the ability to use our own “body parts” (not “drugs”) to treat ourselves successfully for conditions like arthritis if Regenexx is to be believed.