An Arizona woman who formerly owned a company that sold stem cells to clinics to treat patients with incurable autoimmune diseases, such as amyotrophic lateral sclerosis and multiple sclerosis, has entered a guilty plea to charges that she did so without meeting Food and Drug Administration (FDA) requirements. Fredda Branyon apparently purchased umbilical cords from a birthing facility in Texas, hired a South Carolina medical school professor to help her create stem cells from the tissue, and then sold the stem cells to a Texas medical clinic for use in the treatment of disease.
Because the stem cells were not created in an FDA-approved laboratory or under FDA guidelines, and because their use in treating patients was not approved by the FDA, Branyon was charged with introducing an unapproved new drug into interstate commerce in violation of the Food, Drug, and Cosmetic Act. According to the FDA, Branyon faces up to three years in prison and a fine of up to $10,000. A sentencing hearing has been scheduled for November 18, 2011. See U.S. Department of Justice News Release, August 18, 2011.