The D.C. Circuit Court of Appeals has affirmed a lower court’s grant of the government’s motion for summary judgment and the imposition of a permanent injunction against a Colorado-based company and three individuals for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and Public Health Services Act in the manufacture of a stem- cell drug to treat orthopedic conditions. United States v. Regenerative Scis., LLC, No. 12-5254 (D.C. Cir., decided February 4, 2014). The defendants claimed that the laws did not apply to their “procedure,” which involved the extraction of bone marrow or synovial fluid from a patient to isolate stem cells that would be cultured and re-injected in combination with doxycycline, “an antibiotic obtained in interstate commerce and used to prevent bacterial contamination.”
The appeals court rejected the defendants’ claim that their “mixture” is a medical procedure and not a drug or biological product, finding the laws’ definitions sufficiently broad to encompass “an article derived mainly from human tissue and intended to treat orthopedic diseases and to affect musculoskeletal function.”The court also rejected their “flawed syllogism”: “the FDCA was not intended to infringe on states’ traditional role in regulating the practice of medicine; the Procedure fits Colorado’s statutory definition of the ‘practice of medicine’; therefore, the FDA’s [Food and Drug Administration’s] regulation of the Procedure exceeds the FDA’s authority under the FDCA.” According to the court, the case is not about FDA’s effort to restrict the use of an autologous stem cell procedure, rather the agency’s focus is on the “mixture,” which FDA claims is unsafe due to violations of good manufacturing practices and misbranded for failing to include certain information on its label. The court also said that the defendants “are wrong to suggest that the scope of the FDCA depends on state-by-state definitions of the ‘practice of medicine.’”Their interpreta- tion would, in the court’s view, “allow states to gut the FDCA’s regulation of doctors, and thereby create an enormous gap in the FDCA’s coverage, by classifying the distribution of drugs by doctors as the practice of medicine.”
The court further rejected the defendants’ claim that federal regulation was not permitted under the Commerce Clause because the procedure takes place entirely within Colorado. In this regard, the court stated, “not only does the Mixture undoubtedly have effects on interstate markets for orthopedic care, but it actually includes an article shipped in interstate commerce, namely, doxycycline.” Similarly unavailing were the defendants’ arguments that the mixture is exempt from the FDCA’s manufacturing and labeling requirements, with the court finding that (i) the product is more than “minimally manipulated,” and (ii) it does not qualify as a compounded drug. The court concluded by finding that the factors supporting the imposition of a permanent injunction were amply satisfied and showed “a pattern of deliberate, even flagrant violations” of the law.