For those of you who follow this blog, you'll imagine my surprise to wake up the morning to the following announcement from the FDA:
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FDA NEWS RELEASE
For Immediate Release: August 6, 2010
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
Violations of current good manufacturing practice and labeling requirements cited
The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.
The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.
Regenerative Sciences’ cultured cell product 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.
“FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”
The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would 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.
Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.
The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.
2 comments:
For interesting commentary see:
For other background see:
FDA Stops Stem Cells in USA
and
Regenerative Sciences, Inc. Attempts to Avoid FDA Action
Fortunately, I received autologous Mesenchymal Stem Cell (MSC) treatment from the Centeno-Schutz Clinic. Unfortunately, further treatment has been compromised, at least for now, due to FDA. In this instance, the FDA is doing harm to real people.
Perhaps one can make a legalistic or bureaucratic argument that my MSC are drugs. But that simply confirms the deficiency of law and bureaucracy.
I am of the opinion that my MSC are unique to me and cannot be reasonably considered to be a drug so long as they are implanted in me. Of course, bureaucracies know nothing of reason, so here we are.
Obviously all medical procedures require scrutiny and some appropriate level of regulation. By its actions, the FDA demonstrates that it is not an appropriate regulatory body for autologous MSC therapies.
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