A Colorado company and the Food & Drug Administration may finally be headed to court for a showdown the firm calls a referendum on the watchdog agency’s stance on stem cell regulation.
The FDA wants an injunction against Broomfield, Colo.-based Regenerative Sciences LLC to stop it from using a cultured stem cell product as part of a procedure the clinic uses to treat patients with acute orthopedic ailments, which the agency said is “not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.”
Regenerative Sciences cultured cell product is derived from a patient’s bone marrow or synovial fluid, which is grown, processed, and mixed with drug products outside the body before being injected back into the patient.
The FDA requested the injunction in the U.S. District Court for the District of Columbia, naming Regenerative Sciences and three of its employees, Dr. Christopher Centeno, John Schultz and Michelle Cheever. The injunction seeks to “permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.”
Centeno, Regenerative Sciences’ medical director, told MassDevice that the company has voluntarily stopped culturing the cell products and is looking forward to its court date with the regulatory agency.
“We’ve sued the FDA four times in two years,” he told us. “We were on the offense on this.”
The lawsuit will allow the company to question the FDA’s policy that adult stem cells can be classified as drugs, “when used as part of a medical practice,” Centeno said. “We voluntarily decided to stop doing culturing so it’s not about us, but the FDA’s regulatory authority,” he added.
For its part, the FDA says it’s forcing the company to take a timeout because of violations of current good manufacturing practice and that the product is misbranded “due to the lack of adequate directions for use and the failure to bear the ‘Rx only’ symbol.”
“FDA recognizes the importance of the development of novel and promising new therapies. However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk,” said acting director of FDA’s Center for Biologics Evaluation and Research Karen Midthun in a press release.