BrioMD Unapproved Cellular Treatment

The CBER Office of Compliance and Biologics Quality says its review of a BrioMD Web site shows that it is marketing “perivascular cells” or “perivascular cellular therapy” for treatment of respiratory conditions, immunologic and autoimmune diseases, neurologic conditions, and musculoskeletal conditions. A 4/28 Notice of Violation says the Hattiesburg, MS, business appears to be marketing a human cell, tissue, or cellular or tissue-based product that does not qualify for a regulatory exception and thus is regulated as a drug and biologic. To lawfully market such a product, the notice says, it must have a valid BLA or IND in effect.

“Your product is intended to treat a variety of serious or life-threatening diseases or conditions,” CBER writes. “Such unapproved uses raise potential significant safety concerns.”

BrioMD was told to respond within 30 days.