By William T. Koustas –
We have been following the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA for over two years (see here, here, here, here, and here. On Monday, the United State District Court for the District of Columbia ruled in favor of FDA and granted its motion for summary judgment and issued a permanent injunction against the use of the Regenexx Procedure. We will not be surprised if the case ends up in the D.C. Circuit.
As you may recall from prior blog posts, Regenerative is a Colorado company that owns a procedure known as the Regenexx Procedure. It is a non-surgical procedure by which physicians take bone marrow and blood samples from a patient, culture the stem cells, and inject them back into that patient in order to treat joint, muscle, tendon, or bone pain. Regenerative states that the Regenexx Procedure is exclusively licensed for use by a particular Colorado clinic where its inventors practice.
While explained in more depth in our prior blog posts, FDA essentially argued that the Regenexx Procedure is a drug under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and must therefore only be performed pursuant to a New Drug Application and under current Good Manufacturing Practices (“cGMP”). By contrast, Regenerative argued that the Regenexx Procedure is the practice of medicine, which is outside of FDA’s jurisdiction and is not introduced or delivered for introduction into interstate commerce since the entire Regenexx Procedure is performed within the borders of Colorado. FDA countered that this procedure was introduced into interstate commerce because one or more of its components is shipped via interstate commerce and because it substantially affects interstate commerce by depressing the market for FDA-approved out-of-state drugs by encouraging individuals to travel to Colorado to have the Regenexx Procedure performed instead.
The Court ultimately sided with FDA, although it called the decision a “close question.” Among other things, the Court found that the Regenexx Procedure is a drug as defined under the FDCA as it determined the procedure is an article intended to treat a condition (i.e., orthopedic pain).
More importantly, the Court ruled that the FDCA provides FDA with jurisdiction over the Regenexx Procedure despite the fact that it is done entirely in Colorado. The Court held that, “because a component of the [Regenexx Procedure] shipped through interstate commerce prior to its administration to the patient,” the interstate commerce FDCA requirement had been satisfied. Memorandum Opinion at 15. The component the Court referred to is a prescription drug used to process a patient’s stem cells. Therefore, the Court found that the Regenexx Procedure is a drug that is held for sale and introduced into interstate commerce.
It should be noted that the Court only found that the Regenexx Procedure was introduced into interstate commerce because a component used in the procedure moved through interstate commerce. As discussed in a prior blog post, FDA also contended that the Regenexx Procedure substantially affected interstate commerce under the Constitution because individuals traveling to Colorado for the procedure would depress the market for out-of-state drugs. We noted that such an interpretation of the interstate commerce requirement was highly unusual to say the least and would significantly expand FDA’s authority. It is interesting that the Court’s opinion did not even mention that constitutional argument.
Following the interstate commerce ruling, the Court ruled that the Regenexx Procedure is an adulterated and misbranded drug. It is adulterated because it is not “manufactured” in conformance with cGMP requirements and misbranded because the information on the “label” on the syringe that contained the processed stem cells did not include the statutory or regulatory disclosure requirements. The Court also ruled that FDA is not interfering with the practice of medicine by regulating the Regenexx Procedure because FDA is merely attempting to control the availability of a “drug” rather than controlling which approved drug a physician uses.
All of Regenerative’s counter claims were also dismissed by the Court.