IsRegenerative Sciences a drugmaker or a medical practice that simply uses stem cells to perform procedures? This argument has been at the heart of a simmering dispute between the Broomfield, Colorado company, which is run by two enterprising physicians - Christopher Centeno and John Schultz - and the FDA, which is seeking an injunction to cease production.
The battle began two years ago, when the FDA sent a warning letter to Regenerative Sciences, which uses cultured cells taken from patient bone marrow or fluid surrounding the joints, and which are then grown, processed and mixed with drug products outside the body before being injected back into the patient. The FDA 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 so Regenerative filed a lawsuit against the FDA (see this).
In a more recent lawsuit filed two months ago, Regenerative sought to head off the FDA injunction by again claiming the agency, which had recently inspected Regenerative facilities and was about to issue a negative 483 inspection report, has no regulatory authority because the company is practicing medicine and is not a drugmaker (see this).
In its filing, the FDA claims Regenerative violated good manufacturing practices that "cause its cultured cell product to be adulterated, and also misbranded due to the lack of adequate directions for use and the failure to bear the 'Rx only' symbol." The agency argues the cultured cell product was not approved by the FDA, and there are well-controlled studies to demonstrate safety or efficacy "for any indication," according to an agency statement.
UPDATE: On Aug. 9, Regenerative Science issued a statement. This is an excerpt: The Regenerative lab has strictly adhered to the International Cellular Medicine Society’s (ICMS) strict, professional guidelines and has been audited three times by independent third parties with no serious safety concerns. ICMS guidelines are the best fit for autologous cell processing and provide strong patient protection. If the FDA had any valid concerns about our medical practice not using drug factory guidelines, they knew about that in Spring of 2009 and did nothing. They did nothing because there were no safety issues. Their focus on this now is litigation posturing," says Centeno.
“What we're doing in our Colorado medical practice is no different, in principle, than a fertility clinic that uses the in-vitro fertilization technique. The only difference is that we're using stem cells and fertility clinics use fertilized eggs," Schultz says in the statement.
The complaint for the injunction would permanently prevent the company, the two docs and an employee, 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." The FDA also says Regenerative Sciences agreed to cease production while the case is pending.