A recent decision by the United States District Court for the District of Columbia touches on several FDA issues. In U.S. v. Regenerative Sciences, LLC, U.S. District Judge Rosemary Collyer considered a Complaint challenging FDA's determination that the company's "Regenexx Procedure," which uses a patient's stem cells from his or her own bone marrow to treat joint, muscle, tendon or bone pain, constitutes a drug or biologic subject to FDA regulation.
The company contended that the procedure is merely an intrastate method of medical practice subject only to the laws of the state of Colorado.
After considering the definitions of "drug" and "biologic product" and the concept of "intended use," the court held that the Regenexx Procedure meets the statutory definition for both a "drug" under the Federal, Food, Drug and Cosmetic Act and a "biological product" under the Public Health Service Act. The court next considered whether the Regenexx Procedure meets the regulatory definition of "minimal manipulation" applicable to certain human cells, tissues, or cellular- or tissue-based products ("HCT/Ps"), such that it should be regulated solely as a biological product and not as a drug. "Minimal manipulation" is defined as processing that does not alter the relevant biological characteristics of cells or tissues. Referring to the processing of cultured cell product and the culture and expansion of blood-forming and rare bone marrow stromal cells, the court concluded that the biological characteristics of the cells change during the process employed by the company, resulting in more than minimal manipulation of the HCT/Ps originally extracted from the patient. The court also held that FDA's determination that the Regenexx Procedure does not meet the regulatory definition of "minimal manipulation" is entitled to "substantial deference."
The court also held that the company's activities satisfied the element of interstate commerce under the Federal, Food, Drug and Cosmetic Act, notwithstanding that the entire process takes place in Colorado, because it uses components (doxycycline) shipped from out of state.
Finally, the court rejected Regenerative Sciences' argument that FDA cannot regulate the Regenexx Procedure because it constitutes the practice of medicine, concluding that "[t]here is a difference between a licensed physician's use of an FDA-approved drug such as doxycycline in an off-label way, which is permissible within the practice of medicine" and "adding doxycycline to a cell product to be administered to patients, which renders the latter a drug that has connections to interstate commerce."
In granting FDA's motion for summary judgment and entering a permanent injunction, the court found the Regenexx Procedure to be adulterated (under drug cGMPs) and misbranded (failing to bear "Rx only," lacking adequate directions for use, and other labeling deficiencies).
The case is United States v. Regenerative Sciences, LLC, Civil Action No. 10-1327 (RMC); U.S.D.C.; July 23, 2012.
Donald Segal is a partner in the Food, Drug, & Device/FDA Practice of Alston & Bird LLP and can be contacted at donald.segal@alston.com or (202) 239-3449.