On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the disease—that were discovered during an FDA inspection at StemImmune Inc., a San Diego, California company that purports to specialize in “immune-oncology.” Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.

According to the government’s Complaint for Forfeiture, the vaccine was combined with stem cells to create an unapproved treatment for late-stage cancers. The government alleges that the stem cell/ACAM2000 combination contained ACAM2000 at several times the approved dose and was administered intravenously to potentially immune-compromised cancer patients, despite express warnings in ACAM2000’s FDA-approved labeling that the vaccine not be administered intravenously and not be used in individuals with severe immune deficiency. In addition to potential harm to individuals who received the unapproved treatment, the complaint states that the use of live vaccine created a risk that the vaccinia virus could be transmitted to people in close contact with those individuals.

In an announcement of the seizure action, FDA Commissioner, Dr. Scott Gottlieb, took a strong stance against establishments such as StemImmune as “unscrupulous clinics” making “audacious but ultimately hollow claims” in order to take advantage of vulnerable patients. Dr. Gottlieb stated that FDA would pursue both regulatory and criminal enforcement against such companies.

Not long ago FDA took a similarly strong enforcement posture against illegal drug-compounding operations—which has resulted in numerous enforcement actions and continues to be a focus of FDA inspectional resources and compliance activities to this day. So the question is—are more enforcement actions coming in the near future against therapeutic stem cell operations that are not in compliance with FDA requirements?