An August 6, 2010, announcement from the FDA looks like your average news release, but it's much more. The announcement says the regulator is pursuing a federal injunction against Regenerative Sciences for manufacturing violations that "cause its cultured cell product to be adulterated." The product also is misbranded because it lacks adequate directions for use and the "Rx only" symbol.
It sounds like a warning letter, but it isn't.
An FDA Center for Biologics Evaluation and Research official says via email that "the cultured cell product is adulterated because the methods and facilities used for its manufacture do not conform to CGMP."
The company is actually a Colorado medical clinic that uses a stem cell procedure in its treatment of orthopedic disorders. The company extracts patient bone marrow and then cultures cells, which it mixes with drugs. The treatment--administered in hopes of avoiding surgery--is then injected into the patient.
Regenerative Sciences says that the FDA is not distinguishing between a stem cell treatment and a manufactured drug, that it's trying to apply good manufacturing practices to the production of stem cells. It likens its process, from a regulatory perspective, to in-vitro fertilization, with stem cells taking the place of fertilized eggs. "What we're doing is no different, in principle," says John Schultz, a clinic founder, in a statement.
The company says it wants to clear the matter with the FDA and along with it the stem-cell-treatment vs. manufactured-drug debate. It's been performing the procedure since 2005. Regenerative says it has filed two suits against the FDA, challenging its jurisdiction. Its latest suit seeks a temporary restraining order "to prompt the FDA to take ‘final agency action' or leave its practice alone."
Pharmalot reports that Regenerative says it follows International Cellular Medicine Society guidelines, which the company claims are more appropriate to its process than customary GMP methods of drug making.
- here's the FDA release
- and here's the Regenerative Sciences release
- see the Pharmalot article