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From Health Law Daily, February 5, 2014

Physician’s mixture of stem cells and antibiotics violated FDA regulations

By Melissa Skinner, JD

A medical therapy using a mixture produced by combining patient stem cells and antibiotics to treat orthopedic conditions is subject to and in violation of FDA regulations. The mixture’s creators argued that the product and process of using this product to treat orthopedic issues are exempt from federal regulations because: 1) those regulations may not be used to infringe on states’ rights to regulate medical practice; 2) the process does is not subject to the Commerce Clause; and 3) the mixture is minimally manipulated and thus exempt from regulation. The court rejected each of these arguments finding that is within the purview of the FDA and the Commerce Clause to regulate the mixture, that the creators’ own concessions indicate it is more than minimally manipulated, and under the federal Food, Drug, and Cosmetics Act (FDC Act) the mixture is per se misbranded and adulterated (USA v Regenerative Sciences, LLC, February 4, 2014, Griffith, T).

Background. Dr. Christopher Centero and Dr. John Schultz jointly created a process called the Cultured Regenexx™ Procedure (the procedure), which is owned and licensed by Centero’s and Schultz’s company, Regenerative Sciences, LLC (“Regenerative”). Michelle Cheever is the laboratory director for Regenerative. The procedure entails extracting a patient’s bone marrow or synovial fluid, isolating the mesenchymal stem cells (MSCs) in that sample, dividing and multiplying the MSCs, combining the multiplied MSCs with the antibiotic doxycycline, and then injecting that mixture back into the patient. The government brought this suit against Regenerative, Centero, Schultz , and Cheever (collectively Regenerative) claiming the mixture was adulterated and misbranded in violation of the FDC Act and the Public Health Service Act (PHSA). The district court agreed with the government and issued a permanent injunction prohibiting further violations of the FDC Act and the Public Health Service Act (PHSA) by Regenerative.

Federalism and Commerce Clause. While Regenerative argued that the mixture is not a drug or biological but a procedure, Regenerative also conceded that the mixture falls within the plain language that defines drugs and biologicals under the FDC Act and the PHSA. Instead, Regenerative urged the court to consider the issue in terms of federalism and asserted that procedure cannot be regulated by the federal laws because that would infringe on the traditional state role of regulating the practice of medicine. The court refused to apply that argument because: 1) it is not the procedure that is the issue in this matter but the mixture, which is properly regulated under the FDA’s authority and 2) the scope of the FDA’s power is not dependent on a state’s definition of the practice of medicine. Further, the court rejected Regenerative’s allegations that because the procedure occurs completely within the state of Colorado, the Commerce Clause should not be invoked to support regulation. Not only does the procedure utilize an antibiotic that is shipped through interstate commerce, the court also noted that for the last 70 years the Commerce Clause has been used to regulate local activities that have a substantial effect on interstate commerce.

Misbranding and adulteration. Regenerative argued that the mixture is exempt from the manufacturing and labeling requirements of the FDC Act as it is only minimally manipulated human cells, tissues, and cellular or tissue-based product. Relying on Regenerative’s own concessions that the mixture is subject to a culturing process that is meant to “determine the growth and biological characteristics of the resulting cell population” and that in some cases substances are added to the mixture to affect differentiation of the cells, the court found that the mixture fails to qualify for that exemption. Additionally, the court also held it is undisputed that, since an exemption does not apply, the mixture’s processing and manufacturing violates good manufacturing provisions under the FDC Act and is per se adulterated. Finally, the court held that the failure to label the mixture “Rx only” constitutes misbranding as a prescription drug is presumptively misbranded unless it qualifies for an exception which is conditioned in part on the use of the “Rx only” label, which the mixture at issue lacks. For these reasons, the Circuit Court for the District of Columbia upheld the injunction against Regenerative.

The case number is 12-5254.

Attorneys: Alisa B. Klein, US Dept. of Justice, for United States of America. William F. Coffield (Coffield Law Group, LLP) and Mitchell S. Fuerst (Fuerst, Ittleman, David & Joseph PL) for Regenerative Sciences, LLC.

Companies: Regenerative Sciences, LLC

MainStory: TopStory CaseDecisions DrugBiologicalNews FDCActNews AdulterationNews CombinationNews LabelingNews MisbrandingNews PrescriptionDrugNews GMPNews DistrictofColumbiaNews

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