By William T. Koustas –
The litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA may have come to an end on Tuesday, February 4th, when the United States Court of Appeals for the District of Columbia Circuit ruled against Regenerative, concluding that FDA has the authority to regulate certain autologous stem cell procedures. The D.C. Circuit affirmed the lower court’s decision granting summary judgment to the government, dismissing Regenerative’s counterclaims, and permanently enjoining Regenerative’s operations.
Regenerative is a Colorado company that owns a medical technique known as the Regenexx Procedure, which for the purposes of this case we understand is limited to a non-surgical procedure by which physicians take bone marrow and blood samples from a patient, culture the stem cells, mix the cultured cells with doxycycline, and inject the stem cell mixture back into the same patient in order to treat joint, muscle, tendon, or bone pain. This procedure is exclusively licensed for use by a Colorado clinic where its inventors practice.
Our prior blog posts on this case provide more background (see here and here for example), but in essence, FDA’s litigation stance was that the stem cell mixture used in the Regenexx Procedure was a drug under the Federal Food, Drug, and Cosmetic Act (“FDCA”), thus imposing current Good Manufacturing Practices (“cGMP”) and labeling requirements applicable to all drugs. On the other side, Regenerative argued that FDA had no authority over the Regenexx Procedure because it involved the practice of medicine, which is outside of FDA’s purview, and because the stem cell mixture was not introduced or delivered for introduction into interstate commerce.
The D.C. Circuit upheld the district court’s decision, frequently relying on long-standing principles of food and drug law. The court first found that the stem cell mixture met the definition of drug contained in the FDCA as it was “an article derived mainly from human tissue intended to treat orthopedic diseases and to affect musculoskeletal function.” Slip Op. at 6. In addition, and perhaps of more consequence, the court disagreed with Regenerative’s argument that FDA was interfering with the practice of medicine by preventing physicians from performing autologous stem cell procedures. The D.C. Circuit described this argument as “wide of the mark,” clarifying that FDA was seeking to regulate the stem cell mixture and not the procedure itself. Id. at 7.
The court also rejected Regenerative’s argument that FDA lacked jurisdiction over the stem cell mixture given that the Regenexx Procedure is performed entirely within the State of Colorado. Unsurprisingly, the court restated the well-known principle that the interstate commerce requirement of the FDCA is satisfied if a component of a product is shipped in interstate commerce prior to its administration to a patient. Id. at 9. The court also seemed to agree with FDA’s position that the interstate commerce requirement could be satisfied simply because the stem cell mixture would “undoubtedly have effects on interstate markets for orthopedic care . . . .” Id. at 8.
The D.C. Circuit also dismissed Regenerative’s argument that the stem cell mixture was a human cell, tissue, or cellular and tissue-based product (“HCT/P”), and thus exempt from manufacturing and labeling requirements. The court found that the stem cell mixture was likely more than “minimally manipulated” “[b]ecause [Regenerative] concede[d] that culturing [stem cells] affects their characteristics and offer[ed] no evidence that those effects constitute only minimal manipulation, they fail to carry that burden as a matter of law.” Id. at 12.
After summarily rejecting Regenerative’s arguments, the D.C. Circuit ruled that the stem cell mixture was adulterated and misbranded. The court found that the stem cell mixture was adulterated because it was not “manufactured” in conformance with cGMP requirements, and that they were misbranded because the information on the “label” on the syringe that contains the stem cell mixture did not include “adequate directions for use” or bear the “Rx only” symbol. Id. at 14-15.
Although the court upheld the permanent injunction, it did so only after analyzing whether there was a reasonable likelihood of further violations in the future. Id. at 18. While the court determined that such likelihood existed in this case, this suggests that a violation of the FDCA, in and of itself, does not automatically necessitate injunctive relief but must be considered based on the facts of each case.