For the past four years, the FDA has been locked in a dispute with a little-known company called Regenerative Sciences that claimed it was a medical practice using stem cells to perform non-surgical procedures. The FDA, however, argues the procedure actually amounted to the use of drugs that were never approved under a biologics license application or new drug application. In other words, what Regenerative was doing was unlawful and the agency sought an injunction. After enduring FDA inspections, Regenerative fired back by filing a lawsuit against the FDA, claiming the agency lacked jurisdiction (back story). Now, though, Regenerative has lost its case. While calling it a close call, a federal judge last week ruled in favor of the FDA and agreed the agency has the right to regulate therapies made from a patient’s own processed stem cells, setting the stage for oversight of a largely unregulated field.
