United States v. Regenerative Sciences, LLC, et al.

The government filed suit against appellants, alleging that they violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient's stem cells and the antibiotic doxycycline (the "Mixture"). The Federal Food, Drug & Cosmetic Act (FDCA) 21 U.S.C. 301 et seq., and the Public Health Service Act (PHSA), 42 U.S.C. 201 et seq., are statutes that promote the safety of drugs and biological products, respectively, by setting forth detailed requirements for how such substances are to be manufactured and labeled. The court held that, by virtue of its use of doxycycline, the Mixture was within the scope of drugs - and, by extension, biological products, - regulated by section 331(k) of the FDCA; appellants failed to establish that the Mixture was exempt from the FDCA's manufacturing and labeling requirements; the Mixture was per se adulterated where it was undisputed that appellants' facilities, methods, and controls for processing the Mixture violated federal manufacturing standards in numerous respects; because its label failed to provide the minimum information necessary to qualify for either exemption from section 352(f), the Mixture was misbranded; and the district court properly enjoined appellants from committing future violations of the FDCA's manufacturing and labeling provisions. Accordingly, the court affirmed the judgment of the district court and dismissed appellants' counterclaims. View "United States v. Regenerative Sciences, LLC, et al." on Justia Law