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.
During the case, Regenerative claimed that the cells in its Regenexx procedure are not significantly modified before they are reinjected, so the procedure should be considered routine medical practice. The company also argued that because all the processing work is done in Colorado, the procedure should be subject to state law, rather than to regulation by the FDA, Nature notes. But a federal judge disagreed.
The filings by Regenerative confirms "their intentions to use the Regenexx Procedure for 'mitigation' and 'treatment,' among others, of disease and injury. They explain how the 'stem cells... begin to repair the patient’s degenerated or injured area;' how the Regenexx Procedure is 'for the treatment of orthopedic injuries and arthritis,' and how 'the procedure is for the treatment of musculoskeletal and spinal injury,” wrote US District Judge Rosemary Collyer.
"These statements of 'intended use' fully satisfy the statutory definition for a 'drug. Similarly, admissions that the Regenexx Procedure is based on mesenchymal stem cells derived from the patient’s bone marrow and that it is intended to treat orthopedic conditions fully satisfy the definition of 'biological product' under the Public Health Service Act because it is a 'blood, blood component or derivative,...or analogous product... applicable to the prevention, treatment, or cure of a disease or condition of human beings” (here is the ruling).
"It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a ‘manufacturing process’ that includes risk of transmission of communicable diseases,” Leigh Turner, a bioethicist at the University of Minnesota tells Nature. “Maintaining the FDA’s role as watchdog and regulatory authority is imperative.”
One of the Regenerative founders, however, tells Nature he plans to appeal and will, meanwhile, continue to offer three other procedures, although the magazine writes that the FDA has not approved these procedures, and Centeno did not provide documentation to support his claims that the agency views the three treatments as outside its purview. The graphic was removed after Nature asked about approval (here is the company web site).
fight pic thx jnyemb on flickr